NCTId,BriefTitle,Eligibility_Criteria_Raw,Detailed_Description NCT04684836,Comparative Effectiveness of Telemedicine in Primary Care,"Inclusion Criteria: * patients that are attributed to primary care clinics across four health systems in the INSIGHT (Mount Sinai Health System and Weill Cornell Medicine), OneFlorida (University of Florida Health), and STAR (University of North Carolina Health) CRNs. * Patients received two or more outpatient visits at a participating practice during a one-year period before the COVID-19 pandemic, * Patients had one or more of five chronic illnesses (asthma, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), diabetes, hypertension) as defined by the Medicare Chronic Conditions Warehouse algorithm Exclusion Criteria: * Patients who tested COVID-positive * Patients from hospice and palliative care practices * Patients from osteopathic medicine practices * Patients from pediatric practices * Patients that did not reside in states where the four health systems were located: the New York-Tri State Area (Connecticut, New York, and New Jersey), Florida, and North Carolina. * Patients that moved out of state (or out of the New York-Tri State Area) or who died during the study period were also excluded. * Patients who were not continuously enrolled over the entire study period (2019-2021).","During the COVID-19 pandemic, telemedicine has quickly emerged as the primary method of providing outpatient care in many regions with shelter-in-place and social distancing policies. It is critical to understand the impact of this rapid and widespread transition from in-person to remote visits on disparities in access to primary care, especially in chronic disease where ongoing communication between providers and patients is essential. Also, these newly developed or expanded telemedicine programs vary widely, raising important questions about the effect of these differences on uptake of telemedicine among different patient populations and on patient-centered outcomes. Leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care. The overarching goals of this study are to describe the features of telemedicine programs in primary care during the COVID-19 pandemic and to use natural experiment methods to provide rigorous evidence on the effects of these programs. PCORI has granted an extension for the final research report to October 1, 2023." NCT01257464,Sitagliptin in Cystic Fibrosis-Related Diabetes,"Inclusion Criteria: * 19 years of age or older * Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy Exclusion Criteria: * Age under 19 years * Use of basal insulin therapy * Creatinine Clearance \< 50 mL/min * Active cystic fibrosis exacerbation * Pregnancy * Women of child-bearing age not using effective contraception * Current or prior use of DPPIV inhibitor","To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy." NCT05760456,Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.,"Inclusion Criteria: * 18 years or older at the time of enrollment in the study. * Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011). * Fasting blood glucose ≤ 10.0 mmol/L. * No previous treatment with metformin or other antidiabetic drugs. * Ability and willingness to provide written informed consent and comply with the protocol's requirements. * Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study. Exclusion Criteria: * The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents. * Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health. * Pregnancy or lactation. * Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis. * Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.",N/A NCT01099956,Low Grade Inflammation in Type 1 Diabetes Children,"Inclusion Criteria: Type 1 diabetes children group : * Children aged 2 to 17 years * Type 1 diabetes children Controlled group : * Children aged 2 to 17 years * Brother or sister of type 1 diabetes children Exclusion Criteria: * Per os or inhaled corticoid in the previous month of inclusion * Acute infectious disease in the previous week of inclusion * Other chronic disease than diabetes type1","The increase of type 1 diabetes incidence, particularly in young children leads to conduce new diagnostic and therapeutic strategies, notably for associated chronic morbidity.Measurement of chronic inflammation, with modification of the balance between pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients with high risk to diabetes chronic morbidity. After parental consent, blood sampling will be carried out by micromethod for cytokine (500 µl) and CRPhs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). Urine will be collected (50 ml) in the morning for further researches." NCT00256633,Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal,"Inclusion Criteria: Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents. Exclusion Criteria: Patients not registered in the VADT.","Primary Hypothesis: Secondary Hypotheses: Primary Outcomes: Major cardiovascular events Study Abstract: TITLE: CSP 465-C, Fatty Acid Binding protein 2 (FABP2) ancillary proposal to CSP# 465 Glycemic Control and Complications in Diabetes Mellitus Type 2. Angeliki Georgopoulos, M.D. Carlos Abraira M.D. William Duckworth M.D. Fatty acid binding protein 2 (FABP2) is involved in the transport of long chain fatty acids across the intestinal epithelium. A common (40-45%) polymorphism of FABP2 gene (codon 54 Threonine for Alanine) results in increased intestinal fatty acid absorption and triglyceride secretion (Baier et al J Clin Invest 95:1281-87, 1995; Baier et al J Biol Chem 271: 10892-10896,1996). We have found (JCEM 85:3155-60, 2000) that in patients with type 2 diabetes, the codon 54 polymorphism of the FABP2 results in fasting and postprandial hypertriglyceridemia. Since hypertriglyceridemia is a risk factor for atherosclerosis in type 2 diabetes and it is part of the insulin resistance syndrome, the objective of this ancillary study would be to screen the participants of the CSP# 465 study for the polymorphism and assess a) whether those carrying the polymorphism respond differently to the various treatment modalities and b) whether they develop more cardiovascular events compared to the ones lacking the polymorphism. There is one study that suggests an association of the polymorphism with a history of parental stroke (JCEM 85:2801-4, 2000). The only additional request from the study participants will be to agree to the collection of a blood sample to be used for DNA isolation and screening for the polymorphism. No additional funds are requested. If this polymorphism proves to be a predictor of either the response to a specific treatment modality or of the risk to macro-vascular complications, it will be very easy to screen for it and target our treatment modalities appropriately. The data was not analyzed therefore there will be no results for this record/study." NCT00596947,Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant,"Inclusion Criteria: * First time kidney transplant recipients who receives a kidney from a cadaveric, living related or living unrelated donor * Age greater than 18 years and less than 75 years * Caucasian recipients * Patients with current low panel reactive antibody (PRA) levels (\<10%) * Patients with signed and dated informed consent * Women of childbearing potential must have a negative pregnancy test at baseline and agree to use a medically acceptable method of contraception throughout the treatment period. Exclusion Criteria: * Other than Caucasian ethnicity * Patients with HIV+ or * Patients with HbsAg+ or Hepatitis C positive * Patients with a history of malignancy in the past 5 years * Patients with active systemic or localized major infection * Patients with a history of chronic steroid use for other diseases","Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients." NCT01593371,Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients,"Inclusion Criteria: * Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes Exclusion Criteria: * previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions * intake of glucocorticoids in the past one year * major illnesses of heart, lung, kidney, and liver.",N/A NCT00797771,User Satisfaction Using the ADI Insulin Pump,"Inclusion Criteria: * Male/female age 18 years and up. * Subject is diagnosed as Type 1 Diabetes. * Pump Users for at least 6 months * HbA1c: less than 8.5% * Capable of reading pump screens in English. * Subject understands the study procedure. * Subject is willing to sign the informed consent form and comply with the study requirements. Exclusion Criteria: * Major physical, motor, mental, behavioral, or psychiatric limitations. * Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months. * Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump. * Concurrent additional major illness. * Subject objects to the study protocol. * Physician objection * Concurrent participation in other study.",N/A NCT07416344,A Coronary Computed Tomography Angiography-guided Intervention for High Risk Cardiovascular Disease Population in Rural China,"Inclusion Criteria: Inclusion criteria of study villages: 1. Administrative villages 2. The village has no plans to merge with other villages within 3 years 3. The village is at least 2 kilometers away from other participating villages 4. The village has a sufficient number of study participants 5. The village is able to cooperate with the implementation of the study Inclusion criteria of study participants: 1. Men or women aged between 40 and 75 years 2. Live stably in the province where the study is conducted and no intention to migrate within next 3 years 3. Not participating in other clinical trials 4. Meet any of the following: (1)Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 4.9 mmol/L or Total Cholesterol (TC) ≥ 7.2 mmol/L (2)Diabetes mellitus (3)Chronic Kidney Disease (CKD) Stage 3-4: estimated Glomerular Filtration Rate (eGFR) 15-59 mL/min/1.73m\^2 (4)With a history of hypertension and 3 risk factors, combined with LDL-C ≥ 1.8 mmol/L or TC ≥ 3.1 mmol/L \[Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old\] (5)With a history of hypertension and 2 risk factors, combined with LDL-C ≥ 2.6 mmol/L or TC ≥ 4.1 mmol/L \[Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old\] 5. Sign the informed consent Exclusion Criteria: 1. Unwillingness or inability to undergo coronary CTA examination (e.g., previous history of severe contrast allergy, claustrophobia, or inability to cooperate with scanning and breath-holding for physical reasons in study participants) 2. Typical angina symptoms, known coronary artery disease, or other major atherosclerotic cardiovascular disease 3. Known cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction, etc. ) 4. Prior invasive or non-invasive coronary angiography within the last 5 years 5. Known familial hypercholesterolemia or other inherited disorders of lipid metabolism requiring lipid-lowering therapy 6. Presence of active bleeding or diseases with a very high risk of bleeding (e.g., active peptic ulcer disease, gastrointestinal pathologies with increased risk of bleeding, hematologic disorders with increased risk of bleeding, etc.) 7. End-stage diseases such as cirrhosis decompensation, with life expectancy \<3 years 8. Have a malignant tumor 9. Intolerance of all statins 10. Lipid-lowering treatment for \>2 years 11. Pregnant or breastfeeding, planning to become pregnant within the next 3 years 12. eGFR \<30 mL/min/1.73m\^2 13. Platelet count \<100×10\^9/L 14. Poor compliance, unable to cooperate with study investigators 15. Investigators consider unsuitable for participants selected for this study","The CARDIAC trial aims to determine the effectiveness of a coronary CTA-guided intensive intervention strategy, as compared with standard care, on improving clinical outcomes among population at high risk for cardiovascular disease in rural China. This cluster randomized trial will be conducted in 428 rural villages in China. The study will recruit 35 individuals at high risk for cardiovascular disease from each village for a total of 14,980 participants. The participating villages will be randomly assigned to experimental group (CTA-guided group) and control group (standard care group) with 1:1 allocation. Study participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is major adverse cardiovascular events (MACE, a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke) at 18 months. In addition, an extended observational follow-up will be conducted at 36 months, to evaluate long-term outcomes (i.e., MACE)." NCT05781334,Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease,"Inclusion Criteria: 1\. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record: 1. HF (any ejection fraction) 2. CKD with estimated GFR ≥ 20 mL/min/1.73m2 \* 3. T2DM (by clinical history or hemoglobin A1c) Exclusion Criteria: 1. End-stage stage renal disease on dialysis or eGFR \<20 mL/kg/1.73m2. 2. Pre-menopausal woman who are either breast-feeding or pregnant 3. History of heart transplant or actively listed for heart transplant 4. Implanted left ventricular assist device or implant anticipated within 3 months. 5. Enrolled in or planning to enroll in hospice care. 6. Active cancer (except localized prostate, breast, or non-melanoma skin cancers)",N/A NCT00120328,"To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy","Inclusion Criteria: * Male or female patients between 21 and 80 years of age, inclusive * Patients with type 2 diabetes mellitus diagnosed for at least 3 years and receiving oral anti-diabetic treatment and/or insulin * Female patients will either be: * Post menopausal for \>= 2 years; * Surgically sterile; * Or, if sexually active and of childbearing potential, using double contraception, with at least one method being barrier contraception. Women of childbearing potential (defined as those who are not surgically sterile, have not had a hysterectomy or are not 2 years' post-menopausal) must have a negative pregnancy test at screening and at randomisation. Pregnancy tests will be repeated monthly during the study * Proteinuria defined as ACR \>= 35mg/mmol * Male patients with serum creatinine between 1.3 and 3.0 mg/dL * Female patients with serum creatinine between 1.2 and 3.0 mg/dL * On standard treatment for diabetic nephropathy (such as ACE inhibitors, ARBs or the combination thereof) for at least 6 months before screening. Patients who are intolerant to ACE inhibitors or ARBs will be allowed to enter the study * Able to provide written informed consent prior to study participation Exclusion Criteria: * Patients with type 1 diabetes mellitus * Patients with proteinuria of non-diabetic origin * Patients with a renal transplant * Patients who have undergone nephrectomy * Patients with an estimated GFR \<= 15 mL/min * Patients with blood pressure \>= 160/100 mmHg with or without antihypertensive medication * Patients with glycosylated haemoglobin (HbA1c) \> 12% * Patients with normal sinus rhythm who do not have a pacemaker, are not taking antiarrhythmic drugs and do not have complete bundle branch block, but who have absolute QT or QTc \>500 msec * Patients with recent (60 days) percutaneous transluminal coronary angioplasty (PTCA), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or any other major surgical intervention * Patients with recent (60 days) acute myocardial infarction, unstable angina, stroke or transient ischaemic attack * Patients with CHF New York Heart Association grade III or IV * Patients with life-threatening arrhythmias including those at high risk for QT/QTc prolongation such as a family history of Long QT Syndrome, severe hypokalaemia, etc. * Patients who are positive for hepatitis B surface antigen or hepatitis C antibody at Visit 1 (screening) and who have abnormal liver function (specifically ALAT/ASAT \>1 x ULN) * Patients who have been treated with an endothelin receptor antagonist in the 3 months prior to screening * Patients being treated with spironolactone or eplerenone at entry into the study * Pregnant or lactating women * Patients with a neoplasm who are deemed to live \< 12 months * Patients with history of alcohol and/or drug abuse * Patients with a known history of a major psychiatric condition that would interfere with the conduct of the trial * Patients with active endocarditis and/or pericarditis * Patients allergic to avosentan or any other endothelin receptor antagonist * Patients who participated in another clinical study or who have donated blood within 60 days of being randomised to this study.","Diabetic nephropathy has become the leading cause of end stage renal disease (ESRD) in the western world, accounting for approximately 40% of new cases in the US, and up to 20 to 30% in Europe. Current treatments for diabetic nephropathy usually try to deal with the underlying diabetes or they aim to reduce cardiovascular risk factors such as hypertension, hyperglycemia, smoking and dyslipidemia. A few recently approved drugs such as irbesartan and losartan (for type 2 diabetic nephropathy) have a renoprotective activity beyond their antihypertensive effect. However, morbidity and mortality rates remain high. Avosentan may have a positive effect on reducing the amount of protein lost in the urine and if this is the case it will help treat patients with diabetic nephropathy." NCT04135365,Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study,"Inclusion Criteria: * Pediatric T1D sample: Children will be eligible if they meet the following inclusion/exclusion criteria: 1. are between 6 -11 years of age 2. have no history of afebrile seizure (not related to hypoglycemia) or sleep disorders other than insufficient sleep or insomnia 3. no contraindications to high quality MRI of the brain (no metal implants or braces) 4. no premature birth (\<34 weeks) or low birth weight (\<2,000g). Comparison sample: Children will be eligible if they meet the following inclusion/exclusion criteria: 1. no known chronic medical conditions or intellectual disability 2. no known history of concussion or traumatic brain injury 3. no history of afebrile seizure; (4) no braces or metal implants (5) no premature birth (\<34 weeks) or low birth weight (\<2,000g). Parents or primary caregivers of all children will be eligible if they: 1. live with the child 2. read/speak English to allow use of validated parental questionnaires. The parent who is the primary caregiver of the child will be invited to participate. Exclusion Criteria: * N/A","The onset of type 1 diabetes (T1D) in childhood results in clinically significant deficits in neurocognitive functioning that manifest in adulthood. These deficits have implications for adaptive functioning and diabetes management. Studies of neurocognitive function and brain development in T1D suggest that factors such as age of onset, diabetic ketoacidosis (DKA) at time of onset, and exposure to chronic hyperglycemia or severe hypoglycemia may increase risk or severity of these deficits, but findings are mixed. The majority of previous studies were limited by the use of adult or older adolescent samples, cross-sectional designs or short duration of follow-up, lack of racial and ethnic diversity, and small sample sizes. Age-related changes in neurocognitive function and vascular complications associated with T1D in adults make isolating mechanisms more complex. The knowledge gaps are critical because individuals with T1D may live for decades with reduced neurocognitive function. Building on previous work, it is hypothesized that several risk and protective factors for neurocognitive deficits will be evident in youth with T1D. First, sleep is a critical and potentially modifiable risk or protective factor for youth. Prior work has shown that the majority of school-age children do not obtain sufficient sleep (67%), and that sleep disturbances are related to poor glycemic control and risk for DKA, both of which have been posited to increase risk for neurocognitive deficits. Second, caregiver distress (i.e., symptoms of anxiety and depression) is a significant risk factor for child wellbeing, as exposure to maternal depressive symptoms increases children's risk for cognitive deficits and abnormal white matter diffusivity. Third, improved glycemic control via use of continuous glucose monitors and hybrid closed-loop insulin delivery systems, are potential protective factors for youth with T1D, as these devices decrease glycemic variability and limit time spent in hypoglycemia and hyperglycemia. Thus, a prospective longitudinal cohort study of young children with T1D is needed to identify modifiable risk and protective factors for neurocognitive complications. If specific risk or protective factors for adverse or optimal neurocognitive outcomes are defined, treatment protocols could be developed to limit neurocognitive complications associated with T1D." NCT00969592,Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers,"Inclusion Criteria: * Overtly healthy males or females (Women: contraception, Pearl Index \<1%) * Between the ages of 18 and 65 years * Body Mass Index of \<= 27 kg/m² * Safety lab within reference range * Normal blood pressure and heart rate * Sufficient venous access * Written informed consent approved by the Ethical Review Board * HbA1c and fasting plasma glucose in the normal range Exclusion Criteria: * Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees * Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval * Known allergies to insulin or related compounds * Regular treatment with any drug, both over-the-counter or prescribed * an abnormality in the 12-lead ECG increasing the risk for participation * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Significant active neuropsychiatric disease * Regular use of drugs of abuse and or positive findings on urinary drug screening * Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen * Evidence of hepatitis B and/or positive hepatitis C antibody * Evidence of hepatitis B and/or positive hepatitis B surface antigen * Women with a positive pregnancy test or breastfeeding women * Blood donation more than 500 mL within the last 3 months",In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs. NCT01333592,Long-term Study of KAD-1229 in Type 2 Diabetes Patients,"Inclusion Criteria: * Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy * Age in the 20 years or over inclusive * HbA1c in the range of ≥ 6.5 to \< 9% Exclusion Criteria: * Type 1 diabetes mellitus * Patients with serious diabetic complications and other serious complications",N/A NCT02022111,INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study,"Inclusion Criteria: * Age ≥35 years * Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels) * PHQ-9 score≥10 * ≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used * Willingness to consent to randomization. Exclusion Criteria: * The patient reports a ""3"" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral * Any participant reporting a ""2"" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care. * Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI) * Diabetes secondary to uncommon causes (e.g., chronic pancreatitis) * Pregnancy or breastfeeding * Documented CVD event (MI, stroke) in past 12 months * End-stage renal disease awaiting transplant * Malignancy or life-threatening disease with death probable in 3 years * Alcohol or drug abuse * No fixed address or contact details.","It has been shown that targeting both depression and diabetes control has important synergistic benefits. Since diabetes patients in India tend to access specialists (government or private) for their diabetes and other health care needs, they at least have a point of contact with the health system which can be leveraged to also reduce depressive symptoms. The investigators aim to assess if interventions for depression can be integrated into routine diabetes care delivery with only modest modifications. The integrated multi-condition (depression and diabetes) intervention model merges experiences from TEAMCare and an ongoing trial of cardiovascular disease (CVD) risk reduction in India (CARRS Trial) and involves: 1. enhancing the role of care coordinators and training them in disease management; 2. integrating 'intelligent' technology; and 3. weekly physician oversight to review poorly-controlled cases and make responsive treatment adjustments. The investigators propose to take this model from research to practice using an implementation sciences approach. The investigators will first gather formative qualitative data and endeavor to make the intervention more patient-centered, develop locally-understandable educational materials, and identify ways to overcome stigma of mental health disorders and facilitate trustful therapeutic relationships between care coordinators and patients and their families. The investigators will then evaluate the effectiveness and cost-effectiveness of the intervention model in a randomized controlled trial." NCT03087032,Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD),"Inclusion Criteria: * Age: 18 - 75 years old. * BMI must be greater than 24 and less than 45 kg/m2 * Patients with type 2 diabetes who met the World Health Organization (who) diagnostic criteria (1999). * Newly diagnosed type 2 diabetic patients with HbA1c ≥ 9.0%；or patients with uncontrolled type 2 diabetes (HbA1c ≥ 7.5% ) who have received at least two types of oral hypoglycemic drugs (the dose of each drug needs to reach the second largest dose or more), or only insulin (excluding basal-bolus insulin therapy), or insulin with oral hypoglycemic drugs. * Signed informed consent. Exclusion Criteria: * History of pancreatic disease, * History of medullary thyroid carcinoma * Lipase level \> 3 times above normal, * Creatinine clearance ≤ 30 mL/min/1.73m2, * Evidence in the last 6 months of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty, congestive heart failure (New York Heart Association Functional Classification III-IV), or severe ischemic heart disease. * Preparation for pregnancy or having been in pregnancy * Researchers believe that there are any factors that affect assessing subjects' participation in trial. * Patients unable to cooperate in clinical trials","An increasing number of patients with type 2 diabetes are treated with insulin. Patients with diabetes receiving intensive insulin therapy with various combinations of basal and prandial insulin can be caught in a vicious but common cycle, whereby insulin requirements increase over time, and this in turn contributes to weight gain and hypoglycemia and further increases in insulin dosing. At this stage, clinicians observe a practical limit to the efficacy of insulin titration alone on glucose-lowering and often add or continue metformin to reduce insulin resistance. Injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as liraglutide, are a relatively new addition to our treatment armamentarium. These drugs improve glucose control and insulin sensitivity and contribute to weight loss. Treatment with basal insulin plus GLP-1RAs is well-established in diabetes guidelines and may be as effective as adding prandial insulin therapy. When GLP-1 RAs are started, a preemptive reduction in insulin dosage by 25% to 30% in patients with HbA1c \< 9% may reduce the risk for hypoglycemia. In overweight/obese patients with uncontrolled type 2 diabetes treated with more than three oral antidiabetic drugs (OADs) or high doses of premix insulin, Is basal-prandial insulin therapy the option treatment algorithm? Such an intensification strategy carries risk of increased hypoglycaemia and weight gain, both of which are associated with worse long-term outcomes. There have no randomized, controlled trials to evaluate the efficacy and safety of GLP-1 RAs vs insulin glargine added to prandial insulin in overweight/obese patients with uncontrolled type 2 diabetes. So, the current 24-week, prospective, open-label, randomized, multicenter, parallel group trial will be preformed to assess whether Liraglutide plus prandial insulin therapy was superior to glargine plus prandial insulin therapy in overweight/obese patients with uncontrolled type 2 diabetes." NCT02432287,Metformin in Longevity Study (MILES).,"Inclusion Criteria: 1. Men and women; 2. age \>60 years with IGT based on 75g OGTT (fasting plasma glucose \< 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl); 3. this definition of IGT will include individuals with combined impaired fasting glucose (IFG) and IGT. The investigators chose these inclusion criteria in order to study subjects who have evidence of impaired glucose regulation, but are not yet diabetic. Exclusion Criteria: 1. Serious chronic or acute illness: cancer, clinically significant congestive heart failure, COPD, inflammatory conditions, serum creatinine \> 1.4 mg/dl (female) or \> 1.5 mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke); history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use (\>7 drinks in 24 hrs). 2. Treatment with drugs known to influence glucose metabolism (other diabetes medications, systemic glucocorticoids, pharmacologic doses of niacin) 3. Hypersensitivity to metformin or any component of the formulation","Aging in humans is a well-established primary risk factor for many disabling diseases and conditions, among them diabetes, cardiovascular disease, Alzheimer's disease and cancer. In fact, the risk of death from these causes is dramatically accelerated (100-1000 fold) between the ages of 35 and 85 years. For this reason, there is a need for the development of new interventions to improve and maintain health into old age - to improve ""healthspan"". Several mechanisms have been shown to delay the aging process, resulting in improved healthspan in animal models, including mammals. These include caloric restriction, alteration in GH/IGF1 pathways, as well as use of several drugs such as resveratrol (SIRT1 activator) and rapamycin (mTOR inhibitor). At Einstein, the investigators have been working to discover pathways associated with exceptional longevity. The investigators propose the study of drugs already in common clinical use (and FDA approved) for a possible alternative purpose -healthy aging. The investigators goal is to identify additional mechanisms involved in aging, the delay of aging and the prevention of age-related diseases. In this proposal, the investigators explore the possibility of a commonly used drug, metformin, to reverse relevant aspects of the physiology and biology of aging. Metformin is an FDA approved drug in common use in the US since the 1990s. It is the first-line drug of choice for prevention and treatment of type 2 diabetes (T2DM). The effect of metformin on aging has been extensively studied, and has been associated with longevity in many rodent models. Metformin also extends the lifespan of nematodes, suggesting an evolutionarily conserved mechanism. A recent high impact study demonstrated that metformin reduces oxidative stress and inflammation and extends both lifespan and health span in a mouse model . If indeed metformin is an ""anti-aging"" drug, its administration should be associated with less age-related disease in general, rather than the decreased incidence of a single age-related disease. This notion led investigators to further study whether anti-aging effects can be demonstrated in the type 2 diabetes population. Notably, in the United Kingdom Prospective Diabetes Study (UKPDS) metformin, compared with other anti-diabetes drugs, demonstrated a decreased risk of cardiovascular disease. This has been suggested in other studies and meta-analyses and remains an active area of research. In addition, numerous epidemiologic studies have shown an association of metformin use with a decreased risk of cancer, as well as decreased cancer mortality. There is also evidence from studies performed both in-vitro and in-vivo of metformin's role in attenuating tumorigenesis. The mechanisms proposed relate to its effects on reducing insulin levels, improved insulin action, decreased IGF-1 signaling (central to mammalian longevity), as well as activation of AMP-kinase. In fact, metformin's potential protective effect against cancer has been gaining much attention, with over 100 ongoing studies registered on the Clinical Trials.gov website. To characterize pathways associated with increased lifespan and healthspan, the investigators plan to compile a repository of muscle and adipose biopsy samples obtained from young healthy subjects and older adults before and after treatment with potential anti-aging drugs. RNA-Seq analysis will be used to identify a unique biological ""fingerprint"" for aging in these tissues by comparing changes in gene expression in older adults post-drug therapy to the profiles of young healthy subjects. This overall approach is supported by a grant from the Glenn Foundation for the Study of the Biology of Human Aging. The investigators believe that if metformin changes the biology of aging in tissues to a younger profile, it supports the notion that this drug may have more widespread use - as an ""anti-aging"" drug." NCT01611987,The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis,"Inclusion Criteria: * be community dwelling individuals aged 19 -65 who have been diagnosed after 1994 with MS or CIS; * be able to speak and read English or French; * be capable of walking 100 meters without a walking aid (EDSS ≤ 5.5), even if they do use an aid for daily activities. Exclusion Criteria: * have an additional illness that restricts their function; and/or * had suffered at least one relapse during the past 30 days (as defined by Polman) as this may affect physical activity/exercise participation.","The proposal is for an assessor-blind, parallel-group, stratified, randomized controlled trial. Potential participants will be identified from the population of persons enrolled in 3 MS clinics in the Montreal area and in 3 clinics in Toronto. All persons who are known to be ambulatory and not to have co-morbidity preventing exercise engagement or capacity to consent will be informed of the study in writing and will be invited for an assessment to determine eligibility for entry into the trial. Those consenting will be randomly assigned to either the MSTEP program or the general exercise guideline program. The intervention period will be one year with follow-up to a second year. The investigators are targeting a sample size of 120 per group (total 240), which would be sufficient to detect RR of \> 1.5 with 80% power. Sample size estimated using pc-size software. The sample size takes into account that drop-outs will inflate the variance of outcomes as multiple imputation will be used to deal with missing data. The main analysis will be logistic regression to test the main hypothesis related to the superiority of the MSTEP program based on a greater proportion of people making a clinically relevant gain in exercise capacity at 1 year. A secondary outcome will be the differences in proportions at 2 years also using logistic regression. The analysis will be based on intention-to-treat and all persons will be analysed in the groups to which they were randomized. A secondary analysis will estimate the impact of exercise on the other relevant outcomes. For this approach, each outcome will be converted to a binary response variable based on published clinically meaningful changes and generalized estimating equations (GEE) will be used to test the rate of response in the MSTEP program to the rate of response in the general guideline approach. Multiple outcomes improves the efficiency of the study as the total number of data points is equivalent to the total n multiplied by the number of tests and reduced by the extent to which the outcomes are correlated. Highly correlated outcomes will make the effective sample size smaller than less strongly correlated outcomes. If there is a statistically significant effect of the intervention, then and only then, can the effects of the separate outcomes be interpreted as real. The results of the trial will be used to develop guidelines for exercise for MS. The investigators are in the process of copyrighting the name of the program (MSTEP). Upon publication of the findings, the description of content will be made available at no cost. If proven effective, a training guide for professionals and patients will be produced most likely taking advantage of the end-of-grant Knowledge Translation (KT) Supplement. Note: The investigators have been funded by the KT supplement to produce a general guide for people with MS, entitled: Getting on with Your Life with MS. The knowledge generated can be used by people with MS and health professional to promote exercise engagement." NCT06135987,Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU),"Inclusion Criteria: * Adult outpatient having signed informed consent * Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU) * Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface® * Patient can be followed over 12 weeks by the investigator, according to his/her practices * Patient able to participate in the study and complete a self-questionnaire without difficulty Exclusion Criteria: * Hemorrhagic wound * Cancerous wound * Fistulous wound revealing a deep abscess * Presence of dry necrosis partially or completely covering the wound bed * Infected wound * Osteitis * Critical or acute ischemia * Patient for whom a surgical procedure related to the treated wound is scheduled within 12 weeks following the inclusion visit * Patient with known sensitivity to one of the studied dressings components * Pregnant or breastfeeding patient * Patient under the protection of justice or under guardianship or deprived of liberty","This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose. The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745)." NCT04506216,Eating Disorders in Type 1 Insulin-dependent Diabetes Patients,"Inclusion Criteria: * Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump * Patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (Agir à Dom group). * Beneficiary of social security coverage. Exclusion Criteria: * Patient with type 2 diabetes or MODY diabetes * Patient wearing a pacemaker * Breastfeeding or pregnant woman * Deprived of liberty by judicial or administrative decision * Legal guardianship","The risk of developing an eating disorder is increased in type 1 diabetes patients and associated with a poor prognosis in terms of glycemic control, metabolic complications, degenerative complications, and mortality. Therefore the terminology diaboulimia has emerged to characterize an eating disorder specific to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of losing or controlling weight and that can contribute to a deterioration of the body composition. The purpose of this study is to determine the prevalence of eating disorders in an adult cohort with type 1 insulin-dependent diabetes." NCT01119404,Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis,"Inclusion Criteria: Group 1: Metabolic syndrome * 120 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III * MetS diagnosed in routine health examination and laboratory tests * Age: 30 to 65 years Group 2: Coronary heart disease (CHD) * 120 Finnish men with angiographically proven CHD * Age: 30 to 65 years Group 3: Control * 80 Finnish men * Exercising physically more than three times a week and more than 30 minutes per exercise on regular basis * Never been studied or treated because of cardiovascular disease * Age: 30 to 65 years","Accumulation of oxidized low-density lipoproteins (LDL) in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease. In this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control)." NCT00279084,NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels,"Inclusion Criteria: Type 2 diabetes. Age between 18 and 80 years, male or female. Cockcroft's clearance between 25 and 60 ml / min. Haemoglobin level superior to 100 g/L and strictly inferior to 130 g/L Exclusion Criteria: Malignancy Solid organ transplant Acute pathology in the two months before inclusion date Myocardial infarction, stroke, pulmonary embolism in the six months before inclusion date Contra-indication to martial treatment or EPO treatment Present inclusion in another clinical study Patient who cannot answer questions of SF36 questionnaire",N/A NCT06290349,Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control,"Inclusion Criteria: 1. Patients with type II diabetes mellitus aged 19 years or older 2. Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit 3. Patients with fasting plasma glucose≤270mg/dL at the screening visit 4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit 5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study Exclusion Criteria: 1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis 2. Patients with a medical history of New York Heart Association(NYHA) class III\~IV heart failure or with congestive heart failure, acute and unstable heart failure 3. Patients with severe infectious disease or severe traumatic systemic disorders 4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia 5. Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption",N/A NCT05904847,The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes,"Inclusion Criteria: * Volunteering to participate in the study * 40 years and older * Diagnosed with type 2 DM at least 1 year ago * Treated at the hospital where the study will be conducted * Using antidiabetic agents * No communication problem * Contactable by phone Exclusion Criteria: * Those who do not meet the inclusion criteria for the study * Participants who did not give consent at any stage of the study and left",N/A NCT04018430,Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation,"Inclusion Criteria: * apparently healthy subjects or subjects supposedly experiencing a metabolic disease (e.g. prediabetes) Subjects with asked for fasting blood glucose Exclusion Criteria: * current steroid use thyroid dysfunction (free-thyroxin levels \< 9 or \> 19 pmol/L, hsCRP \> 10 mg/L hospitalized","Medical laboratory assays for delineation of impaired glucose metabolism and overt diabetes mellitus, beyond measurement of (fasting) blood serum or plasma glucose levels, include extent of hemoglobin A1c glycation, concentration of fructosamines, insulin concentrations to calculate the homeostasis model assessment (HOMA) index and other clinically putative biomarkers of glucose homoeostasis. HbA1c levels form now part of routine elucidation of metabolic disorders and are used for therapy monitoring. Initially used to monitor glucose levels in follow-up care of diabetics it is considered as a track marker of ups and downs of blood glucose concentrations. Its behavior under the 2 h period of oral glucose tolerance tests (OGTT) is ill known - most clinicians believe the glycation extent will not change. Since the dynamics of glycation is temperature dependent,non-febrile patients under OGTT likely keep their glycation extent between time zero and 120 min after glucose charge constant but this has not been investigated and with the sensitive lab assays for HbA1c now in use we postulate a significant increase in glycation. The Patient Registry includes recruited children and adults sick from diabetes, overweight or metabolic syndrome as a whole. Three medical offices will address their patients to the VidyMed lab to perform the OGTT framed by lab assays on venous blood samples" NCT07195565,Association of Continuous Renal Replacement Therapy With Mortality and Length of Stay in Critically Burned Patients,"Inclusion Criteria: * Patients aged 18 years and older * Admitted to and treated in the Burn Intensive Care Unit Exclusion Criteria: * Patients with an ICU stay of less than 24 hours * Patients younger than 18 years * Patients with known chronic kidney disease or history of kidney transplantation * Patients admitted with toxic epidermal necrolysis (TEN) * Patients with estimated glomerular filtration rate (eGFR) ≤ 15 mL/min/1.73m² at admission","Severe burn injury is frequently complicated by acute kidney injury (AKI), which is associated with high morbidity and mortality in intensive care settings. Continuous renal replacement therapy (CRRT) is often required in this patient population; however, the prognostic factors influencing survival remain incompletely defined. In this retrospective study, we analyzed critically ill burn patients who required CRRT. The primary outcomes were the RIFLE classification at the time of CRRT initiation, the timing of therapy initiation, and patient survival. The secondary outcomes included the presence of comorbidities, the need for mechanical ventilation, inotropic support, and length of hospital stay in non-survivors. By systematically evaluating these clinical parameters, the study aims to clarify the prognostic impact of CRRT in burn patients and to contribute evidence for optimizing the management of acute kidney injury in this critically ill population." NCT00644267,Using a Telemedicine System to Promote Patient Care Among Underserved Individuals,"Inclusion Criteria: * uncontrolled hypertension * systolic blood pressure \> 140 * access to a telephone or internet Exclusion Criteria: * angina * cognitive defects, dementia * end stage renal disease * living in nursing or boarding homes * pregnant * unable to sign informed consent * unable to use a scale, sphygmomanometer, pedometer","Basic demographic information will be obtained for each subject. The subject's primary care physician's name, contact information, and specialty will be recorded. All patients will have an initial medical history, physical examination, electrocardiogram, blood studies, urinalysis, height, weight, and blood pressure measurement. Blood pressure measurements will be obtained in the left arm of seated participants after 5 minutes of quiet rest. A minimum of 3 BP readings will be taken. Systolic and diastolic BP will be recorded. Waist circumference will be measured to the nearest 1 cm at the level of the iliac crest while the subject is standing at minimal respiration. A fasting blood sample will be obtained to determine serum cholesterol, LDL, HDL, triglycerides, creatinine, and glucose levels. All participants will receive their values together with a brochure regarding life-style modification (weight loss, smoking cessation, increased physical activity etc as appropriate). The subjects will take a cardiovascular knowledge questionnaire and the CAHPS® Clinician \& Group Survey (CAHPS 2006). Control Patients. Management of the patient's medical condition will be done by the patient's primary care physician. No restriction will be placed on patient care or the number of office visits with their physician(s). If a subject does not have a primary care physician, we will arrange for the subject to be followed in a Temple based primary care practice. At the final visit at 6 months, the control patients will be given the opportunity to be followed by the telemedicine system. Computer Training: Patients randomized to the telemedicine group will be trained on use of a computer and the Internet and on how to access the Internet and web-site. Each patient will be instructed on the details of Telemedicine system on a demonstration terminal in the research center. At that time, the patient will be provided with login name and password to gain access to the secure telemedicine site. The patient will make data entries with coaching by the research team. An important feature of the Telemedicine system will be telephone-based data entry and communication. This will be added to the current Internet-based system using an Interactive Voice Recognition (IVR) system, which will enable information transmitted via telephone or Internet to be collected in the central database. Training on use of the IVR system (i.e., how to respond to prompts) will be incorporated into the patient training program for the Internet. The study patients randomized to the telemedicine group will be given a sphygmomanometer with memory, a scale if needed, and a pedometer to count their steps per day. The participants will receive instructions regarding proper use of these devices. Initially, the subjects will wear a pedometer for 7 consecutive days and record the total number of steps taken each day to obtain their baseline physical activity level. The participants will be given recommendations for a gradual progression toward 10,000 steps/day. Ten thousand steps per day are consistent with approximately 5 miles of walking per day. All participants will be given a logbook and encouraged to record their measurements at least once a week (i.e., blood pressure, weight, average number of steps) over the course of the study. Life style changes, increased exercise and weight loss, can make a significant impact on blood pressure; a weight loss of as little as 10 lbs can reduce blood pressure. Patients in the telemedicine group will also be provided with a toll-free number with which to access the IVR system (a separate toll-free number will be provided to Hispanic patients for a Spanish language IVR system). This system can be used as an alternate to the web-based data entry screens available to all patients in the Internet arm. Basically, the patient will dial the 800 number and a voice message will ask for the patient ID and password (character strings entered via telephone keypad or spoken in sequence). The numerical values for blood pressure, steps, weight, and cigarettes smoked can be entered via voice recognition or by the keypad. Voice messages from the patient will also be permitted. These will be spoken after a prompt, and will be designed to provide a short (i.e. 1 minute) voice transmission that will be stored as a voice file (WAV) to the telemedicine system database. Data entered via the IVR system will be inserted into the patient's personal health record stored in the Telemedicine database." NCT03344692,Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes,"Inclusion Criteria: * Men with type 2 diabetes diagnosed since ≥ 6 months * HbA1C \<9.0% * Men with primary hypercholesterolemia and/or mixed dyslipidemia * Aged 18-75 years (limits inclusive) * Patient could be treated for type 2 diabetes when diet and physical activity are not sufficient to restore glycemic control. The treatment must be stable 1 month before the inclusion and have to remain unchanged all along the study. The only authorized treatments are: * Metformin * And/or Sulphonylureas (SUs) * And/or Repaglinide * And/or DPP-4 inhibitors * And/or GLP1 receptor agonists: exenatide, liraglutide, dulaglutide * Fasting serum TG ≥ 150 mg/dl and \< 500 mg/dl * BMI: 20-45 kg/m2 * Use of statins or ezetimibe is allowed if treatment is stable for ≥ 1 month before the screening Exclusion Criteria: * Any secondary causes of hypercholesterolemia or of mixed dyslipidemia (nephrotic syndrome, hypothyroidism…) * impaired liver function (AST and/or ALT ≥ 3ULN) * impaired renal function (eGFR with CKD-EPI formula \< 30 ml/min) * Alcohol abuse (\> 2 standard alcoholic drink per day; 1 standard alcoholic drink is the equivalent of 10g of alcohol) * History of myocardial infarction, acute coronary syndrome, unstable angina pectoris, stroke, transient ischemic attack, or cardiac revascularization within the 6 months before the screening visit. * History of PCSK9 mAb use * Known sensitivity to monoclonal antibody therapeutics or to their excipients * Lipid lowering therapies (other than statins), including fibrates, omega-3 fatty acids, bile acid sequestrants, niacin. * Insulin-treated patients * History of bariatric surgery * Inflammatory bowel diseases and gastrointestinal malabsorption diseases * Uncontrolled hypothyroidism (TSH \> ULN and Free T4 \< ULN) or hyperthyroidism (TSH \< ULN) * Active cancer: progressive cancer or remission ≤ 3 years, except for basal or squamous cell carcinoma of the skin that has been successfully treated * Known history of positive test for HIV, hepatitis C or chronic hepatitis B * Corticosteroids therapy * Minors * Adults under guardianship or trusteeship","Recently, human monoclonal antibodies directed against PCSK9 have been shown to be effective in reducing LDL cholesterol. Besides the liver, little is known about the role of PCSK9 in the small intestine, a tissue where it is expressed at a high level. Preclinical studies in mice indicate that PCSK9 inhibition reduces post-prandial hyperlipemia. Here, the investigators will test the effect of PCSK9 inhibition with alirocumab, a PCSK9 mAb, on post-prandial hyperlipemia in 24 patients with type 2 diabetes. The investigators will perform a randomized, double-blind, placebo-controlled, cross-over trial with alirocumab 75 mg every two weeks. In the cross-over design, two periods of 10-weeks treatment (i.e. 5 injections) will be separated by a 10-week wash-out period to avoid carry-over effect. The primary endpoint will be the total area under the post-prandial triglycerides concentration-time curve from meal-time until 8h (AUC0-8h) after a standardized meal test. As secondary endpoints, the investigators will explore the effect of alirocumab on plasma lipids, markers of cholesterol absorption and synthesis, and glycemic parameters. This study will help to decipher the function of PCSK9 on intestinal lipoprotein metabolism in human and to determine whether alirocumab can reduce post-prandial hyperlipemia, which is an independent cardiovascular risk factor. From a patient perspective, this study will give some important clues for the management of cardiovascular disease." NCT04664036,"Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus","Inclusion Criteria: * Type 1 diabetes * Adult age * Informed consent given Exclusion Criteria: * Secondary liver disease * Excess alcohol usage * Pregnancy * Use of steatogenic medication * Active cancer or oncological treatment * History of organ transplantation","This study aims to characterize and follow a thoroughly characterized cohort of adult type 1 diabetes patients free from secondary liver disease due to excessive alcohol usage, viral hepatitis, alfa-1 antitrypsin deficiency, Wilson's disease or steatogenic or hepatotoxic drug use. The investigators will screen for NAFLD and fibrosis using multiple non-invasive techniques including * ultrasound * controlled attenuation parameter * fatty liver index * human steatosis index * transient elastography * FIB-4 * NAFLD fibrosis score * NASH algorithm based on multiple parameters Subjects will be screened for microvascular and microvascular complications with: * ECG * microfilament examination * 24hour urine collection for microalbuminuria * serum kidney test (creatinine, eGFR) * fundoscopy * peripheral arterial pulsation palpation The investigators will subsequently thoroughly characterize various metabolic and anthropometric parameters and document any microvascular or macrovascular complications. The patients will be annually rescreened for both NAFLD-related as cardiovascular variables. Therefore this study will assess the correlation between NAFLD, cardiovascular risk, and type 1 diabetes in a prospective manner." NCT00729144,Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial,"Inclusion Criteria: * Primary complaint of FI with liquid, solid stool, or mucous incontinence, occurring at least monthly for 3 consecutive months. These women are planning to have treatment for FI. * Women with prior treatment, including surgery for their FI, UI, and/or POP may be included if they now have a primary complaint of FI as defined above and are planning to have additional or new treatment for FI. Exclusion Criteria: * Diagnosis of interstitial cystitis, , bladder or colo-rectal malignancy or inflammatory bowel disease * Refusal or inability to provide written consent * Inability to complete telephone interviews conducted in English or Spanish * Prior pelvic irradiation * Incontinence only to flatus * Prior removal of any portion of the colon or rectum * Current or history of rectovaginal fistula(e) * Rectal prolapse * Neurologic disorders known to affect continence, including Multiple Sclerosis, Spinal Cord Injury, Debilitating Stroke, and Parkinson's Disease","It is common knowledge that women with pelvic floor dysfunction will develop, initiate and adopt behaviors which mitigate their symptoms or impairment. For some women, this involves wearing a pad and for others, knowledge of restroom locations. Little is known about the role of such behaviors in helping women adapt to urinary incontinence (UI), pelvic organ prolapse (POP), or fecal incontinence (FI). Additionally, there are no studies that address the persistence of these behaviors following treatment as measured by traditional outcomes. Results of a pilot study that assessed quality of life (QOL) in women with pelvic floor disorders (PFD) indicated that women relied heavily on behavioral adaptation in order to cope with PFD symptoms. Subsequently, a draft Adaptation Index was developed with input from investigators of the Pelvic Floor Disorders Network (PFDN). This measure was further refined by focus groups as part of the 1J06 protocol. The 1J06 study is investigating the properties of this tool in subjects with UI and POP. This study focuses on the validation of this instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI." NCT05104944,Defining Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management,"Inclusion Criteria: * Participants who are willing and have capacity to give informed consent * People with diabetes as diagnosed by the WHO criteria * Age 18 years or over * New or suspected diagnosis of acute CN (no previous incidence of acute CN within the last 6 months on the same foot) treated with off-loading * Understand written and verbal instructions in English Exclusion Criteria: * People who have received a transplant and others receiving immunosuppressant therapy or using long term oral glucocorticoids other than in the routine management of glucocorticoid deficiency. Participants on a low doses of oral glucocorticoids (\<10mgs for ≤7 days) are eligible to participate in the study. * Participation in another intervention study on active CN * Contra-indication for MRI * Treatment for previous suspected CN on the same foot in the last 6 months * Suspected or confirmed bilateral active CN at presentation * Active osteomyelitis at randomisation * Previous contralateral major amputation * Inability to have an MRI scan * Patients receiving palliative care","The aim of the study is to assess the feasibility of using serial magnetic resonance imaging (MRI) to reduce treatment times in Charcot in people with diabetes. Charcot is a devastating complication for people who develop it. There are over 4000 new cases of Charcot diagnosed every year. If the inflammation goes on for long enough it can cause fractures and dislocations within the foot, which left untreated can lead to foot deformity and complications such as ulcerations. A diagnosis of Charcot has been shown to reduce people's quality of life. People who have had this condition die on average 14years younger than the general population. Every year about 50-100 people who have been diagnosed with Charcot neuroarthropathy undergo an amputation of their leg. Charcot is treated by wearing a non-removable cast or boot. No-one knows how long this treatment should last, some recommend 6 months, others more than a year. Early treatment has been shown to lead to fewer complications. There is some information from small studies that repeated assessment with MRI may prove useful in helping clinicians decide when to stop treatment, and it may decrease treatment times. This study will be a feasibility study involving 60 people. Patients will be recruited from hospital run Diabetic Foot Clinics. Patients will be randomised to either receive MRI at baseline 3,6,9 and 12 months or to receive current usual care; repeated foot temperature measurements and x-rays. If the study results indicate the study is feasible to do, the information will be used to design a much larger study. Some patients will also be asked to participate in an interview at the end of the study, to gain insights into their experience of having Charcot and involvement in the study." NCT00175734,Interactive Studies of Endstage Diabetic Dialysis Patients,"Inclusion Criteria: * Diabetics and non-diabetics on hemodialysis * On erythropoietin and iron * On a statin Exclusion Criteria: * Uncontrolled blood pressure (BP) * Ulcers * Amputations * Unstable cardiac function * Malignancy * Planned operations","Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term. Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels. Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative." NCT04203563,Strong People Strength Training Study,"Inclusion Criteria: * Age 50 or older * Willing and able to get health care provider (HCP) authorization if required (PAR-Q answered yes to any question or 70 and older) Exclusion Criteria: * Strength trained in last 12 months * Previous enrollment in Strong People * Enrolled or planning to enroll in lifestyle program * Cognitive impairment * Unable to obtain physician authorization","This study aims to evaluate the effects of a twice weekly, 12-week progressive strength training program, Strong People Strength Training, on cardiometabolic risk factors in a pragmatic, community-based randomized intervention trial among rural men and women 50 and older. We hypothesize that individuals randomized to the intervention group will demonstrate statistically significant and clinically meaningful improvements in cardiometabolic risk factors as well as physical function, quality of life, and physical activity compared to those randomized to the delayed intervention control group." NCT05367063,Canagliflozin and Myocardial Fibrosis,"Inclusion Criteria: * History of type 2 diabetes; * Haemoglobin A1c ≥7.0% and \< 10.5%; * Patients who have received a stable dose of metformin or metformin combined with insulin secretagogues and/or insulin therapy for 4 weeks before enrollment; * Those who met at leat one of the following criteria: 1. Patients with at least 3 of the folllowing risk factors: (1) male \>55 years old, or female \> 65 years old; (2) BMI≥25 kg/m2; (3) hypertension; (4) dyslipidemia; (5) current smoker (Brinkman index ≥ 200; 2. Any of the following signs of target organ damage are present: (1) albuminuria (ACR≥300mg/g); (2) 45 ml/min/1.73 m2 ≤eGFR\<90 ml/ min/1.73 m2; (3) Left ventricular hypertrophy or coupled with retinopathy. Exclusion Criteria: * Female subjects who are pregnant, lactating or of child bearing potential, or pre-menopausal women. (Menopause will be determined by patient and physician history; * Subjects currently treated with SGLT2 inhibitors, GLP1 receptor agonist, or sitagliptin; * Significant allergy or known intolerance to Canagliflozin or Sitagliptin; * History of hypovolemia, amputation, peripheral vascular disease, diabetic foot ulcers; * History of diagnosed cardiovascular diseases, including myocardial infarction, hospitalization for unstable angina pectoris, cerebral infarction (ischemic stroke), coronary artery bypass grafting, percutaneous coronary intervention (with or without stents) Implantation), peripheral vascular reconstruction (angioplasty or surgery), heart failure, arrhythmia, heart valve disease; * AST or ALT ≥ 3 times the upper limit of normal; * eGFR \<45 ml/min/1.73 m2； * type 1 diabetes; * Diabetic ketosis or diabetic hyperosmolar coma; * History of respiratory disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension, etc.); * Existing hypertensive emergency (systolic/diastolic blood pressure exceeding 180/120mmHg) at the time of enrollment, or evaluated For refractory hypertension (after the use of sufficient doses of 3 antihypertensive drugs, the systolic blood pressure is still\> 140 or Diastolic blood pressure\> 90mmHg); * Known impaired gastrointestinal function or gastrointestinal diseases that may significantly affect the absorption of the test drug, such as: diagnosed active ulcers (Forrest grade II and below), inflammatory bowel disease, malabsorption related diseases, and non-absorbent diseases. Controlled diarrhea, gastrointestinal surgery (such as bariatric surgery); * Patients with diagnosed malignant tumors; * Participate in other clinical trials within 3 months; * Other creteria that were not eligible to participate in the clinical trial.","According to the International Federation for Diabetes, diabetes now affects approximately 9.3% of the population worldwide, and the prevalence over the next two decades will continue to increase, reaching 552 million by 2030. In particular, type 2 diabetes (T2D) can cause macrovascular and microvascular complications, for example, T2D can increase the risks of ischemic stroke by 72% and stable angina by 62%. In addition, the incidence of heart failure in T2D patients is 9-22%, 2-4 times that of the general population. A significant breakthrough in contemporary cardiology was the finding that sodium-glucose-cotransporter-2 (SGLT2) inhibitors are associated with a lower risk of heart failure (HF) Hospitalization in patients with or at high risk of CV disease. In the EMPAREG OUTCOME Trial, Empagliflozin reduced cardiovascular death and hospitalisation for heart failure (HF) by 38% and 35%, respectively, with an almost immediate beneficial effect despite only a modest difference in glycaemic control, comparing two study arms over 94 weeks. The reductions in CV death were not accounted for by the reductions in atherothrombotic outcomes, as the rates of myocardial infarction and stroke remained unchanged with therapy. The proposed theory that HF is the outcome most sensitive to SGLT2 inhibition was confirmed in the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program and Dapagliflozin DECLARE-TIMI 58 trials. More recently, the EMPEROR trial showed that SGLT2 inhibition reduces the risk of hospitalisation for HF in patients regardless of the presence or absence of diabetes. The mechanisms by which SGLT2 inhibitors cause the reduction in HF risks and cardiovascular mortality are yet unknown. Myocardial fibrosis is not only an important physiopathological mechanism of heart failure, but also has been shown to be closely associated with the risk of heart failure-related hospitalization and death, especially in patients with T2D. However, whether SGLT2i can exert cardioprotective effects by improving myocardial fibrosis remains to be further investigated. In recent years, the development of cardiac magnetic resonance (CMR) technology enables to detect focal and diffuse fibrosis in myocardial tissue, which makes it possible to systematically explore the role of SGLT2i on myocardial fibrosis. At present, relevant studies have explored the effects of SGLT2i on cardiac structure and function. For example, there have been several related studies on left ventricular structure and function, but no consistent conclusions have been drawn: for example, the EMPA-HEART study showed that empagliflozin can reduce left ventricular mass; DAPA-HEART The LVH and SUGAR-DM-HF studies clarified the effect of dapagliflozin in reducing left ventricular mass and end-systolic volume; the REFORM study did not find that dapagliflozin had any effect on left ventricular weight. plastic effect. In addition, only the EMPA-HEART study investigated the effect of SGLT2i on both focal and diffuse fibrosis, and found that empagliflozin significantly improved diffuse fibrosis in people with diabetes and coronary heart disease. However, the SUGAR-DM-HF study did not observe changes in diffuse fibrosis with empagliflozin intervention in people with diabetes or prediabetes with reduced ejection fraction. At present, whether SGLT2i treatment can change the relevant indicators of myocardial fibrosis in people with diabetes and cardiovascular risk factors has not yet been reported. In addition, previous studies mainly focus on empagliflozin and dapagliflozin, and studies on canagliflozin are still very scarce. Therefore, this study intends to explore the effects of canagliflozin on myocardial fibrosis and other structures and functions of the heart in patients with type 2 diabetes mellitus and high cardiovascular risk factors." NCT04927416,The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer,"* INCLUSION CRITERIA: Data prospectively collected from the 28 subjects enrolled under this protocol, and data from 26 subjects collected under 77-DK-0096 and/or 00-CH-0093 will be analyzed. Among the 26 subjects prospectively evaluated under 77-DK-0096 protocol, 21 out of 26 had research 68Ga-DOTATATE PET/CT performed under the DOTATATE sub-study of 77-DK-0096, and 5 out of 26 had 68Ga-DOTATATE PET/CT done under 00-CH-0093. Again, the inclusion of the above data was per the IRB s request to transition the sub-study into a new standalone protocol. This will give us a total of 54 subjects for the final analyses, with at least 18 subjects from each group (e.g., HTC, DTC, and MTC), which is required to meet the primary objectives of this study with sufficient power of 80% and type 1 error alpha of \< 0.05. Patients with HTC, DTC, and MTC will be identified by the investigators. The potential candidates for the study will be screened for eligibility to participate in the study and invited to sign the Research 68Ga-DOTATATE PET/CT imaging informed consent form. The same inclusion/exclusion criteria were applied to the subjects who underwent imaging with the 68GADOTATATE PET/CT, either under the 77-DK-0096 sub-study or as clinically-indicated imaging under 00-CH-0093. In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria: * Male or female, aged \>18 years. * Patients with established thyroid cancer diagnosis presenting with either: * Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS) OR --Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 1.1 criteria after therapy with RAI. In order to be eligible to participate in this study, an individual with MTC must meet all of the following criteria: * Male or female, aged \>18 years. * Patients with locally advanced or metastatic MTC or patients suspected of locally advanced or metastatic MTC with calcitonin level \> 500 pg/mL. EXCLUSION CRITERIA: Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study: * Pregnancy or lactation by self-report. * Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma; * Patients unable to give informed consent.","Study Description: The study is designed to identify the patients with metastatic radioactive iodine (RAI) non-avid or non-responsive thyroid cancer, whose tumors are characterized by the high expression of somatostatin receptors type 2 (SSTR2) by imaging with 68Gallium(68Ga)-DOTATATE Positron Emission Tomography/Computed Tomography (PET/CT). Participants will undergo a one-time experimental imaging with 68Ga-DOTATATE PET/CT. This imaging will enable identification of patients with high maximum standard uptake value (SUVmax) of 68Ga-DOTATATE defined as SUVmax of \>15, as this SUVmax threshold has been associated with a good response to peptide receptor radionuclide therapy (PRRT) in pre-clinical and clinical models of SSTR2-positive tumors. PRRT will not be offered in this trial. Objectives: Primary Objective: To compare the prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CT between three groups: * Group HTC--the molecularly and histologically unique subtype of differentiated thyroid cancer (DTC) - Hurthle cell thyroid cancer (HTC), * Group DTC--patients with remaining histological types of DTC, * Group MTC--patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC). Secondary Objectives: 1. To analyze the association between the 68Ga-DOTATATE uptake and molecular signature of thyroid cancer and tumor volume, 2. to create a repository of data for future research in thyroid cancer. Endpoints: Primary Endpoint: Prevalence of thyroid cancer patients characterized by a high SSTR2 expression in at least one metastatic lesions per patient documented by SUVmax of 68Ga-DOTATATEPET/CT of above 15 among patients with metastatic HTC, DTC and MTC. Secondary Endpoints: Associations between 68Ga-DOTATATE uptake as measured by SUVmax in up to 10 lesions per organ per patient and: 1. Somatic mutation status in primary tumors divided into BRAF-like, RAS-like, harboring mitochondrial DNA mutations and /or RET protooncogene mutation, 2. Tumor volume measured in cm3 per the ellipsoid formula p/6 length\*width\*depth." NCT06495814,Characterization and Mechanism Research of the Pre-disease State of Obese Type 2 Diabetes Mellitus,"Inclusion Criteria: Inclusion criteria for obese IGT population: * Age range from 18 to 65 years old, including both ends; * Meet the waist circumference cut-off point for central obesity diagnosis specified in the ""Guidelines for Primary Diagnosis and Treatment of Obesity (2019)""; * Meet the IGT diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition); * Voluntarily participate in this study and sign an informed consent form. Inclusion criteria for newly diagnosed obese T2DM population: ① Age range from 18 to 65 years old, including both ends; ② Meet the waist circumference cut-off point for central obesity diagnosis specified in the ""Guidelines for Primary Diagnosis and Treatment of Obesity (2019)""; ③ Conform to the T2DM diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition), and the course of disease is less than 3 months; * Voluntarily participate in this study and sign an informed consent form. Inclusion criteria for healthy individuals: * Age range from 18 to 65 years old, including both ends; * Meets the diagnostic criteria for healthy individuals set by WHO; * Voluntarily sign an informed consent form. Inclusion criteria for IGT for high and low-risk obesity: * Age range from 18 to 65 years old, including both ends; * Meet the waist circumference cut-off point for central obesity diagnosis specified in the ""Guidelines for Primary Diagnosis and Treatment of Obesity (2019)""; * Meet the IGT diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition); * After screening the risk prediction model constructed in this study, it belongs to the high-risk and low-risk populations with abnormal glucose tolerance; * Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: Exclusion criteria for obese IGT patients: * The population who have been continuously using hypoglycemic drugs within the past three months; * Type 1 diabetes and type 2 diabetes (T2DM), pregnancy diabetes, secondary diabetes and other special types of diabetes; * Hyperthyroidism or hypothyroidism caused by endocrine disorders, with poor disease control; * Difficult to control hypertension/hypotension: systolic blood pressure ≥ 200mmHg or diastolic blood pressure ≥ 110mmHg; Or systolic blood pressure ≤ 90mmHg or diastolic blood pressure ≤ 60mmHg; * When screening, patients with various acute infections, or those accompanied by severe infections, severe anemia, or neutropenia; * Accompanied by other major diseases, such as active or untreated malignant tumors, or clinical remission of malignant tumors for less than 5 years; * Organic heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, with NYHA heart function grading\>Grade III; ⑧ The patient has suffered from any of the following diseases within the past 6 months: coronary intervention (such as CABG or PTCA), stroke (including ischemic and hemorrhagic stroke); ⑨ Severe liver and kidney dysfunction (ALT greater than 3 times the upper normal limit, creatinine greater than 132 μ mol/l); ⑩ Fasting TG\>5.6mmol/L; ⑪ Pregnant and lactating women, as well as women of childbearing age who have not taken effective contraceptive measures; ⑫ Participating in any other clinical trials/researchers; ⑬ Patients with a history of alcoholism or long-term drug abuse; ⑭ Individuals with a history of mental illness are unable to cooperate with the researchers; ⑮ For any other reason, the researcher considers it unsuitable to participate in this study. Exclusion criteria for newly diagnosed obese T2DM patients: * Type 1 diabetes, gestational diabetes, secondary diabetes and other special types of diabetes; * The population who have been continuously using hypoglycemic drugs within the past three months; * Patients with complications of diabetes; * Hyperthyroidism or hypothyroidism caused by endocrine disorders, with poor disease control; * Difficult to control hypertension/hypotension: systolic blood pressure ≥ 200mmHg or diastolic blood pressure ≥ 110mmHg; Or systolic blood pressure ≤ 90mmHg or diastolic blood pressure ≤ 60mmHg; * When screening, patients with various acute infections, or those accompanied by severe infections, severe anemia, or neutropenia; * Accompanied by other major diseases, such as active or untreated malignant tumors, or clinical remission of malignant tumors for less than 5 years; ⑦ Organic heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, with NYHA heart function grading\>Grade III; ⑧ The patient has suffered from any of the following diseases within the past 6 months: coronary intervention (such as CABG or PTCA), stroke (including ischemic and hemorrhagic stroke); ⑨ Severe liver and kidney dysfunction (ALT greater than 3 times the upper normal limit, creatinine greater than 132 μ mol/l); ⑩ Fasting TG\>5.6mmol/L; * Pregnant and lactating women, as well as women of childbearing age who have not taken effective contraceptive measures; * Patients with a history of alcoholism or long-term drug abuse; * Individuals with a history of mental illness are unable to cooperate with the researchers; * Participating in any other clinical trials/researchers; ⑮ For any other reason, the researcher considers it unsuitable to participate in this study. Exclusion criteria for healthy individuals: * Any history of chronic diseases of various systems that have been previously diagnosed, such as obesity, endocrine and metabolic diseases, hematopoietic system diseases, respiratory system diseases, cardiovascular system diseases, malignant tumors, liver and kidney dysfunction, etc; * When screening, patients with various acute infections, or those accompanied by severe infections, severe anemia, or neutropenia; * Patients with a history of alcoholism or long-term drug abuse; * Pregnant or lactating women; * Individuals with a history of mental illness who cannot cooperate with the research process;",N/A NCT03746093,Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes,"Inclusion Criteria: * Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria; * Ages 40-80 years; * Non-smoker; * Willing and able to provide written informed consent. Exclusion Criteria: * Changes in oral glycaemic-control medications in the last 3 months; * Subjects with HbA1c levels under 6.4% or above 10%; * Subjects under insulinotherapy; * Subjects with triglycerides levels above 4.52 nmol/L(400 mg/dL); * Intake of antibiotics in the last 12 weeks; * Subjects not willing to avoid drinking beer during the study; * Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS; * Pregnant women or women planning to become pregnant during the study.","This is a parallel, controlled randomized trial. The study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes. All patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist." NCT03358121,Glucose-dependent Asprosin Dynamics,"Inclusion criteria for participants without hypoglycemia unawareness * Age between 18 and 75 years * BMI between 20 und 35 kg per m2 * Persons with manifest diabetes mellitus type 1 and diagnosis according to according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice. Inclusion criteria for participants without hypoglycemia unawareness * Persons who are not aware of hypoglycemia symptoms at glucose levels above 50 mg per dl * Age between 18 and 75 years * BMI between 20 und 35 kg per m2 * Persons with manifest diabetes mellitus type 1 and diagnosis according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice. General exclusion criteria Secondary types of diabetes (ADA criteria type 3 B to H) * Current pregnancy * Acute infections or fever Immune-suppressant therapy * Severe psychiatric diseases requiring treatment (for example personality disorders, schizophrenia, depression) * Known alcohol or drug dependency * Severe heart, kidney, or liver insufficiency NYHA stadium IV * Non-diabetic liver disease (for example PBC, PSC, Wilson's disease, hemochromatosis, autoimmune hepatitis) * severe peripheral artery disease (stadium IV) * non-diabetic glomerulopathy * Cancer or other malignant diseases within the last 5 years * Infectious diseases like hepatitis B, C, E, or HIV * Other severe autoimmune diseases * Current participation in an interventional study * Anemia or disorders of bone marrow Exclusion criteria for clamp study * Past history of deep vein thrombosis or pulmonary embolism * Routine laboratory test results less than 80 percent below lower reference value: Ferritin, iron, leucocytes, haemoglobin, hematocrit, RBC, platelets, blood alcohol levels. Exclusion criteria for bioimpedance * measurement Pacemaker or ICD * Exclusion criteria for lung function testing Ignoring or non-understanding of the instructions","The Pilot study entitled Asprosin Dynamics relating to serum Glucose levels under controlled alterations is designed to date the asprosin kinetics at various metabolic states relating to serum glucose and the correlation between asprosin and the known glucose regulating hormones. Asprosin is the C-terminal cleavage product of profibrilln. This new hormone is encoded by FBN1 Gen (Amino acid residues 2732 to 2871, molecular weight 30 kDa), which also encodes fibrillin. The hormone was initially discovered during the analysis of the genome of patients with the extremely rare Wiedemann Rautenstrauch syndrome. According to the data so far, asprosin is a fast induced protein hormone that acts on the liver through cell membrane receptors, where it activates the G protein cAMP PKA pathway, leading to a rapid release of glucose into the circulation and to compensatory insulin production. The above seems to match the constellation found in overweight type 2 diabetes patients or patients with metabolic syndrome (insulin resistance). Diabetic mice were able to normalize their glucose and insulin levels by asprosin-binding antibodies. According to a recent study, asprosin had no influence on the serum concentration of glucagon, epinephrine, norepinephrine and cortisol in mice. In humans it is known that asprosin increases during fasting. The liver related glucose release into the blood circulation is crucial for the brain function and overall survival during fasting. In addition, a compensatory rise in asprosin is expected during a hypoglycemic episode. In this pilot study, the asprosin concentration is measured both in participants with type 1 Diabetes mellitus, with or without hypoglycemia unawareness during a hypoglycemic phase. These relevant measurements are compared in the two subgroups, consisting of 5 persons each. By correlating asprosin values with other regulating hormones, there is hope to better understand the pathomechanism of hypoglycemia unawareness. Recently discovered is that the recombinant asprosin administration in mice allows both the blood glucose and the insulin to rise. It is therefore very likely that further studying of asprosin could provide new insights into the (patho) physiology of the intermediary metabolism disorder. According to the above, the following hypotheses arise: Asprosin dynamics relating to serum Glucose levels under controlled alteration: Asprosin, as fast induced protein hormone, increases serum levels in type 1 diabetics with or without diabetes late complications during a hypoglycemic phase. Asprosin increases serum levels more significantly in diabetics without hypoglycemia unawareness compared to diabetics with hypoglycemia unawareness. There is probably no correlation between asprosin and the previous known regulating hormones. In order to investigate these hypotheses, study participants will be initially profoundly examined in our Clinical Study Center regarding both their glycemic metabolical responses and the clinical findings relating to their possible micro- and macrovascular complications. In addition to this quality of life, well being, depression and neuropathic pain is going to be taken into account. This is to be the first study of its kind, in which plasma levels of asprosin is determined and Type 1 diabetics with and without hypoglycemia unawareness are thoroughly examined in order to identify possible differences and similarities for the better determination of the new hormone utilizing the framework of hyperinsulinemic Clamp Tests. The intention behind is to better understand the (patho) physiology of the hypoglycaemia unawareness, as well as to better characterize the physiological properties of asprosin" NCT04383314,Targeting Hyaluronan Accumulation Through Exercise in T2DM,"Inclusion Criteria: * Be between the ages of 40 and 75 * Clinical diagnosis of Type 2 diabetes * Have a BMI less than 40 kg/m2 (due to magnet bore restrictions) * Able to walk unassisted Exclusion Criteria: * Serious cardiac pathology or musculoskeletal problems that would limit exercise ability * Current open wound or history of plantar ulcer for the last 3 months * Partial foot amputations * Inability to ambulate without assistive device * Stroke or other central nervous system pathology * Stage 2 hypertension (resting blood pressure \>160 systolic or \>100 diastolic) * Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems). * Subjects with alcoholism, chronic drug use, chronic gastrointestinal disease, or renal or hepatic impairment * Pregnant women and children","This single-center, longitudinal design study uses MRI to evaluate the mechanistic effects of exercise on skeletal muscle function. Twenty-five T2DM patients will be enrolled and be prescribed a 10-week exercise program. The exercise program will comprise aerobic and resistance components; a moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention. MRI data will be acquired at baseline and before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function." NCT05575206,The Influence of Genetic Variations in ELAPOR1 or ELAPOR2 on Insulin Secretion and Glucose Regulation in Humans,"Inclusion Criteria: * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. * subjects with genetic variations in ELAPOR1 and ELAPOR2 Exclusion Criteria: * Women during pregnancy and lactation * Treatment with any medication effecting on glucose metabolism like anti-diabetic drugs or steroids * Any pancreatic disease * Known current presence or history of severe neurological or psychiatric diseases, schizophrenia, bipolar disorder","Type 2 diabetes mellitus is a heterogenic disorder with a complex pathogenesis. Although, loss of beta cell function is crucial for the manifestation of the disease. Genome-wide association studies identified more than 400 genetic variations associated with a reduced beta cell function. Interestingly, beta cells are not only responsible for the secretion of insulin, but are also insulin sensitive cells, whereby insulin secretion and proliferation is regulated. It is well known that an insulin and insulin-like growth factor (IGF-1) resistance lead to the manifestation of type 2 diabetes. Underlying mechanism are mostly unknown. Recently, a new receptor on the surface of beta-cells was identified which mediates the resistance of beta cells to insulin and IGF-1. This insulin inhibitory receptor (Inceptor) induces its inhibitory function via clathrin-mediated endocytosis of the INSR-IGF-1R complex. In mice, inceptor is encoded by lir and its knock-out leads to beta cell proliferation and an increased insulin secretion. In animal models, treatment with monoclonal antibodies against the extracellular domain of inceptor, leads to a significantly improved glucose regulation. Thus, pharmacological interventions on the inceptor could represent a novel therapeutic approach for the treatment of type 2 diabetes mellitus. In humans, inceptor is encoded by genes ELAPOR1 and ELAPOR2. So far, there are no studies in humans that investigate if functional mutations in these genes affect insulin secretion and glucose regulation. The aim of this study is to investigate, whether subjects with genetic variants in ELAPOR1 or ELAPOR2 have altered insulin secretion and thus altered glucose regulation. For this purpose, the study results are compared with a reference cohort without variants in ELAPOR1 or ELAPOR2 (matched for age, sex, waist to hip ratio and BMI) from our databases of previous studies (e.g. PLIS: NCT01947595, PREG: NCT04270578, KNOMA: NCT04950283). Insulin secretion is assessed by hyperglycemic glucose clamp technique. An oral glucose tolerance test will be performed to assess glucose tolerance." NCT06667804,"The Effect of Laughter Yoga on Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes","Inclusion Criteria: * Diagnosed with T2DM for at least 6 months, * Able to use computer and/or mobile applications, * At least primary education graduate, * Using oral antidiabetic drugs, * No diagnosed psychiatric illness, * No communication problems, * Patients who volunteered to participate in the study were included. Exclusion Criteria: * \- Using Parenteral Insulin, * The one who doesn't attend all the yoga sessions, * Patients with physical conditions that prevent them from participating in laughter yoga sessions (respiratory distress, persistent cough, veritgo, severe heart disease, hemeroid, hernia of any kind, severe back pain, urinary incontinence, epilepsy, bleeding tendency, thrombocytopenia and deformity visible on examination), * Patients taking medication or other nonpharmacological methods to reduce stress, * Patients who did not want to participate in the study were excluded.","Non-pharmacological methods, which are now widely used in nursing care, are accepted as a useful approach to reduce pain, stress and anxiety. In this study, the investigators focused on the therapeutic effect of laughter yoga in individuals with diabetes. In the literature, it has been determined that laughter reduces postprandial blood glucose levels, improves the clinical outcomes of disorders such as inflammation, asthma, cancer and heart disease, reduces anxiety and depression, and the reasons for this are the reduction of physiological stress response. In this study, it was thought that laughter yoga would have an effect on blood glucose value, disease perception and perceived stress level in individuals with Type 2 diabetes." NCT06317584,Empowerment-based Complementary and Alternative Medicine (ECAM),"Inclusion Criteria: * People over the age of 20 * diagnosis of diabetes at least 12 months before the interview; and * The use of CAM at least 3 months * Sufficient mental ability to understand the informed consent form and sign it. Exclusion Criteria: * Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.","The objectives of this phase study are to (1) implement the ECAM educational app to empower patients with diabetes in their management of diabetes alongside CAM use; (2) examine the impact of the ECAM educational app on patient empowerment, CAM health literacy, risk management of CAM use, CAM communication and diabetes quality of life in patients with diabetes; and (3) collect feedback from both patients and nurses on how to improve the ECAM educational app for dissemination and implementation." NCT01145833,Guided Self-help for Families With an Overweight Child,"Inclusion Criteria: * child between the ages of 8 \& 12 * an moderately overweight child with a BMI% between 85-97% * child has a parent willing to participate * child has a parent who can read English at a minimum of a 6th grade level * family who is willing to commit to treatment attendance and attendance at all assessments. Exclusion Criteria: * Child psychiatric disorder diagnoses (based on parent report) * Child diagnoses of a serious current physical disease (such as diabetes) * Child who is taking medications that may impact their weight * Child with physical difficulties that limit the ability to exercise * Child with an active eating disorder * Child and parent will be moving out of the San Diego County before study completion * Child and/or parent has a modified diet due to religious or socially conscious reasons (such as Vegan, vegetarian)","An estimated 4-5 million children between the ages of 6-17 in the United States are obese. Children who are obese are at an increased risk for many negative health consequences in childhood and in adulthood. In addition, these children are at an increased risk for psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing, verbal abuse and social isolation. Guided self-help offers an opportunity to provide empirically based programs to a larger amount of the target population. Once such treatment methods are available, it is possible that the guided self-help treatment for childhood obesity can be disseminated to primary care practitioners, psychologists, nurses, and health educators. Ultimately, the goal of this application is to develop a treatment protocol that can be used by clinics and lay health professionals to intervene with children who are overweight and their parents." NCT07360938,Drug Interaction Potential of Pro-Inflammatory Conditions,"Inclusion Criteria: * Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD * Ability to provide written informed consent and HIPAA authorization Exclusion Criteria: * Diagnosis or past medical history of non-IBD autoimmune disorder, including systemic lupus erythematosus, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis * Current infection requiring medical treatment (note: if a prospective patient's infection resolves, they can be re-screened for trial inclusion) * Concomitant treatment with systemic immunosuppressant drugs",N/A NCT02002130,The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes,"Inclusion Criteria: * Patients must be positive for GAD-65 antibody. * They must meet ADA criteria for diabetes: classic symptoms, plus blood sugar \> 200mg/dL or fasting blood sugar \> 126 mg/dL. * Must be enrolled with 5 weeks of diagnosis * Females who are post-menarchal must use 2 forms of contraception if not abstinent. The types of contraception deemed acceptable would be oral contraceptives, intrauterine devices, and barrier methods. * Signed informed consent form. Exclusion Criteria: * Chronic systemic steroid use, including inhaled compounds, or any medication which can alter glucose metabolism * Obesity, defined as BMI \> 95% or BMI \> 27 in adolescents with acanthosis score between 1-1.5. * Pregnant and/or breast feeding * History of seizure disorder * Patients on medications that may disturb GABA action, such as Baclofen, Valium, Acamprosate, Neurontin, or Lyrica * history of any alcoholism or substance abuse. * Chronic Disease (such as liver, cancer, cystic fibrosis, or renal failure) * Chromosome abnormality (such as Trisomy 21, Turner Syndrome, etc.)","The primary defect in autoimmune Type I Diabetes Mellitus (T1DM) involves the infiltration of the pancreatic islet cells by T-lymphocytes, macrophages, and other immune cells, and consequent loss of beta cells. At the onset of T1DM more than 70% of the beta cells are destroyed, whereas the residual beta cells most likely represent the only reservoir for the potential regeneration of the islet beta cell mass. A series of immunological abnormalities have been reported in those with T1DM including, but not limited to, the production of autoantibodies (i.e., glutamic acid decarboxylase (GAD-65), tyrosine phosphatase-related islet antigen 2 (IA2), Zinc Transporter 8 (ZnT8A), or insulin (IAA) as well as alterations in the capacity of regulatory T cells (Treg) to suppress the action of effector T cells (Teff); the latter population thought as playing a key role in the immune destructive process. Therefore, a vast majority of studies attempting to prevent or reverse the disease have focused on immune suppression. While some of these studies have shown limited promise, many has side effects which were significant enough that one must question the value of short term benefits associated with utilizing these drugs. GABA is a naturally occurring substance in physiology and has the potential to locally reduce inflammation and protect pancreatic beta cells from auto-immune destruction. GABA, synthesized from glutamate by GAD, is a well known neurotransmitter in the CNS and acts mainly through the GABAA receptor (GABAAR). GABA is locally produced by the pancreatic beta cells. GABAARs are also expressed in various immune cells, including T-cells, peripheral blood mononuclear cells, and are known to exert immune-inhibitory effects. BABA appears to play multiple roles in the pancreas. GABA promotes beta-cell growth and survival, and GABA can also act on the GABA(A) receptors in the pancreatic alpha cells, in so doing suppressing glucagon secretion, and GABA suppresses inflammation and increases regulatory T-cell numbers. Based on the aforementioned information, we envisage that administering GABA to those with new onset T1DM may preserve or increase residual insulin production, suppress glucagon release, and decrease inflammation surrounding the pancreas. With this, GABA may prolong the beta-cell life after diagnosis. Combining with GAD-alum injections, which aim to halt the autoimmune attack by inducing tolerance thereby saving residual insulin production, may improve glycemic control even more and significantly decrease the risk of hypoglycemia and long-term complications in the future." NCT02544867,Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes,"Inclusion Criteria: 1. Males or females 50 -70 years of age 2. Able to attend 4 measurement visits with study staff in 3 consecutive weeks 3. Spend at least 8 hours per day sitting 4. Willing and able to wear study device for 21 days 5. Able to read and write in English 6. Able to provide written informed consent Exclusion Criteria: 1. Do not sit for at least 8 hours per day 2. Unable to attend 4 visits 3. Diagnosis of serious chronic condition that would limit the ability to stand","Primary aim: To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day. Secondary aim: To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior. Exploratory aim: To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting)." NCT02124967,A Mosque-Based Intervention to Promote Physical Activity in South Asian Muslim Women,"Inclusion Criteria: * Muslim women attending Madinah Mosque Exclusion Criteria: men","South Asian (SA) women (people with origins in Pakistan, India, Bangladesh or Sri Lanka) living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women. Studies suggest that they participate in less physical activity or recreational exercise compared to other SA women. Practical barriers (e.g. lack of time, childcare) are often interwoven with cultural barriers, such as restrictions leaving the home alone to enter mixed-gender settings, and lack of socialization into sporting and other outdoor activities) inhibit participation. The provision of culturally and gender sensitive facilities, such as women-only exercise sessions at mosques could serve as a solution for Ontario SA Muslim women to be more active. Studies indicate health promotion programs in religious institutions (e.g. churches) have demonstrated clinical and psychosocial benefit to women of various ethnic groups. Similar to Canadian churches, mosques have key elements identified in the literature to be beneficial in providing physical activity opportunities for Muslim women: partnerships, available and accessible space and supportive social relationships. To the investigators' knowledge, mosque-based physical activity interventions for SA Muslim women have not been implemented and evaluated in Ontario. Such interventions are needed to help attenuate the risk of diabetes and CHD in this ethnic group who represent a significant part of the Ontario population." NCT00579436,Effects of Fish Oils on Inflammation and Insulin Resistance,"Inclusion Criteria: * BMI 27-45 kg/m2 * age 35-65 years * abnormal carbohydrate metabolism Exclusion Criteria: * triglycerides over 700 mg/dl * renal disease * liver disease * congestive heart failure * history of heart disease or stroke * chronic aspirin or NSAID use (anti-coagulant) * history of a bleeding disorder * use of statins, fibrates, ACE inhibitors, angiotensin II receptor blockers and glucocorticoids * diet heavy in omega-3 fatty acids (salmon, sardines, flaxseeds)","The development of type 2 diabetes (T2DM) represents a complex series of events, involving abnormalities in adipose tissue lipid distribution and insulin action. Along with an increase in adipose tissue mass is an increase in inflammation brought about by macrophages that infiltrate adipose tissue. These macrophages express inflammatory cytokines such as tumor necrosis factor (TNF) and Interleukin -6 (IL-6) which are correlated with insulin resistance and metabolic syndrome, and suggest that metabolic syndrome and diabetes are conditions characterized by a state of chronic, low-grade inflammation. Thiazolidinediones (TZDs) improve insulin sensitivity via activation of peroxisome proliferator-activated receptor (PPAR) , and there is much evidence that PPAR agonists also have anti-inflammatory properties. Fish oils are rich sources of Omega-3 fatty acids and there is a large literature on the potential benefits of fish oils on lowering serum triglycerides, cardiovascular protection, and immune modulation, and there is evidence that fish oils also activate PPAR . Hence, the focus of this study will be on subjects with insulin resistance and metabolic syndrome, but who do not yet have diabetes. We plan to treat insulin resistant subjects with fish oils and ask the following questions. Hypothesis 1. The treatment of insulin resistant subjects with fish oils will reduce adipose tissue inflammation. Aim 1. From blood samples drawn before and after treatment, we will measure levels of circulating inflammatory cytokines. Aim 2. Adipose tissue biopsies will be performed before and after fish oil treatment. From the adipose biopsies, we will quantitate cytokine expression, macrophage number, and we will look for evidence of macrophage apoptosis. Aim 3. We will determine whether fish oil treatment increases the adipose tissue secretion and serum level of the high molecular weight form of adiponectin. Hypothesis 2. The reduction in inflammatory markers occurs through an activation of PPAR by the fish oils. Aim 4. Adipose tissue and macrophages will be treated in vitro with fish oils in the presence and absence of a PPAR inhibitor. We will determine whether fish oils stimulate the secretion of the high molecular weight adiponectin isoform from adipose tissue and whether they induce apoptosis from macrophages, and whether this process is inhibited by the PPAR inhibitor. Hypothesis 3. Fish oils improve peripheral insulin sensitivity through a reduction in intramyocellular lipid, and an improvement in muscle insulin signal transduction. Aim 5. Before and after treatment with fish oils, insulin sensitivity will be measured, along with intramyocellular lipid and genes involved in insulin action and muscle lipid oxidation." NCT00398944,Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes,"Inclusion Criteria: * Hypertension * Mellitus diabetes * Follow-up by GP's","Existing computer-based ordering systems for physicians provide drug-centred checks but offer little assistance for optimizing the overall patient-centred treatment strategy. The ASTI project aims : 1. to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners : 1. to carry out procedures (clinical and biological tests) according to guidelines (the recommended procedure at the recommended moment), and to get a synthetic view of all the elements they need to follow-up the patient 2. to avoid prescription errors and to improve compliance with therapeutic guidelines. The "" critic mode "" operates as a background process and corrects the physician's prescription on the basis of automatically triggered elementary rules that account for isolated guideline recommendations. The "" guided mode "" directs the physician to the best treatment by browsing a comprehensive guideline knowledge base represented as a decision tree. 2. To measure the impact of ASTI when it is implemented with an electronic medical record system. We adopt a randomized design, with the practice as the unit of randomization." NCT06364644,Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure,"Inclusion Criteria: * Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County * Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \[\>75th percentile for the state of Maryland\] plus low income) * Type 2 diabetes * Obesity (BMI≥30 kg/m\^2) Exclusion Criteria: * Age \< 30 or \>70 years * Prevalent heart failure * Uncontrolled glycemia (blood glucose \<60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%) * Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications) * Known coronary artery disease (unless \< 50% stenosis by angiography) * Moderate or severe valvular heart disease * Serious medical conditions limiting life expectancy or requiring active management * Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+). * Weight loss of ≥ 5% in the past year or current use of weight loss medications * Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week * End stage renal disease * Current participation in another behavior change program * Active alcohol or substance abuse disorder * Already engaging in regular exercise with more than 60 minutes of moderate \[3-6 METS\] to vigorous \[\>6 METS\] physical activity per week * Active pregnancy * Evidence of ischemia, dangerous arrhythmia or other clinical instability on baseline exercise stress test","This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components: 1. Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention. 2. Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and/or home visits at least monthly, offering assistance in following areas: * Reinforcing patient education about disease self-management * Helping patients access care and addressing barriers to care and treatment * Serving as facilitators and navigators to clinical care, social services, and other community resources * Providing encouragement and support to engage, activate, and empower patients and their support systems 3. Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week)." NCT06693934,Jockey Club Precision Prevention Programme on Young Onset Diabetes,"Inclusion Criteria: * Aged between 18 and 44 years old * With at least one risk factor for diabetes Exclusion Criteria: * Known history of Diabetes * With conditions considered not suitable by the project team (including illiteracy) The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension/ high blood glucose level/ abnormal lipid level/ vascular disease/ fatty liver, history of gestational diabetes/ polycystic ovary syndrome/ delivery of baby≥ 4kg (for women only), and less than 150mins of physical activity every week.","BACKGROUND AND RATIONALE: In Hong Kong, 1 in 10 adults have diabetes. In hospital-based clinic setting, 1 in 5 adults with diabetes were diagnosed before the age of 40, i.e. young-onset diabetes (YOD). The latter is the major driver of recurrent hospitalizations, critical illnesses and premature death. Compared to fasting plasma glucose (FPG) or HbA1c, 2-hour PG is needed to detect impaired glucose tolerance (IGT) and diabetes (DM). Besides, 2-h PG is more robust than FPG or HbA1c in predicting major events and death. The selection of participants with IGT for intervention is based on the positive effects of lifestyle modification and metformin only in individuals with IGT and not in individuals with isolated IFG in randomized clinical trials. Besides, there is strong familial tendency of YOD and based on our published and in-house 20-year prospective data in a workforce, 80% of people who developed DM came from 20-30% of individuals with high genetic risk unmasked by modifiable risk factors such as obesity and smoking. In this implementation project, investigators shall use a 2-stepped approach to identify adults aged between 18 and 44 (inclusive) with genetic predisposition to undergo yearly OGTT to diagnose IGT and diabetes early for intervention. Investigators shall apply the proprietary DForesee (DF) risk algorithm including clinical and biogenetic risk factors to select the top 25% of participants at the highest risk for IGT or diabetes in next 10 years to undergo yearly OGTT accompanied by a risk-based intervention program. STUDY DESIGN AND METHODS: By using quasi-experimental design based on an evidence-based multi-component strategy, investigators aim to detect and delay the onset of diabetes in adults aged less than 45 years. Investigators aim to identify 9,000 adults aged between 18 and 44 years (inclusive) in community- and clinic settings during a 2-year period, followed by 2 years of risk-stratified intervention. Investigators shall use clinical and biogenetic assessment including DNA testing, capillary blood test and administration of questionnaires to classify participants to high risk and low risk progressors. All participants will receive risk-based intervention. Low risk progressors will receive a personalized report indicating their genetic and modifiable risk explained by nurses and with repeated clinical and biogenetic assessment at year 2. The high risk progressors will additionally undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT) and will receive a personalized report explained by doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices for IGT and DM groups only, weighing scale for all high risk progressors) to motivate behavioural change. INCLUSION and EXCLUSION CRITERIA Age 18-44 (inclusive) years without known diabetes, at least one risk factor for diabetes and with usual place of residence in Hong Kong, The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension, high blood glucose level, abnormal lipid level/ vascular disease, or fatty liver, history of gestational diabetes polycystic ovary syndrome or delivery of baby≥ 4kg (for women only), less than 150mins of physical activity every week. People with known diabetes or conditions considered to be unsuitable by the project team including illiteracy will be excluded. OUTCOME MEASURES The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness." NCT01885234,Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension,"Inclusion Criteria: * age \> 20 years; * gestational age between 20 and 27 weeks (date of the last period and confirmed by ultrasound); * Only one foetus in the womb; * Without orthopedic limitations; * Non-smoker; * Medical clearance for exercise Exclusion Criteria: * Pre-eclampsia; * fetal malformations; * Intrauterine fetal death","The statistical analysis will consist of: * descriptive statistic; * Levene's test * Shapiro Wilk's normality test * Parametric or non-parametric test * a=0.05 * SPSS 17.0" NCT05372809,"Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs","Inclusion Criteria: * At least 18 years of age. * Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy. * Presence of a DFU Wagner 2 grade wound on any aspect of the foot, provided that if the malleolus is involved, not more than 50% of the wound is above the mid-point of the medial malleolus. \[NOTE: DFU must maintain Wagner 2 Grade for the duration of study run-in period - i.e., screening visit 1 (SV1) to randomization visit 1 (RV1).\] * If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. \[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study.\] * Index ulcer (i.e., current episode of ulceration) has been present for ≥ four weeks (≥ 28 days) prior to the initial screening visit (SV1). * Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 10 cm2 at the first screening visit (SV1) and first randomization visit (RV1). * Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) of ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75 at SV1, using the affected study extremity within 30 days of screening visit (SV1). * Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade level 1. * The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through RV1/Randomization). * Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). * Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. * Females of childbearing potential must agree to use effective methods of contraception (birth control pills, barriers, or abstinence) (Screening through End of Study (EOS) and undergo pregnancy tests. * Properly obtained written informed consent. * Subject must have stable living environment in order to manage offloading and wound care management. * The index ulcer has a clean base, free of necrotic debris, and infection at time of placement of treatment product. Exclusion Criteria: * Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1). * Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of screening (SV1). * Index ulcer in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer. * Subjects with history of radiation on the same limb as the index ulcer (regardless of time since last radiation treatment). * Subjects with exposed internal fixation on the same limb as the index ulcer. \[NOTE: External fixation is allowed if deemed stable by principal investigator.\] * Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first screening visit (SV1). ). \[NOTE: NPWT is allowed up to the day of screening (SV1), if in the opinion of the Principal Investigator NPWT may be discontinued.\] * Index ulcer treated within the last 30 days prior to screening with a prohibited treatment as defined in full protocol. * Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg prednisone (or equivalent) daily dose), cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface within 30 days prior to first screening visit (SV1), or who receive such medications during the run-in period, or who are anticipated to require such medications during the study. * Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment. * In the opinion of the investigator, the subject is non-compliant with offloading or index ulcer dressing during the run-in period. * Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1). * Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1). * Subject is pregnant or breast-feeding. * Presence of diabetes with poor metabolic control as documented as not having at least one HbA1c ≥12.0 within 30 days prior to randomization (RV1). * Subjects with end stage renal disease requiring treatment with dialysis and/or evident by an eGFR \<30 mL/min/1.73m2 within 120 days of randomization (RV1). \[NOTE: Subjects with two documented eGFR values within 120 days, the most recent value may be used if the eGFR ≥30 mL/min/1.73m2 and is, in the opinion of the principal investigator, stable and the subject will not require treatment with dialysis for the duration of study participation.\] * Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from SV1 to the RV1/randomization visit. * Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C in the opinion of the investigator at first screening visit (SV1). * Documented history of New York Heart Association Class III or IV congestive heart failure or unstable cardiovascular disease requiring intervention within 60 days prior to screening (SV1). * Requiring surgical intervention (excluding debridement) at the time of consenting and/or increased probability of requiring surgical intervention during study participation \[NOTE: non-invasive surgical intervention is allowed if, per the Principal Investigator, treatment will not affect subject's ability to participate in clinical trial.\] * Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.","This study is a prospective, multi-center, randomized controlled trial (RCT) designed to assess the safety and efficacy of SkinTE with standard of care (SOC) dressings compared to SOC dressings alone (wound debridement, collagen-alginate dressing, multi-layer compression dressings, and offloading) in the treatment of Wagner grade 2 diabetic foot ulcers (DFUs) ranging in size from 1 to 10 cm2. After being informed about the study and potential risks, all patients giving written informed consent who meet eligibility criteria will undergo a 2-week screening period of SOC. Patients meeting eligibility criteria following the screening period will be randomized in a single-blind manner (blinded evaluator with closure confirmed by a blinded adjudicator) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure." NCT03100409,Effect of a Low Residue Diet in Comparison to the Dietetic Recommendations From the INCan in Cervical Cancer Patients,"Inclusion Criteria: * Women 18 years of age and older. * Ability to understand the study and be able to sign the informed consent. * Functional stage ECOG 0 - 2. * Negative pregnancy test, null reproductive potential, or currently using an contraceptive method. * Willing and able to attend the programmed visits. * Diagnosed with cervical malignant tumors of epithelial origin in the neck of the uterus, clinical stages IB2-IVA. * Candidates to receive concomitant Chemo-Radiotherapy, followed by Brachytherapy. * In case of presence of diabetes mellitus and/or hypertension, without retinopathy or albuminuria \<300 mg/dl. * In case of renal deterioration, a creatinine clearance \>20 ml/min. * Hemoglobin \>10 g/l. * Leucocytes \> 4000/mm3. * Platelets \>100000/mm3. Exclusion Criteria: * Under a different nutritional treatment using a nutritional supplement. * Carrying other uncontrolled diseases, including cardiovascular insufficiency, arrhythmia, psychiatric illnesses. * Concomitant treatment with another experimental drug. * Active TB. * Infected with HIV. * History of LES and other rheumatologic diseases that involve renal deterioration. * Presence of vesicular-vaginal fistulae at moment of diagnosis. * Previous malignancy. Study Discontinuation Criteria: * Loss of follow up for 21 days. * Evidence of disease progression. * At the request of patient. * By unacceptable toxicity. * Pregnancy. Criteria must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study.","In Mexico, cervical cancer (CC) is the second most frequent cause of death among women, with a mortality rate of 4000 women/year. Among the patients attended by the INCan, 80% are diagnosed with locally advanced CC and 30% of these present comorbidities. Hypertension may be present in 20% of patients, obesity in 18% and diabetes in 6.8%. These comorbidities affect the efficacy of treatment, increase the risk of malnutrition, of adverse events, hospitalization, increase hospital stay and worsen the quality of life, and even increase the risk of death. Furthermore, 10 to 20% of patients present kidney deterioration. The main reason for kidney disease is ureteral obstruction. The glomerular filtration rate deteriorates with age and many patients have comorbid medical illnesses that further compromise the kidneys. The standard treatment for CC is concomitant chemo-radiotherapy using cisplatin as a radiosensitizer, and brachytherapy at the end of treatment. Studies developed in the INCan described the acute toxicity symptoms in CC patients using this treatment: nausea, vomiting, diarrhea, cystitis, radioepithelitis, leucopenia, neutropenia, thrombocytopenia. Pelvic radiotherapy causes gastrointestinal toxicity, which is the most important limiting factor for the patients to complete their treatment. Cancer treatment, along with the tumor itself and other factors, causes malnutrition, and this confers a bad prognosis for the patient's response to treatment and survival. There is a nutritional risk in these patients at the moment of diagnosis, because of the metabolic alterations caused by the tumor, and the treatment-induced side effects. International guidelines for cancer patients recommend nutritional assessment in these patients before they start treatment, so nutritional risk can be detected and the patient may get started on dietary intervention to prevent malnutrition. Several authors have studied the dietary management that may help reduce the gastrointestinal effects in cancer patients receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended dietary approach is a low residue diet consisting on 20-25% fat, 5g of lactose and 20g of fiber. Currently the INCan does not follow the nutrition care process for cervical cancer patients; written recommendations are given to the patients with a list of foods allowed or not allowed, with no further nutritional assessment or intervention. The investigators described the nutritional status of CC patients undergoing concomitant chemo-radiotherapy. It was observed that by the end of cancer treatment, a period of 9 weeks, 81.8% of patients became malnourished; 96% of patients lost weight, 78% of which had severe weight loss. The aim of this clinical trial is to evaluate a diet low in residue in CC patients, considering the necessary modifications for each patient if morbidities are present, in comparison with the current dietary recommendations used in the INCan. A thorough nutritional evaluation including anthropometric data, dietary data, gastrointestinal toxicity and quality of life evaluations, will be performed. Particular objectives are the following: 1. Identify the nutritional status of CC patients before, during and after treatment with chemo-radiotherapy, in intervention and control groups. 2. Determine the association of malnutrition and gastrointestinal toxicity during and after treatment, in intervention and control groups. 3. Evaluate the quality of life of patients before, during and after treatment, in both groups. 4. Establish the association of nutritional status and response to treatment, in both groups. The aim is based on the following hypothesis: Patients receiving the personalized nutritional intervention with the low residue diet will maintain a better nutritional status during treatment, reflected in fewer malnourished patients, compared to the control group. Methods. Study design. Randomized clinical trial, open, factorial 3X2. To evaluate the efficacy of a low residue diet on the nutritional status, gastrointestinal toxicity and quality of life of CC patients referring to the National Institute of Cancer in Mexico (INCan). 320 patients will be included, with cervical malignant tumors of epithelial origin in the neck of the uterus, candidates for chemo-radiotherapy. Dietary intervention will consist on a low residue diet: 20% kcal from fat, 5g lactose/day, 20g fiber/day (5g from insoluble fiber). Dietary intervention will be adapted to the patient's individual requirements, according to the presence of comorbidities or renal deterioration. 1. No comorbidities. Energy: 20-30 kcal/kg of body weight/day. Protein: 1.3 g/kg of body weight/day. 2. Comorbidities (diabetes, hypertension), or geriatric patient. Energy: 25-30 kcal/kg of body weight/day. Protein: 1.5 g/kg of body weight/day. 3. Renal deterioration. Energy: 30-35 kcal/kg of body weight/day. Protein: 1 g/kg of body weight/day. Sodium: 2000-2300 mg/day Potassium: 1900-2730 mg/day Phosphorus: 800-1000 mg/day Control group will receive the standard written recommendations from the INCan, which enlist allowed foods and not allowed foods. Sample size. A sample space of 320 patients will be included if prior consent is acquired and if they meet the inclusion criteria. This clinical trial contemplates 3 strata with 2 levels. Statistical analysis. A univariate analysis will be performed to describe the study population. Descriptive statistics will be used to obtain measures of central tendency and dispersion, as well as frequency of distribution for qualitative variables. Percentage change of nutritional status will be calculated using the Friedman test. Chi square test will be used to compare basal vs final assessment, and chi square test will be used to compare among study groups. All confidence intervals will be constructed with a confidence of 95% (α=0.05). The interpretation of the study results will be responsibility of researchers. Data processing and analysis will be performed with the SPSS package (version 19.0®) for Microsoft. Efficacy analysis. Efficacy will be evaluated in patients that qualify to be included in the protocol analysis. To evaluate efficacy, nutritional diagnosis through the clinical course will be analyzed in both, intervention and control, groups. Also, toxicity and quality of life responses will be obtained. Procedures. Treatment. Anticancer treatment will consist of Cisplatin as a radiosensitizer, at a dosage of 40 mg/m2/week for 6 weeks. For patients with renal deterioration Gemcitabine will be used instead of Cisplatin, at a dosage of 300 mg/m2/week for 6 weeks. Concomitantly, external pelvic radiotherapy will be applied at a total dosage of 50.4 Gy divided by 28 fractions, 1.8 Gy/day/5 days a week, for 6 weeks. After completing concomitant chemo-radiotherapy, intracavitary brachytherapy will be administered at low dosage (30 Gy of Cesium 137) or high dosage (Iridium). Before initiating chemo-radiotherapy, a complete evaluation will be applied as mentioned. Once eligibility criteria are verified, patients will be randomly assigned to intervention group or control group. Visits during the study. After signing the informed consent, the patient will be informed when she will begin participating in the study (screening visit). If the patient complies with the inclusion criteria, a total of 5 visits will be scheduled: (1) at week -2, 2 weeks before treatment; (2) at week 0, on initiation of treatment; (3) at week 3, on the 3rd cycle of chemotherapy; (4) at week 9, by the end of brachytherapy; and (5) at week 21, 3 months after treatment completion. Monitoring. A thorough evaluation on each visit will be performed using the following tools: * Patient generated subjective global assessment. * Anthropometric data: weight, height, waist circumference, hip circumference, arm circumference. * Body mass index. * Waist to hip ratio. * Body composition (bioelectrical impedance). * % weight loss. * Hand dynamometry. * Dietary data: 24 hour recall and frequency of food intake questionnaires. * % recommended energy intake. * Biochemical markers: serum albumin, number of lymphocytes. * Gastrointestinal toxicity using the CTCAE v4.03. * Quality of life using the QLQ-C30 and CxC24. Sample collection. No tissue or additional blood samples will be obtained, other than the blood samples used as part of the routine clinical laboratory tests. Informed consent acquisition. On the screening visit, the written consent will be read and explained to the patient, clarifying the risks and benefits involved in the study. Two witnesses, independent from the study, will be present. The patient will have the choice to not participate or withdraw from the study at any time, her decision will not affect the quality of care and treatment that the attending physician will provide. The researcher will be governed by the ethical principles established in the Helsinki Accord. The physician will adequately respond all the matters of interest to the patient. Ethical considerations. The Research Committee and the Ethics Committee of the National Institute of Cancer in Mexico has approved the protocol and the informed consent document. Patients participating in this study will be informed, through the informed consent, of all the details concerning this trial. The patients who agree to participate in the trial will express their willingness by signing the informed consent document, being clarified that they can leave the trial at any time, if they wish to do so. Regulatory considerations. This study abides by the ethical principles established by the international community, in accordance to the Good Clinical Practices, the Nüremberg Code, the Helsinki Accord, the Statement of Compliance with International Conference on Harmonization Guidelines for Good Clinical Practice, and the Regulations of the General Law of Health in the matter of research for health." NCT01858532,Study Of Diabetic Nephropathy With Atrasentan,"Inclusion Criteria: * Participant, or legal representative, had voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study had been explained and the participant had the opportunity to ask questions. The informed consent must have been signed before any study-specific procedures were performed. * Participant had type 2 diabetes (including participants with latent autoimmune diabetes or insulin-treated participants without a history of diabetic ketoacidosis who also had a negative anti-glutamic acid decarboxylase test AND an elevated post-prandial serum C-peptide level) and had been treated with at least one anti-hyperglycemic medication and an angiotensin-converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB; RAS inhibitor) for at least 4 weeks prior to the Screening S2 visit. * For entry into the Run-In Period the participant must have satisfied the following criteria based on the Screening laboratory values: * Estimated glomerular filtration rate (eGFR) 25 to 75 mL/min/1.73 m\^2 \[until the eGFR cap on participants (approximately 300) with a baseline of \> 60 mL/min/1.73 m\^2 was reached\] and a urine albumin creatinine ratio (UACR) greater than or equal to 300 and less than 5,000 mg/g (greater than or equal to 34 mg/mmol and less than 565 mg/mmol); * Serum albumin greater than or equal to 2.5 g/dL (25 g/L); * Brain natriuretic peptide (BNP) less than or equal to 200 pg/mL (200 ng/L); * Systolic blood pressure (SBP) greater than or equal to 110 and less than or equal to 180 mmHg; * Serum potassium greater than or equal to 3.5 mEq/L (3.5 mmol/L) and less than or equal to 6.0 mEq/L (6.0 mmol/L); * Participants on a maximum tolerated labeled daily dose (MTLDD) of a RAS inhibitor for greater than or equal to 4 weeks and on a diuretic at the time of screening and who satisfied the above criteria may have proceeded to the last visit in the Run-In Period (R6); * Participants already on a MTLDD of a RAS inhibitor for greater than or equal to 4 weeks and not on a diuretic (unless medically contraindicated) at the time of Screening were to start with a diuretic and participate in Run-In for at least 2 weeks. * For entry into the Enrichment Period the participant must have satisfied the following criteria based on the last visit of the Run-In Period: * RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose; * Participants that were on a MTLDD RAS inhibitor and not on a diuretic (unless medically contraindicated) at the time of Screening must have been in Run-In for at least 2 weeks. * For entry into the Double-Blind Treatment Period, participants must have satisfied the following criteria based on the last visit of the Enrichment Period: * RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose; * Diuretic at any dose unless medically contraindicated or clinically intolerable in the investigator's judgement (i.e., hypotension or hypokalemia); * Participants must not have had a weight change greater than or equal to 3 kg from the beginning of Enrichment to the end of the Enrichment Period and absolute serum BNP greater than or equal to 300 pg/mL (300 ng/L) at the last Enrichment visit; * Participants must not have had an increase in serum creatinine greater than 0.5 mg/dL and greater than 20% increase from the beginning of Enrichment to the end of the Enrichment Period. Exclusion Criteria: A participant was not eligible for entry into the Run-in Period if he/she met any of the following criteria: * Participant had a history of severe peripheral edema or facial edema requiring diuretics unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial Screening S1 visit. * Participant had a history of pulmonary hypertension, pulmonary fibrosis or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema). * Participant had a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure. * Participant had known non-diabetic kidney disease (other than kidney stones). * Participant had elevated liver enzymes (serum alanine aminotransaminase \[ALT\] and/or serum aspartate aminotransaminase \[AST\]) \> 3 × the upper limit of normal (ULN). * Participant had hemoglobin \< 9 g/dL (90 g/L). * Participant had a sensitivity to loop diuretics. * Participant had a history of an allergic reaction or significant sensitivity to atrasentan (or its excipients) or similar compounds. * Participant had a history of chronic gastrointestinal disease, which, in the Investigator's opinion, may have caused significant GI malabsorption. * Participant had a history of secondary hypertension (i.e., hemodynamically significant renal artery stenosis, primary aldosteronism or pheochromocytoma). * Participant had significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. * Participant had clinically significant cerebrovascular disease (CVD) or coronary artery disease (CAD) within 3 months prior to the Screening S1 visit, defined as one of the following: * Hospitalization for MI or unstable angina; or * New onset angina with positive functional study or coronary angiogram revealing stenosis; or * Coronary revascularization procedure; or * Transient Ischemic Attack or Stroke. * Participant had received any investigational drug including atrasentan within 3 months prior to the Screening S1 visit. * Participant received dialysis treatments or was expected to receive dialysis or renal transplant within 6 months of screening. * Participant was currently receiving rosiglitazone, moxonidine, aldosterone blockers, aliskiren or a combination of ACEi and ARB. * Participant was a premenopausal woman defined as (for study purposes) any female subject with a menses in the past 2 years. For women who were \< 50 years old, serum FSH must have been greater than 35 IU/L. Women who were surgically sterile or had a history of hysterectomy may not have necessarily be postmenopausal, and must also have had an FSH \> 35 IU/L. * Participant was at high risk for QT/QTc prolongation such as a family history of Long QT Syndrome, defined as QTc prolongation exceeding 450 ms in men, or 460 ms in women. * Participant had type 1 diabetes. * Participant was considered to be clinically unstable regarding general, metabolic or cardiovascular health as determined by the Investigator.","This was a Phase 3, prospective, randomized, double-blind, enriched-population, placebo controlled, multicenter study in adult participants with type 2 diabetes and nephropathy. Participants who met the inclusion criteria for initial study entry and none of the exclusion criteria were eligible to proceed to the Run-In Period to optimize RAS inhibitor and diuretic doses. Following the Run-In Period, eligible participants entered the 6-week Enrichment Period in which all received atrasentan to determine their urinary albumin to creatinine ratio (UACR) response and to assess tolerability of atrasentan. Responders and nonresponders were then randomly assigned to receive atrasentan or placebo in the Double-Blind Treatment Period. The study was performed in 5 to 6 periods in the following sequence: Pre-Screening Period (optional); Screening Period (Visits S1 and S2); Run-In Period (up to 12 weeks; Visits R1 to R6); Enrichment Period (6 weeks; Visits E1 to E5); Double-Blind Treatment Period (randomization to final treatment visit); and Follow-Up Period (Final Treatment to F1 visit \[45 days post treatment\] and other post-treatment visits). The study was prematurely discontinued because of a lower than expected event rate for the renal composite endpoint, which was adjudicated by a blinded independent events adjudication committee (EAC)." NCT06718998,A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity,"Inclusion criteria: * Female of non-childbearing potential, or male. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion criteria: * Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percentage (48 millimoles per mole \[mmol/mol\]) at screening. * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.",N/A NCT07361263,Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency,"Inclusion Criteria: Part 1 1. Adult healthy controls 2. No medication (including hormonal contraception) 3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months Part 2 1. Confirmed diagnosis of AVP-Deficiency 2. Age ≥ 18 years 3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months or in the case of hormone replacement therapy, with a 1-week pause from the respective treatment Exclusion Criteria: Part 1 1. Participation in a trial with investigational drugs within 30 days 2. BMI \>30 3. Age \>50 4. Illicit substance use (except for cannabis) during the last 30 days 5. Consumption of alcoholic beverages \>15 drinks/week 6. Tobacco smoking \>10 cigarettes/day 7. Pregnancy and breastfeeding 8. Hormonal contraception 9. Migraine with and without aura 10. Any cardiometabolic, cardiovascular, and hematological diseases (including deep vein thrombosis/pulmonary embolism and thrombophilia (DVT/PE)) 11. Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range 12. Diagnosed chronic kidney disease (CKD) \> grade III (GRF \< 30ml/min) Part 2 1. Participation in a trial with investigational drugs within 30 days 2. BMI \>30 3. Age \>50 4. Illicit substance use (except for cannabis) during the last 30 days 5. Consumption of alcoholic beverages \>15 drinks/week 6. Tobacco smoking \>10 cigarettes/day 7. Pregnancy and breastfeeding 8. Hormonal contraception 9. Migraine with and without aura 10. Any cardiometabolic, cardiovascular, and hematological diseases (including DVT/PE and Thrombophilia) 11. Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range 12. Diagnosed CKD \> grade III (GRF \< 30ml/min)","Oxytocin (OXT) and arginine vasopressin (AVP) are hypothalamic peptides involved in water balance and emotional regulation. Patients with AVP-Deficiency (central diabetes insipidus) often experience psychological symptoms such as anxiety and depressed mood, possibly due to coexisting OXT deficiency. Previous research showed that 3,4-Methylenedioxy-N-methylamphetamine (MDMA) can increase plasma OXT in healthy individuals but not in AVP-deficient patients, suggesting a clinically relevant OXT deficiency. However, the side effects of MDMA limit its clinical use as a diagnostic tool. Estrogen is known to stimulate OXT release via estrogen receptor β in the hypothalamus. This study evaluates whether oral estradiol valerate (EV) and ethinylestradiol (EE) can safely and effectively provoke OXT and NP-1 release, offering a potential alternative to MDMA-based tests. The study consists of two parts: Part 1 (Proof of Concept): A randomized, double-blind, cross-over trial in healthy adults to compare the stimulatory effects of EV and EE on plasma OXT and NP-1. Part 2 (Pilot Study): An open-label trial in patients with AVP-Deficiency using the estrogen compound identified as most effective in Part 1, to determine whether OXT and NP-1 responses are blunted compared to healthy controls." NCT01055093,Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients,"Inclusion Criteria: * Clinical diagnosis of diabetes mellitus according to ADA criteria * Age 18-69 * Diabetes duration since diagnosis \< 12 months * Control cohort: proven normal glucose tolerance according to ADA criteria Exclusion Criteria: * Diabetes mellitus category 3 B-H (ADA criteria) * Pregnancy * Severe renal, liver or heart disease * malignant cancer * severe psychiatric illness or addiction * participation in an intervention trial","In detail, the following questions will be answered: 1. Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis? 2. Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)? 3. Can we identify subgroups at baseline with different progression of the disease? Patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between." NCT06606821,The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease,"Inclusion Criteria: * Informed written consent * BMI equal to or above 27 kg/m2 * Age 18 years or older * Referred to coronary angiogram (CAG) due to stable angina * Coronary atheromatosis by angiography (obstructive or non-obstructive) * LCBI4mm \>200 by NIRS in a vessel not subjected to coronary intervention Exclusion Criteria: * History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline * Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA) * History of coronary artery bypass surgery (CABG) * Planned CV intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation * History of heart failure New York Heart Association (NYHA) class III or IV * Left ventricular ejection fraction (LVEF) ≤35% * eGFR \<30 ml/min/1.53 m2 * History of pancreatitis or plasma amylase \>2 times upper normal limit * Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal) * Pregnancy, planned pregnancy or breastfeeding * Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC) * Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients * Left main stenosis (≥50% diameter or haemodynamically significant) * Chronic total occlusion of any major coronary vessel * Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery * Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention","The anti-atherogenic effect of tirzepatide has been studied in preclinical studies and seems to involve mechanisms related to a reduction in vascular inflammation and lipid accumulation. Any direct anti-atherogenic effect of tirzepatide may potentially reduce the incidence of major cardiovascular endpoints in individuals with overweight or obesity. As a proof of principle, it would be of scientific and clinical interest to explore the anti-atherogenic effect of tirzepatide in humans. IVUS-NIRS imaging is uniquely suited for this purpose, as it makes it possible to detect changes in not only atheroma burden by IVUS but also to detect progression within the plaques in the lipidic/necrotic core component by NIRS. LCBItotal allows for consecutive detection of small changes in the same individual, which is pivotal to explore the supposed antiatherogenic mechanism of tirzepatide with enough statistical power. The investigators hypothesize that once-weekly sc. tirzepatide can reduce coronary lipid accumulation in the arterial wall and the progression of atheromatosis in individuals with overweight or obesity and established high-risk atherosclerosis. The investigators aim to investigate this hypothesis in a proof-of-principle study by investigating the change in coronary plaque composition in individuals with overweight or obesity and coronary artery disease (CAD) with high-risk characteristics by NIRS imaging randomised to 52-week treatment with tirzepatide or placebo." NCT05260021,A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both,"Inclusion Criteria: * Male or female, aged 10 to below 18 years at screening visit * Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening. * Have HbA1c \>6.5% to ≤11% at screening * Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \>85th percentile of the general age and gender-matched population for that country or region. Exclusion Criteria: * Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies * After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months. * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). * Had chronic or acute pancreatitis any time prior to study entry * Female participants who are pregnant or breast feeding or intending to become pregnant. * Using prescription or over the counter medications for weight loss within 90 days of the screening visit.",N/A NCT03529006,Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis,"Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis \> 70 % and/or Fractional Flow Reserve \< 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in BMS (bare metal stent), DES (drug eluting stent) or BVS, ISR in lesion previously treated by POBA (plain old balloon angioplasty), DEB or additional stent implantation. * Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention. Exclusion Criteria: * Difficulty with deliver and implant the Absorb scaffold (e.g. highly calcified lesions). * Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb).","Absorb ISR is randomized-controlled trial of Absorb scaffold vs. Sequent Please drug coated balloon in an all-comers population with in-stent-restenosis. The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients. Repeat coronary angiography will be performed 9 months post intervention in all subjects. Optical coherence tomography will be performed at baseline and at 9 months in both groups. All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS)." NCT03575884,Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers,"Inclusion Criteria: * Latino children, 3-5 years old, enrolled from 1 of the 20 Head Start Centers. * Preschoolers do not require a minimum amount of screen time or devices in their household to enroll in the study, because it is preventive and population-based. * Parents must be able to complete forms in English or Spanish. Exclusion Criteria: * Any preschooler that is underweight or under medical supervision to gain weight. * Only one preschooler per family may be enrolled, to avoid clustering of variables by family. * Preschoolers may only enroll once in the study. * Children \<3 years and \>5 years of age. * Children whose parents do not identify them as Latino or Hispanic.","Screen time is a major risk factor for childhood obesity and inadequate physical activity, both of which are determinants of type 2 diabetes (T2D), cardiovascular disease, and multiple cancers. Latinos are the largest and fastest growing minority in the US. Because US Latino children have more screen time and higher rates of obesity than their non-Latino White peers, interventions to reduce screen time adapted for Latino preschoolers are necessary to reduce health inequities related to obesity and T2D in the US. However, a systematic review reported no successful screen time reduction interventions among Latino preschoolers. The investigative team's pilot study tested the culturally adapted Fit 5 Kids screen time reduction curriculum among Latino preschoolers in Head Start. This short term cluster randomized controlled trial (RCT) is the only successful screen time reduction program for Latino preschoolers, having significantly reduced screen time by over 25 minutes/day. The investigative team's culturally adapted, multi-level intervention consists of lessons taught by study staff directly to preschoolers during Head Start, a weekly parent newsletter, and parenting tips via text messages several times/week. The investigative team will use a social ecological model and consider multiple levels of influences for analyses: (1) individual-level influences, e.g., acculturation and social cognitive theory, (2) families, e.g., screen time parenting practices, (3) schools, and (4) macro-environmental influences, e.g., neighborhood disorder. Building on this pilot work, the investigative team proposes a long term, efficacy, cluster RCT of the culturally adapted Fit 5 Kids among Latino preschoolers in Head Start from three US settings: Seattle, Houston, and the Central Valley of Washington State. Among 280 Latino 3-5 year olds at 20 Head Start centers, the investigative team's Specific Aims (SA) and Hypotheses (H) include: SA1) To conduct a cluster RCT of the culturally adapted Fit 5 Kids curriculum to evaluate its efficacy in reducing screen time and excessive weight gain over a school year (8-months) H1) Fit 5 Kids will decrease children's screen time, BMI z-scores and dietary energy intake, and increase fruit/vegetable intake, skin carotenoids, and moderate/vigorous physical activity (MVPA) compared to controls SA2) To examine mediators and moderators associated with reducing Latino preschoolers' screen time H2) Parents' outcome expectations, self-efficacy, and TV parenting practices will mediate the relationship between Fit 5 Kids and changes to preschoolers' screen time H3) Depressive symptoms, stress, and social support will moderate changes to preschoolers' screen time The proposed Fit 5 Kids RCT will confirm the pilot's promising results, and the larger sample will allow for mediation analyses to better understand mechanisms. This research will provide justification for a future community effectiveness trial with implementation by Head Start teachers, and the eventual widespread implementation of Fit 5 Kids in Head Start centers nationally." NCT07061652,Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes,"Inclusion Criteria: Inclusion Criteria for Caregivers * English-speaking. * Ability to provide written or verbal informed consent to participate in the study; * Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee; * Be at least 18 years of age at the time of consent; and * Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes. Inclusion Criteria for patients * English-speaking * Ability to provide informed consent. * Be at least 18 years of age at the time of consent; and * Their identified caregiver is enrolled in the study * Diagnoses: (must have cancer and diabetes) * Have a cancer diagnosis for which they are being actively treated at one of the study sites * Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy * Receiving active cancer treatment s, not including hormonal therapy * Concurrent history of diabetes with need for ongoing management Exclusion Criteria: Exclusion Criteria for Caregivers * Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes; * Existence of another co-morbid disease other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol; * Participation in the intervention development phase of this intervention Exclusion Criteria for patients * Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes; * Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol; * Their caregiver does not enroll in the study or withdraws consent",N/A NCT01221038,Standardization of a Heat Tolerance Test for Young Women as a Basis for Heat Tolerance Tests in Female Soldiers,"Inclusion Criteria:age 20-30 year, no past medical history, BMI 20-29, physically active, after completion of medical questionnaire and physical examination - Exclusion Criteria:heart diseases, respiratory diseases,resting BP\>140/90, DM, anhydrosis, skin diseases, pregnancy, breast feeding, using OC continuously, acute illness in the past two weeks. \-",N/A NCT04621565,Hydrocortisone Use During Peri-operation for Pituitary Adenomas,"Inclusion Criteria: * Patients with pituitary adenomas that need surgical resection of the tumor, whose hypothalamus-pituitary-adrenal axis are intact * Patients of either gender aged from 18 years to 70 years Exclusion Criteria: * Patients with Cushing's disease * Patients with pituitary adenomas who have already developed secondary adrenal insufficiency before surgery * Patients with pituitary apoplexy or other acute pituitary conditions that need emergency surgery * The postoperative pathology result indicates that the tumor is not a pituitary adenoma * Patients that refuse to participate in the study or those who ask to quit after enrollment","Pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. After surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. Therefore, patients undergoing pituitary surgery have been usually given ""stress dose"" steroids whether their hypothalamus pituitary adrenal (HPA) axis are deficient or preserved. Results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. Given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed. For Chinese patients with pituitary adenomas except for those of Cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. Peking Union Medical College Hospital is the China Pituitary Disease Registry Center. Here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose HPA axis are intact are safe." NCT07396792,Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram,"Inclusion Criteria: 1. The presence of written informed consent of the patient to participate in the study 2. Availability of examination data allowing for the verification or exclusion of cardiac and cardiac-associated pathology 3. Age 18 years old and older Non-inclusion criteria: 1. Patients with an implanted permanent pacemaker; 2. ECG changes that prevent spectral analysis; 3. Conditions that may impair the quality of the ECG recording (Parkinson's disease, essential tremor, etc.); 4. Conditions that make ECG recording in lead I impossible (congenital anomalies of the upper limbs, traumatic amputation of the upper limbs). 5. Lack of written informed consent from the patient to participate in the study. Exclusion Criteria: 1. Poor quality of the ECG recording on a single-channel ECG monitor 2. Insufficient examination data to verify or exclude cardiac or cardiac-associated pathology; 3. Patient's unwillingness to continue participating in the study for any reason.","The aim of the study: to create, evaluate the diagnostic efficiency and pilot application of a method for screening cardiac and cardiac-associated pathology based on the analysis of a single-channel electrocardiogram using elements of artificial intelligence. It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 4000 patients over 18 years old in the training sample and 1000 patients 18 years old and older in the test sample (the total number of patients is at least 5000 people). Patients will be included in the study if they have undergone a full examination (laboratory, clinical and instrumental), allowing for the verification or exclusion of cardiac and cardiac-associated pathology in accordance with current recommendations. To detect heart defects and heart failure: an expert echocardiography protocol, blood tests for cardiac-specific markers, and stress tests if indicated. To detect coronary artery disease: detection of significant coronary stenosis during coronary artery imaging: myocardial perfusion or determination of fractional coronary flow reserve, or stress echocardiography. For hypertension: repeated office blood pressure measurements, 24-hour blood pressure monitoring. For coronary heart disease: resting ECG and long-term Holter monitoring. For cardiac-associated pathology: blood tests: hemoglobin and red blood cell levels, glucose, glycated hemoglobin, oral glucose tolerance test, creatinine, uric acid levels, total cholesterol, low- and high-density lipoproteins, and triglycerides. Additional examination data will be taken into account if performed outside the protocol of this study. During the course of the study, the authors of the work do not interfere with the above-mentioned scope of the examination, which is carried out on patients in accordance with clinical guidelines. All patients included in the study will undergo ECG recording in standard lead I for 1 minute twice, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. Single-channel ECG will be recorded using the portable single-lead ECG monitor CardioQvark. It is designed as an iPhone cover. It is registered with the Federal Service for Health Supervision on February 15, 2019. RZN No. 2019/8124.The patient's personal data (last name, first name, patronymic, date of birth, contact information) will not be transferred or taken into account. Each patient is assigned an individual number that is not associated with his/her personal data. Then a spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform, the principles of which are based on the Fourier transform. The analysis involves the evaluation of the following parameters (the parameters listed below will be calculated as the median of the tact-cycle):• TpTe - time from peak to end of the T-wave• VAT - time from the beginning of the QRS to the R-peak• QTc - corrected QT interval.• QT / TQ - the ratio of QT length to TQ length (from the end of T to the beginning of the QRS of the next complex).• QRS\_E - the total energy of the QRS wave based on the wavelet transform• T\_E - T-wave total energy based on wavelet transform• TP\_E- energy of the main tooth of the T-wave based on the wavelet transform• BETA, BETA\_S - T-wave asymmetry coefficients (simple and smooth versions)• BAD\_T - flag of T-wave quality (whether expressed in the current lead• QRS\_D1\_ons - energy of the leading edge of the R-wave (based on the ""first derivative"" wavelet transform)• QRS\_D1\_offs - energy of the trailing edge of the R-wave (based on the ""first derivative"" wavelet transform)• QRS\_D2 - peak energy of the R-wave (based on the ""second derivative"" wavelet transform)• QRS\_Ei (i = 1,2,3,4) - QRS-wave energy in 4 frequency ranges (2-4-8-16-32 Hz) based on wavelet transform• T\_Ei (i = 1,2,3,4) - T-wave energy in 4 frequency ranges (2-4-6-8-10 Hz) based on wavelet transform• HFQRS - the amplitude of the RF components of the QRS wave. Additionally used parameters:• TpTe, VAT, QTc - are duplicated to control the correctness of the record processing (the value of the UCC should be approximately equal to the median of the tick-by-bar).• QRSw - QRS width.• RA, SA, TA - the amplitudes of the R, S, T-waves, respectively, are used to normalize the parameters listed above.Statistical analysis and modeling will be performed using Python V3.8.8 and R V.4.0, as well as SPSS v.17.The correlation between various combinations of time, amplitude and frequency parameters of ECG and the presence of cardiac and cardiac-associated pathology will be analyzed. Certain parameters will be included in various multivariate analysis models: Lasso regression, Random Forest, Multilayer Perceptron, Support Vector Machine and Decision Tree. The model with the highest diagnostic accuracy will be selected, on which the algorithm will be tested.The outcome of this study will be the development and validation of an algorithm for identifying various cardiac and cardiac-associated pathologies based on the analysis of single-channel ECG parameters. The development of a medical-use program will also be undertaken.Study endpoints: • Single-channel ECG parameters that significantly correlate with the presence of various cardiac and cardiac-related pathologies; • Sensitivity, specificity, and diagnostic accuracy of multivariate models for analyzing single-channel ECG data; • Diagnostic accuracy of the algorithm when tested on a test sample of patients." NCT02911792,Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration,"Inclusion Criteria: * Newly diagnosed, drug naïve, hyperfiltering and normofiltration patients with type 2 diabetes mellitus (T2DM) * Hyperfiltration is defined by GFR \>135 ml/min•1.73m2 * Normofiltration by a GFR = 90-134 ml/min•1.73m2 * BMI = 20-45 kg/m2 * HbA1c = 7.5% to 12% * Willingness to participate in the 16 week study protocol * Hematocrit \>34% --BP \< 145/90 mmHg Exclusion Criteria: * \> 300 mg/day albumin excretion * Ingestion of medications known to interfere with the renin-angiotensin system or renal function, including diuretic therapy * Hospitalization for unstable angina, history of recent macrovascular (MI/stroke/TIA/ACS) disease, coronary artery revascularization (within 2 months prior to enrollment) * Proliferative diabetic retinopathy * History of cancer or major organ system disease * New York Heart class II-IV heart failure Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3x ULN or total bilirubin \> 2.0 mg/dL (34.2 µmo/L) * Treatment with steroids, beta blockers, alpha blockers, antiobesity drugs * Pregnant or nursing mothers * Premenopausal females who are not practicing acceptable contraceptive methods Participation in another trial with an investigational drug within 30 days Alcohol or drug abuse within the preceding 6 months * Any condition, psychiatric or medical, which in the opinion of the investigator would interfere with the successful completion of the study * Orthostatic hypotension (\> 15/10 mmHg decrease upon standing for 3 minutes) * Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen, Hepatitis C virus antibody and HIV * Volume depleted patients * Estimated glomerular filtration rate \<60 mL/min•1.73m2. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status","Hyperfiltration is a characteristic feature in experimental models of diabetes and is causally related to an increase in intraglomerular pressure. In newly diagnosed diabetic patients, both type 1 and type 2, hyperfiltration and enlarged kidney size commonly are observed, and these hemodynamic/anatomic abnormalities are associated with an increased risk for the development of diabetic nephropathy. In poorly controlled diabetic individuals, the filtered load of glucose is markedly increased and glucose - with sodium - reabsorption by the SGLT2 transporter in the proximal tubule is augmented. As a consequence sodium delivery to the macula densa is reduced, making the kidney think that it is under perfused and this results in afferent renal arteriolar vasodilation. The efferent arteriole of the hyperfiltrating diabetic kidney also is hypersensitive to angiotensin II despite the absence of systemic RAS activation. The net result of these hemodynamic changes is an increase in intraglomerular pressure and hyperfiltration. Further, angiotensin is a potent growth factor and contributes to the increase in size of individual glomeruli and total kidney size. Since the intraglomerular pressure is related to the radius (r3) by the Law of LaPlace, the increase in glomerular size also contributes to hyperfiltration. Based upon the preceding sequence, it follows that a drug that blocks glucose, along with sodium, reabsorption in the proximal tubule would enhance sodium delivery to the macula densa, cause afferent renal arteriolar constriction, reduce intraglomerular pressure/hyperfiltration, and decrease kidney size. In hyperfiltering diabetic patients with microalbuminuria, the investigators also would expect the microalbuminuria to decrease. Consistent with this scenario, animal studies have documented that both acute and chronic inhibition of SGLT2 decreases hyperfiltration and prevents diabetic nephropathy. A recent study in hyperfiltering type 1 diabetic patients treated with empagliflozin has provided additional support for the tubular glomerular feedback hypothesis. The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated group will serve as controls for improved glycemic control, since the investigators have shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM patients" NCT03674944,FRESH-TEEN: Families Responsibility Education Support Health for Teens,"Inclusion Criteria: * Adolescent age 13-16 years * BMI percentile 85%85%-99.9% (adolescent only) * Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent) Exclusion Criteria: 1. Current enrollment in a weight management program (Child and Parent); 2. Medication that is specifically prescribed for weight loss (Child and Parent); 3. Medical or psychiatric condition that may interfere with treatment participation (Child and Parent); 4. Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent); 5. Current pregnancy or lactating (Child and Parent); 6. Change in psychotropic medication during the previous three months (Child and Parent).","The study will compare the efficacy of BWL + ER and BWL. Investigators will provide 6 months of treatment (BWL + ER or BWL) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit adolescents with overweight and obesity and their parents. Dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). Assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. This program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions. We are currently offering online treatment groups to accommodate the CDC health and safety guidelines." NCT03302234,Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598),"Inclusion Criteria: * Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer version 8) * Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by investigator * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has a life expectancy of at least 3 months * Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study therapy * Female participants of reproductive potential must agree to use contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication Exclusion Criteria: * Has received prior systemic chemotherapy/other targeted or biological antineoplastic therapy treatment for their Stage IV metastatic NSCLC * Has a tumor that harbors an epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation or an anaplastic lymphoma kinase (ALK) translocation * Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy * Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti- Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137) * Has received prior radiotherapy within 2 weeks of start of study therapy or received lung radiation therapy of \>30 Gray (Gy) within 6 months of the first dose of study therapy * Has recovered from all radiation-related toxicities, does not require corticosteroids, and has not had radiation pneumonitis * Is receiving systemic steroid therapy ≤7 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers * Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (i.e., doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy * Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease * Has had an allogeneic tissue/solid organ transplant * Has received a live vaccine within 30 days prior to the first dose of study therapy * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of hepatitis B or known active hepatitis C virus infection * Has a known history of active tuberculosis * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial * Is a regular user of any illicit drugs or had a recent history of substance abuse * Is pregnant or breast feeding or expecting to conceive starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication * Has severe hypersensitivity to pembrolizumab and/or any of its excipients and/or to ipilimumab and/or any of its excipients * Has a c-ros oncogene 1 (ROS1) mutation",N/A NCT01845064,A Study to Evaluate the Safety and Effectiveness of DM199 in Healthy Subjects and Type 2 Diabetes Patients,"Inclusion Criteria: 1. Status : Parts A and C: healthy subjects * Parts B and D: type 2 diabetes mellitus patients : 2. Body Mass Index : Parts A and C: 18.0 - 30.0 kg/m2 * Parts B and D: 25.0 - 35.0 kg/m2 3. HbA1c : Parts B and D: at screening between 6.5% and 9.0%, inclusive for patients using one oral anti-diabetic medication, and between 6.0% and 8.5%, inclusive for patients using two or more oral anti-diabetic medications 4. Fasting blood glucose : Parts B and D: within 7.5-13.5 mmol/L, inclusive at entry into the clinical research center (Day -1 for Part B or Day -2 for Part D) 5. Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm) until 90 days after the follow-up visit. For males: willingness to use adequate contraception from entry in the clinical research center until 90 days after the follow-up visit 6. Medical history without clinically significant abnormalities 7. Parts B and D: Taking a stable dose of one or more oral anti-diabetic medications, such as metformin, sulphonylurea or any other orally administered glucose lowering medication (except for thiazolidinediones) for at least 3 months prior to screening. Receiving no other chronic medications, including dietary supplements, that alter blood glucose control. 8. Parts A and C: Resting supine blood pressure of 140/90 mmHg or lower and higher than 90/50mmHg at screening, and showing no clinically relevant deviations as judged by the Principal Investigator 9. Parts B and D: Resting supine blood pressure of 160/100 mmHg or lower and higher than 90/50mmHg at screening, and showing no clinically relevant deviations as judged by the Principal Investigator Exclusion Criteria: 1. Evidence of clinically relevant pathology 2. Pregnancy or lactation 3. For healthy volunteers: use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research center (after that time the use of a limited amount of acetaminophen is permitted after consultation with the Principal Investigator). Multivitamins and vitamin C are allowed up to 7 days before entry into the clinical research center. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to entry into the clinical research center. 4. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study) 5. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol) 6. Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) 7. Positive screen on HBsAg, anti-HCV or anti-HIV 1/2 8. Illness within 7 days prior to (the first) drug administration 9. Serum creatinine \> upper limit of the normal (ULN) range Additional Exclusion Criteria Specific to Type 2 Diabetes Mellitus Patients (Part B and Part D) 10. The use of insulin and thiazolidinediones for type 2 diabetes mellitus 3 months prior to screening is not allowed. 11. The use of angiotensin converting enzyme (ACE) inhibitors 1 month prior to screening is not allowed. 12. History of diabetic ketoacidosis or hyperosmolar coma 13. Advanced diabetic complications, including neuropathy, nephropathy, retinopathy or other symptoms","DM199 (recombinant human tissue kallikrein-1) is being developed as a new biological treatment for type 2 diabetes mellitus. This is a first-in-human study for DM199 and is a 4-part, single center study in healthy subjects and type 2 diabetes mellitus patients. Part A will be a randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and/or female subjects. Subjects will receive DM199 or placebo subcutaneously (sc). Part B will be a randomized, partially double-blinded, placebo-controlled, sequential SAD study in male and/or female type 2 diabetes mellitus patients. Part C will be a randomized, double-blinded, placebo-controlled, 14-day multiple ascending dose (MAD) study in healthy male and/or female subjects each. Subjects will receive sequential doses of DM-199 or placebo sc for 14 days. Part D will be a randomized, double-blinded, placebo-controlled, 28-day multiple-dose proof of concept (POC) study in male and/or female type 2 diabetes mellitus patients. Subjects will receive parallel doses of DM199 or placebo sc for 28 days. The primary objective is to evaluate the safety and tolerability of single and multiple subcutaneous doses of DM199 in healthy subjects and type 2 diabetes mellitus patients. Another objective is to determine the plasma pharmacokinetic profile of DM199 after administration of single and multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients. Secondary objectives include determining the effect of DM199 on glucose homeostasis (via fasting glucose and HbA1c levels), standardized meal tolerance test, C-peptide, fructosamine, GLP-1 (active and total), glucagon, adiponectin and lipids measurements, and homeostatic model assessment of insulin resistance/beta cell function (HOMA) determination in type 2 diabetes mellitus patients; assessing the formation of antibodies to DM199 after administration of multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients; and determining changes in immune cell populations by fluorescence-activated cell sorting analysis following multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients" NCT07042399,Self-care Behaviors of Type 2 Diabetes Mellitus Patients,"Inclusion Criteria: * Diagnosis of type 2 diabetes; * Age over 18 years old; * Adequate comprehension of the Italian language; * Signed and dated informed consent. Exclusion Criteria: * Presence of documented psychiatric or neurodegenerative disease; * Pregnancy; * Any condition that, by the investigators' judgment, may limit adherence to study procedures",N/A NCT02559232,An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers,"Inclusion Criteria: * Patients ≥18 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres. * Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent). * Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care. * Patients who have given their informed consent in writing. Exclusion Criteria: * Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent. * Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires. * Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant .",N/A NCT00950963,Nurse Telephone Management of Cholesterol in Diabetes,"Inclusion Criteria: 1. Patients included in Denver Health diabetes registry. 2. Type I and Type II diabetic patients 3. Age \>17 years old 4. Actively utilizing Westside Clinic for their primary care (at least two visits in the past year) 5. Speak either English or Spanish. Exclusion Criteria:We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria: 1. Pregnant or lactating women 2. Patients with end-stage renal disease (creatinine \> 3.0 mg/dl) 3. Patients with a co-morbid illness with life expectancy less than 12 months, (e.g. terminal cancer or Child's Class C hepatic cirrhosis).","This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and 381 to participate in our nurse run program. Three registered nurses learned algorithms for diabetes care. These algorithms address management of lipids, glycemic control, blood pressure, nephropathy, aspirin use, eye screening, pneumovax and influenza vaccines, obesity, and cigarette smoking. The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management. The primary goal was to improve lipid control in our diabetic population. Secondary outcomes address blood pressure control, glycemic control, renal function, and medication adherence. In addition, a cost-effective analysis is being performed." NCT04135287,Relationship Between Improvement in Insulin Secretion and Decrease in HbA1c in GLP-1 RA Therapy in T2DM Patients,"Inclusion Criteria: 1. age 21-75 years 2. BMI=18-45 kg/m2 3. HbA1c \>7.% and \<14.0% 4. Subjects must be on stable antihyperglycemic therapy during the 3 months prior to enrolment. 5. Good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, lipid profile. 6. Stable body weight (± 3 lbs) over the preceding three months 7. Not participate in an excessively heavy exercise program. Exclusion Criteria: 1. Subjects receiving therapy with GLP-1 RA or received in the past 3 months. Subjects who received GLP-1 therapy \> 3 months prior to the study are eligible to participate if their body weight has returned to the pretreatment level. 2. Subjects receiving DPP4 inhibitors or who received DPP4 inhibitor in the 3 month preceding the study. Subjects on DPP4 inhibitors who are interested in switching therapy to GLP-1 RA must have 3 months washout period. 3. Haematocrit \< 32.0 4. history of thyroid cancer or pancreatitis, 5. Creatinine \> 1.5 mg/dl, 6. history of malignant disease, 7. Pregnancy. 8. Congestive heart failure","Study Design: Eligible subjects will receive the following: (1) medical history and physical examination, (2) Measurement of general chemistry, CBC, HbA1c, TSH, and (3) 75 grams OGTT. After completing the OGTT, subjects will be randomized to receive for 6 months, in an open label fashion: (1) weekly exenatide (bydureon) 2 mg per week (n=105); (2) liraglutide 1.8 mg per day (n=105); or (3) dulaglutide 1.5 mg per week (n=105). Liraglutide will be started on 0.6 mg/day and dulaglutide will be started at 0.75 mg/week and the dose will be increased to the maximal tolerated dose according to the patient response. During the treatment period, subjects will be seen monthly for follow-up visits. Each visit, medical history, physical examination will be performed. Body weight, blood pressure, FPG, Insulin, C-Peptide, glucagon, and HbA1c will be measured. At the end of 6-month treatment period, the OGTT will be repeated. Patient will be asked to bring the injection device at each monthly follow-up visit, and patient's compliance will be examined. Subjects with compliance rate \<80% will be dropped off the study by the PI and other patient will be recruited to replace him MATERIAL AND METHODS Screening: During this visit a complete medical history and physical exam will be performed. Blood will be drawn for general chemistries, lipid profile, complete blood count (CBC), and thyroid function tests (TSH and T3, T4). An additional 30 ml blood will be drawn and immediately frozen for the measurement of adipocytokines (adiponectin, TNF-alpha, IL6, resistin, leptin and hsCRP) and DNA extraction. OGTT: All subjects will receive a 75 gram OGTT at 0800h after a 10-12 h overnight fast. Plasma glucose, insulin, C-peptide, GLP-1, GIP, glucagon, and FFA concentrations are measured at baseline (-15, -10 and 0 min) and every 30 min for 2 hours after glucose ingestion. Insulin sensitivity is calculated using the Matsuda Index (MI) of insulin sensitivity, which agrees closely with that measured with the euglycemic insulin clamp technique. The following indices of insulin secretion will be measured: early insulin response (ΔI0-30/ΔG0-30; ΔC-Pep0-30/ΔG0-30; ΔISR0-30/ΔG0-30) and total insulin response (ΔI0-120/ΔG0-120; ΔC-Pep0-120/ΔG0-120; ΔISR0-120/ΔG0-120), where ISR = insulin secretory rate calculated by plasma C-peptide deconvolution. Beta cell function is assessed using the insulin secretion/insulin resistance (disposition) index and is calculated as (ΔI/ΔG x Matsuda index; ΔISR/ΔG x Matsuda index). Beta cell function during the OGTT also will be assessed using the Mari-Ferrannini model. This model expresses insulin secretion (in pmol min-1m-2) as the sum of two components: (i) beta cell glucose sensitivity which represents the dependence of insulin secretion on the plasma glucose concentration at any time point during the OGTT; (ii) rate sensitivity which represents the dependence of insulin secretion on the rate of change of plasma glucose. The ISR-plasma glucose dose-response curve is modulated by a potentiation factor that encompasses several potentiating mechanisms (prolonged exposure to hyperglycemia, non-glucose substrates, gastrointestinal hormones, neural modulation, time-dependent molecular/biochemical/enzymatic changes within the beta cell). In normal individuals, the potentiation factor typically increases from baseline to the end of the OGTT. During the OGTT, 20 ml blood will be drawn to extract DNA and genome wide association analysis will be performed to identify genetic markers associated with beta cell function." NCT01335087,Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA),"Inclusion Criteria: 1. Men and women over 18 years old. 2. Patients admitted for documented symptoms of ACS with or without T segment elevation and have an hospital stay between 24h and 72 h in the moment to perform polygraphy . 3. Patients with and Epworth Sleep Scale score ≤ 10 (patients without excessive daytime sleepiness). 4. Written informed consent signed. Exclusion Criteria: 1. Previous CPAP treatment for OSA diagnosis 2. Psycho-physical inability to complete questionnaires. 3. Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome 4. Patients with \> 50% of central apneas or the presence of Cheyne-Stokes Respiration (CSResp) 5. Patients with chronic diseases: neoplasia, renal failure (GFR\<30 ml/min), severe chronic obstructive pulmonary disease, chronic depression and other very limiting chronic diseases. 6. A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions. 7. Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance). 8. Any process, cardiovascular or otherwise, that limits life expectancy to less than one year. 9. Patients in cardiogenic shock who have poor expectations for short-term outcomes.","Methods: Study design: multi-centre, open label, parallel, prospective, randomised, controlled trial. Patients: We will include consecutive patients with an ACS diagnosis evaluated in participating Coronary Care Unit. Study sites: IRB Lleida (Lleida), Hospital Son Dureta (Palma de Mallorca), Hospital Clínic (Barcelona), Hospital Germans Tries i Pujol (Barcelona), Hospital de Bellvitge (Barcelona), Hospital Sant Pau (Barcelona), Hospital Txagorritxu (Vitoria), Hospital de Cruces (Bilbao), Hospital San Pedro de Alcántara (Cáceres), Hospital Parc Taulí (Barcelona) and Hospital de Guadalajara (Guadalajara), Hospital de Vallecas (Madrid), Hospital de Yagüe (Burgos), Hospital de Requena (Valencia), Hospital San Juan, (Alicante), Hospital Central de Asturias (Oviedo). Duration of the study: 3 years. Methodology: During a hospital stay we will assess the degree of daytime sleepiness (Epworth Scale) in patients treated at the Coronary Care Unit with a diagnosis of ACS. The results of this evaluation will define the inclusion of the patient in the study. Patients with and ESS score ≤ 10 will be included in the study and will undergo a cardio-respiratory polygraphy. Patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment or conservative. Patients with and AHÍ \< 15 h-1 will be followed as standard management according to cardiovascular protocols and will be evaluated as a reference group. Therefore, the study will have three groups, with a total of 1,864 patients, as follows: patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment (Group 1) (n=632) or conservative treatment (Group 2) (n=632). Patients with an AHI \< 15 h-1 that will be followed as a reference group (Group 3) (n=600). Patients with an ESS score higher than 10 will be excluded of the study and referred to the sleep unit of each participating center for evaluation. Patients included in the study will be monitored and followed for a minimum of one year and a maximum of three years. Patients will be examined at the time of inclusion (T0), after one month (T1), three months (T2), six months (T3), 12 months (T4) and every six months thereafter, if applicable, during the follow-up period. Evaluations will include; i)new episodes of ACS, stroke, TIA, heart failure, hospitalization for cardiovascular causes and cardiovascular mortality, ii) biological risk markers involved in cardiovascular complications, iii) an evaluation of the cost-effectiveness of diagnosis and CPAP treatment in patients with ACS who have obstructive sleep apnea." NCT00065793,VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors,Cases having first coronary event,"BACKGROUND: Plasma triglyceride concentration is an independent although relatively weak risk factor for coronary heart disease (CHD). The relative weakness of plasma triglycerides to predict CHD may be due to the substantial diversity of lipoprotein particles that carry the triglycerides, some being related to atherosclerosis and CHD more than others. The investigators have shown in patients who have had a myocardial infarction that the rather weak association between triglycerides and subsequent coronary events is secondary to a stronger relationship with specific types of VLDL remnants, those in the LDL density range that contain apoCIIl. DESIGN NARRATIVE: The study will evaluate VLDL and LDL particle types as predictors of initial coronary events in men from the Health Professional Follow-up Study (HPFS) and women from the Nurses Health Study (NHS). A prospective nested case-control design will be used with a total of 1000 CHD cases and 1000 matched controls, with equal numbers of men and women. The investigators will specifically investigate the role of apoCIII containing VLDL and LDL particles in diabetes by over sampling so that 50% of the patients will have type 2 diabetes mellitus. Their previous work shows that LDL apoCIII particles are independent predictors of recurrent CHD in diabetic patients who survived a myocardial infarction. They hypothesize that apoCIII may have a special role in dyslipidemia and CHD in diabetes. Secondary Aims: Besides apoCIII, other small apolipoproteins, apo C1, CII, and All are components of VLDL and LDL and modulate the metabolism of apoB lipoproteins. It is likely that these apolipoproteins have a relationship with human atherosclerosis. They will measure these apolipoproteins in VLDL and LDL and evaluate their relationship to CHD. They will also investigate the associations between these new lipoprotein risk factors and intake of foods and nutrients, physical activity, and other risk factors, including smoking, BMI, age and gender. The results will provide new means to identify nondiabetic and diabetic persons who are at high risk of developing CHD and the environmental determinants, and could form the basis for new lipoprotein targets for lipid management by diet and medicines." NCT06570993,Assessing the Effects of Cool Roofs on Indoor Environments and Health in Niue,"Inclusion Criteria: Participant criteria: * Consenting adults aged 18 years and over. * Expected to be available to participate in the study for at least nine months in the next 12 months. Household criteria: * House has a metal roof. * House is single-story. Exclusion Criteria: Household criteria: * Unstable house structure that does not permit the application of cool roof materials. * Inaccessible by the research team. * Significant roof damage defined as any penetrative roof defect that results in a hole in the roof OR over 25% of the roof rusted.","Increasing heat exposure from climate change is causing and exacerbating heat-related illnesses in millions worldwide - particularly in low resource settings. June 2024 was the 13th consecutive hottest month on record globally - shattering previous records. Heat exposure can instigate and worsen health conditions including cardiovascular, metabolic, endocrine and respiratory disease, heat-related illnesses, pregnancy complications, and mental health conditions. Adaptation is essential for protecting people from increasing heat exposure. The built environment, especially homes, are ideal for deploying interventions to reduce heat exposure and accelerate adaptation efforts. However, there currently is a lack of evidence on a global scale - generated through empirical studies - guiding the uptake of interventions to reduce heat stress in low resource settings. Pacific Islands and other small island developing states are among the most vulnerable to the adverse impacts of climate change and are likely to experience increases in ambient air temperature over the coming decades. People in Niue are exposed to heat and humidity year-round. The Pacific Islands have a large burden of non-communicable diseases (NCDs), with nearly three-quarters of deaths due to NCDs. The combined burden of heat and NCDs places Pacific Island populations at greater risk of adverse health effects from heat extremes. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and lower energy use, offering protection to home occupants from extreme heat. The investigators therefore aim to conduct a cluster-randomized controlled trial investigating the effects of cool-roof use on health, environmental and economic outcomes in Niue. The trial will quantify whether cool roofs are an effective passive home cooling intervention with beneficial health effects for vulnerable populations in Niue. Findings will inform regional policy responses on scaling cool roof implementation to protect people from increasing heat exposure driven by climate change." NCT01135914,"Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)","Inclusion Criteria: * Stable Type 1 or Type 2 diabetes mellitus * Visual impairment due to focal or diffuse DME in at least one eye Exclusion Criteria: * Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment * Active eye infection or inflammation * History of stroke, renal failure or uncontrolled hypertension Other protocol-defined inclusion/exclusion criteria may apply",N/A NCT06443814,Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women,"Inclusion Criteria: * African American women, * 55 years or older with at least one of the five cardiovascular conditions (below): Either/or: * coronary heart disease or * positive coronary angiography or * previous MI or * coronary revascularization or * percutaneous transluminal coronary angioplasty (PTCA). OR a risk factor assessment score of at least two points based on the Framingham study/ATP III report. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking. Exclusion Criteria: Recent (last 3 months): * myocardial infarction * unstable angina * coronary artery by-pass grafting (CABG) * percutaneous transluminal coronary angioplasty (PTCA) * stroke within the preceding three months * carotid artery endarterectomy * atrial fibrillation * second or third degree AV block * heart failure * clinically significant valvular heart disease * major psychiatric disorders, * current alcohol/dependency disorder * other drug abuse dependency disorder * non-cardiac life-threatening illness * participating in a formal stress management program * plans to move out of the study area or travel extensively * unwillingness to accept randomization into any study group.","This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women \>55 years with CVD or at high CVD risk over a one-year intervention and follow-up period. All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use)." NCT04657016,A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program,"Inclusion Criteria: * Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease * History of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: * Diabetes mellitus * Change in body weight greater than 5 kg within 3 months prior to starting study * Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * History of pancreatitis * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt",N/A NCT01326533,Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes,"Inclusion Criteria: 1. Age \> or = 18, able to provide informed consent 2. Body-mass index greater than or equal to 25 3. Presence of at least one indicator of insulin resistance from the following list: * Family history of Type 2 diabetes (parent, sibling) * Fasting glucose 100 - 125 mg/dl * Fasting serum insulin greater than or equal to 7uU/ml * Personal history of gestational diabetes 4. Negative pregnancy test for women with childbearing potential Exclusion Criteria: 1. Diagnosis of diabetes mellitus Type 1 or Type 2 2. Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity 3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months 4. Known allergy or intolerance to HCQ 5. Known glucose-6 phosphate dehydrogenase deficiency 6. Known eye disease associated with retinal pigmentation abnormalities 7. Known diabetic retinopathy requiring past or planned laser therapy 8. Inability to comply with visit schedule and protocol requirements 9. Inability to manage and take medication as instructed 10. Current or planned pregnancy in upcoming 12 months 11. Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment 12. Anemia (HGB \< 9) 13. Any history of bariatric (weight loss) surgery 14. Current use of the medication Glucophage (metformin) 15. Weight changes of 6 pounds or more in the past 4 weeks 16. Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk",Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism. NCT01795833,Diabetes Prevention Using SMS Technology,"Inclusion Criteria: * Adults 18 yrs or over and less than 75 yrs * HbA1c between 6.0-6.4% Exclusion Criteria: * Pregnant or planning pregnancy * Breastfeeding * Enrolled in other clinical trials * Have active malignancy or under investigation for malignancy * Are unable to follow the protocol for any other reason","Recruitment: * Target recruitment number will be 1834 in total (1134 for India and 700 for UK). * In India people at risk will be ascertained using the Indian Diabetes Risk Score followed by measurement of a single blood sample to assess glucose regulation (HbA1c) in those with high scores. * In the UK, high risk subjects will be ascertained from the National Health service (NHS) Health Check Scheme and from routine screening in primary care; UK recruitment will also be based on HbA1c. Trial Design: 1. Visit 1 (Screening) * Potential subjects will be invited to clinic for screening to determine their prediabetic state (defined as an HbA1c of 6.0-6.4%)and suitability to take part in the study. * Screening involves clinical measurements, physical measurements and laboratory measurements. Also, baseline questionnaires will be carried out at this visit. * ActiGraph, physical activity monitoring device will be fitted on that is to be kept for 7 days. 2. Visit 2 (Education and Randomization) * One-to-One structured education on healthy lifestyle will be given to all successfully screened subjects. * The subjects then will be randomized using computer generated numbers either to usual care (control arm) or usual care with text messaging (intervention arm). 3. Visit 3 (6 month follow up), Visit 4 (12 month follow-up) and Visit 5 (24 month follow-up) - each visit involves * clinical measurements, physical measurements and laboratory measurements * Questionnaires * Fitting ActiGraph on subject Data: * During the course of the study visits some data will be stored on laptop computers, not connected to the internet, for later statistical analysis. These data will be coded and non identifiable. * Participant data will be stored in a locked filing cabinet in a secure room in Imperial College Healthcare NHS Trust. Only the research team (clinical research fellow and research nurse) will have access to the filing cabinet. * At the end of each visit the anonymised data will be transferred immediately to the secure NHS computers and will be deleted from the laptop. Access to NHS computers is only by members of NHS staff with appropriate log in privileges. * All data will be stored in an anonymised form by using study numbers for identification of participants. * The NHS code of confidentiality will be followed and all activity will meet the requirements of the data protection act. * Only members of the clinical research team and those responsible for direct care will have access to subjects' data during the study. * The data generated by the study will be analyzed by the research team from Imperial College. The analysis will be on anonymised data and will take place in Imperial College Healthcare NHS Trust and in Imperial College academic buildings in the Faculty of Medicine. Direct Access to Source Data/Documents: \*The investigator(s)/institution(s) will permit trial-related monitoring, audits, and regulatory inspection(s), providing direct access to source data/documents. Statistics: * Sample size is based on previous data from the Indian Diabetes Prevention studies. We estimate that the two year conversion rate to diabetes in the control group will be 25%. A total of 1134 individuals per group are required across both countries to detect a 20% reduction in risk of progression with 80% power at 5% significance. A study of this size will be able to address the question of whether, overall, the text messaging system is effective in reducing progression to diabetes in high risk individuals. It will not be sufficiently powered to address this question in each country separately, nor to detect differences of effect between them. However, a study of this size is extremely well powered to detect an impact on the continuously distributed secondary outcome of moderate to vigorous physical activity (MVPA) as assessed by Actigraph. The standard deviation of MVPA in the ProActive trial was 17 minutes per day. Thus the study overall has \>99% power to detect a difference of 4 minutes per day of extra walking between groups. It will be possible, therefore, to examine country specific effects of the intervention on MVPA * Missing, unused, and spurious data will be assessed on an individual basis and may be ignored, withdrawn or the visit may be removed from the analysis with appropriate justification adjudicated by the Principal Investigator. * Data will be analyzed using parametric and nonparametric statistical methods for the primary and secondary outcomes. Regulatory Issues: * Ethics Approval The Chief Investigator has obtained approval from the Westminster Research Ethics Committee. Local Research and Development(R\&D) Approval at each participating NHS Trust is also required before accepting participants into the study. The study will be conducted in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. * Consent to enter the study must be sought from each participant only after a full explanation has been given, an information leaflet offered and time allowed for consideration. Signed participant consent should be obtained. The right of the participant to refuse to participate without giving reasons must be respected. All participants are free to withdraw at any time from the protocol treatment without giving reasons and without prejudicing further treatment. * The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. * Indemnity Imperial College London holds negligent harm and non-negligent harm insurance policies which apply to this study. * Imperial College Academic Health Science Centre will act as the main Sponsor for this study. Delegated responsibilities will be assigned to the NHS trusts taking part in this study. * The study may be subject to inspection and audit by Imperial College London under their remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS Research Governance Framework for Health and Social Care (2nd edition)." NCT02760433,"Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease","Inclusion Criteria: Subjects may be enrolled in the study only if they meet all of the following criteria. * Subjects willing and able to sign informed consent * Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 24 weeks prior to Screening. (If the subject was diagnosed according to ACR 1987 criteria previously, the Investigator may classify the subject per ACR 2010 retrospectively, using available source data.) * Treatment with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) * The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening. * Subjects must be willing to take folic acid or equivalent throughout the study. * Subjects must have moderately to severely active RA disease as defined by all of the following: * ≥6 tender joints (68 joint count) at Screening and baseline; and * ≥6 swollen joints (66 joint count) at Screening and baseline; and * C-reactive protein (CRP) above Upper limit of normal (ULN) at Screening based on the central laboratory results. * Subjects must have a documented inadequate response to treatment (i.e., TNFi failure) with ≥1 licensed TNFi following at least 12 weeks of therapy with that agent. Inadequate response to treatment is classified as either: * Primary failure: The absence of any documented clinically significant response; or * Secondary failure: Documented initial response with subsequent loss of that response or partial response Exclusion Criteria: * Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus) (However, subjects may have secondary Sjogren's syndrome or hypothyroidism.) * Subjects who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care) * Prior exposure to any licensed or investigational compound directly or indirectly targeting Interleukin (IL) 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase \[SYK\] inhibitors) * Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) with the exception of rituximab, which is allowed if it was discontinued at least 24 weeks prior to baseline (rituximab should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA). * Prior use of bDMARDs, within the following windows prior to baseline (bDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA): 1. 4 weeks for etanercept and anakinra 2. 8 weeks for infliximab 3. 10 weeks for adalimumab, certolizumab, and golimumab 4. 12 weeks for abatacept * Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline * Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline * Prior documented history of no response to hydroxychloroquine and sulfasalazine * Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA): 1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline 2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours 3. 24 weeks for cyclophosphamide * Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study * Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline * Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline * Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline * Use of non steroidal anti inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline * Previous participation in this study (randomized) or another study of OKZ * Subjects with concurrent acute or chronic viral Hepatitis B or C infection as detected by blood tests at Screening (e.g., positive for hepatitis B surface antigen \[HBsAg\], total hepatitis B core antibody \[anti-HBc\], or hepatitis C virus antibody \[HCV Ab\]) a) subjects who are positive for hepatitis B surface antibodies (anti-HBs), but negative for HBsAg and anti-HBc, will be eligible. * Subjects with HIV infection * Subjects with: 1. Suspected or confirmed current active tuberculosis (TB) disease or a history of active TB disease. 2. Close contact (i.e., sharing the same household or other enclosed environment, such as a social gathering place, workplace, or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening * Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to Screening \[and no more than 3 excised skin cancers within the last 5 years prior to Screening\]) * Subjects with any infection requiring oral antibiotic or antiviral therapy in the 2 weeks prior to Screening or at baseline, injectable anti-infective therapy in the last 4 weeks prior to baseline, or serious or recurrent infection with history of hospitalization in the 6 months prior to baseline * Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline * Subjects with planned surgery during the study or surgery ≤ 4 weeks prior to Screening and from which the subject has not fully recovered, as judged by the Investigator * Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with history of such predisposing conditions (e.g., diverticulitis, GI perforation, or ulcerative colitis) * Pre-existing central nervous system demyelinating disorders (e.g., multiple sclerosis and optic neuritis) * History of chronic alcohol or drug abuse as judged by the Investigator * Subjects with a known hypersensitivity to any component of the OKZ drug product or placebo * Subjects with a known hypersensitivity or contraindication to any component of the rescue medication * History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * Female subjects who are pregnant, currently lactating, have lactated within the last 12 weeks, or who are planning to become pregnant during the study or within 6 months of the last dose of study treatment * Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status \[e.g., correlative age\] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels \>40 mIU/mL and estradiol \<20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","The goal of this Phase III study was to assess the efficacy, safety and tolerability of OKZ in subjects with moderately to severely active RA who had responded inadequately to TNFi therapy. The primary endpoint of the trial was assessed at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period. This was a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. This study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety FollowUp Period from Week 24 to Week 44. A total of 350 subjects were planned to be randomized.Subjects were assessed for eligibility to enter the study during a 4-week Screening Period. Eligible subjects were randomized at Visit 2 in a 2:2:1 ratio in one of 3 treatment groups (planned 140, 140, and 70 subjects per group, respectively) : 1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX for 24 weeks, 2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX for 24 weeks or 3. Placebo: SC injection of placebo q2w + MTX for 16 weeks. Subjects who received placebo were re-randomized at Week 16 to receive 64 mg OKZ q4w + Methotrexate or 64 mg OKZ q2w +Methotrexate for 8 weeks. Throughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX with a stable route of administration. Concomitant treatment with folic acid was required for all subjects. The last dose of OKZ was administered at Week 20 for subjects receiving OKZ 64 mg q4w and at Week 22 for subjects receiving OKZ 64 mg q2w. Following Visit 2 (randomization; Week 0), subjects returned to the study site at least every 2 weeks through Week 24 for response and safety assessments. At Week 14, subjects who did not improve by at least 20% in both swollen and tender joint counts were classified as nonresponders and were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment. After completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment. Subjects who discontinued randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continue with the scheduled study visits. Adverse events (AEs) were assessed throughout the study (starting when the subject signed the informed consent form) and evaluated using the Common Terminology Criteria for Adverse Events Version 4.0. There was ongoing monitoring of safety events, including laboratory findings, by the Sponsor or the Sponsor's designee. In addition, safety was assessed throughout the study by an independent Data Safety Monitoring Board and potential major adverse cardiac events were evaluated by an independent Cardiovascular Adjudication Committee. The study was conducted at 123 sites across 11 countries globally (in US,EU, Russian Federation, Asia, Latin America)" NCT02237352,Mechanisms of Diabetic Nephropathy in Ecuador,"Inclusion Criteria: * adults, * age between 21 and 70 years old, * persons able to sign informed consent, * diabetics without diabetic nephropathy, * diabetic with diabetic nephropathy, * not hospitalized, * not suffering acute disease, * living in their home for at least 6 months before to be contacted. Exclusion Criteria: * subjects with acute diseases, * subjects with not metabolic compensation, * persons temporarily residing in the place of contact, * younger than 21 years old, * older than 70 years old.","1. Determinations of social, environmental and biological factor implicated in diabetic nephropathy in Ecuador Investigators will study subjects from the general population. Investigators will contact community and religious leaders in order to invite adult subjects from the general population to participate in this study and 10000 persons will be enrolled. After teaching basic concepts about prevention of diabetic nephropathy in all subjects, investigators will collect demographics data, house conditions and localization (rural, urban or around the cities), number of people that share a home, education level, employment and economical condition, personal health insurance, medical checkup history, toxic habits (alcohol, cigarette abuse of addictive substances) and physical exercises habits. Investigators will collect personal and family antecedent of diabetes mellitus, diabetic nephropathy, hypertension, kidney diseases, diabetes gestational, current treatments and other chronic diseases. Investigators will measure body weight (Kg), height (m) and investigators will calculate body mass index. Investigators will also measure blood pressure, blood glucose, glycosylated hemoglobin, microalbuminuria and proteinuria. Trained personnel will fill out the person's survey. Investigators will supervise and collect data from 2% of the sample. 2. Role of extracellular matrix proteins and growth factors signaling in diabetic nephropathy 1. Systemic and urine studies: proteins involved in diabetic nephropathy pathogenesis as vascular endothelial factor A (VEGF) and extracellular matrix protein as tenascin C (tenascin) concentration will be measured by a commercially available kits in plasma and urine (respectively). Samples will be obtained from diabetics with (n: 20) and without diabetic nephropathy (n: 20) and from non-diabetic subjects (controls) from the general population (n: 2000). Determinations of social, environmental and biological factor will be completed as in aim 1. 2. Kidney tissue studies: investigators will determine the role of protein involved in diabetic nephropathy, VEGF signaling and tenascin in: I) Paraffin embedded kidney tissue obtained from the sample libraries of pathology laboratories will be studied. Slides from non-diabetics (n: 10) and diabetics with diabetic nephropathy (n: 20) and without diabetic nephropathy (n: 10) will be collected. The role of proteins involved in diabetic nephropathy as VEGF signaling and tenascin will be studied by immunohistochemistry and proximity link assay. II) Paraffin embedded kidney slides from diabetics with diabetic nephropathy (n: 12), non-diabetic control (n: 6) with primary glomerulopathy as minimal change disease, and diabetic controls without diabetic nephropathy (n: 6), will be studied. Investigators will recruit patients with kidney biopsy indicated, and scheduled to be performed, by their medical doctors. After pathology diagnosis completion, some of the remnant paraffin embedded tissue will be used for this study. The role of proteins involved in diabetic nephropathy, VEGF signaling and tenascin will be studied by immunohistochemistry and proximity link assay. Urine and plasma will be collected prior to the kidney biopsy in order to measure protein concentration of potentially useful biomarkers of diabetic nephropathy; VEGF and tenascin levels will be quantified. Patients will be informed and signed consent will be required. Blood glucose will be measured by the blood glucose meter and test strip. Glycosylated hemoglobin A1c and microalbuminuria (albumin/creatinine in spot urine) will be quantified using the portable machine (Siemens). In fasting conditions investigators will consider normal blood glucose values \<99 mg%, pre-diabetes between 100 and 125 mg% and diabetes ≥126 mg%. In non-fasting conditions values of blood glucose \>200mg% will be considered as diabetes. Investigators will deem normal glycosylated A1c hemoglobin values \<5.6 %, pre-diabetes between 5.7 and 6.4% and diabetes ≥6.5%. Investigators will deem normal albuminuria values of albumin/creatinine ratio \<29mg/g, microalbuminuria values between 30 and 299 mg/g and macro-albuminuria values ≥300mg/g. Proteinuria will also be evaluated by reactive urine strips. In the case of inconsistent results or out of range values the analysis will be repeated in the same sample or re analyzed by standard laboratory equipment and techniques. Investigators will consider diabetic nephropathy as persistent proteinuria associated to diabetic retinopathy and decreased endogen glomerular filtration rate (in subjects without a diagnosis of other kidney or urinary tract diseases). In Type 1 diabetics, diabetic nephropathy will be diagnosed if the history of diabetes is longer than 10 years prior to the onset of proteinuria; in diabetic type 2, proteinuria associated to a decreased glomerular filtration rate at diagnosis time, investigators will deem diabetic nephropathy. In all paraffin embedded kidney samples we will measure the protein expression and localization. Investigators will use kits, primary and secondary antibodies commercially available to perform immunohistochemistry and proximity link assay. Investigators will perform those experiments in cooperation with pathologist. All subjects recruited from general population will be identified by a unique code. Number and capital letters code will be placed in the survey and in the sample labels as M0001 (M: city, number 0001: person number 0001). Data will be uploaded and saved in a secure data base. Trained personnel will be in charge of handling the data base. Investigators will supervise the data entry. An investigator at least once every 6 months will randomly select 2% survey and will match it against the information uploaded in the database. Furthermore, investigators will analyze and report all collected data from the surveys even if they are incomplete by adjusting the analysis parameters of the incomplete ones. Investigators will use descriptive statistic tools to describe groups (mean, standard deviation and standard error or median and interquartile range). For group comparisons, unpaired T test, Mann Whitney or Fisher's test will be used. ANOVA, Kruskal Wallis and Chi Square test will be performed for to compare unmatched groups; to quantify association between two variables Pearson and Spearman correlation test will be used. Simple or multiple regressions will be considered to predict value from variables. P value \<0.05 will be deemed significant. A sample from the general population was calculated considering the adult population between 21-70 years old in Ecuador." NCT04088552,Preventing Chronic Disease: ActuaYa,"Inclusion Criteria 1. Must self-identify as a Hispanic woman 2. Must be aged 50 years or older 3. Must not already be engaging in exercise for \>150 minutes per week 4. Must be able to ambulate without the use of assistive devices 5. Must have an intelligent phone iOS or Android 6. Must be willing and able to participate in the informed consent process. Exclusion Criteria 1. Participants that do not meet the above-mentioned criteria. 2. In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate. 3. Participants who are currently participating in another investigational study. 4. Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.",N/A NCT04256447,High Salt Intake Unrelated to Obesity in Diabetes,"Inclusion Criteria: * Type 1 Diabetes Mellitus Exclusion Criteria: * Patients with celiac disease, thyroid disease, other autoimmune diseases, concurrent illness, patients with diabetic nephropathy, other renal disease and in therapy with natriuretic drugs","Elevated sodium intake has been associated with hypertension, cardiovascular diseases and stroke, and decreasing sodium intake may reduce blood pressure and the risk of cardiovascular diseases (CVDs), leading cause of death in the world. Recent data on sodium intake show that populations around the world are consuming much more sodium than is physiologically necessary. Studies in children have reported positive associations between sodium intake and adiposity. The aim of our study was to evaluate in a population of children and adolescents with type 1 diabetes mellitus, possible correlations between the urinary sodium excretion (UNa24h), indirect marker of sodium intake, and both duration of diabetes and BMI z-score. Moreover we also evaluated the correlation between UNa24h and duration of diabetes according with the presence/absence of overweight/obesity." NCT01002547,Prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanics With Diabetes Mellitus Type 2 (T2DM) and Role of Treatment,"Inclusion Criteria: * Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent. * Subjects of both genders from within the Veterans Administration Healthcare System with an age range between 18 to 70 years (inclusive). * Have type 2 diabetes mellitus as defined by the American Diabetes Association guidelines. * Female volunteers must be non-lactating and must either be at least one year post-menopausal, or be using adequate mechanical contraceptive precautions (i.e. intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period. * The following laboratory values: * Hemoglobin at least 12 gm/dl in males or 11 gm/dl in females, WBC count 3,000/mm3 (neutrophil count 1,500/mm3) and platelets 100,000/mm3 * Albumin equal or greater than 3.0 g/dl * Serum creatinine less than 1.8 mg/dl * AST and ALT up to 3.0 times upper limit of normal and alkaline phosphatase 2.5 times ULN Exclusion Criteria: * Any cause of chronic liver disease other than NASH (such as -but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency). * Any clinical evidence or history of ascitis, bleeding varices, or spontaneous encephalopathy. * History of alcohol abuse (alcohol consumption greater than 20 grams of ethanol per day) or a positive AUDIT screening questionnaire. * Prior surgical procedures to include gastroplasty, jejunoileal or jejunocolic bypass. * Prior exposure to organic solvents such as carbon tetrachloride. * Total parenteral nutrition (TPN) within the past 6 months. * Subjects with type 1 diabetes mellitus. * Patients on chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for 4 weeks before entry into the study. * Patients on drugs known to cause hepatic steatosis: estrogens or other hormonal replacement therapy, tamoxifen, raloxifene, oral glucocorticoids, chloroquine and others. * Patients with a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or diagnosed pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation). * Patients with severe osteoporosis (-3.0 at the level of spine and hip). * Patients who have clinically significant acute or chronic medical conditions not specifically written in the protocol, but that based in the investigator's clinical judgment he/she considers unlikely that he will be able to complete study participation or that such participation may be potentially detrimental to his well-being.","Many NAFLD studies have found that the progression from ""benign"" steatosis to severe necroinflammation and cirrhosis as observed in NASH varies widely depending upon the initial stage at diagnosis, as well the presence or absence of specific risk factors associated with disease progression. The factors that promote necroinflammation and fibrosis development are complex, but are frequently associated with the presence of long-standing obesity, metabolic syndrome, and in particular, of T2DM. Indeed, hyperglycemia has been identified as the single most consistent factor for disease progression in many studies (Angulo et al, Hepatology 1999) Marceau et al, JCEM 1999; Luyckx et al, Obes Relat Metab Disord, 1998; Mofrad et al, Hepatology 2003; many others; reviewed by Cusi, Current Diabetes Reports, 2009). Given the worse prognosis of NASH in patients with T2DM, it is quite surprising that few studies have focused on the prevalence of the disease and on early screening and treatment of patients with diabetes for NASH. A prospective study conducted by Gupte et al (Gastroenterology \& Hepatology, 2004) reported biopsy-proven NASH in 87% of diabetics, 22% having moderate to severe disease. In a retrospective analysis of 44 patients with T2DM worked-up for NAFLD, Younussi et al also found that cirrhosis was more prevalent in diabetics vs. nondiabetics (25% vs. 10%, p\<0.001) (Hepatology 2004). In recent years, the diagnosis of fatty liver has been made easier with the standardization of liver magnetic resonance and spectroscopy (MRS) which has allowed a fast and highly reproducible test for NAFLD. With this screening tool we have found that NAFLD is present in \>80% of unselected patients with T2DM. In non-diabetic patients a handful of small studies with paired biopsies indicate that fibrosis progresses over time in 32-41% of patients with NAFLD (reviewed by Ali \& Cusi, Annals of Medicine, 2009). Obesity and T2DM were the 2 most prominent factors of poor prognosis, while elevated liver enzymes (ALT or AST/ALT ratio) were of lesser value (Mofrad et al, Hepatology 2003; Sorrentino et al, Hepatology 2004; Kunde et al, Hepatology 2005). This study aims at establishing the role of pioglitazone and of vitamin E in VA patients. Weight loss remains the standard of care because no therapy has conclusively proven to be effective in the long-term. Pharmacological therapies with modest effects have included pentoxifylline, orlistat, cytoprotective agents, ursodeoxycholic acid and lipid-lowering agents, while insulin-sensitizers such as metformin and thiazolidinediones have yielded more provocative results in small uncontrolled studies in NASH. Our research group recently demonstrated in a randomized, double-blind, placebo-controlled trial, that pioglitazone treatment for 6 months in patients with T2DM and NASH significantly improved glycemic control, glucose tolerance, insulin sensitivity and systemic inflammation (Belfort et al, NEJM 2006). This was associated with a \~50% decrease in steatohepatitis (p\<0.001) and a 37% reduction of fibrosis within the pioglitazone-treated group (-37%, p\<0.002), although this fell short of statistical significance when compared with placebo (p=0.08). Our results provided ""proof-of-principle"" that pioglitazone may be the first agent capable of altering the natural history of the disease. However, definitive proof requires establishing its safety and efficacy in a large number of subjects treated for a longer period of time. The CRN is conducting the PIVENS trial (www.ClinicalTrials.gov; NCT 00063622) examining the role of pioglitazone, vitamin E or placebo in NASH, but the study design excluded diabetics, only \~5% of patients were Hispanic and studied a younger population than that typical from VA Medical Centers. Also, this important multicenter trial did not perform the in-depth metabolic measurements this trial will carry out (i.e., insulin clamps with glucose turnover measurements, indirect calorimetry, etc.). Understanding the long-term impact of thiazolidinediones and of vitamin E in patients with NASH and T2DM, who are believed to be at the highest risk for liver disease progression, will have important implications not only for the treatment of NASH but for drug selection and treatment algorithms in T2DM, as an insulin-sensitizer approach of pioglitazone (in addition to metformin) would be preferred over therapies such as sulfonylureas or insulin, if proven to be effective to treat NASH in T2DM. However, currently the most common strategy to treat T2DM is an insulin secretion-based approach (i.e., sulfonylureas and/or insulin) that has little impact on liver fat and promotes weight gain without a major improvement in insulin sensitivity, promoting chronic hyperinsulinemia and self-perpetuating the metabolic milieu that promotes hepatic lipogenesis and fatty liver disease. Therefore, understanding the role of pioglitazone and vitamin combined, of vitamin e alone (plus pioglitazone placebo tablets as control) and compared to a third arm with placebo of both (pioglitazone and vitamin E) is important to move the field forward. Of note, the study started at the San Antonio VAMC, TX where \~60% of the population was Hispanic. However, once Dr. Kenneth Cusi (principal investigator) moved to the Gainesville VAMC, FL the study was transferred to Gainesville and recruitment continued in this new site where the prevalence of Hispanics is only 5% (75% Caucasians, 20% African American). Therefore, the final patient mix will reflect more the latter ethnic mix." NCT00536549,Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes,"Inclusion Criteria: * Type 2 diabetes * Group 1: HbA1c \< 8% with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months. * Group 2: HbA1c \>= 8% and the fasting blood glucose must be \< 130 at the same time with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months Exclusion Criteria: * Use of corticosteroids or hormone therapy within the last 6 months * Presence of another chronic illness","In diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use of SMBG has been shown to be associated with improved medication compliance and better metabolic control by several studies. However, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few seconds, without any information on glucose trends. So we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes. Few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes" NCT02851849,A Study of LGD-6972 in Patients With Type 2 Diabetes Mellitus,"Inclusion Criteria: 1. Female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy or bilateral tubal ligation), or naturally post-menopausal for at least 12 months and with a follicle stimulating hormone (FSH) level in the post-menopausal range (if not taking hormone replacement therapy) 2. Male subjects must either have a vasectomy or agree that they and any female partners will use 2 acceptable forms of contraception, one of which must be a condom, until 30 days after the last dose of study drug. Other acceptable forms of contraception include hormonal contraceptives that have been at stable dose for 12 weeks prior to randomization, intrauterine device, Depo-Provera®, Norplant® System Implants, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, and contraceptive sponge, foam, or jelly. Also, male subjects must not donate sperm during the study and for 30 days after the last dose of study drug 3. Willing and able to provide written informed consent 4. Diagnosis of T2DM according to American Diabetes Association criteria 5. Currently on stable metformin or metformin extended-release therapy (unchanged dose \[minimum daily dose of 1000 mg\] for ≥12 weeks prior to screening) 6. Subjects must have an HbA1c value of ≥7.0% to ≤10.5% 7. Subjects must have a fasting plasma glucose of ≤260 mg/dL 8. Subjects must have a body mass index (BMI) between 25 kg/m2 and 40 kg/m2, inclusive, and must weigh more than 45 kg Exclusion Criteria: 1. History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia or hypoglycemia unawareness 2. Women of childbearing potential, lactating, or has a positive pregnancy test 3. History or presence of alcoholism or drug abuse within 2 years prior to screening 4. Unwilling to comply with study restrictions, including restrictions on strenuous exercise 5. Presence of any of the following conditions: renal impairment (defined as history or estimated glomerular filtration rate at screening of \<45 mL/min using the Modification of Diet in Renal Disease equation), diabetic proliferative retinopathy, severely symptomatic diabetic neuropathy requiring treatment, diabetic gastroparesis, active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, symptomatic gall bladder disease, or pancreatitis 6. Serum triglyceride level \> 400 mg/dL at screening 7. Liver transaminase levels (AST or ALT) \>150% ULN, total bilirubin \>2 ULN, or creatine kinase (CK) levels \> 3 × ULN at screening 8. History or evidence of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease or surgical intervention (eg, bariatric surgery) or allergic conditions (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) 9. Myocardial infarction, unstable angina, arterial revascularization, stroke, symptomatic peripheral artery disease, deep vein thrombosis, New York Heart Association Functional Class III or IV heart failure, or transient ischemic attack within 6 months prior to screening 10. History of malignant hypertension or a recent history of uncontrolled high blood pressure or at screening has a seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg after at least a 5 minute rest. Blood pressure is determined as the mean of triplicate measurements collected at 2- minute intervals after the subject has been sitting quietly for at least 5 minutes. Therapy for hypertension (beta blockers excluded) that has been stable for at least 8 weeks prior to screening is permitted 11. Arm size in excess of the maximum limit of the largest cuff provided with the study blood pressure monitor 12. History of malignancy (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ) within 5 years prior to screening 13. History or evidence of QT prolongation or clinically significant QT prolongation (QTcF \>450 msec) at screening, or other significant ECG findings at screening that may place the subject at increased risk by participating in the study 14. Treatment with any type of insulin (injected or inhaled) for \> 6 consecutive days within 6 months prior to screening or any insulin therapy within 12 weeks prior to screening 15. Treated with peroxisome proliferator-activated receptor-gamma agonists (thiazolidinediones \[TZDs\]), incretin therapy (GLP-1 agonists). or amylin mimetics within 12 weeks prior to screening 16. Taking any of the following prohibited medications * Antidepressants, antipsychotics, anti-epileptics, hormone replacement therapies (estrogen, progestin), testosterone therapies, and thyroid replacement medications that are not at a stable dose for at least 12 weeks prior to screening * Lipid-modifying medications and anti-hypertensive medications that have not been at a stable dose for at least 8 weeks prior to the Screening Visit (excluding bile acid sequestrants, ezetimibe, and beta blockers, which are prohibited * Over-the-counter herbal medications and supplement (aside from once daily multivitamins) 17. Treatment with systemic corticosteroids, which must be discontinued at least 4 weeks prior to screening. Note: Inhaled, intraarticular, intranasal and topical corticosteroids are permitted 18. Currently treated with weight-loss medications. These must be discontinued ≥12 weeks prior to screening 19. History or evidence of intravenous illicit drug use, active hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) infection 20. Known hypersensitivity or idiosyncratic reaction to glucagon receptor (GCGR) antagonists or LGD-6972 21. Participation in another interventional clinical trial within 30 days prior to dosing or treatment with an investigational product with 14 days or 5 half-lives of the Screening Visit (whichever is longer) 22. Donated ≥ 450 mL of blood within 56 days of screening or has donated blood products within 30 days of screening 23. Inability to comply with study procedures or to adhere to study-required restrictions","This will be a 12-week, randomized, double-blind, placebo-controlled, 4-arm, parallel group, multi-center study to evaluate the safety and efficacy of LGD-6972 in subjects with T2DM inadequately controlled on metformin monotherapy (a stable \[≥12 weeks\], daily dose of ≥1000mg at randomization). Subjects with T2DM will be treated with one of 3 dose levels of LGD-6972 (5 mg, 10 mg, or 15 mg) or placebo once daily (QD) for 12 weeks. Randomization will be stratified by HbAlc ≤8.5% or \>8.5% at the Placebo Lead-in Visit. Qualified subjects who require adjustment or stabilization of their metformin dose will participate in a run-in period of up to 12 additional weeks prior to randomization. Subjects will have the option to participate in an oral glucose tolerance test (OGTT) at baseline and end of treatment for assessment of exploratory endpoints." NCT04586348,Prenatal Iodine Supplementation and Early Childhood Neurodevelopment,"Inclusion Criteria: * Pregnant women ≤13 weeks of gestation. * Consume greater than 165 µg/d of iodine from food alone based on our validated Iodine Specific Food Frequency Questionnaire (I-FFQ). * English is main language spoken at home as child will need to understand and take instruction in English to participate in the neurodevelopmental assessment. * Able to give informed consent. Exclusion Criteria: * Known history of thyroid disease. * Previous child diagnosed with thyroid dysfunction. * Carrying a fetus with a known or suspected congenital abnormality.","It is known that severe iodine deficiency during pregnancy leads to profound intellectual disabilities in the child. Following results of a 2004 national survey of school-aged children showing that mild iodine deficiency had re-emerged in the south-eastern parts of Australia, the Australian government mandated the addition of iodine to salt used in bread making to increase population iodine intake. It is also recommended that all pregnant and lactating women take an additional iodine supplement containing 150 µg/d of iodine. Since this time, further evidence has emerged from cohort studies that children born to women with high iodine intake (as well as low iodine intake) have poorer neurodevelopmental scores, suggesting that more tailored supplementation may be a better strategy. Our PoppiE trial will determine if limiting iodine supplementation in women who already consume adequate iodine from food, improves cognitive scores in early childhood. A total of 754 pregnant women from around Australia who are ≤13 weeks of gestation will be enrolled and randomised to receive a standard prenatal vitamin and mineral supplement with a reduced amount of iodine (20 μg - intervention) or a standard prenatal vitamin and mineral supplement with 200 μg of iodine (control). The control supplement contains a level of iodine to match the amount in most commonly used vitamin and mineral supplements sold in Australia. Infant neurodevelopment at 24 months of age will be assessed using the Bayley-IV and conducted at participating centres or a location convenient to the family." NCT01871428,A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy,"Inclusion Criteria: * Adult patient, \>/= 18 years of age * Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening * Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time in the past) * HbA1c \>/= 7% and \= 1 month) statin therapy * Prior intolerance to fibrate * Triglycerides (fasting) \> 4.5 mmol/L (\> 400 mg/dL) at screening or within 4 weeks prior to screening * Clinically apparent liver disease * Anemia at or within 4 weeks prior to screening * Inadequate renal function * Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening * Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit * Known macular edema at screening or prior to screening visit * Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years * Uncontrolled hypertension * History of active substance abuse (including alcohol) within the past 2 years",N/A NCT00364767,"Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity","Inclusion Criteria: * Healthy men aged between 18 and 40 years * Lean subjects BMI 18.5-25 kg/m2 and overweight/obese subjects BMI \>27 kg/m2 (including 18.5, 25 and 27) * Alcohol consumption between 7 and 28 units/week (including 7 and 28) Exclusion Criteria: * Smoking * Family history of alcoholism * History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders * Recent blood donation * More than 8 hours/week of intense exercise * Blood haemoglobin concentration below 8.4 mmol/l * Allergic to betadine or lidocaine.","To investigate the effect of moderate alcohol consumption on * enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle * transporters of fatty acids and glucose in fat tissue * post-prandial glycemic response in healthy, lean or overweight, young men Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design Participants * Description : Healthy, lean and overweight young (18-40 years) men * Number : 20 Study substances * Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol) * Reference substance : 100 ml mineral water (Spa blauw) Duration: 2 treatment periods of 4 weeks (28 days) Test parameters: * Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase, cytochrome c oxidase * Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA etc.) * Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin, HbA1c) * Liver enzymes (safety) * Body weight * Urinary ethyl glucuronide (compliance)" NCT01808911,Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study),"Inclusion Criteria: * men or women * women post-menpausal or with ongoing contraception * 18 years old or more * diagnosis of acquired hemophilia * patient must be insured * patient has provided written informed consent prior to enrolment * patient compliant Exclusion Criteria: * constitutional hemophilia * chemotherapy * ongoing treatment with prednisone \> 20mg further more 1 month * ongoing treatment with prednisone \>0.7 mg/d further more 10 days * thrombocytopenia * leukopenia * chronic disease","CREHA project is a multicenter, randomized, controlled efficacity and safety study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia" NCT04857411,Peers LEAD Plus Healthy Living With Diabetes (HLWD),"Shared Inclusion Criteria for Ambassadors and Buddies: * Self-identify as AA * Can speak/read English * Self-report being prescribed one oral or injectable diabetes medication * Access to/can use a cellular phone, tablet or computer to join a web-based meeting by video camera during the study period * Diagnosed with diabetes for ≥1 year (obtained by self-report or verified by electronic medical record) * Will reside in the geographical area throughout the study period Inclusion Criteria Specific to Buddies: * Self-reported nonadherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale * Most recent A1c is ≥8% based on information collected at point of care A1c testing Inclusion Criteria Specific to Ambassadors: * Self-reported adherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale * Most recent A1c is \<8% based on point of care A1c test * Willing to provide support to a Buddy and track phone conversations * Willing to attend all training sessions and meetings related to being an Ambassador Shared Exclusion Criteria for Ambassadors and Buddies: * Diagnosed psychiatric disorder * Older than 65-years old with a history of severe hypoglycemia requiring medical assistance or glucagon administration Exclusion Criteria Specific to Buddies: * Currently participating in another diabetes lifestyle self-management or medication adherence program","This project represents the next phase of prior work at the University of Wisconsin School of Pharmacy to create and implement community-based programs for AAs with diabetes that focus on improving medication use and glycemic control. The overall objective is to integrate Peers LEAD into HLWD using a community-engaged approach and an evaluation to document outcomes. This project will produce a culturally-tailored curriculum that can be used broadly across social service and community organizations, faith-based organizations, and federally-qualified health centers committed to improving AAs diabetes self-management. This project will be achieved through the following objectives: * Objective 1: To gather and incorporate key stakeholders input in the current and future adoption of Peers LEAD+HLWD into community organizations, health system and/or practices. Objective 1 is not a clinical trial. * Objective 2: To implement and measure the outcomes of Peers LEAD+HLWD to improve medication adherence and hemoglobin A1c. Objective 2 represents the clinical trial aim of this study to be registered in this record. HLWD is a successful community-based program that offers tools and resources to enhance understanding of what it means to have diabetes, including helping participants to build the confidence to manage diabetes and maintain an active and fulfilling life. HLWD is endorsed by the American Diabetes Association and the Centers for Disease Prevention and Control and proven to reduce emergency department visits by 53%, improve A1c levels, enhance regular treatment and diabetes education, create a community-clinical link in care, provide social benefits for participants, improve self-rated health and communication with physicians, and improve health status, health behavior, and self-efficacy. The investigators chose HLWD as the diabetes self-management education (DSME) program to adapt because it is an effective and widely-disseminated evidence-based DSME program. HLWD has enrolled over 5,000 participants in more than 400 workshops across 52 Wisconsin counties. However, between 2013 and 2016, only 120 AAs (3.1%) participated compared to 1,656 non-Hispanic Whites. In 3 years, only 46% of AAs reported that they took their diabetes pills (HLWD's measure of medication adherence) after the workshop, compared to 55% of non-Hispanic Whites. Despite HLWD's positive outcomes and wide reach, there is limited inclusion of AAs. HLWD does not offer culturally-tailored content for AAs, and lacks one-on-one peer support from an AA who successfully manages diabetes, an important factor influential in improving diabetes outcomes among AAs. There is also insufficient attention to medication adherence. Adding Peers LEAD to HLWD will improve the reach, effectiveness, and impact of diabetes self-management programs among AAs. Peers LEAD is a culturally-tailored program designed to provide AAs with diabetes and medication beliefs information, behavioral skill-development, and one-on-one peer support to increase medication adherence. Group sessions include discussions of personal discrimination experiences that resulted in provider mistrust, making the most of clinic/pharmacy visits, necessity and concerns about medicines, and enhancing patient-provider communication. Ambassadors are paired with Buddies, and Ambassadors help deliver Peers LEAD content via face-to-face interaction with their Buddies during group sessions and phone follow-ups. Ambassadors address misperceptions of medicines and diabetes, share their experiences managing diabetes and medicines, and discuss building relationships with providers. As well, they are able to provide one-on-one social support. Peers LEAD+HLWD allows for sufficient attention to medication adherence in a DSME program. For example, HLWD includes only one 20-minute activity on medication use in a 2½ hour session during Week 5. This activity only covers purpose of medicines, medication effects, and remembering to take medicines, but does not address known specific barriers to AAs adherence. In this study, HLWD will be adapted for AAs by adding components of Peers LEAD to overcome key barriers to AAs medication adherence. Core components of Peers LEAD to be incorporated are two group sessions on beliefs about medicines and diabetes, discrimination/mistrust, and provider communication, as well as peer-based phone support from Ambassadors. The investigators hypothesize that, by implementing Peers LEAD+HLWD, there will be increased reach, engagement, and impact for AAs because psychosocial/sociocultural factors and barriers identified in their work to influence AAs medication adherence (i.e., culturally embedded health beliefs and provider mistrust) will be addressed. Objective 2 is a pre-post single group design to conduct Peers LEAD+HLWD in Milwaukee. There will be two groups of participants: (1) Ambassadors (who are not consented into the intervention, but help facilitate it) - AAs who have diabetes and are adherent with their medicines and (2) Buddies (consented into the intervention) - who are AAs who have diabetes but are nonadherent with their medicines. Training of Ambassadors: To prepare to implement Peers LEAD+HLWD, Ambassadors will attend a 6-hour orientation and training meetings, co-facilitated by Wisconsin Network for Research Support (WINRS). This meeting will be an orientation and will prepare the Ambassadors to implement specific elements of Peers LEAD+HLWD, such as the phone calls. WINRS will consult with the research team on all meetings. For \>8 years, WINRS staff have been deeply involved in stakeholder engagement, as well as trained, planned and facilitated \>250 lay advisory board meetings. Ambassadors are involved in two group sessions focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and peer-based phone support with buddies to occur weekly for the first 2 weeks, then for 5 weeks after the completion of the 8-week program. Building on the previously piloted version of Peers LEAD, Peers LEAD + HLWD has added phone-based peer support from Ambassadors comprised of bi-weekly calls to monitor progress toward goals (Month 4) and finally monthly calls to support goal adherence (Months 5-6), representing the Maintenance Phase." NCT06700044,Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies,"Inclusion Criteria: * Pregnant women ≥ 18 years old * High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019 guidelines); or low risk of PE (no high-risk factors, or \<3 moderate risk factors): * High risk factors are: * Auto-immune diseases such as SLE or anti-phospholipid syndrome * Previous preeclampsia or eclampsia * Previous hypertension of pregnancy with preterm birth before gestational week 34, growth restriction, intrauterine fetal death or ablatio * Type 1 or 2 diabetes * Duplex (or triplex) pregnancy * Kidney disease * Chronic hypertension * IVF with egg donation * Moderate risk factors are: * Nulliparity * Heredity for preeclampsia (at least one of mother, maternal grandmother, or sister) * BMI\>30 * Age\>40 * Pregnancy interval \>10 years * Systolic blood pressure \>130 mmHg or diastolic blood pressure \> 80 mmHg at admission in antenatal maternity care * African descent * Verified obstructive sleep apnea * Ability to give written informed consent Exclusion Criteria: * Enrollment in another clinical study * Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study * Use of antibiotics in the last 6 weeks * Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives) * Immunosuppression * Diabetes mellitus (type I and type II) * Inflammatory bowel disease * Celiac disease * Bad obstetric history * Other serious conditions that might affect gut flora or capability of the subject to participate * Language difficulties or difficulties understanding informed consent","PE is a leading cause of maternal and fetal morbidity and mortality worldwide, affecting 3-7% of pregnant women. PE is characterized by hypertension and organ damage manifesting after 20 gestational weeks, and is associated with an increased systemic inflammatory response in the mother. The clinical manifestations may vary greatly and are often more severe in early-onset PE (onset \<34 gestational weeks) than late-onset PE (onset ≥34 gestational weeks). Severe features include blood-pressure ≥160/110 mmHg, severe organ dysfunction, stroke, and eclampsia. Placental failure is central in the pathophysiology of PE, although the underlying mechanisms causing the disease remain partly unknown. Current research, including a previous study conducted by the investigators, suggests that disturbances in the gut microbiome might be involved in the pathogenesis of PE, leading to a dysfunctional immune response and damaged gut barrier functions. The investigators' previous study also indicated that PE is associated with gastrointestinal symptoms. GutMagnific is an evidence-based probiotic dietary supplement, shown to be effective in correcting disturbances in the gut microbiome, reduce inflammation and repair a damaged gut barrier. It was originally developed for treatment of irritable bowel syndrome (IBS). There is an overlap in immunological responses involved in PE and IBS, and women with IBS have a higher risk of developing PE. Therefore, the investigators expect that the product might also have positive effects in pregnant women with a high risk of PE." NCT03565744,The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth,"Inclusion Criteria: * Age 10 and no older than 14 when recruited at baseline * A parent or guardian will be available in person or by phone at all clinical visits. * Registered in both the Montefiore School Health Program clinic and Mosholu Montefiore Community Health Center afterschool program at Public School (PS) /Middle School (MS) 95 Exclusion Criteria: * Has a major mental illness that would render them incapable of consenting for the research or complying with the B'N Fit POWER afterschool program protocol * Has medical problems that make it unsafe for them to participate in the afterschool program.","In this proposal, the investigators aim to test a school-based intervention to promote resilience and prevent obesity related co-morbidities for impoverished racial/ethnic minority Bronx youth who are at increased risk for diabetes. B'N Fit POWER is a wellness program that integrates existing school wellness promotion activities, the Montefiore School Health Program (MSHP) - a network of school-based health clinics, and the Mosholu Montefiore Community Center (MMCC) - a network of afterschool programming, to promote health and build on the resilience of the adolescents. It offers culturally-relevant guidance related to the attainment of 7 Target Behaviors, namely to increase fruit, vegetable and sugar-free beverage intake, obtain adequate sleep, daily physical activity, eating breakfast and lunch daily, and limiting fast food and unhealthy snacks. Although B'N Fit POWER targets youth with overweight and obesity and at high risk for diabetes, it is open to all middle school students at the school, via community-led recruitment efforts to reduce obesity-related stigma by promoting wellness and fitness. Grounded in Youth Development (YD) Theory and using the principles of Community Based Participatory Research (CBPR) the program integrates patient, family, clinical, and community linkages, and targets individual behaviors as well as the school environment to address environmental and structural barriers to behavioral change. YD program elements are incorporated to build positive identity, youth resilience, and foster youth leadership by having youth contribute to planning community activities with incentives to promote attendance and retention. The investigators will conduct a quasi-experimental trial of B'N Fit POWER and will compare participants receiving B'N Fit POWER (Group 1) to two comparison groups: one from the same school receiving standard of care (Group 2) and, to assess the external validity of Group 2 in terms of characteristics and outcomes, an additional group from another school also receiving standard of care (Group 3) to address the following specific aims: 1) Determine whether B' N Fit POWER is effective in improving fitness, healthy weight attainment, and 7 target behaviors; 2) To assess the impact of moving the B'N Fit program into a school setting on participant engagement; and 3) To assess the mediating pathways associated with program effects. Following an initial health screening, participants enrolling in B'N Fit POWER (Group 1) will receive comprehensive medical assessments at the MSHP integrated with MMCC afterschool programming that incorporates a curriculum focusing on 7 Target Behaviors during weekly leadership sessions and daily physical activity. The comparison groups receive the standard of care (standard MSHP and MMCC afterschool program). Effects of the program will be evaluated using data routinely collected at the schools (e.g. anthropometrics and labs from clinic and the school fitnessgram, attendance, grades) and surveys. Multivariate logistic regressions and mixed-effects linear models will assess program effects for categorical or continuous outcomes and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) approach will identify barriers and solutions to implementation." NCT02191644,Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes,"Inclusion Criteria: * subjects who had IFG (100≤ fasting glucose \<126 mg/dL) * or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL) Exclusion Criteria: * current and/or past history of cardiovascular disease including angina * liver or kidney dysfunction * thyroid or pituitary disease * pregnancy or lactation * taking medications or supplements",Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy. NCT02918032,International Registry Study of Neutral Lipid Storage Disease (NLSD) / Triglyceride Deposit Cardiomyovasculopathy (TGCV) and Related Diseases,"Inclusion Criteria: * Patients who are diagnosed with NLSD / TGCV Exclusion Criteria: * None","Since NLSD is a rare disease, its clinical manifestation and clinical course have not been sufficiently clarified. Also, the number of patients in each country is limited. As such, it is considered difficult to fully investigate this disease without international collaboration. Therefore, we have established the International Registry of NLSD / TGCV. Also, all patients with Jordans' anomaly of peripheral polymorphonuclear leukocytes are established as the subjects of entry when starting the registry, to allow entry of patients with NLSD due to genes other than mutations of ATGL and CGI-58 genes. Time Perspective:This study is both Prospective (registering patients who are diagnosed with NLSD / TGCV) and Retrospective (registering only the medical record of previous patients)." NCT07118098,INNODIA Family & Friends Early-Stage T1D Detection Protocol,"Inclusion Criteria: 1. Have given written informed consent to participate 2. Be aged between 1 and 45 years 3. Have a family relative with T1D or close friend diagnosed with symptomatic T1D at age \<45 years Exclusion Criteria: 1. Previous diagnosis of stage 3 T1D or other forms of diabetes 2. Unable/unwilling to consent to participation",N/A NCT01213498,The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy,"Inclusion Criteria: * Men and women * minimum 20 years * Chronic Kidney disease * Estimated GFR (eGFR) between 30 and 90 ml/min Exclusion Criteria: * Nephrotic Syndrome * Diabetes mellitus * Anamnestic or clinical signs of significant heart, lung, lever, kidney, thyroid and brain disease * Neoplastic disease * Alcohol abuse, * Drug abuse * Pregnancy or nursing * Blood donation within a month before examination * Hgb \< 6,0","Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet. On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion. Renal function is measured by renal clearance of 51Chromium-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from NCC, NKCC and ENaC will be measured to evaluate channel activity in the nephron. Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor." NCT05123963,Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors,"Inclusion Criteria: * Pre-diabetes: * Fasting plasma glucose: 6.1 to 6.9 mmol/L or * 2-hour plasma glucose post 75g OGTT: 7.8 to 11.0 mmol/L and * HbA1c: 6.0 to 6.4% * or Insulin resistant: glucose clearance rate ≤ 360 ml/kg/min as determined using the Oral Glucose Insulin Sensitivity Index at Time 120 min. * BMI \> 25 kg/m2 * To be willing and able to adhere to the specifications of the protocol; * To have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and were willing to participate in the study. Exclusion Criteria: * overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG * Treatment with any drug known to affect lipid or carbohydrate metabolism, except statins (to be stopped 3 weeks prior to study A), metformin or anti-hypertensive drugs (to be stopped 7 days prior to the studies); * presence of liver or renal disease other than uncomplicated NASH or mild isolated proteinuria; uncontrolled thyroid disorder; * Uncontrolled severe hypertension, systolic pressure ≥ 180 mm Hg or diastolic pressure ≥ 110 mm Hg; * History of ischemic heart disease, tachyarrhythmia, QT interval prolongation, risk factors for torsade de pointes (eg hypokalemia), or taking any medication known to prolong the QT interval; * History of serious gastrointestinal disorders (malabsorption, peptic ulcer, gastroesophageal reflux requiring surgery, etc.); * Presence of a pacemaker; * Having undergone a PET study or CT scan in the past year; * Any contraindication to stopping statins for 3 months and stopping an anti-hypertensive medication and metformin for 7 days; * smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day; * No blood donation two month prior the study; * prior history or current fasting plasma cholesterol level \> 7 mmol/l or fasting TG \> 6 mmol/l.","Three metabolic studies A, B and C using PET imaging will be carried out at the CRCHUS. The 12-week exercise training intervention will consist of supervised cycling high-intensity interval training (i.e. short bouts of high-intensity exercise interspersed with short periods of rest) every other day at the CRCHUS. Continuous glucose monitoring will be used to measure 24h glucose profiles over 3-4 days prior to and following the acute exercise bout and again during the last week of the intervention. Continuous blood pressure monitoring will be used over 18-24 h, at the beginning and at the end of the 12 week-training. Participants will take part in three postprandial metabolic studies: 1) before (A); 2) 18-24h after an acute exercise bout (B), and; 3) after 12-weeks of exercise training (C). Experiments will be conducted between 07:30 AM and 5:00 PM, following a 12 hr fast. Adipose tissue dietary fatty acid storage and partitioning of dietary fatty acids in skeletal muscles will be measured by the oral \[18F-\]-FTHA PET method. Changes in lean tissue mitochondrial function in vivo will be determined using magnetic resonance spectroscopy (MRS). Participants will complete Visit A (baseline), followed 7 to 14-days later by a pre-breakfast (9 AM) or pre-dinner (4PM) exhaustive glycogen lowering exercise bout. The following day (18-24h after the exercise bout), participants will return for a second metabolic visit (Visit B). Participants will then begin a 12-week supervised high-intensity interval training program, performed either only in the morning or only in the afternoon (9 AM vs. 4 PM), on every other day. At the end of the 12 weeks, and at least 48h after the last exercise bout, participants will return for their final metabolic visit (Visit C)." NCT02367287,USDA Western Human Nutrition Research Center (WHNRC) Cross-Sectional Nutritional Phenotyping Study,"Inclusion Criteria: * 18-65 y * Male or female * Body Mass Index 18.5-45.0 kg/m2 (Normal to obese) Exclusion Criteria: * Pregnant or lactating women * Known allergy to egg-white protein * Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg measured on three separate occasions * Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to: * Diabetes mellitus * Cardiovascular disease * Cancer * Gastrointestinal disorders * Kidney disease * Liver disease * Bleeding disorders * Asthma * Autoimmune disorders * Hypertension * Osteoporosis * Recent minor surgery (within 4 wk) or major surgery (within 16 wk) * Recent antibiotic therapy (within 4 wk) * Recent hospitalization (within 4 wk) * Use of prescription medications at the time of the study that directly affect endpoints of interest (e.g. hyperlipidemia, glycemic control, steroids, statins, anti-inflammatory agents, and over-the-counter weight loss aids)","Many inflammatory responses can be modulated by specific dietary components. For example, in cardiovascular disease, macrophages and T-cells react with oxidized LDL (an endogenous modified antigen) to produce arterial plaque and subsequent blockage of coronary arteries. High intake of saturated fats (or simple sugars that drive synthesis of saturated fatty acids) may promote this inflammation by affecting macrophages and T-cells. Conversely, increased intake of omega-3 fatty acids may decrease inflammation by suppression of macrophage and T-cell pro-inflammatory activity. Long-term sub-clinical inflammation caused by intestinal bacteria has been linked to the development of Irritable Bowel Disease and related disorders. Low intake of fruits, vegetables, or whole grains or high intake of saturated fats may promote sub-clinical gut inflammation by promoting dysbiosis of the gut microbiota. Allergic asthma develops in predisposed individuals as a result of an overactive allergic-type immune response to inhaled environmental allergens. Dietary factors such as vitamin D and omega-3 fatty acids may diminish pro-inflammatory responses to environmental allergens by promoting the development of T-regulatory cells and other anti-inflammatory factors. Individual variability in chronic disease risk is well recognized. For example, why does excess adiposity lead to disease in some individuals and not others? The nature of the fat tissue rather than the abundance, may impact cross-talk with other metabolically-relevant tissues and affect disease risk. It is important to characterize healthy vs. unhealthy phenotypes across various tissues and to understand how micro- and macro-nutrients interact with molecular and metabolic pathways to support a healthy body weight. This study brings together scientists with expertise in nutritional sciences, immunology, analytical chemistry, physiology, neuroendocrinology, and behavior to understand how diet impacts metabolism and disease risk through the interplay and coordination of signals and metabolites arising from multiple organ systems. The overall objective is to characterize the phenotypic profile of participants according to their immunologic, physiologic, neuroendocrine, and metabolic responses to a dietary challenge and a physical fitness challenge by addressing the specific aims listed below. The cross-sectional study is organized into two study visits (Visit 1 and Visit 2) separated by approximately two weeks of at-home specimen and data collection. Specific Aim 1: To determine if diet quality is independently associated with systemic immune activation, inflammation, or oxidative stress differentiated by: 1. pro-inflammatory T-helper cells (Th1, Th2, and Th17 cells) and related cytokines 2. anti-inflammatory T-regulatory cells and related cytokines 3. dysbiosis of the gut microbiota and markers of gut inflammation (e.g. neopterin and myeloperoxidase) a. and to evaluate the association between dysbiosis of the gut microbiota, gut inflammation, and systemic immune activation 4. plasma metabolomic response to a mixed macronutrient challenge meal (includes diet quality and physical activity as independent variables) 5. endothelial (dys)function and vascular reactivity Specific Aim 2: To determine if a high fat/sugar challenge meal induces differential effects over time (0-6h postprandial) according to habitual diet characteristics, physical activity levels, stress levels, age, sex, or BMI on: 1. postprandial monocyte activation 2. plasma lipid metabolomic responses including non-esterified fatty acids, phospholipids, triacylglycerols, red blood cell fatty acids, endocannabinoids, bile acids, eicosanoids and related oxylipins, ceramides, sphingoid bases, and acylcarnitines 3. plasma amino acid metabolomics 4. glucose metabolism and metabolic flexibility (i.e. the ability to switch from glucose to lipid oxidation as energy sources) 5. changes in endocrinology and self-report of hunger and satiety 6. postprandial free cortisol Specific Aim 3: To determine the mechanisms of: 1. postprandial monocyte activation 2. suppression of challenge-meal induced monocyte activation by docosahexaenoic acid (DHA) (in an ex vivo experiment using a subset of samples) Specific Aim 4: To evaluate the associations between eating behavior, physical activity, and/or anthropometry and the outcomes: 1. endocrinology of hunger and satiety 2. plasma metabolomic responses 3. vulnerability and resistance to stress 4. endothelial (dys)function and vascular reactivity 5. prediction of insulin sensitivity Specific Aim 5: To determine how genetic variants affect nutrient metabolism, cardiovascular physiology, and immune function and improve understanding of how dietary factors affect these metabolic, cardiovascular and immune phenotypes." NCT04190693,IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo,"Inclusion Criteria: * All patients who were treated with IMCY-0098 or placebo in the IMCY-T1D-001 clinical trial who are willing to participate to this long-term follow-up study. Exclusion criteria: * Ongoing pregnancy or lactation * History of or current malignancy (except excised basal cell skin cancer) * Primary or secondary immune deficiency disorders * Human Immunodeficiency virus (HIV) infection. * Ongoing treatment with immunosuppressive agents with the exception of topical or intra nasal corticosteroids. * Treatment with an investigational drug within the past 3 months","In this Long-Term Follow-Up (LTFU) study, the below objectives will be assessed 36 and 48 weeks after the first injection of IMCY-0098 in the study IMCY-T1D-001, in patients treated with IMCY-0098 at three doses or placebo: Primary Objective The primary objective of this study is to assess the long-term safety. Secondary Objective The secondary objective of this study is to evaluate the clinical response to IMCY-0098 by assessing disease activity. Exploratory Objectives * To evaluate the proinsulin-specific cytolytic CD4+ T cells induced by IMCY-0098 * To evaluate the impact of IMCY-0098 on autoreactive T-cell responses specific for autoantigens expressed by islet β-cells (proinsulin, GAD65, IGRP) on the longer-term. * To evaluate the impact of IMCY-0098 on autoantibodies against GAD65, IA 2, ZnT8 and insulin * Transcriptomic analysis on mRNA extracted from samples collected for Immunogenicity" NCT04035993,The HEADWIND-Study,"Inclusion Criteria: * Informed Consent as documented by signature (Appendix Informed Consent Form) * DM1 as defined by WHO for at least 1 year or is confirmed C-peptide negative (\<100pmol/l with concomitant blood glucose \>4 mmol/l) * Subjects aged between 21-50 years * HbA1c ≤ 8.5 % based on analysis from central laboratory * Functional insulin treatment with insulin pump therapy (CSII) or basis-bolus insulin for at least 3 months with good knowledge of insulin self-management * Only for the main-study: Passed driver's examination at least 3 years before study inclusion. Possession of a valid Swiss driver's license. Active driving in the last 6 months before the study. Exclusion Criteria: * Contraindications to the drug used to induce hypoglycaemia (insulin aspart), known hypersensitivity or allergy to the adhesive patch used to attach the glucose sensor * Women who are pregnant or breastfeeding * Intention to become pregnant during the study * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * Other clinically significant concomitant disease states as judged by the investigator (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with an investigational drug within the 30 days preceding and during the present study * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons * Total daily insulin dose \>2 IU/kg/day. * Specific concomitant therapy washout requirements prior to and/or during study participation * Physical or psychological disease is likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator (especially coronary heart disease or epilepsy). * Current treatment with drugs known to interfere with metabolism (e.g. systemic corticosteroids, statins etc.) or driving performance (e.g. opioids, benzodiazepines) * Only for the main-study: Patients not capable of driving with the driving simulator or patients experiencing motion sickness during the simulator test driving session (at visit 2).","Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. These are important prerequisites for safe driving. Accordingly, hypoglycaemia has consistently been shown to be associated with an increased risk of driving accidents and is, therefore, regarded as one of the relevant factors in traffic safety. Despite important developments in the field of diabetes technology, the problem of hypoglycaemia during driving persists. Automotive technology is highly dynamic, and fully autonomous driving might, in the end, resolve the issue of hypoglycemia-induced accidents. However, autonomous driving (level 4 or 5) is likely to be broadly available only to a substantially later time point than previously thought due to increasing concerns of safety associated with this technology. Therefore, solutions bridging the upcoming period by more rapidly and directly addressing the problem of hypoglycemia-associated traffic incidents are urgently needed. On the supposition that driving behaviour differs significantly between euglycaemic state and hypoglycaemic state, the investigators assume that different driving patterns in hypoglycemia compared to euglycemia can be used to generate hypoglycemia detection models using machine learning neural networks (deep machine learning classifiers)." NCT05625321,Stepping Into Lifestyle Changes,"Inclusion Criteria: * self-identifies as Black and/or African American * ≥ 30 years old * a measured BMI \>25 kg/m2 and at least one other cardiometabolic risk factor (physician diagnosis of pre-diabetes and/or hypertension within past 2 years) * lives, works, or worships in one of the 12 intervention communities and expresses no intentions to move outside of that community in the 18 months following enrollment * a willingness to participate in the study for the 18-months duration. Exclusion Criteria: * being or planning to become pregnant during the 18-month study duration * a baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate * medical contraindications","This study leverages two evidence-based interventions (EBIs) that have been culturally-adapted for the target population and have previously achieved clinically-relevant weight loss and other clinical outcomes (educational group weight loss intervention) along with improvements in diet and physical activity (home gardening intervention). Combining these EBIs addresses multiple domains (behavioral, personal environment, sociocultural) and levels (individual, interpersonal, community) of influence on risk factors for obesity and other cardiometabolic diseases prevalent in the Deep South. These interventions, delivered by local lay staff and non-academic partners, have a high potential for sustainability; however, there is a need to further evaluate the external validity and implementation-related barriers and facilitators to maximize reach, adoption and implementation. The investigators will employ a pragmatic, multilevel, cluster-randomized, type 1 hybrid effectiveness-implementation trial. A total of 264 Black women (age ≥ 30 years) with overweight or obesity and pre-diabetic or hypertensive from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined educational group weight loss intervention plus a home gardening intervention or the educational group weight loss classes alone. The specific aims are to compare interventions on: (1) primary outcomes related to implementation effectiveness (reach, adoption, maintenance of health behaviors), (2) secondary outcomes on clinical effectiveness, and (3) cost effectiveness. Findings will inform discussions with coalition partners to achieve our long-term goal of widely disseminating and sustaining multi-level interventions to reduce the multiple chronic disease burden and health disparities in the Deep South." NCT05408416,Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR,"Inclusion Criteria: * patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with PDR; * persistent VH for more than 1 month or recurrent VH with or without panretinal photocoagulation (PRP); * TRD detected by indirect ophthalmoscope or B-scan ultrasonography. Exclusion Criteria: * previous vitrectomy or intravitreal injection in the study eyes; * eyes with any ocular disease that may hinder visual improvement other than PDR, such as optic atrophy or macular hole; * poor control of diabetes mellitus (DM) with hemoglobin A1c (HbA1c) \> 12%; * history of thromboembolic events (including cerebral vascular infarctions or myocardial infarctions) or coagulation system disorders or receiving anticoagulant or antiplatelet therapy; * eyes given gas tamponade or additional treatment during follow-up periods.","Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).It is characterized by progressive loss of vision, retinal edema, vitreous hemorrhage (VH), retinal neovascularization, fibrovascular proliferation, tractional retinal detachment (TRD) and neovascular glaucoma (NVG).Although pars plana vitrectomy (PPV) is the cornerstone for treatment of advanced PDR, related postoperative complications such as recurrent VH, NVG, and progressive fibrovascular proliferation may still cause serious visual impairment.It is well known that vascular endothelial growth factor (VEGF) is a leading role of the neovascularization, vascular permeability, and diabetic macular edema.Intravitreal injection of anti-VEGF drugs before or during PPV maybe a good adjunct to vitreous surgery for severe PDR. Some studies have confirmed that the application of anti-VEGF drugs before vitrectomy for PDR patients can reduce the difficulty of surgery and improve postoperative best corrected visual acuity (BCVA),but very few researches focused on the injections of anti-VEGF during surgery.Therefore, investigators carried out this study to compare the effects of preoperative and intraoperative intravitreal injections of ranibizumab (IVR) on vitrectomy outcomes for PDR patients.Investigators enroll PDR patients whose baseline characteristics including age, sex, BMI, type of diabetes, HbA1c level, duration of DM, hypertension, previous history of laser photocoagulation, status of lens, indication for surgery, baseline BCVA, IOP, baseline CRT and extent of VAG are comparable.The enrolled eyes are randomly assigned according to the Central Randomization System with a ratio of 1:1 to preoperative IVR group and intraoperative IVR group. Intraoperative and postoperative indices are collected for further comparison. Intraoperative indices including surgery time, intraoperative bleeding, intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade. Investigators compare whether there are statistical differences in the above indicators between the two groups. Meanwhile, postoperative indices are collected during 1week, 1 month, 3 month follow-up, including best-corrected visual acuity (BCVA), central retinal thickness (CRT), postoperative vitreous hemorrhage (VH), neovascular glaucoma (NVG), recurrent retinal detachment, postoperative fibrovascular proliferation progression and reoperation. Investigators compare whether there are statistical differences in the above indicators between the two groups at different visit time." NCT02578004,Risk Factors for Pressure Ulcers,"Inclusion Criteria: * presenting with at least of a wound and confirmed diagnosis of PU, age≥18 years old, bedridden, not feeds only and without trophic and mental disorders. Exclusion Criteria: * paediatric study populations, age \> 90 years old, allergy to wound products, malignant origin",N/A NCT03921333,"The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults","Inclusion criteria * Females and males, aged 18 years to 65 years * Body Mass Index (BMI) 27-35 kg/m2 * Not dieting within the last month and not having lost \>5% body weight in the previous year * Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study * Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice * Able to eat most everyday foods * Habitually consumes three standard meals a day (i.e. breakfast, lunch and dinner) Exclusion criteria * Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders) * Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study * Pregnant, planning to become pregnant or breastfeeding * History of anaphylaxis to food * Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients * BMI \<27 kg/m2 or \>35 kg/m2 * Volunteers self-reporting currently dieting or having lost \>5% body weight in the previous year * Participants with abnormal eating behaviour * Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit * Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study * Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters * Participants on specific food avoidance diets * Participants who work in appetite or feeding related areas","The aim of this human intervention study is to evaluate the impact of a botanical-based extract on gut health, immunity and metabolic disorders in healthy adults." NCT07151833,GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes,"Inclusion Criteria: * Adults aged 20-70 years. * Diagnosed with type 2 diabetes mellitus (T2DM) based on ADA criteria. * HbA1c ≥ 7%. * At risk of diabetic foot ulcer (ABI \< 0.9 or early neuropathy signs). * Willing to consume study cookies and comply with study protocol. * Provided written informed consent. Exclusion Criteria: * Current use of herbal supplements or functional foods containing Gynura procumbens. * Presence of active diabetic foot ulcer or severe infection. * Severe cardiovascular, renal (eGFR \< 30 mL/min/1.73 m²), or hepatic impairment. * Pregnancy or breastfeeding. * Known allergy to ingredients in study cookies. * Participation in another clinical trial within the last 3 months.","Type 2 diabetes mellitus is a chronic condition associated with serious complications, including neuropathy and diabetic foot ulcers. Many people in Indonesia still struggle with poor blood sugar control despite standard treatments. This highlights the need for safe, affordable, and culturally acceptable nutritional strategies. This study is testing GlucoBites, a functional cookie made with Gynura procumbens, a traditional medicinal plant with potential glucose-lowering and vascular protective properties. Researchers want to see if adding GlucoBites to daily care can improve blood sugar control and reduce early risk factors linked to diabetic foot ulcer development. The study will help determine whether functional food innovation can be integrated into community-based diabetes management and offer a preventive approach to reduce long-term complications." NCT02344433,Using Virtual Counselors to Overcome Genetic Literacy Barriers,"Inclusion Criteria: * 21 years of age or older; * current Boston Medical Center patient - must have an upcoming returning patient appointment at Boston Medical Center or affiliated clinic within 3 months of recruitment; * speaks English and/or Spanish. Exclusion Criteria: * Under 21 years of age; * not a current patient of Boston Medical Center or affiliated clinic; * unable to speak English and/or Spanish.",N/A NCT05593133,PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients,"Inclusion criteria: Both male and female in the age group 40-65 • Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months. * HbA1c more than 7 from 6 months. * Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5. Exclusion Criteria: * Patients suffering from significant CNS dysfunctions. * Musculoskeletal deformities * Vestibular dysfunction * Internal ear infections * Complete sensory loss","Objective To determine the effects of PNF and Gait Training Exercises on Balance and Gait in diabetic neuropathy patients Hypothesis Null hypothesis : There is no difference between PNF and Gait Training Exercises. Alternative hypothesis : There is difference between PNF and Gait Training Exercises Methodology (Design, sample size, sampling technique, inclusion and exclusion criteria and tool) Study design: This study is Randomized Clinical Trial Sample size: Sample size will be 40 (Two groups of 20 each) Assumed standard deviation=6.5 Confidence interval= 0.95 Desired precision=2 Calculated by epitool. Sampling technique: Convenient sampling will be used to collect data. Study design setting: Data will be conducted from Hospital wards and Outpatient departments Inclusion Criteria: Both male and female in the age group Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months. * HbA1c more than 7 from 6 months. * Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5. Exclusion Criteria: * Patients suffering from significant CNS dysfunctions. * Musculoskeletal deformities * Vestibular dysfunction * Internal ear infections * Complete sensory loss * Hypoglycemia * Lower extremity arthritis or pain that limits standing or weight bearing. Data collection procedure All 40 patients will be explained in detail about the study procedure. Informed consent will be taken. Patients will be divided in two groups each consisting of 20 people. Subjects will be evaluated using the Michigan Neuropathy Screening Questionnaire (screening tool) . One group will be tested by PNF techniques and the second group will be tested by Gait Training exercises. PNF techniques will comprise of Warm up, Rhythmic stabilization, Hold Relax, Contract Relax and light exercises and performed on three muscle groups ( Hamstring, Quad and Calf). Gait Training exercises will comprise of One Foot Balancing, Leg raises, Heel raises, Tight-rope Walking. Balance will be assessed by Berg Balance scale (BBS) and Tinetti scale before, during and after the study to assess risk of fall and injury. Gait will be assessed by Dynamic Gait index in the same manner. All patients will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks." NCT05399433,Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis,"Inclusion Criteria: * Patients of both sexes * hospitalized in the Dermatology department of the CHU of Nice for moderate to severe psoriasis (defined by a PASI \> or = 10) * covered by a social security scheme after obtaining a free * Clinical diagnosis of plaque psoriasis by a dermatologist with or without type 2 diabetes (defined by glycated hemoglobin \>7%) * For the control group: without psoriasis or other inflammatory dermatosis aged in the presence or not of type 2 diabetes (glycated hemoglobin \>7%). * free and informed consent Exclusion Criteria: * Minor or incapable or unwilling to consent freely or in an informed manner Pregnant or nursing woman. * Patient in a period of exclusion from other biomedical research * Patient with generalized chronic inflammatory disease or other inflammatory dermatosis * Patients on general corticosteroid, immunomodulator or immunosuppressant therapy in the month prior to local inclusion or treatment with corticosteroid therapy in the 15 days prior to inclusion, on anti- treatmentIL-23 or anti IL12/23 for less than 3 months or under anti-IL-17 or anti-TNF treatment for less than 1 month. * Contraindication to cutaneous biospsis (known hemostasis disorder, taking anticoagulants, allergy to xylocaine, history of cheloid scars, congenital immune deficiency)",N/A NCT06477900,"Impact of SMS Reminder on Weight Loss, As Part of a Health Pathway in Patients with Prediabetes (PREDIABCOACH)","Inclusion Criteria: * Subject with prediabetes as defined by HAS (fasting blood glucose \> 1.10g/L and \< 1.26g/L; or blood glucose 2h after ingestion of 10g of glucose \> 1.40g/L and \< 2g/L \[HGPO test\]) * included in a health and diet care program for patients with pre-diabetes offered by one of Réunion's CPTS (FindRisc Péi-CPTS program) * age \> 18 years * in possession of an SMS-enabled telephone * able to complete self-efficacy questionnaires * not expected to move within 12 months Exclusion Criteria: * participant currently being monitored in the PREDIABRUN study * protected adults (under guardianship or curatorship) * pregnant women * refusal to participate in the study * patients unable to speak Creole or French","The outcomes of this study are : * A better understanding of the effectiveness of the SMS intervention in the context of health and diet prevention programs for patients with pre-diabetes. * More precise recommendations for healthcare professionals and decision-makers on the use of SMS intervention in this context. * Improved health outcomes for prediabetes patients through the identification of effective diabetes prevention strategies. * A positive impact on healthcare costs by reducing the progression from prediabetes to diabetes, and by reducing the use of costly healthcare associated with diabetes." NCT01414192,A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204),"Inclusion criteria: * Resident of Continental France * Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®) * Incident treatment with ezetimibe at the time of recruitment into the study Exclusion criteria: * Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence * Participating in a clinical trial * Unable to read the information letter in French and/or unable to participate in the telephone interview in French",N/A NCT06384911,InvesT1D: Promoting Adolescent Investment in Diabetes Care,"Inclusion Criteria: * Diagnosed with type 1 diabetes ≥12 months * Utilize a continuous glucose monitor (CGM) to support diabetes management * Average daily CGM use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day * Are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration * Cognitively able to participate in incentive program and complete surveys * Have access to a mobile phone to receive information about goal attainment and incentive updates * Have the ability to upload glucose and insulin administration data remotely per processes used by participant's diabetes care team * Caregivers are willing to participate in study and complete surveys Exclusion Criteria: * At time of screening, average CGM wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day * Adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration * Cognitively or physically unable to participate * Adolescent is a ward of the state * Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes * Caregivers are not willing to participate in study and complete surveys","Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management. The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual. Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes." NCT06534411,"A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both","Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: * Metformin * sodium-glucose co-transporter 2 inhibitor (SGLT2i) * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.",N/A NCT05690009,Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease,"Inclusion Criteria: * Men and women aged 40 and older at the time of data entry; * A possibility to check for albuminuria using dipsticks and/or analysis for microalbuminuria or albumin-to-creatinine ratio in a single urine sample. Exclusion Criteria: * Unwillingness of the patient to participate in the register; * Diagnosis of CKD made before the screening for the register; * Diagnosis of diabetes mellitus (DM) type 1 or type 2 made before the screening for the register; * Pregnancy; * Long distance running or very strenuous physical activity in the last 24 hours.","This register was sponsored and organized by the Association ""Eurasian Association of Internal Medicine"". It is a multicenter non-interventional register of real clinical practice. The database will include patients aged 40 years and older without pre-existing nephrological disease who are available for a dipstick test for albuminuria. The subjects will be identified by screening all patients who meet inclusion/exclusion criteria during routine outpatient and hospital follow-up. The register does not include follow-up (cross-sectional design). Patients eligible for the register should be enrolled and documented. The procedure for obtaining informed consent for the collection and analysis of the retrospective data must comply with the local legislation. If necessary, patients will be asked to sign an informed consent document. All study sites will use standardized electronic CRFs. The Electronic Data Capture (EDC) system should be validated in accordance with current standards and legal requirements. The investigators will log into this system using individual usernames and passwords. Data may only be entered and corrected by the investigator or other authorized study site personnel." NCT00903799,Medico-economic Evaluation of ENTERRA Therapy,"Inclusion Criteria: Nausea and/or vomiting refractory to prokinetics and antiemetics fulfilling the following criteria 1. Due to diabetes mellitus type 1, secondary to oesogastric surgery (vagotomy, partial gastric resection) or idiopathic 2. Non related to other cause 3. Chronic (duration \> 12 months) 4. Occurring at least weekly 5. Refractory to anti-emetics (chlorpromazine, ondansétron, granisétron) and/or prokinetics (domperidone, metoclopramide, erythromycin), 6. Leading to weight loss or significant reduction of food intake 7. occurring in patients without any contra-indication for the surgical implantation of the device, in particular severe cardiac or respiratory failure or haemostasis disorders, 8. in patients older than 18 years 9. with a negative pregnancy test at entry into the trial in women 10. Patients who signed the study consentment 11. Affiliation to the the welfare system Exclusion Criteria: 1. Patients older than 70, 2. Patients in whom nausea and/or vomiting are related to another aetiology than that previously described. 3. Patients with an absolute contraindication for general anaethesia and surgery 4. Patients with a contra-indication for implantation of the device 5. Patients with a severe psychiatric disorder 6. Patients under guardianship or curatorship 7. Patients with a major obesity or as severe eating disorder. 8. Patients unable to understand French. 9. Pregnant women or nursing mothers 10. Lack of effective contraception 11. Patients having undergone a pancreatic graft within the previous 6 months and being in a unstable clinical conditions at enrollment 12. Patients with an underlying disease leading to a follow-up by MRI",N/A NCT02185963,Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes,"Inclusion Criteria: 1. Type 2 diabetes 2. HbA1c ≥ 7.5% 3. Age ≥ 30 4. low HDL-C (\<40 mg/dl in men or \<50 mg/dl in women) and having 1 or more risk factors: 1) Body mass index (BMI) ≥ 25 kg/m2 (overweight); 2) LDL-C level ≥ 130 mg/dl; 3) TG level ≥150 mg/dl; 4) Systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥140/90 mmHg or taking antihypertensive medication; 5) Current smoker; 6) Family history of CHD. Exclusion Criteria: 1. Contraindication to rosuvastatin 2. Pregnant or breast feeding women 3. Reproductive-age women who refuse contraception 4. Type 1 diabetes, gestational diabetes, or diabetes with secondary cause 5. Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal) 6. Renal failure (Cr \> 2.0) 7. Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) 8. Not appropriate for lipid lowering treatment 9. Medications which affect glycemic control 10. Diseases which affect efficacy and safety of statin 11. Other clinical trial within 30 days","1. Study design Study subject Number of Subjects (N = 30) 2. Study outcome Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol 3. Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)" NCT00797563,Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood,"Inclusion Criteria: * Have type 1 or type 2 diabetes * Be \> 18, \< 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age * Be willing to complete all study procedures * Be routinely testing their blood sugar at home (at least once per day) * Be able to speak, read, and understand English and understand the Informed Consent document * Be able to read the labeling instructions Exclusion Criteria: * Minors \< 18 years of age and adults \> 75 years of age * Pregnancy * Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS * Disorders in the fingertip lancing areas * Acute or chronic infections, particularly skin infections * Infection with a blood borne pathogen * Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81 mg or 325 mg) is not reason for exclusion * Hemophilia or any other bleeding disorder * Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study * Working for a competitive medical device company",The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features. NCT02771093,An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus,"Inclusion Criteria: 1. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements. 2. Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures. 3. Participants diagnosed with type 2 diabetes mellitus. 4. Participants with a glycated hemoglobin (HbA1c) \[National Glycohemoglobin Standardization Program (NGSP value)\] value ≥ 6.5% and \< 8.5% at the start of the observation period (Day -2). 5. Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks. 6. Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period. 7. Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period. 8. Men or women aged 20 years or older at the time of informed consent. Exclusion Criteria: 1. Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period. 2. Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period. 3. Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period \[Day -2\]). 4. Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance \< 50 mL/min or serum creatinine \> 1.4 mg/dL in men or \> 1.2 mg/dL in women \[equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg\] at the start of the observation period \[Day -2\]). 5. Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases. 6. Participants with a history of gastric or small intestinal resection. 7. Participants with proliferative diabetic retinopathy. 8. Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma). 9. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors. 10. Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2). 11. Participants with any malignant tumors. 12. Habitual drinkers whose average daily alcohol consumption is \> 100 mL. 13. Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert. 14. Participants anticipated to require any prohibited concomitant medications during the study period. 15. Participants who are day and night lifestyle reversal. 16. Participants participating in any other clinical studies at the time of informed consent for this study. 17. Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant. 18. Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.",The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective. NCT03259893,Secondary Prevention of Atrial Fibrilation,"Inclusion Criteria: * Age 18 years or older * Diagnosis of paroxysmal AF (based on 12-lead electrocardiogram or event monitor showing AF). * Body mass index of greater than 27 kg/m2 * Eligibility to participate in cardiac rehabilitation with negative exercise stress test within 6 months. Exclusion Criteria: * Permanent AF. * Undergone catheter ablation of AF in past 6 months. * Class I or Class III anti-arrhythmic drugs at the time of enrollment * Unable to participate in cardiac rehabilitation. * Prognosis of less than 1-year. * Do not own a smart phone. * Unable to operate (transmit data) their smart phone. * Are not fluent in English or Spanish. * Unable to read in English or Spanish. * Not able to provide informed consent. * Women who are pregnant. * Prisoners.","The proposed study is designed as a Hybrid Type 3 effectiveness-implementation study. This study design will enable the investigators to primarily focus on core implementation outcomes while also assessing the effectiveness of the intervention on clinical outcomes. Since this is a Type 3 Hybrid trial, there are both effectiveness and implementation evaluation components, but the primary focus is on the implementation outcomes of feasibility, acceptability, adoption, and appropriateness. The specific aims, data collection, and analytic plans are grounded in the Proctor Conceptual Model of Implementation Research that posits improvements in outcomes are dependent not only on the evidence-based interventions that are implemented but on the implementation strategies used to implement those interventions. The model distinguishes between the intervention strategy (evidence-based practice), different types of implementation strategies (system environment, organizational, group/learning, supervision, individual providers/consumers), and three levels of outcomes (implementation, service, and client). The appropriate outcome measures in each category (implementation, service, client) depend upon the specific evidence-based practice and local context. AF patients with a BMI of ≥ 27 kg/m2, who are referred to outpatient cardiology clinic, inpatient cardiology service, or cardiology consult service at Boston Medical Center (BMC) will be screened until 50 participants are enrolled. Eligible participants will undergo 1:1 randomization to standard of care (SoC -group 1) or to the interdisciplinary AF program (intervention- group 2). Randomization will be performed using a computer randomizer algorithm with 5 blocks of 6 and 5 blocks of 4 in random order for a total of 50 participants. The rational for the randomization design is primarily for the purpose of feasibility and to establish effect sizes and guide the design of the future trial. All patients will be enrolled for a total duration of six months. Outcomes will be measured via 30-minute individual interviews at the end of 6-months. The implementation and service outcomes will be examined including acceptability, appropriateness, adoption, feasibility, and patient centeredness, as well as the client outcomes of satisfaction, function and symptomatology. Data will be collected using both quantitative and qualitative data methods to determine which aspects of the program achieved good patient adherence and acceptability." NCT03908021,The Salivary Microbiome in Children With Type 1 Diabetes Mellitus,"Inclusion Criteria: • Children with type 1 diabetes mellitus Exclusion Criteria: * Children Unable to give saliva sample * Children On antibacterial medicaments","Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender. Each patient or their legal guardian will sign an informed consent to participate in the study. The investigators will request a permission to access the medical records of the patients. Data will be collected from patient medical history. The investigators will measure salivary flow rate, pH and glucose, salivary Calcium, inorganic phosphate and urea and perform microbiome analysis and 16S rRNA gene-based analysis comparing children with diabetes to healthy children." NCT06068114,Gastric Pathophysiology in Diabetes,"Inclusion Criteria (diabetic group): * Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years Exclusion Criteria (diabetic group): * Diabetes mellitus type II being treated with a diet only * Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization * Concomitant treatment with more than one prokinetic agent * Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment * Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation) * Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.) * Severe coagulopathy * Esophageal or gastric varices and /or portal gastropathy * Advanced liver cirrhosis * Pregnancy or puerperium * Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment * The presence of a rumination syndrome or eating disorders (anorexia nervosa, bulimia). In case of doubts, a psychiatric examination will be performed. * Systemic connective tissue disorder * Inability to obtain informed consent * Any other condition, which in the opinion of the investigator would interfere with study requirements",N/A NCT01259206,Plantar Faciitis and Diabetes Mellitus,"Inclusion Criteria: * Clinical diagnosis of Diabetes mellitus * Must be obese Exclusion Criteria: * Previous radiotherapy to the foot, * previous trauma to the foot (fracture, rupture of tendon), * rheumatic or vascular diseases, * malign diseases, * lymphatic edema.","OBJECTIVE-Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS-Ninety-three obese patients with T2DM and forty-two obese subjects without any metabolic disturbances as control were evaluated with lateral calcaneal x-ray in blinded fashion by a radiologist. All participants were informed and written consents have been obtained. Control cases were subjected to 75g glucose challenge test and glucose intolerant subjects were excluded. RESULTS-T2DM and control groups were statistically similar in mean age (59±10.5 vs. 55±8 yrs, P=0.196, respectively) and mean body mass index (BMI)(35.1±4.3 vs. 33.1±3.3 kg/m2, P=0.073, respectively). Existence of calcaneal spur was 72% in 93 patients (77%) in T2DM group and 24 in 42 (57%) in control group. Groups were significantly different according to existence of CS (P=0.023). Mean age and mean BMI were significantly higher in diabetic patients with calcaneal spur than diabetic patients without calcaneal spur (p=0.001 and p=0.015, respectively). There was positive correlation between existence of calcaneal spur and peripheral neuropathy (p=0,043) in diabetics but no significant relation between existence of CS and glycolysed hemoglobin levels or diabetes duration (all P\>0.05). CONCLUSIONS-Clinicians should pay attention the increased incidence of CS in patients with T2DM to avoid foot complications." NCT01834404,Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients,"INCLUSION CRITERIA: * Obese subjects with BMI\> 30 Kg/m\^2. Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease. * Women of childbearing potential will have negative pregnancy test before initiation of medication. EXCLUSION CRITERIA: * Weight \>300 lbs, which is the limit of safety for the SPECT scanner * Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®) * Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg) * Concentration of fasting glucose greater than 240 mg/dl * Concentration of triglycerides greater than 400 mg/dl * Type 1 Diabetes * Use of anti-diabetic drugs other than metformin, * History of nephrolithiasis, * Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire-9, 21 total score ≥10). * Concomitant use of Monoamine Oxidase Inhibitors (MAOI) (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants * Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale \[HADS\] self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety and Depression Scale (HADS) score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. * End stage renal disease or liver cirrhosis * Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.","Investigators propose a randomized controlled trial of combination phentermine topiramate ER versus placebo given orally for 10-15 days. At visit 1 subjects had a brief interview, body measurements, and completed 4 questionnaires to rule out any gastrointestinal or significant psychological distress. At visit 2 subjects did a satiation/nutrient drink test. They drank a nutrient drink until they reached the maximum volume that could be tolerated, symptoms were recorded and blood samples taken at 4 times. They were randomized to one of the arms, and received a 5 day supply of study medication or placebo. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. At visit 3 subjects returned to pick up a nine day supply of study medication or placebo. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14. At visit 4 subjects underwent imaging to measure the volume of their stomach with an external camera that revolved around abdomen while they were lying on a table. Stomach volume was checked during fasting, starting 10 min after an intravenous injection of a radioactive material. The subjects ingested more of the liquid nutrient drink and 2 more images were obtained over 30 minutes. On the same day, subjects participated in an all you can eat meal, starting 4 hours after the ingestion of the liquid nutrient drink. At visit 5 subjects repeated the satiation/nutrient drink test. They drank a nutrient drink until they reached the maximum volume that could be tolerated, symptoms were recorded and blood samples taken at 4 times. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals." NCT00771004,Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.,"Inclusion Criteria: * Stable coronary artery disease with planned percutaneous coronary intervention with stent implantation. * Type II-diabetics and/or an IRIS II score greater than or equal to 50 (measure for the identification of patients with insulin resistance and increased vascular risk). * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Exclusion Criteria: * A planned percutaneous coronary intervention with stent implantation less than 15 days after the screening visit. * Planned multi-vessel intervention. * Use of systemic corticosteroids within the last 3 months prior to screening visit. * Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures. * History of severe or multiple allergies. * Treatment with any other investigational drug within 3 months before trial entry or earlier participation in the present study. * Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit. * Progressive fatal disease. * History of drug or alcohol abuse within the last 10 years. * A history of significant cardiovascular (New York Health Association stage II - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the normal reference range), renal (creatinine greater than 1.2 mg/dL in women and greater than 1.5 in men and/or glomerular filtration rate less than 45), neurological, psychiatric and/or hematological disease as judged by the Investigator. * Pre-treatment with peroxisome proliferator-activated receptor (gamma) agonists within the 3 months prior to screening. * If insulin therapy applicable: initiation of insulin therapy within the last 3 months. * If statin therapy applicable: change of medication within the last 4 weeks. * Myocardial infarction within 3 months prior to screening visit. * Blood donation within last 30 days.","Type 2 diabetes increases the risk of coronary heart disease at least by two to three fold compared with non-diabetic subjects. Moreover, prospective studies have shown a significant correlation between several glycemic confounders and morbidity from coronary heart disease even in patients without diabetes mellitus. In patients with previously diagnosed coronary heart disease, impaired glucose tolerance was found in 30 to 67 %. The cardiovascular risk of patients with insulin resistance, with or without glucose intolerance has become more and more apparent within recent years and quantitative coronary angiographic studies have revealed a correlation between the severity of coronary heart disease and impaired glucose tolerance. A new pharmaceutical class for the intervention of insulin resistance, the peroxisome proliferator activated receptor (gamma) agonists have been successfully introduced in the treatment of type 2 diabetes. Beyond their metabolic effects on glucose and lipid metabolism, peroxisome proliferator activated receptor (gamma) agonists show to exert a couple of pleiotropic, anti-inflammatory and vasoprotective effects in patients with type 2 diabetes and impaired glucose tolerance. The incidence and severity of peri-procedural myocardial injury during percutaneous coronary interventions with stent implantation in diabetic and in non-diabetic patients is an important prognostic confounder for the patient. Different laboratory biomarkers have been investigated as diagnostic tools for the estimation of the risk of peri-procedural myocardial injury. Recent studies have convincingly demonstrated that the risk of subsequent ischemic heart events is related to the extent of cardiac troponin or CK-MB increase after coronary intervention, and the prognosis for these individuals is usually worse than that for patients who do not develop an increase in these biomarkers. In a recent trial it was shown that pretreatment with atorvastatin could reduce procedural myocardial injury in elective coronary intervention. The incidence of Troponin I increase was 48% in the placebo group compared to 20% in the atorvastatin group. The aim of this study is to investigate the effect of pioglitazone on the incidence of peri-procedural myocardial injury in patients undergoing percutaneous coronary interventions with stent implantation. Total participation time is anticipated to be 3 weeks." NCT04974333,Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes,"Inclusion Criteria: * Men and women treated for type 2 diabetes with an HbA1C\>8.5%; * ≥20 years-of-age; * Signed up for diabetes treatment and control in one of the participating primary healthcare practices. * Having access to a mobile phone (or having a family member who will help them in sending, understanding, and retrieving messages and information provided in Spanish language through the mobile application) Exclusion Criteria: * Participants who are pregnant, within 3 months postpartum or planning pregnancy during the trial; * Breastfeeding; * Serious medical condition (i.e. dialysis treatment); * Having been admitted to hospital within the last 3 months for hyperglycemia or hypoglycemia; * Not permanent residents of the states where the study is conducted.","Trial setting This trial will be conducted within primary health care practices in three states (Colima, Tlaxcala y Guanajuato) of Mexico. These states were selected because they have a high prevalence of diabetes and have implemented an Electronic Health Record System. Patient and Public involvement During the planning phase of the study, a pilot project was carried out evaluating the design and applicability of the information board and mobile application in 31 type 2 diabetes patients. The final intervention was then modified according to the qualitative data received from the patients. the investigators also involved primary healthcare clinicians in the development and evaluation of the information. The results of the study will be made available to all trial participants and participating general practices. Finally, the General Health Council of Mexico who manages the countries public health system is included as collaboration partner in this trial and has been involved in all phases of the design of this study. Sample size calculations Considering a difference in HbA1C of 0.5% between the intervention and the control group, a standard deviation of 1.5%, a power of 90% and an alpha of 0.05 (two-sided tests) with a drop-out rate of 25% during the study, a minimum of 504 will be needed in total in each of the three states. Thus, the total number of patients will be 1512. Screening and recruitment The participating healthcare centers were selected because they have the most recent version of the Electronic Health Record System that allows linking clinical information to the mobile app and the information board used in this study. In addition, these centers count with the necessary health information system infrastructure. Finally, each of these centers take care of the clinical control of diabetes patients. The primary healthcare workers of the participating centers will screen their type 2 diabetes patient lists and will invite eligible patients. Patients will receive an invitation letter and a leaflet with general information about the study. Eligible patients may also be contacted by phone, emails, or text by the healthcare professionals. Patients will be enrolled for screening and random allocation over a six-month period. During the first visit of the screening phase, the eligibility criteria and medical record will be revised by the healthcare professionals. In case the patient is potentially eligible, the patient will be invited to the study upon obtaining informed consent. Before the next screening visit, the HbA1C of the patient will be measured to complete the eligibility assessment. Once the diagnosis of uncontrolled type 2 diabetes has been made, all other baseline measurements and laboratory tests will be conducted. Random allocation This trial will use a parallel group design, randomizing patients to either the intervention or the control arm by a computer-generated sequence with an allocation ratio of 1:1. The randomization of the study participants will be done after having provided consent and when all baseline assessments have been completed to minimize reporting and selection bias. Random allocation will be done using a validated secure web-based randomization operated by a data manager, not involved in the patient recruitment, located at the Autonomic University of Mexico. This will ensure concealment of the treatment sequence up to the allocation. The treatment sequence will be generated by a computer-generated sequence of random numbers. Allocation will be carried out with an algorithm to ensure groups are balanced for important baseline prognostic and other factors: study site, age (\<65/≥65 years), sex (male/female), duration of diabetes (\<5 years/≥5 years) and number of medications (\<5/≥5) which are considered as a key prognostic variable for the primary outcome of this trial. The treatment allocation codes will be concealed in sequentially numbered envelopes that will be opened each time a patient will be enrolled." NCT00732147,Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM,"Inclusion Criteria: * Type 2 DM study participants will be C-Peptide positive (levels \> 0.3 nmol/L) * Receiving insulin, metformin and/or sulfonylurea/glitinide. * Maintained on stable anti-hypertensive medication. * BMI \< 52 kg/m2. * T2DM for at least 3 months with HBA1C under 10%. Exclusion Criteria: * Receiving TZDs, exenatide, sitagliptin or pramlintide therapy. * Receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids. * Triglyceride levels \> 400 mg/dl. * BMI \> 52 kg/m2.","A well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal. To date the mechanisms driving this increased post prandial glycemia are unclear. Pramlintide is believed to affect intermediary metabolism as well as nutrient absorption. The relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and TG concentrations remain uncertain, however. Combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions. Aims: 1. To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein (VLDL)-triglycerides(TG) following a high fat breakfast, lunch and dinner in patients with type 2 diabetes mellitus (T2DM). A triple isotope approach will be used to determine rate of appearance of (VLDL)-triglycerides following breakfast, lunch and dinner. 2. To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production (glucagonstatic mechanism) in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM." NCT00727038,Lucentis for New Onset Neovascular Glaucoma,"Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 21 years * Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP \> 21 mm Hg and \> 5 mm Hg IOP compared to the fellow eye). * Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.) Exclusion Criteria: * Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. * Prior enrollment in the study * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial * \> 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae) * History of active inflammatory, infectious, or idiopathic keratitis precluding view of the anterior segment structures. * Previous intravitreal injections of ranibizumab or bevacizumab in either eye.","Hypothesis: Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone. Specific Aims: To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone. Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae. Neovascular glaucoma has many etiologic causes, the vast majority resulting from retinal ischemia secondary to relatively common diseases such as central retinal vein occlusion, proliferative diabetic retinopathy and ocular ischemic syndrome (carotid stenosis). (Sivac-Callcott et al., 2001) Vascular endothelial growth factor is likely a major contributor to the development of angle and iris neovascularization. (Ferrara, 2004) Although panretinal photocoagulation and/or cryoablation are mainstays of conventional treatment for neovascular glaucoma, the delayed therapeutic effect of these interventions often results in the formation of peripheral anterior synechiae and permanent angle closure. Recent limited case series have demonstrated a role for bevacizumab (Avastin) in reducing rubeosis iridis and as an adjunct for neovascular glaucoma. (Grisanti et al., 2006; Davidorf et al., 2006; Iliev et al., 2006; Kahook, Schuman, Noecker, 2006) However, no prospective studies have examined the potential utility of anti-vascular endothelial growth factor agents in the treatment of neovascular glaucoma. Intravitreal Lucentis is the standard of care for the treatment of exudative macular degeneration. Pharmacologic agents such as Lucentis, which selectively inhibit vascular endothelial growth factor may provide an important therapeutic adjunct for the treatment of neovascular glaucoma by more immediately causing regression of angle neovascularization and thereby providing a window for permanent treatment with laser or cryotherapy." NCT02314858,Tailored Treatment to Enhance Risk Perception in Sleep Apnea,"Inclusion Criteria: * Polysomnography (PSG) confirmed diagnosis of Obstructive Sleep Apnea (OSA) * choice of PAP as preferred treatment * judged by sleep physicians to be responders to PAP * participants will be considered responders to PAP if they have an AHI of less than 5, do not snore, and have an arousal index of less than 10 when titrated to the proper pressure of PAP Exclusion Criteria: * Apnea-Hypopnea Index (AHI) \< 15 on the diagnostic PSG and no daytime functional symptoms or associated cardiovascular disease * a sleep disorder other than OSA that causes arousals from sleep (e.g., periodic limb movements, restless legs syndrome, insomnia) * a current substance abuse problem * a serious sleep-disruptive medical condition (e.g., end stage renal failure, severe Chronic Obstructive Pulmonary Disease (COPD), severe asthma) * significant global cognitive impairment * history of or current diagnosis of psychosis, bipolar disorder, or borderline, schizotypal or antisocial personality disorder, and uncontrolled depression or suicidal ideation * change in antidepressant medications over the past 3 months * women pregnant women, breast feeding, or planning on becoming pregnant * currently enrolled in another research study",N/A NCT00071526,Urinary Vitamin C Loss in Diabetic Subjects,"* INCLUSION CRITERIA: To be included in the study, study subjects should be: * Aged 18-65 years. * Either: * Have no diagnosis of diabetes: ""nondiabetic controls"", or * Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes EXCLUSION CRITERIA (for outpatient study, arm 1) Exclusion criteria will include the following: * Unable or unwilling to provide a signed and dated informed consent form * Unable or unwilling to comply with study procedures and lifestyle considerations EXCLUSION CRITERIA (for inpatient studies, arms 2 and 3) Study participants interested in participating in Arms 2 and/or 3 will be excluded from this further participation if they meet any of the following: * significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion * other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability * pregnancy or lactation * presence of other conditions which, in the judgment of the investigators, can influence vitamin C metabolism or vitamin C renal handling","Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and sample processing. Consequently, it is unclear whether diabetic subjects truly have both low plasma and high urine vitamin C concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy controls. We will study nondiabetic controls and cohorts with diabetes. Vitamin C concentrations in plasma, RBCs, and urine will be measured in outpatients. In those willing to be admitted to the Clinical Center, we will measure vitamin C pharmacokinetics to determine the relative bioavailability for vitamin C in individuals with and without abnormal urinary loss of vitamin C (or renal leak). Single nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two proteins mediating sodium dependent vitamin C transport, SVCT1 and SVCT2. We will also explore mechanisms underlying abnormal urinary vitamin C loss." NCT07095777,Study on the Recovery of Visual Perceptual Function Dysfunction in Patients With Diabetes,"Inclusion Criteria: * moderate to severe non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy(PDR) prior to treatment(17) * prior pan retinal laser photocoagulation (PRP) at least 4 weeks before enrollment or vitreoretinal surgery at least 8 weeks before enrollment * stable clinical condition * best-corrected visual acuity (BCVA) \> 1.0 logMAR (equivalent to a Snellen visual acuity of \< 20/200) * clear refractive media * age ≤ 65 years * ability to comprehend the examination and training procedures Exclusion Criteria: * significant refractive media opacity * psychiatric disorders, chronic alcoholism and traumatic brain injury * new-onset vitreous hemorrhage, myopia, strabismus, amblyopia, glaucoma and macular diseases.",N/A NCT07266077,Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations,"Inclusion Criteria: * US military Veterans willing to travel to the Minneapolis VA Health Care System * Unilateral, below-knee amputation * Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation) * Medicare Functional Classification Level K3 ambulator (unlimited community ambulator) * Well-fitting and well-aligned prosthesis * Uses a prescribed energy storage and return foot (ESAR) * Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment) * Access to computer, tablet, or smartphone and internet for video conferencing and REDCap data collection Exclusion Criteria: * Residual-limb skin problems * Not a regular prosthesis user * Mass over 125 kg (275 lbs) * Residual limb too long to accommodate the study feet (104 mm of build height) * Has used a hydraulic foot previously as part of clinical care or a research study * Documented major neurocognitive disorder (i.e., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living * Baseline PROMIS-APSRA or PROMIS-SSRA scores at the maximum levels (no room for improvement on primary outcomes)","Background and Relevance to VA - Over 90% of Veterans who use a below-knee prosthesis in the community are prescribed an energy storage and return (ESAR) foot. ESAR feet are designed to assist with forward propulsion during walking, which many users find helpful for certain activities. However, ESAR feet lack ankle articulation, making it difficult to walk on non-level surfaces. To overcome this limitation, typical hydraulic feet incorporate damped ankle motion to accommodate walking on uneven terrain. While potentially improving aspects of participation and fall-related health, typical hydraulic feet have reduced energy storage and return compared to ESAR feet. To combine the benefits of ESAR and typical hydraulic feet, the Minneapolis VA, in collaboration with Fillauer Motion Control, Inc., has developed a novel hydraulic Slope Adaptive Foot (SAF). During pilot testing, most Veterans preferred the SAF over their prescribed ESAR foot and reported improvements in participation. Further research is needed to evaluate the impact of different prosthetic feet on participation and fall-related health in order to identify which patients are best suited for an ESAR foot, a typical hydraulic foot, or the SAF. Innovation and Impact - The long-term goal of this project is to inform prescription of hydraulic feet for Veterans living with lower-limb amputation to optimize their participation in important life roles and activities. Results of this study will help to develop evidence-based provider training and patient education materials to assist with precision rehabilitation and a patient-centered care approach to prescribing hydraulic prosthetic feet. Aim 1 - Evaluate the influence of different prosthetic foot-related factors on participation. PROMIS Ability to Participate in Social Roles and Activities (APSRA) and PROMIS Satisfaction with Social Roles and Activities (SSRA) will be administered during a cross-over randomized control trial (RCT). This aim will test the hypothesis that using the SAF will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores relative to a typical hydraulic foot and that using either hydraulic foot will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores compared to the ESAR foot. Aim 2 - Characterize the lived experiences of Veterans using their preferred prosthetic foot to inform clinical decision making. Mixed-methods will be used to explore how participation in social roles and activities is influenced by hydraulic and ESAR feet. Gaining a deeper understanding of Veterans' experiences across a range of situations and environments will inform the development of evidence-based education materials. Exploratory Aim - Evaluate the influence of different prosthetic foot-related factors on fall-related health outcomes. The Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH), which includes four distinct and important domains, will be administered during a cross-over RCT. This aim will test the hypothesis that using the SAF will be associated with improved fall-related health outcomes relative to a typical hydraulic foot and that using either hydraulic foot will be associated with improved fall-related health outcomes compared to the ESAR foot. Methodology - To address these aims, this study will 1) conduct a cross-over RCT of the SAF versus a typical hydraulic foot (Motion Foot SLX, Fillauer) among 30 Veterans with a below-knee amputation who use an ESAR foot and have no prior experience with a hydraulic foot, and 2) conduct a one-year observational study in which Veterans use their preferred prosthetic foot. Participants will complete quantitative (PROMIS-APSRA, PROMIS-SSRA, PLUS-FRH) and qualitative (semi-structured interviews) assessments at baseline and after each period of the cross-over RCT and quarterly during the one-year observational study. A participatory method will be used in which Veterans will be asked to share photos with a short narrative to portray their experiences with their preferred prosthetic foot to prompt discussion during the quarterly interviews of the one-year observational study. Participating Sites - Minneapolis VA Health Care System (data collection site) and the University of Washington. Duration of Participant Intake (Study Duration) - This project is projected to occur over four years. The project will begin with a 3-month start-up period and recruitment will continue for 18 months following start-up. Data collection will conclude with 9 months remaining in the study timeline, which will be used for data analysis, dissemination, development of implementation materials, and study closure. Path to Implementation - Data gathered from this study will be used to draft evidence-based education materials for providers and Veterans. These materials, which will provide pertinent and useful information about foot options (ESAR, SLX, SAF) for prosthetic prescription, will be used in a future implementation study." NCT05564481,Research on Optimizing the Use of Technology With Education,"Inclusion Criteria: * 10-15 years old * Type 1 diabetes * Type 1 diabetes diagnosis ≥ 6 months \\ * Starting a continuous glucose monitor for the first time or restarting after ≥ 1 year Exclusion Criteria: * Younger than 10, older than 15 * Diagnosed less than 6 months * Already using CGM or has used within last year * Other major medical condition such as cancer, cystic fibrosis","Young adolescents (ages 10-15) with type 1 diabetes (T1D) are at high risk for deterioration of glycemic control and relatedly poor overall T1D self-management. Continuous glucose monitors (CGM) provide real-time indicators of glucose levels and alert users to hypoglycemia and hyperglycemia. Consistent, informed use of CGM has the potential to improve glycemic control and related T1D health outcomes. However, adolescents with T1D are the least likely age group to utilize CGM and significant health disparities exist in access to and use of CGM among youth from racial and ethnic minority backgrounds and youth with public insurance. Adolescent CGM users also continue to evidence A1c levels above recommended targets, potentially due challenges related to perceived CGM burden and related family functioning. Novel, developmentally targeted interventions delivered early in adolescence could promote optimal uptake and use of CGM and reduce psychosocial barriers to sustained use but must be evaluated in rigorous pilot trials that attend to health disparities. The current study proposes to evaluate an innovative behavioral intervention that utilizes certified diabetes care and education specialists (CDCES) to teach problem-solving and communication skills around CGM data and use, targeting adolescent-parent T1D interactions related to glucose data, individualized CGM challenges, and weekly adolescent-parent joint review of CGM reports. The intervention also addresses HCP knowledge of health disparities in diabetes technology through interactive education, and boosts family support through connection with peer parent consultants. This study aims to evaluate the preliminary efficacy of the behavioral intervention to enhance CGM use and resulting T1D health outcomes. Sixty adolescents and their parents will be recruited for this pilot randomized trial, randomly assigned to either an immediate intervention group or a delayed intervention group serving as a standard care comparison. Intervention content will be delivered via 3 telemedicine sessions with adolescents and a parent and supported by connection with a peer parent consultant. Medical and psychosocial data (including A1c, CGM indicators, CGM burdens and benefits, diabetes distress, and diabetes-related family conflict) will be collected from adolescents and a parent at baseline and three follow-up time points across the first year after CGM initiation. The investigators will employ quantitative and qualitative analyses to evaluate intervention feasibility, acceptability, and impact. Enhancing CGM access and use at this key developmental juncture provides an excellent opportunity for tailored support and problem-solving, resulting in potentially lasting improvement in diabetes self-management. Results of this pilot trial will directly inform a multi-site randomized clinical trial to evaluate efficacy, with the long term goal of identifying effective behavioral strategies that can be integrated into routine diabetes education and care." NCT00271700,Improving Glycemic Control on GMS: A Quality Improvement Study,"Inclusion Criteria: * Subjects will include all type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who do not have an indication for IV insulin. Exclusion Criteria: * Type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who have an indication for IV insulin.","This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year." NCT00356265,Alpha-Adrenoceptor Vascular Function In Chronic Kidney Disease Focus On The Role Of Endothelial Nitric Oxide,"Inclusion Criteria: * Men and Women-18 to 55 years of age. * There are three groups of volunteers. * Group A. People who are hypertensive with kidney disease. When not taking blood pressure medicines, blood pressure must have a systolic between 140-170 mmHg. Diastolic must be between 90-109 mmHg.Kidney function should be around half of normal. Urine protein must be no more than 1 gram in a 24-hour urine time period. * Group B. People who are hypertensive without kidney disease. Blood pressure must have a systolic between 140-170 mmHg. Diastolic must be between 90-109 mmHg. Kidney function should be normal. Normal amounts of protein in their urine. * Group C. People who are normotensive. Blood pressure must have a systolic below 131/mmHg. Diastolic must be below 81 mmHg. Kidney function should be normal. No more than normal amounts of protein in their urine. Exclusion Criteria: People with: * Diabetes * Lung disease * Stomach disease * Liver disease * Blood vessel disease * Heart disease * Hereditary blood disorders * Hematocrit (amount of red blood cells) less than 30% * Current tobacco use * Kidney disease who require dialysis * Women who are pregnant or breastfeeding","Enhanced adrenergic vascular reactivity may significantly contribute to hypertension and the excessive cardiovascular disease burden in patients with chronic kidney disease (CKD). Nitric oxide (NO), a modulator of neurovascular function, may be linked to adrenergic vascular responsiveness. The central HYPOTHESIS is that the reduction in endothelial nitric oxide (NO) bioavailability contributes to the enhancement of α1-adrenoceptor vasomotor function in patients with CKD. Specific Aims: In patients with mild to moderate CKD, compared to matched hypertensive and normotensive controls without CKD: 1. Determine if α1-adrenoceptor vasoreactivity is enhanced less by inhibition of endothelial NO 2. Determine whether α1-adrenoceptor vasoreactivity correlates with plasma levels of the endogenous NO inhibitor, asymmetrical dimethylarginine. Methods: CKD will be confirmed by I125-iothalamate glomerular filtration rate. Regional α1-adrenoceptor vasoreactivity (sensitivity \[EC50\], reactivity \[slope\]) will be assessed by venous plethsymography using a graded intra-arterial infusion of the α1-adrenoceptor agonist, phenylephrine. Comparisons of vasoreactivity at baseline and during infusions of L-NMMA will be made between hypertensive non-diabetic subjects with glomerular filtrations rates between 30-70 ml/min age-, gender-, ethnicity- and % body fat-matched hypertensive and normotensive subjects with normal kidney function. In addition, plasma levels of the endogenous NO inhibitor, asymmetric dimethylarginine will be measured in the hypertensive subjects with and without CKD and compared to vasoreactivity. Significance. These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1 vasoreactivity in subjects with progressive renal disease." NCT00635492,CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy,"Inclusion Criteria: * are aged 18 or above * diagnosed with type 2 diabetes * have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes * have not previously been treated with either insulin or exenatide * are not simultaneously participating in another study which includes an investigational drug or procedure at study entry * have been fully informed and given their written consent for use of their data * have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.",N/A NCT02420392,Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell,"Inclusion Criteria: * Type 2 diabetes for dapagliflozin arm * Normal glucose tolerance (fasting plasma glucose \<100 mgd/l, HbA1c \<6.0%) for normal glucose tolerance arm * Age 18 to 75 years * BMI \<35 kg/m2 * For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea Exclusion Criteria: * Who is allergic to dapagliflozin * Type 1 diabetes * Patients with history of diabetic ketoacidosis * Reduced renal function (eGFR \<60ml/min/1.73m2) * Taking loop diuretics or dehydrated patient * History of hypotension when taking hypertensive medication * Diagnosed with heart failure * Diagnosed with cerebral infarction * Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor * Above upper limit of normal hematocrit range (male 39-52%, female 36-48%) * Pregnant or breastfeeding women * History of recurrent genitourinary infection * AST/ALT more than two fold increased above normal upper limit * Hemolytic disorder",N/A NCT07226336,Dietary Interventions to Reduce Ultra-Processed Food Intake,"Inclusion Criteria: * Ages 18-70 years old * BMI \>25 and \<50 kg/m2 * Wish to reduce their UPF intake * Consume at least 2 UPF items per day and at least 4 distinct UPF items per week Exclusion Criteria: * Have ever been diagnosed with anorexia nervosa or bulimia nervosa * Are using medications known to influence eating behavior and/or weight (e.g., semaglutide) * Currently using insulin * History of bariatric surgery * Current pregnancy or planning to become pregnant during the study period","The DISRUPT clinical trial will test 2-month interventions for reducing ultra processed food (UPF) intake among 60 adults with overweight or obesity (ages 18-70) who frequently consume UPFs. Participants will be randomly assigned to receive a standard dietary change (SDC) intervention (ON/OFF), in which they will receive the typical toolbox of evidence-based methods for changing diet (e.g., meal planning, problem solving, reflecting on the benefits of change) to help them reduce their ultra-processed food intake. Participants will be also randomly assigned to receive a cognitive dissonance intervention (ON/OFF). In this intervention, participants will learn about the harms of the food industry and be engaged in activism against this industry to elicit cognitive dissonance for consuming UPFs. Participants will be randomly assigned to each condition separately (through a 2x2 factorial design, resulting in four possible experimental conditions: 1) Control (both OFF), 2) Standard Dietary Change Condition (SDC ON, Dissonance OFF), 3) Dissonance Condition (SDC OFF, Dissonance ON), and 4) SDC + Dissonance Condition (SDC ON, Dissonance ON). All participants will receive an introductory educational workshop on UPFs, how to identify them, and their harmful health effects. Participants assigned to receive at least one of the interventions (i.e., SDC, dissonance, or both) will attend weekly group sessions for weeks 2-8. Aim 1 is to test the isolated and interactive effects of standard behavior change strategies and dissonance-based strategies on treatment outcomes. Participants randomly assigned to the SDC condition and the Dissonance condition, respectively, are expected to have larger reductions in UPF intake, greater improvements in indicators of dietary quality (e.g., added sugar, sodium intake), and more weight loss, compared to those in the control condition. The effect of the SDC + Dissonance condition (vs. the control condition) on treatment outcomes is expected to be synergistic, greater than the additive effect either condition alone. Aim 2 is to test the hypothesis that having the dissonance intervention ON will attenuate the disparity in treatment outcomes for individuals with socio-structural barriers to healthy eating (i.e., low perceived socioeconomic status, low income, limited access to healthy food, and unhealthy neighborhood food environment)." NCT03323411,End-of-life Intervention for African American Dementia Caregivers,"""Inclusion Criteria"" * Caregiver spouse or adult child of care recipient * Caregiver knowledgeable about care recipient's medical history * Care recipient must be African American * Care recipient must have moderate to severe stage dementia * Care recipient must lack decisional capacity ""Exclusion Criteria"" * Not a caregiver * Care recipient not African American, * Care recipient without moderate to severe dementia","The investigators conducted a randomized controlled trial for efficacy of the Advance Care Treatment Program in an African American church-based community model. The investigators compared the effect of the experimental and control groups on knowledge, self-efficacy, intentions and behaviors from 4 urban African American churches randomly assigned to experimental (n=2) or control (n=2) conditions,304 (experimental n=152; control (n=152) health care proxies of participants that have advanced stage dementia: (a) were concurrently recruited in small classes each with 8-9 healthcare proxies." NCT03487887,Secondary Care - Continuous Glucose Monitoring,"Inclusion Criteria: * T2DM diagnosed at least one year prior to study entry * Only basal insulin in therapy * Patients' ability to understand and answer the questionnaire by themselves * Signed informed consent Exclusion Criteria: * Known coagulopathy * Oral anticoagulants in therapy * Skin disease that enables continuous glucose monitor device application * Febrile illness * Patient's inability to physically visit a general practitioners office * Patient's inability to answer the questionnaire by themselves","STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 diabetologist from four Croatian regions will recruit up to ten subjects of both sexes from May 2018 till the end of May 2019, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with only basal insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and hemoglobin A1c findings. Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol, and high density cholesterol, and low density cholesterol, triglyceride and serum creatinine) and habits data will be collected. SETTING: Totally 100 of patients will be included. At diabetologist office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days and return it to the office for download. Patients only see the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist who are not familiar to the method will have a short education. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM." NCT02091193,Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus,"Inclusion Criteria: * Clinical diagnosis of Type 2 Diabetes Mellitus * Stable on glucose lowering agents Exclusion Criteria: * Age of less than 18 * Currently pregnant or lactating * Blood coagulation disorder or taking oral anticoagulants other than aspirin * Seafood allergy * Presently taking fish oil or krill oil supplements",N/A NCT01951716,Effects of Xenin-25 on Insulin Secretion and Gastric Emptying in Humans With and Without a Complete Truncal Vagotomy,"Inclusion Criteria: * Ages 18-70. No minors will be studied. * Individuals must be able to consent for their own participation (no mental impairment affecting cognition or willingness to follow study instructions). * Healthy volunteers with no clinical evidence of Type 2 Diabetes * Healthy volunteers who have undergone a complete truncal vagotomy * Healthy volunteers who have not had a complete truncal vagotomy * Women of childbearing potential must be currently taking/using a method of birth control that is acceptable to the investigators. A pregnancy test will be done at the beginning of each visit. Any woman with a positive pregnancy test will be removed from the study. * Willingness to complete all required visits Exclusion Criteria: * \<18years of age or \>70 years of age * Lacks cognitive ability to sign the consent \&/or follow the study directions for themselves * Women unwilling to comply with using an acceptable method of contraception during the course of the study, or who are currently breast-feeding. * Volunteers with Type 2 diabetes * Volunteers with a history of Acute Pancreatitis * Volunteer with a history of Chronic Pancreatitis and/or risk factors for chronic pancreatitis including hypertriglyceridemia (triglycerides \>400mg/ml) hypercalcemia (blood calcium level \>11.md/dl) and/or the presence of gallstones. * Volunteers with a history of gastrointestinal disorders, particularly related to gastric motility/emptying such as gastric bypass, documented gastro-paresis in diabetic volunteers. * Volunteers with a history of cancer. Exception: skin cancer. * Known heart, kidney. liver or pancreatic disease requiring medications. * Subjects unwilling to allow the use of their own blood or the human albumin in the preparation of the peptides. * Unwillingness to allow blood glucose level adjustment (if needed) with IV insulin.","Two groups of subjects, both without T2DM, will be studied. One group will consist of people who previously received a complete truncal vagotomy as part of a surgical treatment unrelated to this research project. The other group will be subjects who have not had a truncal vagotomy. Initially, each potential participant will be administered an oral glucose tolerance test at the screening visit to make sure that they do not have type 2 diabetes. They will also have a sham feeding test to check for the completeness (or absence) of the vagotomy. As outlined below, each subject will then receive 4 graded glucose infusions (GGI) and 2 meal tolerance tests (MTT)- each on a separate occasion following an overnight fast. For each GGI, the subject will be given an intravenous infusion of glucose such that blood glucose levels slowly increase over a 4 hour period. On separate occasions, the participant will also receive a primed-continuous infusion of GIP alone, xenin-25 alone, GIP plus xenin-25, or placebo (constant dose of 4 pmoles x kg-1 x min-1). Blood samples will be collected before and during the GGI for the measurement of glucose, insulin, C-peptide, glucagon, pancreatic polypeptide, GIP and xenin-25 levels. Insulin secretion rates will also be calculated. By comparing results for the two groups, we will learn if the vagus nerve mediates the effects of GIP, xenin-25, or the combination of GIP plus xenin-25 on insulin secretion in humans and thus, if this signaling circuit is impaired in humans with T2DM. For the MTTs, the participant will ingest a liquid meal (Boost Plus) plus acetaminophen (Tylenol). On separate occasions, a primed-continuous infusion of vehicle alone or xenin-25 alone (constant dose of 12 pmoles x kg-1 x min-1) will be initiated at the same time the meal is ingested. Blood samples will be collected before and during the MTT for the measurement of acetaminophen, glucose, insulin, C-peptide, glucagon, GIP and xenin-25 levels. Insulin secretion rates will also be calculated. The rate of acetaminophen appearance in the blood is an indirect measure of the rate of gastric emptying. By comparing results for the two groups, we will learn if the vagus nerve mediates the effects of xenin-25 on gastric emptying in humans." NCT00914706,A Study of the Effect of a Chronic Disease Management System on Diabetes Care Within Multidisciplinary Primary Care Practices in Ontario,"Inclusion Criteria: * Ontario primary care practitioners able to provide a list of patients within their practice. * High-speed internet access in the practice environment or willingness to obtain high-speed internet access. * Physicians willing to use the CDMS or already using it currently. Exclusion Criteria: * Ontario primary care practitioners involved in the QIIP Learning Collaboratives who are practicing in one of the following local health integration networks: * LHIN 2 South West * LHIN 7 Toronto Central * LHIN 11 Champlain AND * LHIN 14 North West so as to not interfere with other Provincial diabetes initiatives.","Practice Guidelines recommend that patients with chronic diseases should be monitored with specified clinical measurements each with regular repeats at different specified time intervals or on specified conditions. It is virtually impossible for health care providers to adhere consistently to guidelines and to do so sustainability as well as equitably for ""most if not all"" of their patients with diabetes. Ontario Health Technology Advisory Committee (OHTAC) has requested the following study. Aggregate monthly primary care practice level data will form the basis of the analysis. Primary care practitioners in Ontario will be enrolled. Differences in 1-year outcome measures within will be performed. Baseline, 2 month, 6 month and 12 month site team member surveys will be completed. Using patient level data from each site, a cost-utility analysis will be conducted. Six aspects related to the use of the CDMS will be examined. 1. Change in proportion of the patients in whom monitoring frequency is up to date for A1C, blood pressure and cholesterol. 2. Change in proportion of patients who are well controlled with A1C \< 0.07, blood pressure \< 130/80 and LDL-cholesterol \< 2.0. 3. Change from baseline across sites in the percentage of patients with an up-to-date foot exam, retinopathy screening, use of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) and documentation of self-management goals. 4. Site questionnaires. 5. Changes in physician MOHLTC diabetes incentive billings. 6. Long-term cost-utility of the use of the CDMS." NCT01092806,Insulin Secretion and Advagraf,"Inclusion Criteria: * Renal transplant recipients on stable Tac based immunosuppressive therapy. * 18 years of age or older. * Stable prednisolone dose of 5 mg/day or less. * S-creatinine below 150 umol/L. * Signed informed consent. Exclusion Criteria: * Acute rejection episodes within the last 2 weeks prior to inclusion. * Changes in Tac dosing within the last 2 weeks prior to inclusion. * Diabetes mellitus (WHO criteria). * Pregnant or nursing mothers or women of childbearing potential without acceptable contraception strategy. * Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazepine, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin. * Patients treated with investigational drugs.","Study objectives The primary objective is to compare insulin secretion (Secr2.phase) between the two different formulations of Tac. Secondary objectives are to compare the effect of the two formulations on Secr1.phase, insulin sensitivity and to investigate possible associations with individual systemic tacrolimus exposures. Study design Twenty adult kidney transplanted patients treated with Prograf® twice daily or Advagraf® once daily will be included in the study. Eligible patients may be included in a stable posttransplant phase (no Tac dose adjustments or acute rejection episodes the preceding 2 weeks). A 3-hour hyperglycaemic clamp will be performed while patients are treated with their standard Tac formulation and repeated 4-6 weeks after switching to the alternative Tac formulation. The clamp investigation will be done after administration of the morning dose of Tac. Samples for measurement of Tac whole blood concentrations will be drawn for all patients up to 24 hours after morning Tac dosing. It is not mandatory for all patients to perform full 24 hour pharmacokinetic investigations. Switching to the alternative Tac formulation will be performed in a 1:1 daily dose ratio and subsequently adjusted according to centre protocol for trough concentrations (5-10 ng/mL). Patients will meet for trough concentration measurements at Rikshospitalet for appropriate dose adjustment in the period between the two investigations days. Patients The patients will primarily be recruited from the great-Oslo area and all study visits will be performed at Rikshospitalet. Patients will otherwise follow standard post transplant procedures at their local hospital during the study period. Patients included in other clinical trials are also eligible for inclusion in the present study as long as they are not treated with investigational drugs. Informed consent will be obtained according to the Declaration of Helsinki and ICH-GCP guidelines. Patients and investigator will sign the patient information which will be kept on file. The patient will receive a copy of the patient information. Patient data will be recorded in Case Report Forms (CRF) and all information will be handled confidentially. Any complications will be recorded. Glucose clamp calculations Lean body mass (lbm) is estimated using Hume's formula \[12\] which correlates well with tritiated water or electrical bioimpedance measures \[13\]. Secr1.phase is calculated as the area under serum insulin vs. time curve (AUC, trapezoidal rule) during the first 10 min of the clamp procedure, and Secr2.phase is calculated as the insulin AUC during the last hour (120-180 min) of the clamp procedure. The same calculations were also performed for C-peptide concentrations. Glucose disposal rate (GDR) is calculated from the amount of glucose infused during the last hour of the clamp. The IS index (ISI) is calculated as GDR \[mmol/kg (lbm)\*min\] divided by mean serum insulin (pmol/l) in the same period. Glucose clearance is calculated as ISI divided by mean serum glucose during the last 60 min of the clamp \[14\]. Pharmacokinetic calculations Nonlinear mixed effects modeling (NONMEM software version VI and Intel Fortran (version 8) compilation tool) will be used to analyze the dose-concentration-time data for Tac using a population approach. The pharmacokinetic profile data will be used to develop a pharmacokinetics model including the effect of major covariates (e.g. age, gender, body size, renal function, hematocrit, acute rejection status etc.) on CL/F and V/F from the 24-hour pharmacokinetics investigations. If applicable additional trough concentration data from the routine follow-up of the patients in the study will be used to develop the model. Exclusion of patient data will only be allowed if Tac concentrations have not been able to be measured accurately or in case of unavailable information that may interfere with pharmacokinetic evaluation, e.g. exact blood sampling time or dose given. The POSTHOC, MAXEVAL=0 option in NONMEM will be used to estimate individual AUC0-24 and half-lives for each individual. Actually measured Ctrough, Cmax and Tmax values will also be used to describe the pharmacokinetic properties of the patients. Statistical considerations Sample size: Based on the assumption that a 15% relative change in insulin secretion between the two formulations are clinically relevant and a relative standard deviation of 25% 20 patients are needed to assure a power of 80% at a 5% significance level. Patients that drop-out during the study will be substituted. Analysis plan: The primary end-point will be analyzed per-protocol by comparing the ratio of insulin sensitivity (Secr2.phase) for the two formulations. Data will be transformed to obtain normal distribution if appropriate. Secondary endpoints will be analyzed as follows: * Insulin Secr1.phase * Insulin sensitivity index (ISI) * Association between insulin Secr2.phase, Secr1.phase and ISI and systemic exposure of Tac (derived from individual NONMEM estimations) * All analysis above also performed for C-peptide" NCT04753606,Randomized Study of Obicetrapib as an Adjunct to Statin Therapy,"Inclusion Criteria: * LDL-C \> 70 mg/dL and TG \< 400 mg/dL, * Treated with a high-intensity statin therapy Exclusion Criteria: * BMI \> 40 kg/m * Significant cardiovascular disease * HbA1c \> 10% * Uncontrolled hypertension * Active muscle disease * GFR \< 60 ml/min * Hepatic dysfunction * Anemia * History of malignancy * Alcohol abuse * Treatment with investigational product * Treatment with PCSK9 * Clinically significant condition * Known CETP inhibitor allergy","This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up." NCT00654004,Fatty Acid Oxidation Disorders & Body Weight Regulation Grant,"Inclusion Criteria: * confirmed diagnosis of TFP, LCHAD, CPT2 or VLCAD deficiency * at least 7 years of age * willingness to complete overnight admission * generally healthy Exclusion Criteria: * inclusion in another research project that alters macronutrient intake * diabetes, thyroid disease or other endocrine dysfunction that alters body composition. * pregnancy * anemia","A role for mitochondrial fatty acid oxidation in the peripheral signaling cascade of leptin, adiponectin and insulin has recently been proposed from animal studies but has not been investigated in humans. Children with trifunctional protein (TFP, including deficiency of long-chain hydroxyacyl-CoA dehydrogenase) and very long-chain acyl-CoA dehydrogenase (VLCAD) deficiency, inherited disorders of long-chain fatty acid ß-oxidation, lack an ability to oxidize fatty acids for energy. They have increased levels of body fat and circulating leptin and a high incidence of obesity. Current therapy for children with these disorders is based on frequent meals and consuming a low fat, very high carbohydrate diet. Despite treatment, exercise induced rhabdomyolysis is a common complication of TFP and VLCAD deficiency that frequently leads to exercise avoidance. The effects of these genetic defects on body composition and weight regulation have not been investigated. The contribution of fatty-acid oxidation during moderate intensity exercise in children has also not been reported. Two groups of subjects were recruited: one group of subjects had a long-chain fatty acid oxidation disorder (n=13). The other group is a group of controls (n=16). We studied peripheral signals of body weight regulation, glucose tolerance, body composition, and exercise metabolism in subjects with a long-chain fatty acid oxidation disorder compared to normal controls." NCT00371033,Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS),"Inclusion Criteria: * Participant has signed and dated the appropriate Informed Consent document. * Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months. Exclusion Criteria: * Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment. * Participant has a calculated creatinine clearance of \<60 mL/min. * Participant has a platelet count \<100,000/mm3. * Participant is allergic to antiepileptic/antiseizure medications. * Participant has a known allergy or sensitivity to pregabalin (Lyrica®). * Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone). * Participant has New York Heart Association Class III or IV congestive heart failure. * Participant has a history of thrombocytopenia, or a bleeding diathesis. * Participant has a history of prostate, bladder or urethral cancer. * Participant has a history of alcohol abuse. * Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome). * Participant has undergone pelvic radiation or systemic chemotherapy. * Participant has undergone intravesical chemotherapy. * Participant has been treated with intravesical BCG. * Participant has unilateral orchalgia without other pelvic symptoms. * Participant has an active urethral stricture. * Participant has a neurological disease or disorder affecting the bladder. * Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.","Primary Objectives 1. To compare six (6) weeks of treatment with pregabalin versus placebo in CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI 2. To evaluate the safety and tolerability of six (6) weeks of pregabalin in CP/CPPS participants Design Eligible participants will receive either pregabalin or placebo, randomly assigned at a ratio of 2:1. Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily, to maximum tolerated dose. Participants will be advised to take the study medication 3 times per day. There are 3 clinic visits and 2 telephone contacts. Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks. For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts." NCT00853619,Clinical Decision Support Consortium,"Inclusion Criteria: * PHS clinics using the LMR (Partners electronic health record system). These clinics include Massachusetts General Hospital Back Bay, Brigham Primary Physicians at Faulkner Hospital, Brigham PCA in Brookline, and Brigham and Women's Hospital at Foxboro. Exclusion Criteria: * None","Investigators and developers of electronic health records from both academe and industry have come together to form the Clinical Decision Support (CDS) Consortium. Members of the CDS Consortium are intimately involved in creating and providing CDS tools and services in electronic health records used in both academic settings as well as community-based physician office practices. These investigators share a common interest and goal of enhancing the wide-spread adoption of CDS tools and services to improve the delivery of healthcare both domestically and world-wide. Our approach to the project is iterative and cyclical: we will begin with a survey of the knowledge management lifecycle and supporting infrastructure (such as knowledge management systems, terminology services and data standards) at the participating clinical sites. We will then work together to define best practices for translating knowledge into a multi-layered array of human readable knowledge artifacts and public web services. At each point in this process, we will conduct careful evaluation, documenting lessons learned from each site. The ultimate work products will fall into three main categories: First, tangible, actionable knowledge artifacts such as the shareable, human-readable and computable forms of clinical practice guidelines (CPGs) under study, public web-services for CDS demonstrations, and a CDS Knowledge Portal and Repository to facilitate widespread adoption of these artifacts. Second, detailed guidance and recommendations, based on what we learn from our combined efforts, for external parties such as the Certification Commission for Health Information Technology (CCHIT), the Health Information Technology Standards Panel (HITSP), and the clinical practice guideline developer community. Third, a set of knowledge and best practices, such as methods for the knowledge management lifecycle, development of both human readable knowledge artifacts and machine-interpretable knowledge, and management of decision-support related organizational change. We will share this knowledge through a variety of channels, such as presentations and academic papers." NCT06205030,Efficacy of NOSHINtrial in Diabetic Patients,"Inclusion Criteria: 1. Age between 20 and 65 years 2. HbA1c more than 6.5 3. Consistency of diet and exercise program 4. Body mass index less than 35 5. Not receiving insulin 6. The patient should take standard medicine except insulin Exclusion Criteria: 1. Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year. 2. Taking anti-inflammatory drugs such as aspirin with an anti-inflammatory dose, antioxidant supplements, vitamins and omega-3 capsules (\<1 g/day), and immunosuppressive drugs in the last three months. 3. Presence of cancer, liver and thyroid diseases. 4. pregnancy 5. Smoking and alcohol consumption","All the volunteers (Diabetic men and women with HbA1c more than 6.5 from the age of 20 to 65 years who usually use their standard medicine) who meet the entry criteria were directed to the laboratory and imaging center so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received medicine three times a day after food. It is worth mentioning that the patients will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the six week, the patient was asked to visit the clinic for a final evaluation. In this stage, the patient is asked about possible side effects, and the last stage of sample collection will be done to review all the tests of the next stage of receiving the drug (biochemical tests). Return at the end of week 6. The sample size in this study is 70 people." NCT02730767,SURfit - A Physical Activity Intervention for Childhood Cancer Survivors,"Inclusion Criteria: * Registered in the Swiss Childhood Cancer Registry. * Age at cancer diagnosis \<16 years. * Diagnosed with a cancer classifiable within the International Classification of Childhood Cancer (ICCC-3) or diagnosed with a Langerhans Cell Histiocytosis. * Diagnosed and/or treated at the University Children's Hospital Basel, Cantonal Hospital of Aarau and/or Cantonal Hospital of Lucerne. * Survived ≥5 years since primary cancer diagnosis or any subsequent cancer event (relapse or further cancer diagnoses) * Age at the time of the study ≥16 years * Informed Consent as documented by signature Exclusion Criteria: * Participation in another clinical trial \<4 weeks prior to baseline assessment (eventually later re-enrolment) * Contradiction to one of the inclusion criteria mentioned above * Inability to exercise * Exercise potentially harmful * Women who are pregnant or breast feeding * Women who intend to become pregnant during the course of the study * Instable clinical condition (eventually later re-enrolment) * Under treatment for relapse or further cancer diagnoses * Cardiac arrhythmias under exercise (during baseline assessment or by history) * Diagnosis of diabetes \<3 months ago (eventually re-enrolment after 3 months if diabetes is under good control) * Detection of a clinical condition that needs immediate treatment during baseline assessments (eventually re-enrolment after 3 months if in stable clinical condition) * Planned relevant surgeries for the next 12 months * Major musculoskeletal injuries, fractures \<2 months ago (eventually later re-enrolment) * Recent change in medication that interfere with the parameters of the CVD risk score (primary outcome) \<1 month ago (eventually later re-enrolment) * \>4 hours of reported vigorous activities per week * Inability to follow the procedures and understand the intervention and assessments of the study e.g. due to cognitive impairment, language problems, psychological disorders etc.",N/A NCT00871507,"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus","Inclusion Criteria: * Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus * Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening * Body Mass Index (BMI) between 22 and 39.9 kg/m2, inclusive * On a generally stable antihyperglycemic agent regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the Screening Visit, including volunteers who are:(a) Not currently on antihyperglycemic therapy and have an HbA1c =7.0% and =10.0%, or (b) On a single oral antihyperglycemic agent \[metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)\] and have an HbA1c \>=6.5% and \<=9.5%, or (c) On low-dose dual oral agent therapy (i.e., \<50% maximum labeled doses of both agents) and have an HbA1c \>=6.5% and \<=9.5% * On Day -1, FPG concentrations between 120 mg/dL and 260 mg/dL, inclusive. Exclusion Criteria: * Taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other GLP-1 analogues), or taking a thiazolidinedione (i.e., a PPARg agonist) within 3 months of Day -1 * History of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness * History of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis * Positive test for alcohol and/or drugs of abuse * Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements * Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.","This is a double-blind (neither physician or participant knows name of the assigned study drug), placebo-controlled (substance containing no medication), crossover study in male and female volunteers with type 2 diabetes mellitus. For each volunteer, the study consists of a screening phase (up to 45 days), a run-in phase during which volunteers discontinue their oral hypoglycemic drugs (28 days), a treatment phase during which volunteers will continue to be off their oral hypoglycemic drugs (28 days) and will receive 4 single dose study treatments in a randomized (study sequence assigned by chance) sequence, and a follow-up phase (10 days). After the follow-up phase volunteers will restart their oral hypoglycemic drugs. During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), Blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be incremental glucose after an oral glucose tolerance test. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo." NCT00542334,Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS),"Inclusion Criteria: * Type 1 diabetes * less than 18 years of age * \>2 year duration of diabetes * on a conventional TID insulin regimen (morning and bedtime NPH) for a minimum of 3 months * informed consent and assent Exclusion Criteria: * medical conditions other than treated hypothyroidism or asthma requiring oral glucocorticoids more than once per year * intention to move outside of CHEO's catchment area within the next 4 months * more than 17 years of age and unwilling to continue receiving diabetes care at CHEO until study completion * intention to switch to a different insulin regimen prior to study completion",N/A NCT01284634,Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease,"Inclusion Criteria: * Participant gave informed consent for participation in the study. * Participant was aged 18 years or above. * Participant had documented evidence of liver fat content ≥5% as measured by MRI/MRS scanning or a biopsy within two months prior to screening, or willing to undergo an MRI/MRS scan at Visit 1 (Day -10 to -2) to confirm a liver fat content of ≥5%. * Participant had, in the opinion of the investigator, no changes in levels of exercise or diet for four weeks (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment, and participant agreed to keep stable for the duration of the study. * Participant was able (in the investigator's opinion) and willing to comply with all study requirements. * Participant was willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable. * Participant was willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion Criteria: * Participant had clinical diagnosis or treatment for Type I/II diabetes. * Participant had received an unapproved investigational medicinal product (IMP) within the 30 days prior to the screening visit. * Participant was receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study. * Participant was using or had used recreational cannabis, medicinal cannabis, or cannabinoid medications (including Sativex) within one month prior to study entry and unwilling to abstain for the duration of the study. * Participant had any known or suspected history of alcohol or substance abuse, or epilepsy or recurrent seizures. * Participant had any known or suspected history of major depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression, in the opinion of the investigator). * Participant had clinically significant cardiac, renal, or hepatic impairment, in the opinion of the investigator. * Participant had known history of Hepatitis B or C. * Participant had genetic dyslipidaemia, in the opinion of the Investigator. * Participant had any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, influence the result of the study, or affect the participant's ability to participate in the study. * Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s). * Participant had presence of any metal implants. * Participant had any known or suspected history of claustrophobia. * Female participants of child bearing potential not able or willing to use effective contraception for the duration of the study and for three months thereafter, or male participants whose partner was of child bearing potential, who was not willing to ensure that they or their partner would use effective contraception during the study and for three months thereafter. * Female participant who was pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. * Participants who weighed \>150 kilograms (kg). * Participant had any abnormalities following a physical examination that, in the opinion of the investigator, prevented the participant from safe participation in the study. * Participant was unwilling to abstain from donation of blood during the study. * Participant had planned travel outside the country of residence during the study. * Participant had previously enrolled into this study.","This study was conducted as a 10-week (eight-week treatment period and one-week safety follow-up), randomized, partially-blind study that evaluated the effect of GWP42003 in participants with raised liver triglycerides (liver fat ≥5%). Participants were clinically diagnosed with FLD and had liver fat levels ≥5% as measured by Magnetic Resonance Imaging/ Magnetic Resonance Scanning (MRI/MRS), or were willing to undergo MRI/MRS scan at the screening visit to confirm a liver fat content of ≥5%. Eligible participants entered the study at a screening visit (Day -10 to -2) and then returned for a fasted baseline visit (Day 1), a mid-treatment visit (Day 29) and an end of treatment visit (Day 57). Safety follow-up telephone calls took place throughout the treatment period up to Day 64 after completion of treatment or seven days after date of last dose/withdrawal." NCT01835964,Biobehavioral Mechanisms of Glucose Variability,"Inclusion Criteria: * Clinical diagnosis of type 1 diabetes mellitus for ≥2 years. For an individual to be enrolled at least one criterion from each list must be met. * Criteria for documented hyperglycemia (at least 1 must be met): * Fasting Blood Glucose (BG) ≥126 mg/dL * 2h Oral Glucose Tolerance Test (OGTT) ≥200 mg/dL * Hemoglobin (HbA1c) ≥6.5% * BG ≥200 mg/dL with symptoms * History of hyperglycemia consistent with diabetes * Criteria for requiring insulin at diagnosis (1 must be met): * required insulin at diagnosis and continually thereafter * no insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and insulin eventually required and used continually * no insulin at diagnosis but continued hyperglycemia, positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and insulin eventually required and used continually * Use of an insulin pump for at least six months prior to the study. * Using a bolus calculator with pre-defined parameters for carbohydrate ratio(s), and insulin sensitivity factor(s). * Signed informed consent. * Age ≥21 and \<65 years old. * HbA1c ≤10% as measured with DCA 2000 or equivalent device. * Willingness to use lispro (Humalog) insulin for metabolic challenge admission. * Willingness to perform self-monitoring blood glucose (SMBG) \>4 times/day. * Willingness to avoid consumption of acetaminophen-containing products during the study. * Willingness to perform 4 days of outpatient assessment with timed, prepackaged meals and snacks, and \>7 SMBGs. Exclusion Criteria: * Uncontrolled arterial hypertension (resting blood pressure \>160/100 mm Hg). * Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥3 times the upper reference limit. * Impaired renal function: glomerular filtration rate (calc GFR) of \<60 ml/min/1.73 m2. * Diabetic ketoacidosis in the past 6 months * Conditions which may increase the risk of induced hypoglycemia such as: * uncontrolled coronary artery disease * stable or unstable angina * episode of chest pain of cardiac etiology with documented Electrocardiography changes or positive troponin levels * positive stress test * catheterization with coronary blockages \>50% * congestive heart failure * significant cardiac arrhythmia * history of a cerebrovascular event * seizure disorder * syncope * adrenal insufficiency * hypoglycemia-induced migraine within the past year * neurological disease * Diabetic complications altering insulin kinetics or food absorption * Pregnancy, breast-feeding or intention of becoming pregnant. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment). * skin condition that prevents sensor placement on the abdomen or arm. * Difficulties to operate Continuous Glucose Monitor. * Uncontrolled thyroid disease: thyroid-stimulating hormone (TSH)\>10. * Bleeding diathesis or dyscrasia. * Alcohol or drug abuse within 1 year of enrollment by patient history. * Allergy to components of the CGM sensor. * Blood donation \>473 ml in last 56 days * Prior noncompliance with study procedures. * Hematocrit outside of the normal range. * Magnesium \<1.6 mg/dl. * Potassium \<3.4 mmol/L. * Active enrollment in another clinical trial * Allergy to or intolerance of insulin lispro (Humalog) * Anticoagulant therapy other than aspirin. * Oral steroids. * Use of acetaminophen-containing medication that cannot be. * Use of Type 2 Diabetes Mellitus medications: including metformin, sulfonylureas, meglitinides, thiazolidinediones, Dipeptidyl peptidase-4 (DPP-IV) inhibitors, glucagonlike Peptide (GLP-1) agonists and alpha-glucosidase inhibitors. * Unwillingness to withhold Pramlintide for the duration of the study intervention.","Glucose variability (GV) in type 1 diabetes (T1DM) is increasingly viewed as a primary marker of glycemic control, responsible, along with chronic hyperglycemia reflected by HbA1c, for diabetes complications. In this study, we propose to investigate: (i) the time course of deterioration of physiological glucoregulatory mechanisms leading to increased GV, and (ii) the association of GV with metabolic and behavioral factors such as insulin sensitivity and treatment adequacy. Our primary hypothesis is: Glucose variability in T1DM is triggered by behavioral events (e.g. meals, insulin injection, exercise) that challenge the metabolic system. The timing and the magnitude of the behavioral challenges, and the ability of the metabolic mechanisms to absorb these challenges, determine the magnitude of GV. This process develops in a certain time frame, and can be accelerated by inadequate treatment, or attenuated by precise timing and dosing of bio-behavioral control. This study will use a combination of treatment records, continuous glucose monitoring (CGM), and an inpatient admission to clarify the relationships between behavioral challenges to the metabolic system, physiological glucoregulatory mechanisms, and GV. This study will test the following hypotheses: 1. Suboptimal treatment behavior, e.g. insulin mistiming (early/late meal insulin) or unbalanced insulin (higher basal/bolus ratio), is correlated with higher GV and repeated hypo- and hyperglycemia; this relationship is mediated by a patients' insulin sensitivity; 2. A metabolic challenge (e.g. consecutive sequence of hypo- and hyperglycemia), will push the metabolic system into a transient super-critical state characterized by increased GV as defined by the Variability Grid Analysis (VGA) and the Average Daily Risk Range (ADRR), which will persist for several days beyond the discontinuation of the challenge." NCT06627309,Rapid DFLC Response Predict CHR in AL Amyloidosis,"Inclusion Criteria: 1. Diagnosis of systemic AL amyloidosis; 2. Daratumumab, bortezomib, dexamethasone used in treatment; 3. Informed consent explained to, understood by and signed by the patient; 4. dFLC ≥ 50 mg/L; Exclusion Criteria: 1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma; 2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 3. Severe or persistent infection that cannot be effectively controlled; 4. Presence of severe autoimmune diseases or immunodeficiency disease; 5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); Patients with HIV infection or syphilis infection; 6. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.",N/A NCT02815787,The Drug -Drug Interaction of SP2086 and Glyburide,"Inclusion Criteria: * Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2 * Had signed the informed consent himself or herself. Exclusion Criteria: * Have the abnormal lab or other examination results and the change have clinical significance. * Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide. * History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs. * History of severe unconsciousness hypoglycemia * History of any surgery prior to screening in 6 months. * History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month. * History of participate any drug or medical device prior to screening in 3 months. * Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins). * 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion. * The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive. * Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. * Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.","This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Glyburide in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences.The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be administered orally (by mouth) as 200mg on Days 8." NCT00263393,Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS),"Inclusion Criteria: * Age 30 years and above * Personal history of heart attack or stroke * Presence of other cardiovascular risk factors such as smoking, overweight, diabetes Exclusion Criteria: * Mental disability * Not living in the Study area","STUDY TYPE This project is a community intervention study that will use a large-scale, cluster-randomised design to compare the management of individuals at high cardiovascular risk in villages assigned to receive the cardiovascular prevention program (intervention) and villages assigned to continue usual practices (control). The definition of high-risk for treatment is based on an established history of previous vascular disease -heart attack or stroke- known hypertension or systolic blood pressure \> 160mmHg, or the presence of other risk factors such as smoking, high blood pressure, obesity, older age and family history which combined would result in a very high level of risk. INTERVENTION PROGRAM TO BE EVALUATED The program to be evaluated comprises: (1) simple strategies designed to facilitate the opportunistic identification of high-risk individuals, (2) clinical algorithms for the implementation of proven preventive interventions based on World Health Organisation recommendations (3) a health promotion campaign designed to aid self-identification and self-referral of high-risk people and (4) simple, structured education programs to assist patients to comply with their treatment. DATA COLLECTION Data to be collected will comprise an interviewer administered questionnaire with demographic details, basic medical history, cardiovascular risk factors, previous cardiovascular disease and any current treatments. This will be followed by a brief physical examination including measurement of blood pressure, heart rate, weight, height, waist and hip circumferences. Urine will be tested using a dipstick in all and all will have a fasting blood glucose assay. Fasting venous blood samples will be collected for assay of cholesterol, glucose and creatinine from a sample of 1,000." NCT01693406,"Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers","Inclusion Criteria: * Between 28-40 weeks gestation * Plan to Exclusively Breastfeed for at least 5 months * Between 20 - 35 years old * Carrying a singleton pregnancy * Parity less than or equal to 5 * Pre-pregnancy BMI between 18.5 and 39.9 Exclusion Criteria: * No known infant anomalies or birth defects * Maternal Type 1 Diabetes * Maternal major medical condition (ie: Kidney Disease or Pre-eclampsia) * Delivery of the infant before 35 weeks gestation * Smoking During pregnancy",N/A NCT02222506,Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers,"Inclusion Criteria: * Male or female 18 years of age and older; * The subject or legal guardian must have signed an informed consent form; * Female of child bearing potential must have a negative pregnancy test result at Baseline and both male and female patients must be willing to adhere to a medically-accepted birth control method during the course of the study; * Willingness to return for all study visits; * Willing and able to adhere to an off-loading protocol. Patient must adhere to wearing orthopedic shoe for the study duration (from first day of Screening until end of study); * Target cutaneous, full thickness ulcer with University of Texas classification I-A (superficial, non-infected, non-ischemic wound not involving tendon, capsules, or bone) or II-A (non-infected, non-ischemic wound penetrating to tendon or capsule but not in the bone or joint). A patient with more than one diabetic foot ulcer may be included in the trial but only one ulcer will be selected for the investigational treatment, based on investigator's judgment; * Ulcer present for more than 4 weeks prior to study entry (Screening/Visit 1); * Ulcer area between 1 and 16 cm2 inclusive. The maximum diameter of the wound must not exceed 8 cm; * Diabetes mellitus (Type 1 or 2) with an A1C \< 12% at Screening; * Diagnosis of neuropathic foot ulcer (10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area and/or biothesiometry or tuning fork 128 Hz); * Wound area has not changed by more than +/- 30% between Screening visit and Week 1/Visit 1 (before treatment). * Adequate arterial blood perfusion (ABI (ankle brachial index) between 0.7 and 1.3, inclusive, or toe pressure \> 50 mmHg, or tcPO2 \> 40 mmHg). Exclusion Criteria: * Diabetic foot ulcer present for more than 12 months; * Target ulcer is over a deformity (such as Charcot deformity) that interferes with off-loading based on investigator's opinion; * Patient cannot tolerate off-loading method; * The ulcer to be treated is planned for operative debridement; * The ulcer has significant necrotic tissue (e.g., more than 20% of the ulcer area); * Major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia; * Severe or significant hypoalbuminemia (albuminemia \< 30 g/L, and/or pre-albumin \< 5 mg/dL), or hypoproteinemia (proteinemia \< 55g/L); * Patient with moderate to severe anemia (Hb \< 90g/L); * Patient currently treated for an active malignant disease; * Patient with history of malignancy within the wound; * Patient with history of radiation therapy to the wound region; * Patient with prior diagnosis of active malignant disease who is less than 1 year disease-free; * Patient with a known osteomyelitis or active cellulitis; * Patients that are immunosuppressed or on high dose chronic steroid use; * Patients on systemic corticosteroids (a completion of corticosteroid course at least 30 days prior to study enrolment is required); * Patient with active or systemic infection (note that the patient is however eligible for re-screening after the systemic infection has subsided); * Successful revascularization surgery of the leg with the ulcer to be treated less than 8 weeks prior to Screening; * Patients with severely uncontrolled diabetes mellitus (defined as A1C \> 12%); * Raynaud disease or other severe peripheral microvascular disease; * Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease); * Active bleeding; * Pregnancy, or breast feeding; * Patients with bleeding diathesis; * Patients on Warfarin or IV Heparin; * The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study (e.g., severe morbid obesity, recent hip fracture, suspected non-compliance, etc.); * Patients with ulcers from burns (from exposure to high heat), pressure ulcers or venous leg ulcers; * Concurrent disease or drugs known to induce severe photosensitivity of the skin, such as porphyria; * Patient has received biological-based therapy in any wound within 3 months of Screening; * Concurrent participation in another clinical trial that involves an investigational drug or device that wound interfere with this study; * Previous participation in other interventional wound healing clinical investigation within the 60 days prior to Screening visit.",N/A NCT02736084,Boosting Emotions & Happiness in Outpatients Living With Diabetes,"Inclusion Criteria: * Current patient of the MGH Diabetes Center or inpatient on Ellison 9-11, White 8-11, Ellison 16, or Bigelow 11 * Diagnosis of type 2 Diabetes (confirmed via medical record and patient's treatment provider) * Age 18 and older * Able to read/write in English * Suboptimal adherence, defined as a score of 15 or less on three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items related to adherence to medications, diet, and exercise. Exclusion Criteria: * Cognitive disorder precluding informed consent or meaningful participation in the PP exercises, assessed using a six-item cognitive screen developed for research. * Lack of telephone access","This is a pilot and feasibility study in adult inpatients and outpatients at MGH. Participants will have Type 2 Diabetes (T2D) and are required to report suboptimal adherence to health behaviors, measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS). All participants will receive a 12-week PP intervention and pre- and post-intervention assessments of mood and physical symptoms. Participants will be enrolled from the outpatient Diabetes Center and inpatient medical units of MGH; research staff will introduce the study, assess for inclusion and exclusion criteria, and obtain written informed consent. Post-enrollment, and prior to initiation of the intervention, participants will complete baseline self-report measures of clinical outcomes. During the initial enrollment visit, participants will receive a treatment manual. In person or by telephone, the study interventionist will review the introductory portion of the manual and discuss the first exercise (Gratitude for Positive Events) with the participant. In subsequent weeks, exercises will be completed independently by participants, recorded in their treatment manual, and then discussed over the phone with their trainer. In the final week, after the final exercise is reviewed, the interventionist and participant will discuss future implementation and ways to incorporate the principles into daily life. The 12-week intervention will consist of 7 distinct PP exercises, to be completed weekly for the first 4 weeks and then biweekly over the next 8 weeks. For feasibility, interventionists will record rates of exercise completion at each participant phone session. For acceptability, participants will rate their optimism and positive affect on a 0-10 scale prior to completing the exercise and then immediately following the exercise. Additionally, participants will also rate the ease and overall utility of the exercise on a 0-10 scale after each exercise. At baseline, 6 weeks, and 12 weeks, non-interventionist study staff obtained the following validated measures of study outcomes: * Optimism = Life Orientation Test-Revised (LOT-R) * Gratitude = Gratitude Questionnaire-6 (GQ-6) * Anxiety and depression = Hospital Anxiety and Depression Scale (HADS) * Diabetes-related distress = Diabetes Distress Scale (DDS) * Health-related quality of life and function = Patient-Reported Outcomes Measurement Information System physical function scale (PROMIS-PF-10) * Diabetes self-care behaviors = Summary of Diabetes Self-Care Activities Measure (SDSCA) * Health behavior adherence = Medical Outcomes Study Specific Adherence Scale (MOS SAS)" NCT00005784,Evaluation and Treatment of Patients With Retinal Disease,"* INCLUSION CRITERIA: Each study participant must have the ability to understand and sign an informed consent form. Patients with diabetic retinopathy and age-related macular degeneration. Patients with vascular occlusive disease, central serous retinopathy, or rare/unknown retinal disease. EXCLUSION CRITERIA: Patients will be excluded from this study if they are unable or unwilling to give informed consent or they are unwilling to be followed and treated at the NEI Clinical Center for at least the next 3 years.","This 'Evaluation and Treatment Protocol' will allow the retinal specialists at the NEI to identify, follow and provide ""standard of care"" treatment to patients with various retinal diseases. A primary purpose of the protocol is to accumulate a cohort of patients with retinal diseases for possible participation in new clinical trials and epidemiological protocols. Also, by providing long-term follow-up and treatment for a variety of retinal diseases, the retinal specialists at NEI will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills. The availability of cohorts of patients with a spectrum of retinal diseases will be valuable for the training of retinal fellows, an important mission of the NEI. The ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols. The retinal specialists at the National Eye Institute will be free to choose those retinal diseases that interest them. However, the total number of patients that can be enrolled in the protocol will be restricted. This protocol is not designed to test any new treatments. Any evaluations or treatment under this protocol will be based on the current standard of care for each retinal disease. Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are developed. If eligible, patients may be asked to participate in the new protocol. However, they will not be required to enter any protocol and their decision to participate will be entirely voluntary. No more than 150 patients will be accepted in this ""Evaluation and Treatment Protocol.""" NCT03749057,Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation,"Inclusion criteria: 1. Over 18 years 2. Acute cerebral infarction caused by non-valvular atrial fibrillation 3. NIHSS score ≤ 15 4. Within 12 days of onset 5. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1) 6. Signed informed consent Exclusion Criteria: 1. Hemorrhagic stroke or mixed stroke 2. Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction 3. Patients with severe infection or serious diseases 4. Gastrointestinal bleeding or major operation within 3 months 5. Planed cerebrovascular reconstruction or cardiac surgery within 3 months 6. Planed major surgery within 3 months 7. Participating in other clinical trials within 3 months 8. Unsuitable for this trial assessed by research",N/A NCT05949957,Harnessing Human Potential and Improving Health Span in Women and Their Children,"Inclusion Criteria: 1. Female, age: 21 - 45 years 2. Had a history of GDM (at least 1 year and not more than 10 years) 3. Chinese, Malay or Indian ethnic groups 4. Body mass index (at least 18.5 kg/m2 and not more than 35 kg/m2) 5. Not planning to conceive in the next one year 6. Not performing exclusive breastfeeding during study period 7. Own a smartphone compatible with the study mobile Apps 8. Proficient in English language 9. Plan to stay in Singapore for the next 4 years 10. Willing to comply to study protocol 11. Able to provide a written informed consent Exclusion Criteria: 1. Current or previous diagnosis of diabetes (Type 1 or 2), except GDM 2. Currently pregnant 3. Given birth within the last 12 weeks 4. Severely limited mobility (e.g., wheelchair bound, require long-term walking aid, etc.) 5. Diagnosed with malnutrition or eating disorder 6. Diagnosed with cancers, unstable heart diseases, severe kidney diseases, severe liver diseases 7. Diagnosed with severe insomnia, unstable mental conditions, dementia, or cognitive impairment 8. Experienced alcohol or drug abuse 9. Currently having medications known to influence glucose metabolism (e.g. peroral corticosteroids) 10. Currently participating in concurrent clinical trial or lifestyle intervention study","The overall goal of this study is to reduce the risk of Type 2 diabetes (T2D) and pre-diabetes in Asian women and their children by focusing upon a major high-risk group - women with a history of gestational diabetes (GDM) in Singapore. GDM is diabetes diagnosed for the first-time during pregnancy and has traditionally been considered a benign condition because typically glucose levels return to normal after delivery. Women with pregnancies complicated by GDM often progress to develop T2D later in life. There is evidence that holistic lifestyle modifications that include strategies to improve dietary intake, physical activity, and mental well-being can prevent or delay the onset of type 2 diabetes. The use of digital health interventions can also assist in the prevention of T2D. However, limited studies have been conducted with Asian populations. This study aims (1) to identify post-GDM women from large community settings in Singapore and to assess the efficacy of a holistic lifestyle digital intervention (focusing on diet, physical activity, sleep, and mental well-being) on glucose regulation with those identified women. Secondary objectives are: (a) to examine the potential impacts of the proposed intervention on the health and well-being of subjects' family members (e.g., children); (b) to determine the diabetes risk of the subjects over a 3-year follow-up period; (c) to explore potential economic impacts of the proposed intervention (e.g., healthcare expenditures); (d) to study the importance of gut microbiota and epigenetic factors in relation to changes in glucose metabolism, and (e) to ascertain the safety of the proposed intervention. The study is a 1-year randomized controlled trial with three years of follow-up. The primary outcomes involved the incidence of Type 2 diabetes confirmed by a 2-hr 75g Oral Glucose Tolerance Test (OGTT) over a 4-year period. Secondary outcomes are (1) incidence of impaired fasting glucose and impaired glucose tolerance; (b) changes in cardiometabolic variables (e.g., body weight, HbA1c, insulin, blood lipids, blood pressures) in the women; (c) changes in women's body composition; (d) changes in women's mental well-being (e.g., defined by BDI-II, STAI, WHO-5, PSS-4); (e) changes in the health and wellbeing of their children, and (f) a composite of major adverse events (MAE) comprising fatal and non-fatal events associated with Type 2 diabetes. Eligible women will be randomized at baseline to either Group 1 (Intervention) or Group 2 (Control) for 1 year. Group 1 (Intervention) consists of several virtual coaching sessions about healthy lifestyle delivered by a conversational agent (chatbot) embedded in the LvL UP App within 24 weeks (weeks 2 to 26) to complete three levels of health literacy. Additionally, individuals will receive an Oura ring at baseline (activity-tracking wearable that collects lifestyle data), as well as the HAPPY App (educational content about lifestyle and health outcomes \[e.g., body mass index, blood pressure, OGTT results\]). Group 2 (Control) subjects will receive an Oura ring at baseline, and the HAPPY App Follow-up Period Upon completion of the one-year RCT period, both groups will be followed-up for 3 years. During the follow-up visits, body measurements, OGTT, bio-sampling, and data collection will be conducted. Both groups will be assessed at baseline, week 26, 1 year visit, 2-year visit (follow-up 1), 3-year visit (follow-up 2), and 4-year visit (follow-up 3)" NCT03617757,Progression From Impaired Fasting Glucose to Diabetes Mellitus Among Chinese,"Inclusion Criteria: 1. Aged ≥ 18 year 2. Chinese ethnicity 3. Diagnosis of impaired fasting glucose (i.e. FG between 5.6-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.0mmol/L) confirmed by latest OGTT results within 60 months prior to recruitment Exclusion Criteria: * Confirmed diagnosis of DM or on hypoglycaemic treatment * Women who are pregnant or breast-feeding at recruitment * Patients taking glucocorticoid at recruitment * Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment * Severe renal impairment i.e. eGFR ≤ 30 ml/min/1.73m2 * Clinically significant anaemia at recruitment * History of blood donation or blood transfusion within 3 months prior to recruitment","Impaired fasting glucose (IFG) represent an intermediate state of abnormal glucose regulation that exist between normal glucose homeostasis and diabetes mellitus (DM) and is a significant risk factor for DM and cardiovascular complications. IFG is defined by an elevated FG level between 6.1-6.9mmol/L according to the World Health Organization (WHO). The lower cutoff level for IFG was further lowered to 5.6mmol/L by the American Diabetes Association (ADA) in 2003 in order to maximize sensitivity and specificity for predicting DM over a 5-year period. In Hong Kong, IFG individuals can be more readily identified by primary care doctors than subjects with impaired glucose tolerance (IGT) or elevated HbA1c - the other 2 pre-diabetic categories - because fasting glucose (FG) test is recommended by the Hong Kong reference framework for diabetes care for adults in primary care setting for DM screening. Thus, this group of individuals should be targeted opportunistically for DM prevention. On the other hand, IFG is a heterogeneous group with variable risk of progression to DM. Individuals with IFG may have concomitant IGT, elevated HbA1c or even DM. Thomas et al. found that around 20% of Hong Kong Chinese subjects with impaired glucose relation had concomitant IFG and IGT, whereas 49.5% had isolated IGT and 30.5% had isolated IFG. Ko et al. followed up 55 Chinese subjects with IFG for a median period of 1.12 year and showed that 8.4% progressed to DM annually as defined by fasting glucose criteria (FG ≥7.0mmol.L). Lee et al. followed up 238 Chinese women with persistent impaired glucose tolerance after gestational diabetes over a mean period of 52 months and found that 20% of the studied population developed diabetes mellitus based on OGTT criteria; the highest rate of progression to DM was noted among those women with concomitant postpartum impaired fasting glucose. A recent cross-sectional study by Yu et al on 1,200 Chinese primary care patients with IFG demonstrated that 20% had DM confirmed by OGTT as the gold diagnostic standard, 14.3% had concomitant IGT, and 16.1% would regress back to normoglycaemia upon retest within 18 months. However, all of these local studies had short follow-up period and used different diagnostic tests for confirmation of DM; the long term risk of progression to DM among Chinese subjects with isolated IFG or combined IFG-IGT had not been fully evaluated. Moreover, only few studies examined the risk factors for progression from IFG (+/- IGT) to DM among Asians or Chinese. Female gender, smoking, low physical activity, obesity as well as truncal obesity, high blood pressure, high triglyceridaemia and most importantly higher baseline FG level had all been reported to increase risk of progression from IFG to DM among Caucasians. In the only Asian study conducted in Japan, Toshihiro et al. found that stress in daily life, night duty and administrative position were risk factors of DM development among IFG subjects. To the best of our knowledge, no published data on the risk factors of progression from IFG to DM among Chinese is currently available. It was not certain that the risk factors identified among the Caucasians or Japanese were applicable to the Chinese. Although intensive lifestyle modifications targeting these risk factors had been reported to reduce progression from IFG to DM, their effects on Chinese subjects with IFG had not been evaluated. Between May 2013 and March 2015, our team have already collected a prospective cohort of around 700 non-diabetic adults who have underwent both 75g OGTT and HbA1c tests as rigorous determination of their glycemic status. We aim to conduct a 3-year follow-up study to estimate the incidence of progression to DM among Hong Kong Chinese primary care patients with IFG with or without concomitant IGT using OGTT as the gold diagnostic standard as recommended by the Hong Kong Reference Framework. In addition, we aim to identify determinants, in particular the modifiable risk factors, for the progression from IFG to DM. These results will provide valuable information for designing optimal follow-up plan and diabetes prevention programme for local IFG patients, with the ultimate goal to reduce health care burden of DM on our society." NCT06172257,A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2),"Inclusion Criteria (selection): 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1). Exclusion Criteria (selection): 1. Have macular edema considered to be because of a cause other than DME. 2. Have a decrease in BCVA because of causes other than DME. 3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.","A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema" NCT02068781,"Aldosterone, Microvascular Function and Salt-sensitivity","Inclusion Criteria: Obese individuals * Age 18-65 years * Caucasian * Waist circumference \> 102 cm (men)/\> 88 cm (women) Lean individuals * Age 18-65 years * Caucasian * Waist circumference \< 94 cm (men)/\< 80 cm (women) Exclusion Criteria: Obese/lean individuals * Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death) * Diabetes mellitus/impaired glucose metabolism (fasting glucose values \> 5.6 mmol/L * Stage 3 hypertension (blood pressure \> 180/110 mm Hg) * Unstable or severe pulmonary disease * Unstable or severe thyroid disorders * Inflammatory diseases * Smoking * Alcohol use \> 2 U/day (women)/\> 3 U/day (men) * Use of antihypertensive, lipid-lowering or glucose-lowering medications * Use of corticosteroids and regular use of NSAIDs * eGFR\< 60 mL/min * Impairment of hepatic function * Pregnancy or lactation",N/A NCT04877730,Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation,"Inclusion Criteria: 1. Age ≥18.0 and ≤70 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin for at least six months 4. Currently using insulin pump for at least three months 5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 6. Access to internet and willingness to upload data during the study as needed 7. For females, not currently known to be pregnant or breastfeeding 8. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 9. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 10. Willingness to use the University of Virginia (UVa) closed-loop system throughout study admission 11. Willingness to use the insulin supplied by the study for the hotel stay, if not already using that preparation. Study insulin will be lispro (Humalog) or aspart (Novolog) 12. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals) 13. Willingness to eat at least 1g/kg of carbohydrate per day during the hotel admission 14. Willingness to reschedule if placed on oral steroids 15. An understanding and willingness to follow the protocol and signed informed consent 16. Willingness to commit to self-quarantine for at least 5 days before COVID-19 testing (If participant has received a full course of COVID-19 vaccine and data emerge suggesting significantly reduced transmissibility among those receiving that vaccine, this self-quarantine requirement can be waived.) Exclusion Criteria: 1. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 3. Pregnancy or intent to become pregnant during the trial 4. Currently being treated for a seizure disorder 5. Planned surgery during study duration 6. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) 7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 8. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team 9. Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.","This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order; 1. without the meal anticipation module and without carbohydrate announcement (FCL) 2. with the meal anticipation module and without carbohydrate announcement (FCL+) 3. without the meal anticipation module and with carbohydrate announcement (HCL), This study will target completion of up to 36 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order." NCT01113307,The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds,"Inclusion Criteria: 1. Patients between 18 and 90 years of age with one ulcer that has not shown signs of normal healing (according to physician experienced in wound therapy) for more than 3 weeks 2. The patient suffers from diabetic ulcer, decubitus ulcer, venous insufficiency ulcer and post operative wound. 3. In patients with suspected malnutrition albumin \> 2.5 g/dL in blood tests performed within the last three weeks. 4. Patients with adequate blood perfusion: palpated distal pulses TP or DP or if not palpable, arterial pressures during rest ABI \> 0.6. 5. Patients without edema over +2 (patient's edema must be controlled by medical and/or bandaging or lympha press). 6. Use of elastic bandaging in wounds due to venous insufficiency (when there is no involvement of an arterial problem). 7. Wound condition does not immediately jeopardize the extremity. 8. The patient's life is not at risk (for any reason). 9. The Patient has a life expectancy of at least one year. 10. Women of childbearing potential must be willing to use reliable methods of birth control. 11. Willing and able to sign an informed consent form and attend the follow up according to the treating staff instructions until complete wound closure. Inclusion criteria in the 'treatment blinding guessing test': 1. A patient suffering from diabetes and a chronic ulcer in the lower extremity (ankle and below) and is CureXcell™ -naive. 2. Signing an appendix to the consent form for the 'treatment blinding guessing test'. Exclusion Criteria: 1. More than one wound; 2. Inadequately treated recurrent pressure components in the wound. If required, ulcer will be treated with preliminary treatment for local pressure components (shoes and even cast or wheel chair for the treatment period) 3. Neoplastic ulcer 4. A patient with active malignant disease during the last five years, except for a patient suffering from adequately treated Basal Cell Carcinoma which does not present in the wound area. 5. Sepsis 6. Confirmed osteomyelitis 7. Patients suffering from significant immunosuppression. 8. INR \> 3 in patients receiving anticoagulation drugs, in blood tests performed within two weeks prior to the first injection 9. A response to previous blood infusions (in case administered) 10. Patient receiving unique blood components (radiated, washed etc.) 11. Pregnant patient 12. Wounds for more than a year 13. A fistula/cavity which anatomical shape does not enable a direct injection into the wound 14. A patient participating in another clinical trial, or who participated in another clinical trial within the last 30 days.",N/A NCT03669211,Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program,"Inclusion Criteria: * Male or female, aged 18 or older * Patient with newly diagnosed or recurring Acute Coronary Syndrome, or presenting a coronary heart disease detected on ischemia test and stented * Patient included in the SCArabée therapeutic education program * Patient assessed stable on the basis of a clinical examination, or exercise test, or ultrasound data * Patient in physical capacity to perform a cardiorespiratory test * Patient giving free, informed and written consent * Patient affiliated to the social security system Exclusion Criteria: * Impossibility to submit to follow-up of the study for geographical social or psychological reasons * Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (corresponds to all persons protected): pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person making the subject of a legal protection measure",N/A NCT06134934,TeleCare North Diabetes,"Inclusion Criteria: * Women and men ≥ 18 years * Poorly controlled T2D, i.e. HbA1c \> 58 mmol/mol * Diagnosis of T2D for at least 12 months * General Practitioner responsible for diabetes treatment * Residence in Hjørring, Morsø, Jammerbugt, or Rebild municipality * Ability and willingness to use a smartphone/tablet along with the other devices to be used in the trial * Signed informed consent * Ability to understand and read Danish Exclusion Criteria: * Pregnancy or breastfeeding * Insulin treatment * Prednisolone treatment * Severe diabetes complications such as severe neuropathy or nephropathy (dialysis treatment) * Participation in diabetes rehabilitation courses * Participation in other intervention trials * Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate","Background: Maintaining optimal glycaemic control in type 2 diabetes (T2D) is difficult. Telemedicine has potential to support poorly controlled people with T2D in the achievement of glycaemic control if the telemedicine solution includes a telemonitoring component. However, only few telemonitoring solutions for non-insulin treated T2D exist. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring intervention designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial. Method: The trial will be conducted as a three-month randomized feasibility study in four municipalities in North Denmark with 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, differences in direct intervention costs between the two alternative interventions will be evaluated." NCT02448498,Strength Training Regimen for Normal Weight Diabetics,"Inclusion Criteria: * Recent hemoglobin A1c result between 6.5%-13% * Diagnosis of Type 2 Diabetes Mellitus * BMI between 18.5 -25 kg/m2 * Blood pressure \< 160/100 * Sedentary lifestyle * Able and willing to enroll and meet requirements of the study Exclusion Criteria: * Age less than 30 years or greater than 75 years * Type 1 diabetes or use of insulin pump * Triglycerides \>500 mg/dL * Use of weight loss medication * Bariatric surgery * Consumes \>14 alcoholic drinks per week * Pregnancy * Plans to be away for more than four weeks * Medical conditions which would prevent long-term participation or which would contraindicate physical activity","In the STRONG-D study, participants are randomly assigned to strength training, aerobic training or a combined strength and aerobic training group. Participants in the exercise group will attend exercise sessions over the course of 9 months at the YMCA. Participants will have opportunities to engage in other activities such as educational run-in visits that will allow for measurement of hemoglobin A1c and emphasize the importance of exercise in improving Type 2 diabetes." NCT03131687,A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus,"Inclusion Criteria: * Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification. * Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory. * If on metformin, have been treated with stable doses of metformin for at least 3 months. * Have a body mass index (BMI) ≥23 and \<50 kilograms per square meter. Exclusion Criteria: * Have type 1 diabetes (T1D). * Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past. * Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke). * Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial. * Have had chronic or acute pancreatitis any time prior to study entry. * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation. * Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry. * Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.",N/A NCT00523393,Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells,"Inclusion Criteria: * Type 2 Diabetes * Oral antidiabetic therapy * Age 35 - 70 * 6,5%\< HbA1c ≤ 9% * Ability of subject to understand character and individual consequences of clinical trial * Written informed consent must be available before enrollment in the trial * For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test * 6,5%\< HbA1c ≤ 9% * Ability of subject to understand character and individual consequences of clinical trial * Written informed consent must be available before enrollment in the trial * For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test Exclusion Criteria: * MODY * Malignant disease * Hematopoietic disorders * Impairment of renal function (Serum creatinine \> 1,5mg/dl) * autoimmune disease * treatment with immunosuppressive drugs * Psychiatric disease * Myocardial ischemia during previous 6 month * Acute coronary syndrome * pAVK IIb, III, IV (Fontaine-Ratschow) * Erythropoietin treatment * Glitazone treatment during two weeks before inclusion * Insulin treatment during two weeks before inclusion * Pregnancy and lactation * History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product * Participation in other clinical trials and observation period of competing trials, respectively * No subject will be allowed to enroll in this trial more than once.",N/A NCT06613893,Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients,"Inclusion Criteria: * Age 30 - 70 years * Sex: Both sexes * Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs * Patients with ASA classification II,III * Duration of surgery (≥2 h) Exclusion Criteria: * Declining to give written informed consent * ASA classification Ⅳ to V * Severe systemic diseases * Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood Glucose more than 140 mg/dl) * Hepatic and/or renal dysfunction * Neuromuscular disease * Pancreatic cancer * History of malignant hyperthermia * Emergency surgery * Ischemic heart disease and valvular heart disease * Body mass index more than 40 * Diabetic patients on insulin therapy","* Type of Study: prospective , randomized . * Study Settings: Ain Shams University hospitals, Cairo, Egypt. * Study period: 12 months starting from janurary 2024 . * Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes: 1. Group A will receive total inravenous anesthesia (TIVA). 2. Group B will receive inhalational anesthesia (IHA)" NCT06101706,Assessment of Fatigue in Psoriatic Arthritis and Cutaneous Psoriasis Patients,"Inclusion Criteria: * Patient over 18 years old. * Patient with psoriatic arthritis of any stage or duration, followed in the center's rheumatology or dermatology departments, whether or not treated with systemic therapy. * Patient with all forms of cuteaneous psoriasis (plaque, inverted, erythrodermic or guttate), whatever the stage or duration of the disease, followed in the center's dermatology department, whether or not treated with systemic therapy. Exclusion Criteria: * Patient with auto-inflammatory joint disease: ankylosing spondylitis, rheumatoid arthritis. * Patient with auto-immune disease involving skin lesions: lupus, dermatomyositis, morphea, pemphigus, pemphigoid, Sjögren's syndrome. * Cancer. * Pregnant women. * Severe heart failure (New York Heart Association Class III or IV). * Severe renal failure (DFG \< 30). * Hepatic failure. * Anemia \< 10g/dL. * Patient under legal protection, deprived of liberty or unable to be included in a research protocol.",N/A NCT00221052,Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men,"Inclusion Criteria: * Body Mass Index (BMI): 25.1 - 32.0 kg/m2 * Normal Dutch eating habits Exclusion Criteria: * diabetes, cardiovascular disease or hypertension * Not suitable to receive diclofenac treatment * Smoking * Extreme physical activity (more than 6 hours/week) * Reported slimming or medically prescribed diet",N/A NCT02233491,Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients,"Inclusion Criteria: * Age\>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant Exclusion Criteria: * Organ transplant recipient, pre-existing diabetes, pregnancy",N/A NCT01414660,"Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation","Inclusion Criteria: * Male and Female * More than 18 years old * BMI inferior to 30 kg/m2 * non diabetic patients who need a kidney or a liver transplantation(Glucose blood level \<1,26 g/L without any antidiabetic drug) * OR included in the islet transplantation protocol because of a C peptide negative brittle or difficult to treat diabetes. * cover under the social security Exclusion Criteria: * Unable to receive enlightened information * Refusal to sign the consent * Auto immune disease (kidney, liver or chronic inflammatory disease) * need for a kidney-pancreas transplantation * Creatinin \> 15 mg / L for patients non concerned by kidney transplantation * Sepsis * Oestrogens, raloxifene * Active alcohol Intoxication * Cancers or autoimmune diseases; * Psychiatric Pathology * Active infection including hepatitis C or HIV; * Age under 18 years or above 65 years * Participation in another study excluded the possibility of participating in another protocol * No cover under the social security * Pregnant or lactating women * patients under guardianship, persons deprived of liberty","Rationale: Due to their ability to store fatty acids and to secrete numerous pro-inflammatory cytokines, adipocytes appear to be key cells in the regulation of energy metabolism and immune response. Moreover, it has been recently shown that adipocytes play a role in the recruitment of cells involved in innate and adaptive immunity in adipose tissue. White adipose tissue-related diseases are numerous, whether from its excess (obesity), or its complete (lipoatrophies) or partial absence (lipodystrophies); these 3 different disorders are paradoxically able to induce metabolic insulin resistance syndrome. Among the involved cytokines, interleukin-7 (IL-7), mostly known for its immune functions, also participates in the quantitative and qualitative balance of fat mass. Thus, IL-7 over-expression in animal models induces a lipodystrophic syndrome with insulin resistance, whereas in humans a preliminary study shows that LMNA-linked lipodystrophies are associated with an increase of blood IL-7 levels. IL-7 also participates in reactivation of autoimmunity in patients with autoimmune type 1 after islet transplantation. Otherwise, mammalian target of rapamycin (mTOR) inhibitors have immunosuppressive, metabolic and anti-tumoral properties through different signaling pathways. Rapamycin (or sirolimus) (Rapamune®), an mTOR inhibitor used in islet transplantation, has much greater ability to inhibit adipocyte differentiation and to modulate ß cell function according to the energetic status. In contrast to most organ transplantation, diabetes cell therapy is associated with body weight loss, which is possibly related to the antiadipogenic effects of mTOR inhibitors; the specific role that this plays on the prognostic factors of islet transplantation remains to be determined. Conversely, organ transplantation is usually associated with weight gain, which is involved in the genesis of post-transplantation diabetes, AKA new-onset diabetes after transplantation (NODAT), and long-term vascular complications of transplantation. Adipose tissue redistribution has not yet been studied in patients after transplantation. The aim of this study is thus to determine blood IL-7 and other cytokine levels; metabolic parameters; and fat mass distribution before and after a immunosuppressive regimen in patients receiving different kinds of transplantation (liver, kidney or islets) with normal weight and no type 2 diabetes before transplantation. In these patients, blood samples will be taken before and after transplantation, as will adipose tissue during the transplantation surgery, in order to constitute a plasma, serum, gene and tissue bank for determining the mechanisms linking fat mass, insulin resistance and immunity, both ex vivo and in vitro. Patients: The included patients are normal-weight subjects enlisted for liver, kidney or islet transplantation, with no type 2 diabetes (for liver and kidney transplantation). Methods: Blood IL-7 levels, other immune and/or pro-inflammatory cytokines, lymphocyte immunophenotype, metabolic parameters, and fat mass with non-invasive methods (DEXA and RMN) will be assessed before and one-year after transplantation. Blood, before and after transplantation, as well as adipose tissue during transplantation surgery, will be sampled in order to constitute a blood, gene and tissue bank for defining the inflammatory status of this tissue using histological and molecular analysis. Primary endpoint: The primary endpoint will be IL-7 blood levels in the different groups according to fat mass, metabolic parameters and immunosuppressive regimen. The hypothesis is that an increase of IL-7 levels, possibly induced by immunosuppressive regimen, is associated with quantitative and/or qualitative disturbances of adipose tissue and the development of insulin resistance. Expected results and possible implications: This study will enable the consequences of immunosuppression on IL-7 levels, adipose tissue disturbances and glucose metabolism to be determined. Our approach combining clinical investigation and ex vivo and in vitro analysis is original and should result in better understanding of the cellular mechanisms responsible for the inflammatory process initiated in white adipose tissue and accompanying the disorders of this tissue (especially post-transplantation diabetes), thus opening new therapeutic perspectives in a major complication of transplantation." NCT03937960,Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome,"Inclusion Criteria: 3 out of 5 of the following criteria * Metabolic syndrome with dyslipidemia * (HDL \<40mg/dL * Triglyceride (TG) TG\>150mg/dL) * Glucose intolerance (fasting blood sugar \>100mg/dL) * Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower) * Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension Exclusion Criteria: * Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants) * Pregnancy * Untreated thyroid disease, heart disease, cancer, kidney disease * Children on statin/fibrate treatments or other lipid-lowering medications * Prior surgical procedure for weight control or current weight loss medication","Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming." NCT02061124,"Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota","Inclusion Criteria: Both groups * Caucasian ethnicity * Normal haemoglobin * Age above 35 years and below 80 years * Informed and written consent * BMI \> 23 kg/m2 and \<35 kg/m2 Patients with type 2 diabetes * Type 2 diabetes for at least 3 months * Diagnosed according to the criteria of the World Health Organization (WHO) Healthy Subjects * Normal fasting plasma glucose (FPG) \<6.5 mM and * Normal glycated haemoglobin (HbA1c) \<6.0 % Exclusion Criteria: Both groups * Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder * Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery * Hypo- or hyperphosphataemia * Nephropathy (serum creatinine \>150 µM and/or albuminuria * Treatment with medicine that cannot be paused for 12 hours * Intake of antibiotics six months prior to study * Hypo- or hypercalcaemia * Hypo- and hyperthyroidism * Treatment with oral anticoagulants * Active or recent malignant disease * Any treatment or condition requiring acute or sub-acute medical or surgical intervention * Lack of effective birth control in premenopausal women * Positive pregnancy test on study days in premenopausal women * Tobacco smoking * Any condition considered incompatible with participation by the investigators Patients with type 2 diabetes * Treatment with insulin * Treatment with incretin-based therapy Healthy Subjects * Diabetes or * prediabetes (fasting plasma glucose levels \>6.5 mM or HbA1c \>6.0%) * First-degree relatives with diabetes",N/A NCT03067324,Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol,"Inclusion Criteria: * Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP Exclusion Criteria: * Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.","Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential. The project aims to : * develop the bio-sensor necessary to measure islet membrane electric potential * develop interface between bio-sensor and user * correlate analysis data collected by bio-sensor with metabolic results of islet graft" NCT04742023,Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation,"Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Undergoing first-time renal transplantation 5. Have a pre-existing diagnosis of Type 2 diabetes mellitus Exclusion Criteria: 1. Age less than 18 years 2. Use of insulin pump at time of transplant 3. Insulin infusion requirement during hospitalization 4. Pregnancy or lactation 5. Known allergic reaction to Guardian™ Sensor 3 or adhesives 6. History of hypoglycemia unawareness",N/A NCT05552859,Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment,"Inclusion Criteria: 1. Is an adult aged ≥18 years at screening. 2. Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of \>1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period. 3. Has an HbA1c ≥7.5% and ≤10.5% at screening. 4. Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of \<60 mL/min/1.73m2 and ≥15 mL/min/1.73m2. 5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion. 6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period. 7. Is capable of understanding the written informed consent, and provides signed written informed consent. 8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements. 9. Is willing and able to fast without having administered study drug for scheduled site visits. Exclusion Criteria: 1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA. 2. Has a body mass index (BMI)\* \>45 kg/m² during the screening period. 3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms \[eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion\] or as the failure to sense a significant fall in blood glucose below normal levels). 4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening. 5. Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","The trial will consist of the following periods: * A screening period of up to 2 weeks, * A 24-week, open-label treatment period, including a titration period and a maintenance period. * A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary." NCT06542679,Pregnancy Weight Management Mobile Health App,"Inclusion Criteria: * Aged between 18 and 45 years * Singleton pregnancy * Able to read and write in Turkish * Pregnant women with a gestational age ≤ 12 weeks * Pre-pregnancy/starting BMI between 18.5 and 39.9 kg/m² (including normal weight, overweight, and obese individuals) * Own a smartphone Exclusion Criteria: * Having a multiple pregnancy * Pre-pregnancy/starting BMI \<18.5 kg/m² (underweight) or BMI \>40 kg/m² (morbidly obese) (due to the need for specialized nutrition/exercise counseling) * Pregnant following fertility treatment * Having a diagnosis of diabetes prior to pregnancy * Having a diagnosis of or a history of eating and nutrition disorders * Having a history of bariatric surgery * Having diagnosed thyroid disease and/or adrenal disease * Having a psychiatric illness or history of psychiatric illness * Having a physical disability * Pregnant women who do not wish to participate in the study","During the data collection phase, pregnant women will first fill out the Enrollment Criteria and Preliminary Registration Form to create their records, determining included and excluded participants. After preliminary tests, participants will be divided into intervention and control groups using stratified randomization based on their BMI. Participants will be stratified into normal BMI, overweight, and obese BMI categories. Pregnant women who meet the inclusion criteria will be given general information about the study and their written and verbal consent will be obtained. Pregnant women will be included in the study by the 12th week of pregnancy and/or earlier, and after their information and preliminary tests are collected, those in the intervention group will start using the mobile application when they reach the 12th week of pregnancy. Data for the study will be collected using the Pregnancy Introduction Form, which includes sociodemographic information about the pregnant women, the Follow-up Form, which includes information from interim and final follow-ups, the Healthy Eating Attitude Scale developed to measure the attitude towards healthy eating, and the International Physical Activity Questionnaire to determine physical activity levels. Interim follow-ups of pregnant women in both groups will be conducted at the 24th week of pregnancy, during which the Follow-up Form, Healthy Eating Attitude Scale, and International Physical Activity Questionnaire will be administered, and current weight and height will be recorded. Similarly, the final follow-up will be conducted during the last prenatal check-up (38th week of pregnancy), where the same forms and measurements will be repeated. At the end of the study, to objectively evaluate participants in the intervention group, the User Version of the Mobile Application Rating Scale (uMARS) will be applied within the first week after birth to evaluate the mobile application. The control group will receive routine care following the Ministry of Health's Prenatal Care Management Guide of the Republic of Turkey. To enhance adherence among control group participants, weekly antenatal health information unrelated to healthy eating, physical activity, and weight management will be provided via phone. Interim follow-ups will be conducted face-to-face during routine check-ups (for OGTT) at the 24th week of pregnancy, during which the Follow-up Form, Healthy Eating Attitude Scale, and International Physical Activity Questionnaire-Short Form will be administered, and current weights will be measured with a standard simple scale brought by the researcher (same scale) and recorded. The final follow-up will be conducted face-to-face during the last prenatal check-up at the 38th week of pregnancy, where the Follow-up Form, Healthy Eating Attitude Scale, and International Physical Activity Questionnaire-Short Form will be administered again, and current weights will be measured (with the same scale). In addition to the routine care provided according to the Turkish Ministry of Health's Prenatal Care Management Guidelines, the intervention group will receive a mobile application intervention. The intervention (mobile application) will begin in the 12th week of pregnancy. Participants in the intervention group will start using the mobile application at the 12th week of pregnancy and continue to use it throughout their pregnancy. The content of the mobile application includes information on healthy nutrition and exercise during pregnancy, as well as monitoring and notifications. Pregnant women will be guided, encouraged, and monitored for healthy nutrition and exercise through the mobile application. At the 24th week of pregnancy, interim assessments will be conducted for the participants in the intervention group. These assessments will include the Tracking Form, the Attitude Scale Towards Healthy Nutrition, and the Short Form of the International Physical Activity Questionnaire, administered face-to-face during routine check-ups. The current weight of the participants will be measured using a standard scale (the same scale) brought by the researcher, and the data will be recorded. The final assessment for the group will be conducted during the last prenatal check-up (at the 38th week of pregnancy), where the Tracking Form, the Attitude Scale Towards Healthy Nutrition, and the Short Form of the International Physical Activity Questionnaire will be administered face-to-face, and the current weight will be measured using the same scale. At the end of the study, within the first week after childbirth, participants in the intervention group will be asked to evaluate the mobile application using the User Version of the Mobile Application Rating Scale (uMARS)." NCT05241262,Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels,"Inclusion Criteria: * Ages 18-80 years * Low brain glutathione (GSH) levels as determined by magnetic resonance spectroscopic imaging (MRSI) * Individuals who carry, or are suspected of carrying the m.3243A\>G mitochondrial mutation (genetic confirmation of mutation required prior to initiation of NAC) Exclusion Criteria: * Individuals with normal brain glutathione levels * Pregnant or lactating individuals * Medically unstable as determined by the Principal Investigator * Allergy to NAC or other sulfur-containing drug * Inability to adhere to study protocol","Patients with the m.3243A\>G mitochondrial mutation often have low brain glutathione levels. These low levels can reduce the repair processes in the brain to fix toxic chemicals that result from a mitochondrial disorder. The investigators are aware of a potent anti-oxidant, called N-Acetylcysteine (NAC), that may improve the brain glutathione level when taken in sufficient quantity. In turn, cognitive and motor skill impairment may improve as these toxic levels are reduced. will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life." NCT01340079,Virtual World Health Behavior Counseling for Patients With Diabetes,"Inclusion Criteria: 1. Diagnosed with T2DM 2. HbA1c level \>= 8.0 3. Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents 4. African-American origin 5. \>= 18 years old 6. Telephone in home or easy access to one 7. Able to understand and participate in the study protocol 8. Functionally capable of meeting the activity goals 9. Understands and can provide informed consent 10. Physician approval to participate in the study. Exclusion Criteria: 1. History of diabetic ketoacidosis 2. Gestational diabetes 3. Unable or unwilling to provide informed consent 4. Plans to move out of the area within the 12-month study period 5. Required intermittent glucocorticoid therapy within the past 3 months 6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 months 7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease) 8. Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an neuroleptic medication). We will not exclude based on history of depression or anxiety or taking anti-depressants or anti-anxiety medications.","This study will provide health education to African-American women with type 2 diabetes either face to face, or using the Internet. The study seeks to determine how feasible the internet method is for this type of health education, and how it compares to the face to face method. Patients will be recruited from Boston Medical Center. They will do baseline surveys and have blood drawn. They will then be randomized into receiving their diabetes education in a face to face group at BMC, or receiving it online while at home. The online group will receive a computer to access the Internet program and Internet access. Both groups will participate in 8 diabetes education groups, and 4 individual counseling sessions. Subjects will complete surveys before and after the study to measure changes in physical activity, diet, and use of medications, and will have blood tests drawn at BMC before and after the study to measure changes in diabetes control, cholesterol. They will also have blood pressure measured before and after the study period." NCT01392027,Biospecimens for Identification of Diseases of the Pancreas.,"Inclusion Criteria: Overall Inclusion (all subjects must meet these criteria to be enrolled) * Adults 18 years of age or older * Able to physically tolerate removal of 50 ml of blood * Willing to sign informed consent. Exclusion Criteria:Overall Exclusion (for all subjects) * Pregnant or lactating * Known HIV/AIDS or Hepatitis C * Prepped for colonoscopy at the time of blood collection * Unable to understand English * Receiving chemotherapy or radiation at time of enrollment * Any cancer within 5 years of enrollment except any of the following: * Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin * Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation) * Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery","The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI and several COREs, including a biospecimen core. Each project that has a human subjects component will require a separate protocol and IRB submission when those projects are to begin. The specific populations we are recruiting are determined by the aims of project 2 and by the need to create a repository as part of the biospecimen core (please see the grant for details on the aims of these 2 projects). A specially designed database is being built for this study to handle the data aspects. Our collaborators at Dartmouth College have significant experience in managing data as they have been our partners for our work in the EDRN (PI Brenner). Case report forms and other data collection tools have been developed and are being used to populate the database. All of the actual data will be completely deidentified per HIPAA regulations. We intend to model the data and specimen collection on the model used by our work with the NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded aliquots, and standardized data collection forms (CRFs)." NCT02057861,Reversal of Neuromuscular Blockade in Diabetic Patients,"Inclusion Criteria: * The patients (diabetic and non-diabetic) between 18-65 years with risk of anesthesia I-II, * For diabetic group patients with Diabetes mellitus Type 2 over 10 years. * For non-diabetic group patients without any glucose metabolism disease Exclusion Criteria: * myasthenia gravis, myotonic dystrophia, motor neuron diseases * diabetic neuropathy and nephropathy * hepatic, renal and cardiac diseases","Aim: In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients. Methods: Included patients were divided into 2 groups: diabetic (n=21) and non-diabetic (n=20). All patients were premedicated. After arrival in the operating room, all patients were monitorised with Datex Ohmeda S/5 Anesthesia Machine and electrocardiography (DII derivation), hemodynamic variables, respiratory rate, and inspiratory sevoflurane concentrations were recorded. Neuromuscular monitoring system was used. Anesthesia was induced with propofol 2 mg/kg and fentanyl 1 mcg/kg. After the loss of eyelid reflex the neuromuscular monitoring system automatically identified supramaximal stimulating currents and after that rocuronium 0,6 mg/kg was given. Train of four (TOF) stimulation with the supramaximal current were applied and by recording of second TOF value (TOF2) the patient was intubated. Anesthesia was maintained with 50% O2 + 50% air and sevoflurane of 1-2 % concentration. TOF stimulation was applied and recorded every 20 seconds. Intraoperatively by return T2 rocuronium 0,15 mg/kg was given. T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded." NCT01945242,"Alogliptin Tablets Special Drug Use Surveillance ""Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones""","Inclusion Criteria: * Patients who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy Exclusion Criteria: * Patients contraindicated for Nesina 1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.) 2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.) 3. Patients with a history of hypersensitivity to any ingredient of Nesina","This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting. Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects. The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily." NCT01308242,Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease,"Inclusion Criteria: * Adults between ages 18-80 years old, with a GFR less than or equal to 50 ml/min/1.73 m2 as determined by the Modification of Diet in Renal Disease (MDRD) formula will be included. Exclusion Criteria: * Patients will be excluded if they have a history of renal transplant or are pregnant. In addition, patients with dysphagia, swallowing disorders, severe GI motility disorders, severe constipation, history of major gastrointestinal surgery and patients taking levothyroxine for hypothyroidism will be excluded.",N/A NCT06318442,The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes,"Inclusion Criteria: * Adults ≥ 18 years; * Male or female; * Pre-diabetes (HbA1c ≥42 and \<47 mmol/mol, or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol); measurements within range on two separate occasions ≥90 days apart) * Body mass index ≥22.5 kg/m2 Exclusion Criteria: * Prior treatment with any diabetes medication within 90 days; * Current or planned pregnancy, or current breastfeeding; * Previous treatment with GC (topical, oral, injected) within 30 days or 90 days for extended-release injected GCs (e.g. Depo-Medrone); * Continuing requirement for GC treatment (e.g. for steroid replacement, chronic inflammatory or immunological condition); * Treatment with medications altering DEX pharmacokinetics (e.g. phenytoin, carbamazepine, ritonavir). * History of pancreatitis, renal disease (eGFR \<30), severe hepatic impairment, gallbladder disorders, or GI disease (e.g. IBD), heart failure, history of medullary thyroid cancer (MTC), or previous skin reactions. * History of bleeding disorders of anticoagulant therapies (exclusion from the biopsy substudy only) * History of giving blood or having taken part in another non-related study in the last three months * History of any other medical, psychological condition, or use of any medications, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.",N/A NCT06261086,Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study,"Inclusion Criteria: * Patients with vitiligo ≥ 18 years old, both male and female patients will be included. Exclusion Criteria: * Patients with the following criteria will be excluded from our study: 1. Pregnancy and breast-feeding women 2. patients on antioxidants or anti-inflammatory drugs 3. Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study 4. Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc. 5. Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.",N/A NCT04228055,Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2),"Inclusion Criteria: * Diagnosed with prostate cancer Stage I, II or III * On androgen deprivation therapy with last 5 years * Willing to participate in a lifestyle modification program * Willing to modify diet and eating practices * Willing to participate in blood collection, urine collection and measurements * Minimum of 30 days since participating in another study/trial * English speaking * 40 to 80 years of age * BMI \>25% Exclusion Criteria: * Currently participating in another study or trial * Currently in hospice * Inability to walk two city blocks * Inability to comprehend informed consent or procedural requirements * Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake * Subjects already following an intensive lifestyle modification plan * BMI \<25%","INTRODUCTION: Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa). ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality. There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors. CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP) with an emphasis on low carbohydrate and a Keto Diet, a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer. INTERVENTION: * 24 Weeks * Health Coaching Weekly * Serum \& Urine Baseline, Week 12 and Week 24 * Anthropometric Measures * Questionnaires * BMI Measurements" NCT05614115,"Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD","Inclusion Criteria: * include diabetic and non-diabetic adults * dialysis treatment history of ≥3 months Exclusion Criteria: * type 1 diabetes * ongoing intravenous antibiotic therapy for infectious disease * active treatment for malignancy * unhealed lower extremity skin ulceration * history of Fournier's gangrene * diabetic ketoacidosis * severe hypoglycemia (requiring external assistance within the past one year) * allergy to empagliflozin * pregnancy","Patients on dialysis have a very high risk of heart failure and heart-related death compared to people who do not require dialysis. While treatment options for heart failure have improved over the years for those without kidney disease, there has been very limited discoveries to improve survival for dialysis patients. Empagliflozin, a new diabetic medication that works by making the kidney put out more sugar in the urine, has recently shown to have significant efficacy to protect the kidney and to reduce heart failure hospitalization and cardiovascular death in both diabetic and non-diabetic patients. Studies suggest that this medication may have benefits on the heart, fat cells, blood vessels, and possibly other organ systems. The benefit remains consistent whether you have diabetes or not. Empagliflozin is now approved by the U.S. Food and Drug Administration (FDA) to treat not only diabetes but also chronic kidney disease and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults regardless of the diabetes status. The clinical studies, however, have excluded those with severe kidney disease and those requiring dialysis. The safety of empagliflozin in the dialysis patients has not been established, and thus it is not available for people with end-stage kidney disease. If empagliflozin is safe in dialysis patients, it may potentially become a very powerful tool to lower the risk of heart-related complications and prolong survival. Although empagliflozin is approved by the FDA to treat patients with chronic kidney disease, heart failure, and/or diabetes, our study will evaluate empagliflozin as an investigational drug to assess if it is safe in patients receiving chronic dialysis. If we can establish safety, the next step would be to conduct a larger clinical study to evaluate its ability to lower heart failure and death risk in dialysis patients." NCT03765008,The Effect of Water Intake on Glucose Regulation,"Inclusion Criteria: BMI 27.5-35 Exclusion Criteria: * BMI \<27.5 or \>35 * high physical activity * diabetes * impaired liver or kidney function * cardiovascular disease * weight change of more than 3 kg in the past month * pregnancy * previous surgery on digestive tract (except appendectomy) * fluid balance will be exclusionary such as * serotonin re-uptake inhibitors.",N/A NCT03832725,Pathobiology of Remission of Type 2 Diabetes,"Inclusion Criteria: i) Age range 20 yrs to 50 yrs; ii) BMI \> 30 kg/m2 to 55kg/m2; iii). Fasting blood glucose \>126 mg/dl and 2 hour glucose \>200 mg/dl determined by OGTT; iv). HbA1c \> 6.5 % to ≤10%. \- Exclusion Criteria: i) Proteinuria or elevated serum creatinine (\>1.5 mg/dl); ii) Surgical or premature menopause; iii) liver disease or abnormal liver function tests; iv) T2DM of greater than 2 yrs; v) Thyroid disease with abnormal TSH; vi) Weight \> 350 lbs, (due to fit on DXA); vii) Triglycerides\>400 mg/dl or LDL cholesterol \>160 mg/dl; viii) SBP\>145, DBP\>100 mm of Hg; ix) on medications known to effect lipid or glucose metabolism; x) Pregnancy or become pregnant in next 6 mo; xi) Weight loss \>10% of body weight in last 6 mo; xii)History of cancer \<5 yrs or undergoing active treatment; xiii) smoking, xiv)alcohol abuse; xv) having CPAP treatment. xvi)Subjects with HbA1c \>10% will be referred to an endocrinologist for pharmacological treatment. \-","Greater than 30 million people have diabetes. Over time diabetic patients need more and more medications and develop numerous medical complications. Remission of Type 2 Diabetes (T2DM) would have profound effects on people with diabetes with respect to overall health improvement (insulin sensitivity(Si), cardiovascular risk factors(CVR), inflammation markers (IC)), reduction of retinopathy, nephropathy, neuropathy and reduction in medical costs. Methods to accomplish this have not yet been determined, however, it is generally accepted that non-drug methods to treat T2DM is the most cost effective and have the fewest side effects. The primary risk factor for T2DM is obesity. Our randomized clinical trials comparing the effects of High Protein (HP) vs High Carbohydrate (HC) weight loss diets in obese, prediabetic(IGT) women and men where all foods were provided daily for 6 months(mo) showed that while both diet groups had similar weight loss, 100% of HP diet subjects had remission from IGT to Normal Glucose Tolerance(NGT), but only 33% of HC diet group had remission. Also, the HP diet provided greater improvement in Si, CVR, IC, and an increase in % lean body mass (LBM) compared to the HC diet demonstrating that weight loss is not the only factor involved in remission. Based on these findings, we now propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 mo. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics predictors for assess-ment of remission. The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission. We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance. The rationale is the HP diet is palatable for subjects to continue after the 6 mo study and stay in remission using diet plans we provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 mo feeding study and determine: (a)remission of NT2DM to NGT, (b)weight loss and LBM preservation, (c)improvements in metabolic markers, CVRs, IC, epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM. This study is innovative in that we propose to use a non-pharmaceutical means (HP diet) for remission of T2DM diabetes and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies. The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be a significant improvement in health risk and medical cost to subjects" NCT06903897,Social Needs Screening and Chronic Diseases Study (WE CARE),"Inclusion Criteria: * Adults and children with diagnosed chronic diseases (hypertension, diabetes mellitus, hyperlipidemia, asthma, or depression) who receive Family Medicine care at one of the study sites. * Children (\<18 years of age) with a diagnosis of asthma. * Adult patients (18 years or older) with a diagnosis of diabetes mellitus, hypertension, hyperlipidemia and/or depression. Exclusion Criteria: * In adults (\>18 years of age), those without one or more of the following diagnoses as recorded by ICD-10 codes in their EHR: hypertension, hyperlipidemia, diabetes mellitus, or depression. * In children (\<18 years of age), those without a diagnosis of asthma.","With a multidisciplinary team of social determinants of health (SDOH), implementation, antiracism, community-engaged, and practice-based researchers, the investigators will apply an antiracism framework to an existing evidence-based SDOH screening and referral system and develop a holistic implementation toolkit aimed at reducing bias and mitigating unequal treatment for families of color. The investigators will first conduct qualitative interviews with adult patients and caregivers to understand their experiences with racism and discrimination within the context of their experiences with screening and referral for SDOH; the investigators will then share their findings with stakeholders (e.g., clinic directors, community agency leaders, health system leaders, Medicaid leaders) and elicit their ideas on how best to address these issues within the systems they lead. Subsequently, the investigators will refine the WE CARE implementation protocol using this stakeholder input with the guidance of antiracism and implementation experts. The investigators will then implement the refined WE CARE protocol in family medicine clinics since adverse SDOH impact the whole family unit; it will also allow them to examine WE CARE's impact on improving health outcomes for racialized groups across the life course. The investigators will conduct a hybrid effectiveness-implementation study with a stepped wedge cluster RCT design in three large family medicine clinics (including 2 health centers) that serve racially/ethnically diverse low-income families from Worcester, Massachusetts. The specific aims are to: * Aim 1: Refine the WE CARE implementation protocol using an antiracism lens and community engagement approach to: (a) conduct key informant interviews with families to identify racism and discrimination related barriers to SDOH screening/referral; (b) present these barriers to systems-level stakeholders to elicit input on strategies to address patient concerns; and 3) create an antiracist informed toolkit for the implementation of SDOH screening/referral.).\* * Aim 2: Deploy the refined WE CARE protocol in family medicine practices and assess implementation outcomes including equity, appropriateness, and patient-centeredness * Aim 3: Conduct a clinical trial to evaluate the effectiveness of the refined WE CARE protocol on prevalent pediatric and adult chronic diseases (e.g., asthma, diabetes, hyperlipidemia, hypertension, depression) outcomes" NCT01594060,Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards,"Inclusion Criteria: * Patients admitted to internal medicine ward with blood glucose (BG) between 140-400 mg/dl. * Known history (\>6months) of diabetes. * Aged 18-80 years old. * Previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (GLP-1) analogs and long acting insulin analogs or Neutral Protamine Hagedorn (NPH). Exclusion Criteria: * Pregnancy * Patients with ketoacidosis * Patients with unknown history of diabetes * Patients with type 1 diabetes mellitus * Patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl) * Use of corticosteroid therapy * Patient with any mental disorder preventing him to cooperate and give informed consent. * Patients on multiple daily doses of insulin regimen.",N/A NCT01278160,Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756,"Inclusion Criteria: * Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756 * HbA1c above or equal to 7.0% * Body Mass Index (BMI) below or equal to 40.0 kg/m2 Exclusion Criteria: * Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756 * Known proliferative retinopathy or maculopathy requiring acute treatment * Any disease or condition which the Investigator (trial physician) feels would interfere with the trial",N/A NCT02571582,Predictors of Mortality in Patients With Advanced Lung Disease in Home Oxygen Therapy,"Inclusion Criteria: Advanced Pulmonary disease using home oxygen therapy; • Have a diagnosis of chronic hypoxemia proven by blood gas analysis on room air PaO 2 ≤ 55 mm Hg or SaO2 ≤ 88; or PaO2 between 55 and 60 mmHg or SaO2 between 89 and 90%, with evidence of pulmonary hypertension, or polycythemia (hematocrit\> 55%) as GOLD - Global Obstructive Lung Disease, 2015; Exclusion Criteria: No records found Patients who failed to perform the periodic reviews established by the team responsible","The advanced chronic lung disease (PAD) is characterized by the development of several structural abnormalities, and pulmonary and systemic functional with low potential for reversibility, in spite of the treatment. It is defined DPA whole lung non-neoplastic chronic in its final phase. Most people with DPA consists of elderly people who have lung function and quite compromised gas exchange. These conditions determine chronically limitations in activities of daily living, negative impact on mental and social state, frequent exacerbations of the disease and numerous hospitalizations, recognized risk factors for increased morbidity and mortality (MACHADO, 2006). Clinically, patients with APD may have one or more of the following signs and symptoms: dyspnea; cough; intolerance efforts; hypoxemia and / or hypercapnia; malnutrition and / or cachexia; anxiety and / or depression (BTS 2004). According Garden 2004, the DPA affects millions of people worldwide and it is estimated that in Brazil there are two million individuals with APD. The most prevalent lung diseases, which in the final stage, fall under the DPA definition are classified as obstructive, restrictive, vascular and hypoventilation syndromes. Obstructive chronic respiratory insufficiency are part individuals with COPD, bronchiectasis and other bronchiolitis. Already restrictive covers patients with interticiais diseases and neuromuscular diseases. And the pulmonary vascular diseases fit patients with primary pulmonary hypertension and secondary and chronic pulmonary thromboembolism (MACHADO, 2006; PAUL, 2005). Within the restrictive diseases with high prevalence we find the interticiais diseases are heterogeneous disorders, grouped according to clinical, radiological and functional similar. In the group of conditions that account for the majority of advanced pulmonary diseases are idiopathic pulmonary fibrosis, hypersensitivity pneumonitis and sarcoidosis. The etiology is unknown in many situations; and any known causes that stand out are the tobacco-related diseases (Guidelines interticiais lung diseases, 2012). Vascular diseases also fits in advanced lung disease and presents significant pulmonary and systemic changes in patients. Before insulting stimuli of different nature, the pulmonary vessels undergo changes, known as pathological remodeling of the circulation. The vessel is tougher and reactive, causing pulmonary vascular diseases. Morphologic lesions in the arterial tree leads to local changes in the pattern of blood flow, that flow slowly added to the changes detected in the endothelial surface and abnormalities of the coagulation system proteins provide local thrombus formation. Pulmonary hypertension is a pathological condition that is present when the mean pulmonary artery pressure above 25 mmHg (CONSENSUS, 2009). The alveolar hypoventilation is the major injury to the respiratory function by obesity. The concept of alveolar hypoventilation reflects the incompetence of the respiratory system to eliminate carbon dioxide in the same proportion that reaches the lungs. Implies, therefore, the presence hypercapnia (PaCO2\> 45 mm Hg) accompanied by equivalent degree of hypoxemia (low PaO 2). Alveolar hypoventilation syndrome-obesity is defined as chronic alveolar hypoventilation in obese patients (body mass index greater than 30 kg / m2), without any other respiratory disease to justify the disorder of gas exchange. Palliative treatment consists in controlling chronic hypoventilation and hypoxemia and resolute treatment is to combat obesity (SILVA, GA 2006). Among the obstructive diseases of major relevance are bronchiectasis and COPD. Bronchiectasis refers to the dilatation of the bronchi and irreversible distortion due to the destruction of the elastic and muscle component of its wall. It can be congenital or acquired. To purchase no need to aggression by an infection and disability in hygiene bronchial secretions. The patient has a cough, possibly with episodes of hemoptysis (GARDEN, 2004). COPD is a preventable and treatable respiratory disease characterized by the presence of chronic airflow obstruction that is not fully reversible. The airflow obstruction is usually progressive and associated with an abnormal inflammatory response of the lungs to inhaled particles or toxic gases. Although COPD affects the lungs, it also produces significant systemic consequences that contribute to disease severity (GOLD - Global Obstructive Lung Disease, 2013). The ODP is considered a non-pharmacological treatment critical for patients with chronic respiratory insufficiency. Maintaining low and stable level of oxygen in blood is of great importance for the organic homeostasis. Oxygen supplementation improves survival of patients with chronic hypoxemia and your prescription is recommended in the consensus on the subject. The main benefits of oxygen to the body are the decline in ventilatory work and improves the cardiovascular and muscular functions (Machado, 2006). Classical studies have found that the use of ODP for more than 15 h / day in patients with chronic respiratory diseases increases survival in patients with severe hypoxemia (Lancet, 1981; Ann Intern Med, 1980...). The use of oxygen is indicated in patients with (as GOLD - Global Obstructive Lung Disease, 2013): * PaO2 mmHg or SpO2 ≤ 55 ≤ 88, with or without hypercapnia confirmed two times over a period of 3 weeks, or * = 55 to 60 mmHg PaO2 or SaO2 = 89%, with evidence of pulmonary hypertension, or polycythemia (hematocrit\> 55%) The number of patients who require ODP is increasing every year. This type of therapy is being used more frequently in order to reduce morbidity and mortality and improve the quality of life of patients. This practice allows you to optimize the occupation of the beds, reduce the length and the number of hospitalizations and thus reduce hospital costs (Tanni, S. E et al 2007). Two large studies have evaluated the benefits of ODP. The first study conducted by the Medical Research Concil compared the use of oxygen for 15h / d X 0 h / d, showing improved survival in those patients who regularly used oxygen. The second study, the Nocturnal Oxygen Therapy Trial, compared the use of 24h / d with 12h / d, showing improved survival in those patients who used oxygen for longer (Nocturnal Oxygen Therapy Trial Group, 1980). The DPA's are an important public health problem in the world. Many people suffering from these diseases for years and die prematurely from the disease itself or its complications. The DPA, particularly COPD, are classified as a major cause of morbidity and mortality worldwide and results in an economic and social impact is substantial and growing, the debt is having a major highlight in the medical field in recent years (Gold, 2013). Thus this work will identify the predictors of mortality in patients with DPA in ODP and help professionals and public and private policy health directly linked to treat these patients, to optimize the clinical management, helping improve the treatment of these patients, increasing life expectancy, reducing costs and improving the quality of life of these patients." NCT03052582,Whole Milk Compared With Skimmed Milk and Effect on Lipids,"Inclusion Criteria: * All subjects must give their informed consent in writing, after having received oral and written information about the study * Age: 20-70 y * BMI: 18.5 - 30 kg/m2 * Healthy men and women (with no known diseases) Exclusion Criteria: * Current or previous cardiovascular disease, high blood pressure or cholesterol * Diabetes Mellitus or other severe chronic disease, including severe allergies * Lactose intolerant or milk allergy * Use of dietary supplements two month prior to and during the intervention Blood donations 1 month prior to and during the intervention * Known or suspected abuse of alcohol, drugs or medication * Pregnant or are planning pregnancy during the study period * Extreme physical activity level (more than 10 hours tough physical activity pr. week) * Participation in other research studies * Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff","This study will be a randomized controlled 2 x 3 weeks crossover intervention study with no wash-out period, as the lipids in the blood are known to adjust after 2 weeks. The effects of a diet containing 0.5 L of whole milk (17.5 g of milk fat/day) will be compared with a diet containing 0.5 L of skimmed milk (1.5 g of milk fat/day). Blinding is not possible since the appearance of the test foods cannot be concealed. The study subjects will receive the two test foods in random order, decided by draw of lots. Blood samples will be drawn on the first day of the period and in the end of the period for each 3 week-periods." NCT00464880,"Effects of Aliskiren, Irbesartan, and the Combination in Hypertensive Patients With Type 2 Diabetes and Diabetic Nephropathy","Inclusion Criteria: * Male and/or female subjects between the ages of 30-80 years with a diagnosis of type 2 diabetes (World Health Organization criteria) * Body mass index (BMI) within the range of 20 and 32. * Incipient or overt diabetic nephropathy (urinary albumin excretion ≥ 100 but ≤ 2000 mg/day). * Glomerular filtration rate (GFR) ≥ 40 ml/min documented in the last 4 months prior to randomization * To be eligible for randomization, patients must fulfill the following criteria: 1. Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (run-in period). 2. Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1). * Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 (Day -1). * Patients must be willing and medically able to discontinue all angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study. * Female patients must be postmenopausal, have had a bilateral oophorectomy, or have been surgically sterilized or hysterectomized at least 6 months prior to screening. * Oral body temperature within the range of 35.0-37.5 °C * Able to provide written informed consent prior to study participation. * Able to communicate well with the investigator and comply with the requirements of the study. Exclusion Criteria: * Severe hypertension, Grade 3 World Health Organization (WHO) classification (mean sitting diastolic blood pressure \[MSDBP\] ≥ 110 mmHg and/or mean sitting systolic blood pressure \[MSSBP\] ≤ 180 mmHg) * Acetylsalicylic acid (ASA) treatment \> 1 g/day or regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) * Kidney disease not caused by diabetes or hypertension * Serum potassium \< 3.5 or \> 5.1 mEq/L * GFR \< 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula * Serum albumin \< 2.0 mg/dL * History of hypertensive encephalopathy or cerebrovascular accident in the last 12 months prior to Visit 1 * Transient ischemic cerebral attack during the 6 months prior to Visit 1 * Current diagnosis of heart failure (New York Heart Association \[NYHA\] Class II-IV) * History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1 * Second or third degree heart block without a pacemaker * Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia * Clinically significant valvular heart disease * Type 1 diabetes mellitus * Uncontrolled type II diabetes mellitus; hemoglobin subtype A1C (HbA1C) \> 11% * History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years * Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing. * Significant illness within the two weeks prior to dosing. * Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: * History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection * Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 * Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1. * Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase * Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portacaval shunt * Current treatment with cholestyramine or colestipol resins * History of immunocompromise, including a positive test result. * History of a positive hepatitis B surface antigen (HBsAg) or hepatitis C test result. * History of drug or alcohol abuse within the 12 months prior to dosing. * Persons directly involved in the execution of this protocol. * Any condition that, in the opinion of the investigator or the Novartis medical monitor, would jeopardize the evaluation of efficacy or safety * History of noncompliance to medical regimens or unwillingness to comply with the study protocol * Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drug * Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study * Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol. * Patients who previously participated in any aliskiren study. Other protocol-defined inclusion/exclusion criteria may apply.","Antiproteinuric Effects of Aliskiren (Renin Inhibitor), Irbesartan (Angiotensin Receptor Antagonist) and the Combination in Hypertensive Patients With Type 2 Diabetes and Incipient/Overt Diabetic Nephropathy" NCT06962280,A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight,"Inclusion Criteria: * Have type 1 diabetes and on insulin treatment for at least one year prior to screening * Have an HbA1c value of 7.0% to 10.5% inclusive, at screening * Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening * Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study Exclusion Criteria: * Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization. * Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have had chronic or acute pancreatitis * Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening",N/A NCT07322380,Feasibility and Adoption of a Screening Program for T1D Relatives in Canada,"Inclusion Criteria: * Males and females ≥18 years old living in the Québec province * Having a FDR living with T1D (parents, siblings or offspring) * Willing to adhere to follow-up care if screened positive Exclusion Criteria: * Having a diagnosis of T1D * Pregnancy (ongoing or current attempt to become pregnant) * Current or future expected use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®) or any systemic immunosuppressive agents * Planned or recent (\< 6 weeks) monoclonal antibodies treatment, immunoglobulin perfusions or plasmapheresis. * Other serious medical illness likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator",N/A NCT00910780,Metabolic Effects of Antipsychotic Substitution in Children,"Inclusion Criteria: * Age 6-18 years (at any point during study participation * BMI \> 85th percentile * One or more DSM-IV diagnoses, including disruptive behavior disorders (attention deficit disorder, conduct disorder, oppositional defiant disorder and disruptive behavior disorder not otherwise specified), affective disorders (bipolar affective disorder, major depressive disorder and mood disorder not otherwise specified), anxiety disorders (generalized anxiety disorder, obsessive compulsive disorder, separation anxiety, social and other specific phobias) as well as other disorders, including autism spectrum disorders (autistic disorder, Asperger's Syndrome and pervasive developmental disorder not otherwise specified), psychotic disorders (schizophreniform disorder, schizophrenia and psychotic disorder not otherwise specified) and movement disorders (tic disorder, Tourette's Syndrome) * At least 12 weeks of treatment and no more than approximately 12 months treatment with risperidone or olanzapine immediately prior to study enrollment (assuming that the initial phase of prior treatment involved a dose titration; clinically minor dosing deviations such as changes in dose or missed doses will be evaluated for inclusion by the PI on an individual basis) * No clinically significant changes in permitted medications (e.g., stimulants) for 1 month prior to Baseline Evaluations (inclusion determined by evaluation on an individual basis by the PI) * Clinically significant weight gain during an initial course of antipsychotic treatment; for non-MEAC participants, this is defined as \> 10% increase from baseline weight during the prior treatment if treatment lasted approximately 5-12 months or defined as \> 7% increase from baseline weight during the prior treatment if treatment lasted approximately 3-4 months (based on the totality of information from primary care provider, school and home); for prior MEAC participants, clinically significant weight gain is defined as \> 7% increase from baseline weight over the course of the 3 month MEAC study and/or \> 10% increase in total body fat as measured by DEXA during the MEAC study * Score of \> 18 on the irritability subscale of the Aberrant Behavior Checklist prior to initiating antipsychotic treatment: MEAC participants will automatically meet this criterion based on similar inclusion criteria for MEAC; for non-MEAC participants, the ABC questionnaire will be administered to parents and one or more collateral source (such as a teacher, social worker or alternate caregiver) by study staff to retrospectively gather information about symptoms of irritability and aggression prior to initiation of antipsychotic treatment. Non-MEAC participants with a retrospective, consensus (i.e., clinician evaluation of all available sources of ABC data) ABC irritability subscale score of \> 18 in proximity to (e.g., within 3 months of) initiation of treatment will be included (based on combined evaluation of the totality of available corroborative resources), and viii) Clinically significant improvement in psychiatric symptoms during the initial course of antipsychotic based on \> 30% decrease in ABC irritability score from baseline to endpoint in the MEAC study or a retrospective consensus of 30% decrease in ABC over the prior course of treatment OR a CGI-I score of 2 or better or psychiatric symptoms experienced for at least 1 month prior to enrollment as measured by a CGI-S score of 3 or less (mildly ill). Exclusion Criteria: * Active suicidality * The presence of any serious medical disorder or condition that may, in the judgment of the PI, confound the assessment of relevant biologic measures or diagnoses, including: clinically significant organ system dysfunction; significant endocrine disease, including diabetes mellitus; coagulopathy; significant anemia; or significant acute infection; or pregnancy * Participants taking within the last 3 months any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism, oral glucocorticoids (glucocorticoid nasal spray and inhalers are permitted), sedating antihistamines (non-sedating antihistamines like Claritin (loratadine) and Zyrtec (cetirizine) are permitted), non- serotonin selective reuptake inhibitor antidepressants and mood stabilizing agents (exposure to SSRI's, stimulants, clonidine and guanfacine permitted) * IQ \< 70 (based on school records and/or evaluation by clinician) * Current substance abuse; vi) past history of, or current dyskinesia * Stimulant dosage higher than approximately 2 mg/kg/day methylphenidate or equivalent dose of non-methylphenidate stimulant * Participants who at baseline have elevated total cholesterol or low density lipoprotein cholesterol (\> 95th percentile for age and gender) will be excluded based on recent American Academy of Pediatric recommendations to treat this level of dyslipidemia with pharmacotherapy,(63) unless is can be documented that they achieved the \> 95th percentile dyslipidemia during antipsychotic treatment but did not have it at baseline (e.g., MEAC recruits) given the clinical equipoise around whether the planned intervention could lower lipids back below the threshold and allow them to avoid the risks of lipid lowering drugs * Baseline fasting triglyceride \> 400 mg/dl",N/A NCT04182646,Effect of Adjustable Intragastric Balloon in Obese Non-alcoholic Fatty Liver Disease,"Inclusion Criteria: 1. Participants (age 18- 65) diagnosed to have NAFLD / NASH as per imaging and histological criteria of American Association for Study of Liver Diseases (AASLD) with or without Diabetes Mellitus and who have failed the non-invasive approach to weight loss within the last 6 months. This would include patients who have failed to lose at least 10% of their base weight with dietary and lifestyle changes along with pharmacotherapy. 2. Patients with BMI \> 27.5 kg/m2 who are unable to tolerate exercise program for weight loss. 3. Patients with BMI \> 32.5 Kg/m2 who have NAFLD / NASH but are not willing for bariatric surgery. Exclusion Criteria: 1. Previous history of gastric or bariatric surgery 2. Current or recent (within 6 months) gastric or duodenal ulcers 3. Cirrhosis patients with clinically significant portal hypertension defined as Hepatic Venous Pressure Gradient (HVPG) \> 12 or recent variceal or Portal hypertensive gastropathy related bleed within the last 3 months 4. Presence of inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease. 5. A large hiatal hernia or \>5 cm hernia or ≤5 cm with associated severe or intractable gastro-esophageal reflux symptoms. 6. Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device. 7. Any gastric space occupying lesions including polyps, 8. Patients who are known to have or suspected to have an allergic reaction to materials contained in Adjustable balloon. 9. Psychologically unstable patients or patients with known psychiatric illness. 10. Patients unwilling to participate in an established medically-supervised diet and behaviour modification program, with routine medical follow-up. 11. Patients receiving aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, not under medical supervision.","Introduction: Nonalcoholic fatty liver disease (NAFLD) is an emerging major health problem worldwide which affects a significant proportion of the western population and there is gradual spread of this epidemic to south-east Asian countries. NAFLD encompasses two entities: Non-alcoholic fatty liver (NAFL) and Non-alcoholic steatohepatitis (NASH). NAFL is defined as the evidence of hepatic steatosis without inflammation either by raised liver enzymes, imaging or by histology in individuals without significant alcohol consumption in whom secondary causes of steatosis are absent. NASH on the other hand, is characterized by the presence of both steatosis and inflammation with evidence of hepatocyte injury in the form of ballooning with or without fibrosis. Materials and Methods: Study Enrollment: Participants with diabetes attending the liver and bariatric clinic of the institute who have a Body Mass Index (BMI) \> 27.5 Kg/m2 would be screened for eligibility. At first diagnosis of NAFLD / NASH, participants would be advised as per protocol to first attend the department of dietetic and nutrition for a low calorie diet and would also be advised for life style modifications for the next 6 months. They would be explained that the target weight loss would be 10% of the base weight. The exercise program would include a combination of aerobic, resistive and core building exercises. The participants would also be screened for secondary causes of obesity like hypothyroidism, hypercortisolism etc. Co morbidities like hypertension, hypothyroidism etc. would be screened and treated accordingly as per protocol. Secondary causes of NAFLD/ NASH would be ruled out by adequate history of intake of any steatogenic drugs as well as ruling out other conditions like Wilson disease, Autoimmune hepatitis, Viral hepatitis etc. Baseline investigations would include complete hemogram , liver function tests, anti-nuclear antibodies, anti-smooth muscle antibodies, anti-liver-kidney-microsomal antibodies, serum copper, serum ceruloplasmin, thyroid stimulating hormone , 8 am serum cortisol, fasting insulin, hepatitis B surface antigen and anti-hepatitis C antibody screening. Additional tests would include renal function tests, gut hormones assessment, electrocardiography, ultrasonography of the abdomen with acoustic resonance fibrosis imaging (ARFI) or a fibro scan. Additional tests like CT abdomen or high density proton fraction estimation by Magnetic resonance imaging would be done wherever clinically indicated. A liver biopsy would be advised to assess the presence of NASH and grading of fibrosis would be done by the interventional radiologist and reported by expert pathologist. Follow-up: At the 3rd month visit, participants would be re motivated and re-explained the weight loss importance and the lifestyle and dietary changes for resolution of NAFLD/ NASH. At this stage, they would be introduced the concept of endoscopic intragastric balloon as a prospective treatment as a part of the clinical study. At the 6-month visit, if the participants has failed to lose at least 7% weight despite adequate exercise and lifestyle and dietary changes, then they would be offered to be enrolled in this clinical study. Alternative therapies including bariatric surgery and continuing with life style modifications and medications would be explained. Method of Balloon Insertion and Post Procedure Care: All participants will undergo upper gastrointestinal endoscopy using conscious sedation with or without an anaesthetist using one or more of the following medications - Propofol or midazolam. The Spatz balloons are usually inflated with a mean 450ml (400-500ml) of normal saline with the addition of 2-3 ml of a 1% solution of Methylene Blue. After the 5th post-procedure day, a progressive full liquid to soft solid 1,200-1,400 kcal diet will be started. At one month follow up with principal investigator will be done. Participants who are intolerant to the balloon could be adjusted downward by 50-100 ml. Participants with one or more of the following were offered upward adjustments of the balloon volume (100-200 ml at the discretion of the endoscopist): weight loss plateau; lack of balloon effect; ability to overeat without resultant symptoms (any of the following: nausea, vomiting, bloating, eructation, abdominal pain, acid reflux symptoms). After 12 months of placement, the balloon will be deflated by aspiration via catheter and then retrieved under endoscopic/fluoroscopic guidance. The data will be collected in excel sheets and later analysed using statistical analysis software. Any adverse effects would be noted and any serious adverse effects like severe pain, severe diarrhoea or catheter impaction which has been reported in less than 1% participants would be reported and adequate measures will be taken." NCT03712462,Improving Weight Loss Outcomes for Binge Eating Disorder.,"Inclusion Criteria: * Meet the DSM-5 criteria for Binge Eating Disorder * Have a BMI range of 27-50kg/m2 Exclusion Criteria: * are unable to fluently speak, write, and read English * are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., suicidality, substance use disorder, psychotic disorder) * are unable to engage in moderate physical activity (i.e., walk 2 blocks without rest) * have a medical condition (e.g., acute coronary syndrome, type I diabetes) that would pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the recommendations of the program * Pregnant or planning to become pregnant in the next 2 years * Recently began a course of or changed the dosage of medication that can cause significant change in weight * Have a history of bariatric surgery * Have had weight loss of \> 5% in the past 6 months","In the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (ABBT) that targets both binge eating and weight loss in patients with binge eating disorder (BED) to a Standard Behavioral Weight Loss Treatment (SBT), (b) evaluate the extent to which ABBT and SBT target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in ABBT. Our study will be the first to evaluate an ABBT for BED designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to BWL prescriptions." NCT02935855,ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON),"Inclusion Criteria: * non-valvular atrial fibrillation * nondiabetic patients * type 1 and 2 diabetic patients Exclusion Criteria: * patients with cancer * patients with chronic inflammation diseases","Parameters evaluated: * anthropometric indices * glycated haemoglobin, basal and postprandial glycemia * lipid profile * small and dense LDL; oxidized LDL * I troponin * red and white cells count; platelets count * creatinin, transaminases, iron * fibrinogen, D-dimer, anti-thrombin III * Hs-CRP, metalloproteinases 2 and 9 * incidence of bleeding" NCT00842426,Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care,"Inclusion Criteria: * Ethnicity: All ethnic groups; * Body mass index 25.0-39.9 kg/m2; * Fasting plasma glucose between 100 and 125 mg/dL; * Any two of the following: Waist circumference \>40 inches in men, \>35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides \>150 mg/dL; High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men, \<50 mg/dL in women; Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>85 mm Hg. * Having a primary care physician (PCP) at the PAMF Los Altos Center; * Seen in primary or specialty care in the Palo Alto Region at least once in the preceding 24 months; * A PAMF patient for ≥ 12 months; * Able and willing to enroll and meet the requirements of the study. Exclusion Criteria: * Inability to speak, read or understand English; * No regular access to a computer with Internet and email capabilities; * Triglycerides \>400 mg/dL; * Systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg; * Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months * Having a medical (e.g., celiac disease) or social condition (e.g., religious beliefs) that precludes dietary changes; * Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe; * Use of weight-loss medications in the past 3 months; * Regular use (\> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.); * Currently enrolled in a lifestyle intervention program at PAMF or elsewhere; * Planning to undergo a bariatric surgery during the study period; * Diagnosis of Type 1 or Type 2 diabetes mellitus; * Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse; * Renal insufficiency (i.e., GFR \< 60 mL/min/1.73m2) * Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol; * Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years; * Diagnosis of a terminal illness and/or in hospice care; * Pregnant, lactating or planning to become pregnant during the study period; * Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings; * Family/household member of another study participant or of a study staff member; * No longer a PAMF patient or planning to transfer care outside of PAMF during the study period; * Planning to move out of the area during the study period; * PCP determination that the study is inappropriate or unsafe for the patient; * Investigator discretion for clinical safety or protocol adherence reasons.","In the United States, there is an epidemic of obesity and, as a result, an epidemic of diabetes. Obese individuals with pre-diabetes (defined as impaired fasting glucose or impaired glucose tolerance) are at high risk for progression to diabetes. A vast majority of these individuals also have an increased risk of cardiovascular disease because of concomitant risk factors, such as abdominal obesity, dyslipidemia, and elevated blood pressure. Intensive lifestyle interventions that focus on dietary change, physical activity, and behavior modification have demonstrated efficacy in achieving and maintaining clinically significant (\>5%) weight loss in populations of patients with pre-diabetes. However, the effectiveness, cost-effectiveness, generalizability, and sustainability of such interventions in routine primary care settings remain unknown, and rigorous clinical research is needed. The primary hypothesis for the E-LITE Study is that the CM intervention will reduce BMI more than the SM intervention, which in turn will reduce BMI more than usual care, over 15 months. Secondarily, we hypothesize that, compared with usual care, intervention participants will be associated with greater improvements in waist circumference, lipids, blood pressure, blood glucose, lifestyle behaviors, and psychosocial well-being. In addition, we will examine the durability of weight loss and behavioral change in the months after the initial 3-month intensive stage." NCT01762826,"Myo-inositol, D-chiro-inositol, and D-chiro/Myo-inositol in Gestational Diabetes","Inclusion Criteria: * pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived Exclusion Criteria: * obese patient Fasti g glucose above 126 or below 92","The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account." NCT07414355,Switching to E-Cigarettes After Type 2 Diabetes Diagnosis and Health Outcomes,"Inclusion Criteria: * Patients diagnosed with diabetes who reported being a ""current smoker"" at a health examination within the 4 years prior to the diabetes diagnosis. Exclusion Criteria: * age \<40 years or ≥75 years * Pre-existing AMI before diabetes diagnosis * Pre-existing Revascularization before diabetes diagnosis * Pre-existing diabetes complications before diabetes diagnosis * Pre-existing cancer before diabetes diagnosis * Death within 6 months of the first health examination after diabetes diagnosis * Cancer within 6 months of the first health examination after diabetes diagnosis","Use of electronic cigarettes has increased, partly driven by the perception that they may serve as a ""harm-reduction"" alternative to combustible cigarettes. Evidence cited in prior work includes higher cessation rates versus nicotine replacement therapy in a randomized trial and reductions in biomarkers of potential harm after switching from combustible cigarettes to e-cigarettes; observational data in high-risk PCI populations have also suggested lower MACCE risk after switching. However, constituents such as nicotine and heavy metals may adversely affect diabetes management, and most prior studies have emphasized potential harms of e-cigarette use itself. As a result, whether switching from combustible cigarettes to e-cigarettes confers a harm-reduction benefit in patients with diabetes remains uncertain. In this regards, the current study evaluated clinical outcomes associated with switching from combustible cigarettes to e-cigarettes in patients with diabetes and to assess whether the degree of switching (partial vs full transition) modifies the risk of adverse clinical events." NCT02639455,Survey of the Collective 16s rRNA Genes From Bacterial Populations From Exercising and Non-exercising Participants,"Inclusion Criteria: * Participants must be between the ages of 18-24 and must be willing and healthy enough to start a modest exercise program if they are chosen, at random, to do so. Exclusion Criteria: * Pregnant women, minors, and people over the age of 24 are excluded from the study. * Anyone with a heart condition or other health condition that is not safely able to initiate a modest exercise program are excluded from the study.",N/A NCT03516968,Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents,"Inclusion Criteria: * Aged between 5 to 18 year-old * Being obese (BMI \>97th percentile, \> IOTF 30, for age and gender using the WHO references) * Patients (parents) having given their informed consent * Patient having insurance from the national health system Exclusion Criteria: Children will be excluded from the study if: * Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure) * Vitamin D supplementation in the 3 months preceding the inclusion visit (V1) * Signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying) * Chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia (calcium \> 2.65 mmol/L), liver/kidney disease, malabsorption diseases; * Hypercalciuria (urinary Calcium/Creatinine \> 0.7 mmol/mmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D \> 250 nmol/L); nephrocalcinosis; * Ongoing treatment with anticonvulsants/barbiturates or steroids which increase the catabolism of 25(OH)D; * Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium; * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product; * Pregnancy, breastfeeding; * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant; * Simultaneous enrolment to another study which could influence the results of the current study; * Patient under legal protection or deprived of liberty.",N/A NCT05199350,Distinguishing Participant Groups Using Autonomic Dysfunction,"Inclusion Criteria: 1. Able to provide informed consent 2. Age between 18 to 85 3. Body Mass Index (BMI) between 25 and 40 kg/m2 4. Individuals with normal glucose levels, pre-diabetes and diabetes Type 2 for at least 1 year (diagnosed by ADA criteria) and up to 20 years 5. Stable dose of meds for 3 months 6. Stable diet and lifestyle for 3 months 7. Medical history without clinically significant abnormalities Exclusion Criteria: 1. Have a disorder that would impede performing the HRV measurement procedure (i.e., abnormal cardiac rhythm, heart disease, including coronary artery disease, angina, and arrhythmia, cardiac pacemaker, stroke, panic attack, cognitive impairment, renal failure) 2. Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.) 3. Cancer and anticancer treatment in the last 5 years 4. Pregnancy or lactation 5. Subjects with major physical disability 6. Subjects with previous history of cerebrovascular accident 7. Any disorder, which in the investigator's opinion might jeo","The Autonomic Nervous System (ANS) is a fundamental part of the nervous system in the body. And yet, there is no technique to test or measure the health and functioning of a person's autonomic nervous system.This type of study will determine the most accurate methodology to test the autonomic nervous system through heart rate variability (HRV) monitoring and gain vital information to distinguish patient groups in the diabetic population. There is no gold standard for measuring autonomic dysfunction. Currently the method of power spectral analysis is finding very wide usage. It Is known that power spectral analysis does not discriminate the two subsystems of the ANS well. There are other beat to beat methodologies that have not yet gained traction. The reason for conducting this trial is to take a group of subjects in various stages of impaired fasting glucose, impaired glucose tolerance and diabetes (with and without complications) and determine which methodology stratifies these subjects most accurately. Our study aims to introduce a new measurement method named the 'Beat to Beat' (BB) method for gauging autonomic dysfunction in patients. The investigators hope to observe that the average beat to beat method (BB) score could help discriminating diabetic patients into the following five distinct groups from the pilot study: 1. Normal Glucose Tolerance (NGT) is defined as a plasma glucose concentration i.e \< 140 mg/dl. 2. Impaired Fasting Glucose (IFG) is defined by an elevated fasting plasma glucose (FPG) concentration i.e ≥ 100 and \< 126 mg/dl. 3. Impaired Glucose Tolerance (IGT) is defined by an elevated post-prandial plasma glucose concentration i.e ≥140 and \< 200 mg/dl. 4. Presence of confirmed diabetes (HbA1c level \> 6.4 %) without complications i.e no neuropathy, no retinopathy, no nephropathy etc. 5. Presence of confirmed diabetes (HbA1c level \> 6.4 %) with at least one of the above complications. By showing that this measurement bears no relationship to the other four vital signs parameters (heart rate, blood oxygenation, blood pressure, body temperature), it will prove the necessity of this measurement in addition to the four vital signs for distinguishing patient groups among the diabetic population." NCT00577174,Mitochondrial Function in Pediatric Obesity,"Inclusion Criteria: 1. Girls and boys ages 8 to 18 years old 2. Non-obese cohort: body mass index less than 75th percentile for age 3. Obese cohort: body mass index more than 95th percentile for age Exclusion Criteria: 1. Underlying medical problem with potential to affect growth, pubertal development or glucose homeostasis 2. Chronic medical therapy with glucocorticoids, growth hormone, estrogen, progesterone, testosterone, or other medications with the potential to alter growth, pubertal development or glucose homeostasis within the proceeding 6 months 3. Personal history of diabetes 4. Family history of diabetes in first degree relative 5. Inability to have MRI scan performed due to metal prosthesis or implant","Aim I: A cross sectional study to evaluate baseline mitochondrial function in obese children compared to non-obese children. Determine whether children with pediatric obesity have impaired mitochondrial function based on 31P magnetic resonance spectroscopy when compared to healthy non-obese control children.Examine the relationship between mitochondrial function and insulin resistance in obese and non-obese children. Determine the impact of pubertal stage on mitochondrial function in obese and non-obese children. Aim II:A prospective evaluation to determine in a longitudinal cohort study the timing and relationship of mitochondrial dysfunction to the development of insulin resistance in prepubertal/early pubertal obese children compared to prepubertal/early pubertal non-obese children. Determine in a longitudinal cohort study if obese children with mitochondrial dysfunction develop greater insulin resistance and/or impaired glucose tolerance at an earlier time point. Evaluate the relationship of obesity, timing of puberty and related changes in hormone levels to mitochondrial function and the development of insulin resistance and/or impaired glucose tolerance in longitudinal analyses." NCT04529590,Precise Treatment of Prediabetes and Stage 1 Hypertension,"Inclusion Criteria: 1. aged from 18-76 years old 2. lived in Shanghai Pingliang community for 20 years 3. all participants' blood pressures are at baseline Exclusion Criteria: 1. aged \<18 years old or \> 76 years old 2. with second primary malignant diseases. 3. other situations assessed by investigator can disturb quality control of the investigation.","To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after18 years follow up, then explore the role of risk factors. After assessing the association between BP categories and all-cause mortality and cardiovascular mortality, to analyze the risk for all-cause and cardiovascular mortality by blood glucose categories and BP categories combined by using multiple Cox regression analysis. To analyze the corresponding incidence of all-cause mortality per 1,000 person-years for the BP\<130/80 mmHg, 130-139/80-89 mmHg, and ≥140/90 mmHg or treated groups respectively after adjusting for age, sex, and other factors. To identify the associations between cardiovascular mortality and BP categories alone or combined with blood glucose categories were consistent with that of all-cause mortality. To identify relative metabolic molecular biomarker panel detected by mass spectrometry in blood samples correlating with efficacy in prediabetes and stage 1 hypertension among Chinese adults. Compare the plasma metabolic profiles of different groups and the metabolic markers were screened and optimized by multivariate statistical analysis, logistic regression analysis and receiver operating characteristic (ROC) curve analysis. To determine whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis." NCT02425410,Analysis of Viral Infections' Exposition Preceding the Type 1 Diabetes (T1D) Diagnostic in Children of the Isis-Diab Cohort. Search for Explanations of of the Disease's Early Onset,"Inclusion Criteria: * Type 1 diabetic patients included in the Isis-Diab cohort * Patients with available genetic data (GWAS) Exclusion Criteria: * Patient refusal (or parents) to participate in the study.","The ""hygiene hypothesis"", which has been proposed to explain the observed increase of the incidence of T1D, relies on experimental evidence acquired in mouse models. However, epidemiological data are still lacking to validate this hypothesis in man. This is critical, because -in opposition with the hygiene hypothesis- there are many reasons to believe that, at contrary, certain virus can trigger the disease. Genetic predisposition to a severe infection form (particularly primary infection) was demonstrated for several infectious diseases (Casanova JL, Science 317:617-619, 2007; Casanova JL, EMBO J 26:915-922, 2007). It usually corresponds to deficiencies in genes involved in the host's immune response, the transmission of which being Mendelian. Genetic factors affect the ability of enteroviruses and other viruses to damage beta cells and to induce diabetes. Recently, Nejentsev et al have demonstrated a link between enteroviruses and diabetes genes: they have indeed identified 4 rare IFIH1 polymorphisms that reduce the T1D risk. However, this gene encodes an enzyme recognizing the DNA enterovirus, causing immunity activation; mutations inhibit gene activation. Except one study on HIV-1, there is to our knowledge no genome wide association studies (GWAS) in humans on the role of host's genetic polymorphisms in the risk of infection, clinical expression, duration of viral shedding, or response to therapy or to anti-viral vaccines. We relied on our cohort of T1D children (Isis-Diab) to investigate the possible relation between viral exposures, genetic polymorphisms, and subsequent T1D. The search for viral factors responsible for the increased T1D prevalence in youth children is difficult to implement. The absence or scarcity of infections is difficult to assess robustly at the individual level. The analysis of digestive, ENT or blood samples in the search for viruses themselves can only be done at T1D diagnosis and is therefore unlikely to be positive several years after the causal infection. It is not possible to reconstitute retrospectively viral events, which an individual has been exposed between birth and date of diabetes diagnosis. That is why our project proposes to use a proxy of viral infections crossed by a child, quantifying viral exposures to which he was submitted before the T1D diagnosis. We focused on early childhood's viral infections that may interfere with early forms of T1D. We combine 2 data sources: * The geolocation of the child's address will locate places where he lives. Spatio-temporal data from Sentinel Network, collected since 1984, will provide access on the following viral exposures: seasonal influenza, viral diarrhea (mostly enteroviral), mumps, measles, chickenpox. If the defect of our approach is that it does not see real viral infections experienced by children, but only the level of exposure to which they were exposed according to their address, the advantage is an objective spatio-temporal description of virus epidemics around children, making it more or less likely infection of these. Only France has such Sentinel data. * Vaccination (including MMR) and information on infectious past of children will be collected from data recorded in his book health. We will focus on the mother's pregnancy and the child between birth and 2 years of age. Environmental data from these 2 sources will be crossed with already available genetic data from GWAS to identify gene-virus associations potentially determining age of T1D onset. This ""high dimensionality"" analysis will be addressed with ""machine learning"" programs. If avoidable risks are identified, it would be possible to think to design clinical trials for prevention of the identified forms of T1D." NCT04897113,Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old,"Inclusion Criteria: * Signed informed consent form. * Men and women aged 40-55. * Body mass index \<30 kg / m2. * Level increase of one or several aging markers. * Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol. * Negative pregnancy test for women of childbearing potential. Non-inclusion Criteria: * Refusal to participate in the study. * Any health conditions that, according to investigators, might prevent volunteers from participating in the study. * Mental disorders, past medical history included. * 10 + alcohol units per week (one alcohol unit equals 0,5 l of beer, 200 ml of wine or 50 ml of hard liquors) or any records of alcohol addiction. * Drug addiction, chemical abuse. * Pregnancy or breastfeeding. * Past medical history of severe allergic reactions. * General contraindications to plasmapheresis procedures. * Any other health conditions or reasons that, according to investigators, might increase risks for participants or reduce the likelihood of results needed to meet the study goals. Exclusion Criteria: * Voluntary refusal to participate in the study. * Investigator doctor's decision on participant's exclusion for this participant's own benefit. * Participant refuses to cooperate with investigator or is undisciplined. * In case participant misses one or several study procedures or follow-up visits. * Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy. * Positive pregnancy test.","Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state. One of the initial approaches of anti-ageing therapy is detoxification, reocorrection and immunocorrection. Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by ""dynamic equilibrium"" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation). Thus, at this stage, experts assess effectiveness and organize data of existing prevention methods for premature aging and correction of aging biomarkers, as well as develop comprehensive programs for drug-free and pharmacological intervention. Introduction of the body detoxification method based on extracorporeal hemocorrection (developed in FGBU Russian Scientific Center for Medical Rehabilitation and Balneology of Ministry of Health of Russian Federation) may extend the range of effective and safe methods within such programs, as well as lower patients' biological age and, thus, lower risks of developing age-related diseases, decrease number of disability cases, which can contribute to life prolonging and improvement of its quality." NCT04372810,Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals,"Inclusion Criteria: Patients of both sexes aged between 35 and 70 years, and with more than 5 years of Diagnosis of Diabetes Mellitus. Exclusion Criteria: Patients with skin lesions or lower limb fractures in the last six months, plantar malformations, severe postural changes and real difference in the length of the lower limbs.","Diabetes Melittus (DM) is a disease of great incidence, and one of the main public health problems worldwide, having as complications the deficit in the functional performance of the lower limbs, which can interfere in the maintenance of the balance, besides being a Strong predictor of functional limitations. Individuals affected by diabetes are predisposed to reduce the mobility of the tibial-tarsal joint. Manual therapy is often used for the purpose of improving range of motion. The objective of this study is to evaluate the acute effect of manual therapy on ankle joint mobility in diabetic patients. 40 volunteers, aged 59,35±7,85 years, DM type 2 and tibial-tarsal joint amplitude limitation, of both genders were recruited, divided into two groups: group 1 (Sham: submitted to evaluations and follow up of seven days), and group 2 (intervention: submitted to the evaluations, manipulative manual intervention, with follow up of seven days). The analysis of joint range of motion was acessed by digital goniometry and the static discharge of weight was evaluated by baropodometry computed with open and closed eyes. After tabulation of variables, the Shapiro-Wilk normality test was applied to analyze the distribution. Before a normal and related distribution, ANOVA followed by Tukey post-hoc tests were used. For the variables that presented a non-normal distribution, the Kruskal-Wallis test was used, followed by the Dunn post-hoc test. For the variables that presented a non-normal distribution, the Kruskal-Wallis test was used, followed by the Dunn post-hoc test. The SAS software was used and a significance level of 5% was considered. The results showed an increase in joint range of motion, in the right and left dorsiflexions of the GI between the initial moment and the post-manipulation moments, as well as after seven days of the follow-up. There was also a significant difference between GI when compared to GS in the post and follow-up moments. Regarding the clinical effect of the intervention over time, the intragroup analysis showed that in GS there was no difference between the amplitude of movement registers comparing the pre-intervention moment with the subsequent records (post and follow-up), even for plantar and dorsiflexion flexion movements on both sides. In relation to static plantar weight discharge, there was a change in recorded values for the peak of total foot pressure, on the right and left sides of the GI, between the moments after the immediate intervention and in the measurement 7 days after the manipulative intervention (follow -up), for registration with open eyes. Regarding intra-group comparisons over time (pre, post-intervention and follow-up), a significant difference was observed for the condition amplitude of anteroposterior displacement (DAP) with open eyes of the GI, observing an increase after intervention and reduction in the follow-up. In view of the obtained results, it can be inferred that the acute intervention with manual therapy produces an increase in the joint amplitude of the ankle of diabetic individuals." NCT06713720,Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy,"Inclusion Criteria: * Age between 40 and 80 years. * Diagnosed with Type 2 diabetes mellitus. * Diagnosed with mild to moderate non-proliferative diabetic retinopathy (NPDR) with a DR Severity Score (DRSS) grade of 20-47D. * Capable of performing daily activities independently. * Willing and able to provide informed consent. Exclusion Criteria: * Presence of diabetic macular edema (macular thickness \> 250 μm). * Significant eye diseases affecting evaluation, such as high myopia, severe cataract, corneal leucoma, glaucoma, retinal detachment, retinal vein occlusion, congenital eye diseases, ocular tumors, or severe infection. * History of ocular laser or intraocular surgery. * Poor imaging quality due to refractive media opacity. * Contraindication to fluorescein fundus angiography. * Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs. * Severe diabetes complications within the past 6 months. * Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg). * Body mass index (BMI) ≥ 28 kg/m². * Hepatic or renal insufficiency: Alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m². Urine albumin/creatinine ratio ≥ 30 mg/g. * Myocardial infarction within the past 6 months. * Neurological diseases such as Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm. * Contraindications to RIC, including one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities. * Severe systemic diseases, such as malignant tumors with a life expectancy of less than 24 months. * Known pregnancy or breastfeeding. * Participation in other experimental clinical studies. * Any other conditions deemed unsuitable by the investigator.","Non-proliferative diabetic retinopathy (NPDR) represents an early yet critical stage of diabetic retinopathy, a leading cause of vision loss globally. Despite advancements in medical treatments such as anti-VEGF therapy and laser photocoagulation, there remains a significant gap in safe and effective interventions to halt or reverse NPDR progression. Current therapies often focus on advanced disease stages, leaving early-stage management a challenge. Remote ischemic conditioning (RIC) introduces a novel, non-invasive approach to NPDR treatment. Based on the concept of ""fighting hypoxia with hypoxia,"" RIC employs intermittent cycles of ischemia and reperfusion in the limbs to trigger endogenous protective mechanisms against hypoxic damage. Experimental studies have highlighted RIC's potential benefits, including enhanced retinal oxygenation, reduced pathological vascular proliferation, and preservation of retinal ganglion cells. This study is designed as a randomized, double-blind, placebo-controlled clinical trial to evaluate RIC's safety and efficacy in adults aged 40-80 years with mild to moderate NPDR. The trial features meticulous inclusion and exclusion criteria to ensure the reliability of findings. Participants will undergo either RIC or placebo therapy using a specialized device. The RIC group will receive therapy at 200 mmHg inflation pressure, while the placebo group will undergo sham treatment at 60 mmHg. Both treatments will follow the same cycle and frequency, ensuring blinding is maintained. The study's outcomes include comprehensive assessments of retinal structure and function, systemic biomarkers, and safety metrics. These encompass changes in Diabetic Retinopathy Severity Score (DRSS), retinal neurovascular parameters, visual acuity, and retinal oxygenation. Serum biomarkers such as VEGF, CRP, and IL-6 will provide insights into systemic inflammatory and vascular changes post-treatment. The findings from this trial are expected to offer preliminary evidence on RIC as a safe and effective intervention for NPDR. This work aims to lay the groundwork for future large-scale studies and provide clinicians with a potential strategy to reduce the burden of diabetic retinopathy and its associated complications." NCT00628524,Homburg Cream & Sugar Study,"Inclusion Criteria: * Stable CAD Exclusion Criteria: * Acute Coronary Syndrom * Relevant Arrhythmias * Severe valvular heart disease * Decompensated heart failure * Severe inflammtory disease (infectious, rheumatoid) * Metabolic diseases (e.g. thyroid) * Inability to swallow * Liver or kidney failure * Lactose intolerance * Fat intolerance (e.g. chronic pancreatitis, gall stones) * Malignant Disease * Psychiatric Diseases (including alcohol / drug abuse) * Pregnancy",N/A NCT04905680,GluCoach - Technology-enabled Lifestyle Intervention Study,"Inclusion Criteria: 1. Singaporean Citizens and Permanent Residents 2. Aged 21 to 55 3. Must be literate in English (i.e. able to read and communicate in English) because the primary mode of communication is English 4. Willing and able to use a smartphone 5. Must be at risk of developing Type 2 Diabetes, defined as: i) Glycated haemoglobin (HbA1c) - At least 5.7% to 6.5% OR Fasting blood glucose of 6.1 to 6.9mmol/L, AND ii) BMI of at least 20kg/m2 Exclusion Criteria: 1. Non-Singaporean Citizens and Permanent Residents 2. Under age 21 or above age 55 3. Ever diagnosed as Type 1 or Type 2 Diabetic (does not include previously diagnosed GDM) 4. Pregnant or planning to be pregnant in the next 6 months or lactating 5. History of skin allergies 6. Taking medications that are known to alter blood sugar levels/ glucose tolerance e.g. glucocorticoids g) History of mental illness/conditions h) Work requirement that does not allow the carrying of electronic devices (e.g., phone and smartwatch) i) Frequent overseas travelling (e.g., more frequently than once a month, daily or weekly commuting across borders etc.)","Face-to-face health coaching is a common lifestyle intervention for healthy individuals who are at risk of chronic diseases such as diabetes. However, it is highly resource-intensive and has limitations in scaling up to reach wider populations. Advances in technology present opportunities to scale health coaching to the wider population through automation, enabling the delivery of personalised messages for individuals via mobile applications. In addition, continuous glucose monitoring (CGM) devices could also potentially augment the effectiveness of health coaching by providing coaches with a tool for coachees' self-discovery of their individual physiological responses to lifestyles and modifications such as diet and exercise. As such, the present study seeks to leverage smart wearable devices (e.g., Bluetooth smartwatches) and CGM devices accompanying a customized mobile application to deliver lifestyle coaching interventions. This suite of lifestyle interventions, including feedback about their own blood glucose levels, aims to influence participant's lifestyles and behaviours through guided self-discovery and face-to-face coaching. This intervention will be compared with a control group to examine its effects on lifestyle change, anthropometric measures and biometric measures. In addition, the findings from this study will contribute to the development of a novel coach-light intervention that can be implemented at a wider population level via Singapore's Health Promotion Board's (HPB) existing programmes and channels." NCT06767774,Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus,"Inclusion Criteria: * Age Requirement: * Patients aged 18 years or older. Glycemic Status: * Patients who are not taking oral hypoglycemic agents (OHAs) and meet all of the following criteria: * Fasting glucose less than 126 mg/dL.\* * HbA1c less than 6.5%. * Plasma glucose less than 200 mg/dL after 2 hours during a 75 g oral glucose tolerance test (OGTT).\*Note: For fasting glucose, two measurements of 126 mg/dL or greater within 3 months are required for a diagnosis of diabetes. Cardiovascular Disease: * Patients with established atherosclerotic cardiovascular disease, defined as having at least one of the following: * Coronary Heart Disease (CHD): * Documented history of myocardial infarction (MI). * History of coronary revascularization. * 50% stenosis of a major epicardial coronary artery confirmed by cardiac catheterization, computed tomography (CT), or coronary angiography. * Cerebrovascular Disease: \>History of stroke of atherosclerotic origin. * History of carotid revascularization. \>≥50% stenosis of the carotid artery confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound. * Symptomatic Peripheral Arterial Disease (PAD): \>Intermittent claudication with an ankle-brachial index (ABI) of 0.90 at rest. * Intermittent claudication with ≥50% stenosis of a peripheral artery (excluding the carotid artery) confirmed by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound. * History of revascularization of peripheral arteries (excluding carotid arteries). * Lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding trauma or osteomyelitis). Dietary Requirements: * Patients must be on a stable diet prior to randomization and able to adhere to the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Change (TLC) diet or an equivalent throughout the study. Informed Consent: * Subjects or their legal representatives must provide written informed consent to the study protocol and clinical follow-up schedule. * An informed consent form approved by the institutional review board (IRB)/ethics committee of the study site must be signed. Exclusion Criteria: * Patient is pregnant or breastfeeding or of childbearing potential. * Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins). * Chronic kidney disease (eGFR \< 30 ml/min/1.73m²) or dialysis-dependent renal failure. * Uncontrolled hypothyroidism. * Personal or family history of an inherited muscle disorder. * History of statin-induced muscle toxicity. * Alcohol-dependent person. * Hypersensitivity to statins and ezetimibe. * Hemodynamic instability at the time of enrollment: cardiogenic shock, refractory ventricular arrhythmia, or congestive heart failure (New York Heart Association class IV) at randomization. * History of hemorrhagic stroke or intracranial hemorrhage, TIA, or ischemic stroke within the past 6 months. * Planned surgery requiring discontinuation of statins or ezetimibe within 6 months of randomization. * Current treatment for active cancer. * Clinically significant abnormal findings identified at the screening visit, physical examination, laboratory tests, or electrocardiogram that, in the investigator's judgment, may interfere with safe completion of the study. * Liver disease or biliary obstruction, elevated liver enzymes (ALT or AST \> the upper limit of normal) or elevated total bilirubin (total bilirubin \> 2 times the upper limit of normal) at screening. * Life expectancy for noncardiac or cardiac causes \< 1 year. * Unwillingness or inability to comply with the procedures described in this protocol. * Previously diagnosed with diabetes mellitus and compliant with lifestyle modification and taking oral hypoglycemic agents (OHAs) or insulin.",N/A NCT02095418,Comparison of New-onset Diabetes After Transplantation Between Two Steroid Withdrawal Group With CellCept,"Inclusion Criteria: * 1.Male or female patients between 20-70 years 2.De novo patients 3.Recipients from living or cadaveric donors 4.Single organ recipient (liver only) 5.White Blood Cell(WBC) ≥ 3,000uL 6.Women of childbearing potential had to have a negative serum or urine pregnancy test within 1 week prior to beginning study treatment. Effective contraception has to be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy 7.Patients co-operative and able to complete all the assessment procedures. 8.Patients provided written informed consent Exclusion Criteria: 1. Patients who receive immunosuppressive therapy (except steroid treatment) within the preceding 28 days. 2. Incompatible A,B, and O blood group system. 3. Active infection 4. Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value \< 9 g/dL for adults receiving erythropoietin, 6.5 g/dL for adults not receiving erythropoietin, leukopenia (as defined by a white blood cell \[WBC\] value of \<1500/mm3) or thrombocytopenia (as defined by a platelet count of \<30,000/mm3). 5. Mandatory intake of prohibited drugs or if it is probable that the patient would require treatment with such drugs after transplant 6. Patient is allergic or intolerant to excipients, steroids, Mycophenolate mofetil(MMF), tacrolimus or basiliximab. 7. Patients with any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator or with study procedures. 8. The receipt of a new investigational drug within the previous 3 months 9. Pregnant or lactating females. 10. Women of child-bearing potential not willing to use a reliable form of contraception. 11. Previous organ transplantation 12. Patients who have diabetes mellitus prior to transplantation 13. Patients who have cancer other than liver cancer 14. Patients who have HGPRT(hypoxanthine quinine phosphoribosyl transferase) deficiency, Lesch-Nyhan syndrome, Kelly-Seegmiller syndrome",N/A NCT04155060,The Prognostic Value of Lactate is Different Among Septic Patients,"Inclusion Criteria:18 years or older, informed consent signed, admission serum lactate level obtained, and admission to the hospital with sepsis or septic shock diagnosis. \- Exclusion Criteria:congenital metabolic and psychiatric diseases and clinical data deficiency. \-","Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still controversial.The reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis. DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM." NCT00738920,Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome,"Inclusion Criteria: * Males or female patients aged 18 to 70 years (inclusive); * All ethnic groups; * Meet Rome III criteria for IBS with symptoms of at least moderate severity (at least 2 days per week); * Ability to understand and provide informed consent; * With the exception of antibiotics, participant is willing to remain on a stable dose only through the 4-week pretreatment baseline period prior to randomization; * Participant either not taking medications or if taking medications willing to suspend starting any new medications only during the initial 4-week pretreatment baseline period; * Participant demonstrates an ability to speak understand and read, English a the sixth grade level or higher; * Willingness to be randomized to CBT or Support/Education to which s/he has been assigned to to adhere to protocol requirements; * Participant is willing to attend regularly scheduled therapy session during active phase of the trial; * Participant is willing to be contacted and scheduled for follow-up assessment at week 12 and 3, 6, 9, and 12 months after the conclusion of acute treatment phase; * Participant is willing and able to enter symptom information into an assigned portable computer and complete questionnaires through treatment and at regularly scheduled follow ups * Participant has access to a telephone; and * Participant is willing and able to provide adequate information for locator purposes. Exclusion Criteria: * Evidence of current structural or biochemical abnormalities or medication use that better explain the participant's IBS symptoms (e.g. IBD); * Evidence of a current infection or infection of any type within the 2 weeks prior to the study gastroenterologists' evaluation which would obscure the presentation of IBS symptoms. In such cases the baseline can be delayed until 2 weeks after complete recovery. * Participant has received antibiotics (e.g. rifaximin and or neomycin) specifically targeted to treat IBS symptoms within the past 3 months. In this instance eligibility will be suspended for 12 weeks from the initial date the antibiotic was consumed. * Participant has undergone previous abdominal surgery that would have caused significant alternation of the anatomy/physiology of the digestive/GI tract, which adequately explains GI symptoms; * Participant has been diagnosed and/or treated for malignancy in the past 5 years with the exception of localized basal or squamous cell carcinomas of the skin; * Participant has an unstable extraintestinal medical condition whose immediate or foreseeable treatment needs (e.g., hospitalization, conflicting physician visits) would realistically interfere with study demands (e.g., consistent attendance at treatment sessions and/or ability to participate in telephone interventions) or may affect the interpretation of clinical efficacy data; * Participant has a major psychiatric disorder, which in the opinion of the senior clinical staff may impede conduct of the clinical trial. These disorders include but are not limited to major depression diagnosis with a high risk of suicidal behavior (i.e. intent or plan), alcohol or substance abuse/dependence within the past year, a lifetime history of schizophrenia or schizoaffective disorder or gross cognitive impairments; * Participant has other conditions which in the opinion of the senior clinical staff would influence negatively the conduct of the clinical trial; * Participant is currently receiving targeted psychotherapy for IBS and is unwilling or unable to discontinue his/her treatment for the acute treatment phase of this study; * Participant is unable to complete all scheduled screening visits; and participant is inaccessible for interventions and/or follow-up evaluations.","Irritable bowel syndrome (IBS) is a chronic, prevalent, often disabling, GI disorder for which there is no reliable and satisfactory medical option for its full range of symptoms (abdominal pain, bowel dysfunction). An accumulating body of evidence indicates that a specific psychosocial treatment called cognitive behavioral therapy (CBT) is associated with significant reductions in IBS symptoms and related difficulties. Despite its apparent efficacy, CBT's clinical effectiveness (i.e., its generalizability, feasibility, cost effectiveness) has not been adequately established due partly to its duration, cost, and limited accessibility. As the ""second generation"" of IBS treatments undergo development and validation, it has become increasingly clear that efficacy demonstration is a necessary but not sufficient condition of treatment viability. In a pilot study funded under NIDDK's R03 mechanism, we addressed these problems by developing a briefer, largely self administered version of CBT that requires only 4, 1 hr clinic visits. Our RCT data showed that a 10 session version of CBT can be translated into a 4 session version without compromising patient acceptability or short term efficacy. It is unclear whether treatment effects are maintained long term (out to 12 months), due to theoretical change mechanisms (vs. nonspecific factors common across different forms of therapy), are more pronounced among specific subgroups of patients, or, generalize to a large sample of Rome III diagnosed patients treated by different investigative sites. We seek to address these questions by conducting a larger, more definitive, multisite RCT that will recruit from 2 treatment sites 480 patients with moderate to severe IBS and assess their acute and long term response to brief (4 session) CBT, extended (10 session) CBT, or a credible education/support condition. We will use the first year to develop a clinical infrastructure to ensure the success and integrity of the proposed trial. In the short term, a successful trial will lend empirical validation to a self administered version of CBT that retains the efficacy of standard CBT but is more transportable, accessible to patients outside of research protocols, and less costly to deliver. In the long term, we hope to show that a self guided behavioral treatment program is an effective and efficient treatment delivery system that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable GI disorders." NCT02617160,Evaluation of Automated Insulin Pump Settings Using the Advisor Pro (Previously Called) MD-Logic Pump Advisor-three Segments Study,"Inclusion Criteria: * Documented Type 1 Diabetes for at least 1 year prior to study enrollment * Segment A:Subjects aged ≥ 10 years and up to 25 years Segment B: Subjects aged ≥ 6 years Segment C: Subjects aged ≥ 6 years and up to 30 years * HbA1c at inclusion ≤ 11% * Insulin pump therapy for at least 4 months for segment A and C and at least 3 months for segment B * BMI Standard Deviation Score - below the 97th percentile for age * Subjects have continuous glucose monitoring data for at least 2-3 weeks before the clinic regular visit (for segment B only) * Without routine sensor use (for segment C only) * Subjects willing to follow study instructions Exclusion Criteria: * An episode of diabetic keto-acidosis within the month prior to study entry * Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment * Concomitant diseases/ treatment that influence metabolic control * Significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety * Participation in any other interventional study * Known or suspected allergy to trial products * Female subject who is pregnant or planning to become pregnant within the planned study duration.",N/A NCT05221359,Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes,"Inclusion Criteria: 1. Adult men or women (age ≥ 18 years); 2. Diagnosis of Type 1 Diabetes (T1D) for more than 2 years at the start of screening; 3. Body mass index (BMI) \> 16 kg/m2 and \< 35 kg/m2; 4. Well managed intensive SubCutaneous (SC) insulin therapy, i.e. patient using for at least 3 months: * CSII, whatever the insulin pump used, and * Continuous Glucose Monitoring (CGM), by using Dexcom G6; 5. 7.0% \< Serum HbA1c \< 12.0%; 6. Patient characterized by one of the following conditions: * Unstable diabetes/poor glycemic control, meaning patient presenting: * at least one episode of severe hypoglycemia during the 12 months prior to study screening. Severe hypoglycemia is defined by American Diabetes Association (ADA) standards as ""severe cognitive impairment requiring assistance from another person for recovery"" (as per ADA's definition in ""standards of care in diabetes""); * or glycemic excursions (post-prandial hyperglycemic or nocturnal hypoglycemic episodes) considered as too frequent and of high amplitude by the investigator, during the previous month; * Presence of adverse side effects of SC insulin-therapy: * SC insulin resistance; * or severe acquired lipodystrophy resistant to pump treatment; * or genetic skin atrophy or lipodystrophy. Exclusion Criteria: 1. Renal glomerular filtration rate \<30 mL/min/1.73m2 as per Chronic Kidney Disease - Epidemiology Collaboration (CDK-EPI) calculation; 2. Immunocompromised patient; 3. Local or systemic acute or chronic inflammation (rheumatoid arthritis, sclerodermia); 4. Active infection or inflammation; 5. Known history of skin affliction that could impact ExOlin® tolerance; 6. Ongoing active anticoagulant therapy; 7. Severe wound healing issues; 8. Parietal reinforcement prostheses; 9. Known allergy to one of the devices' components, including known allergy to fixation systems (e.g. patch, plaster) for SC administration devices such as external pumps and CGM, or chronic allergy related to prolonged wearing of such systems; 10. Known allergy to insulin NovoRapid®; 11. Known allergy to anesthetics, or products containing iodine and its derivates, or antibiotics used during surgery (cefazolin, and combination of clindamycin and gentamycin); 12. Activity contraindicated as per external pump and CGM use recommendations; 13. Patient willing to practice activities with risks of trauma or major change in the environment pressure such as combat sport or scuba diving; 14. Cardiac condition incompatible with surgery requirements as per anesthesiologist's opinion; 15. Unstable diabetic retinopathy (as per ophthalmologist's review within 6 months before screening); 16. Current or history of unresolved malignancy within 5 years before screening (with exceptions for squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast carcinoma without lymph node metastases, well-differentiated thyroid carcinoma or other non-invasive lesion that, in the opinion of the investigator, is considered as cured with minimal risk of recurrence within 5 years); 17. Other surgical or medical condition that, in the judgment of the investigator, might warrant exclusion or be contraindicated, like for instance visual or hand-use symptoms; 18. Mental handicap or psychiatric condition incompatible with appropriate handling of devices or compliance to treatment or investigation-related tasks; 19. Known active alcohol or drug abuse; 20. Having received corticoid treatment within 4 weeks prior to enrollment; 21. Having received an investigational product within 12 weeks prior to enrollment, or currently participating in another clinical trial, with the exception of observational / non-interventional; registries, for which written prior approval of Defymed is needed; 22. Women planning for pregnancy, being pregnant or breastfeeding or unwilling to use adequate contraceptive methods for the duration of the study (oral hormonal contraceptives, implants, injectables, hormonal or copper intrauterine device, or vasectomized partner); 23. Person under guardianship, trusteeship or deprived of liberty; 24. Person not affiliated to one of the French social security systems; 25. Unwilling to give written informed consent to participation in the study, or unable to do so for psychiatric, cognitive or linguistic reasons.",N/A NCT04496388,The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.,"Inclusion Criteria: * adults aged 40 to 70 years old. * without regular exercise in the past six years. Exclusion Criteria: * recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP \> 200 mmHg, or diastolic BP \>110 mmHg. * those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.",N/A NCT04029103,Evaluation of The Effectiveness of m-DAKBAS on Foot Care,"Inclusion Criteria: * having a diagnosis history of \>1 year; * having Type 1 or Type 2 diabetes; * having a mobile phone with Android or IOS operating system; Exclusion Criteria: * having visual impairment, * hand skill problem, difficulty in communication, or mental insufficiency; * currently having foot ulcer.","Diabetic foot, one of the important complications of diabetes, is a health problem that affects quality of life in a negative way, that has high treatment and care costs and mortality rates, long hospitalization duration and thus with all these aspects a psychological, physical, social and economic priority. Despite all these, diabetic foot complications and amputations could be decreased with the help of a good foot care, education and a multidisciplinary team work. Mobile technologies have been continuously increasing worldwide for the management of diabetes, and the use of these technologies is recommended by international institutions as well. Therefore, the purpose of this study is to develop a Turkish mobile application that would increase patients' knowledge levels about foot health and care, improve their behaviours and self-efficacy, and evaluate its effectiveness so that it could be possible to prevent foot ulcer and the related amputations in individuals with diabetes. The Mobile Diabetic Foot Personal Care System (m-DAKBAS) developed for this purpose enables to increase individuals' self-confidence, improve communication with the health personnel, involve patients in their own care in an interactive way, and take responsibility. The usability of the application was indicated by the patients' feedback, and in line with the purpose of the mobile application, improvements in the patients' knowledge, behaviours and self-efficacy about foot care in diabetes." NCT03771261,Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race,"Inclusion Criteria: * Age \> 60 years * Identifies as Caucasian/white or African-American/black * Obese body weight (\>30 kg/m2) * Able to speak and understand spoken and written English * Elevated fasting plasma glucose (≥95 and \<126 mg/dL) * Age-normal Kidney function (≥ 45 mL/min/1.73 m2) Exclusion Criteria: * Body weight \> 224 kg (limit of the BodPod) * Treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose ≥126 mg/dL) * Presence of unstable, acutely symptomatic, or life-limiting illness * Positive screen for dementia using Mini-Cog evaluation tool * Neurological conditions causing functional or cognitive impairments * History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation) * Allergy or intolerance to egg products * Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing, or continuously participate in a randomly assigned lifestyle intervention program for four months * Inability to walk independently * Unable to give consent * Unable to complete written recording forms including journals of eating and exercise behaviors. * Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications, insulin, metformin or any other hypoglycemic agent * Primary Care Physician advises against participation * Smoker * Unusually or unstable renal function","Older (\>60 yrs) men and women (50% African American, 50% white) who are obese (BMI \>30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d; and 2) High protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (\> 30g protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months." NCT07075588,"Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure","Inclusion Criteria: * 21-70 years * Self-identify as Black/African American or Hispanic/Latino * Have Stage 2 CKM defined as: * Systolic BP ≥130mmHg (measured at screening) AND at least one of: * Hypertension (ICD-10: I10-I16) * Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%) * Stage 3 chronic kidney disease (CKD) (eGFR 30-59 mL/min/1.73m²) * Live in census tracts identified by the Montgomery/ Prince George's/Baltimore City County Departments of Planning as HFPA: * Healthy Food Availability Index score is low (0-9.5), * Median household income ≤185% of Federal Poverty Level * 30% of households have no vehicle, * Distance to supermarket \>1/4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App Exclusion Criteria: * Age \<21 years * Diagnosis of end-stage renal disease (ESRD), dialysis * Serious medical condition that either limits life expectancy or requires active management (e.g., cancer) * Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence * Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days) * Patients with cognitive impairment or other condition preventing their participation in the intervention * Pregnant, breastfeeding, or planning pregnancy * Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) or another clinical trial that could interfere with the study protocol * Planning to move out of the geographic area in 12 months","Cardiovascular-kidney-metabolic (CKM) syndrome is a devastating public health crisis that affects nearly 90% of US adults. CKM accounts for \>30% of all US deaths and \>5 million hospitalizations annually and imposes an annual economic burden of ≥$1 trillion, with a disproportionate impact on Black, Hispanic adults. Inequitable access to care, high-quality food, culturally tailored dietitian support, and living in ""food deserts"" (also known as Healthy Food Priority Areas (HFPAs) exacerbate CKM disparities. Innovative approaches are urgently needed to sustainably improve food access and CKM health of Black and Hispanic adults. More than three times as many Black adults (31%) in Baltimore City live in HFPAs compared to White adults (9%). About 45% of households in Montgomery County earn less than the self-sufficiency standard, 64% of Supplemental Nutrition Assistance Program (SNAP)-eligible adults are unenrolled, the highest rate in MD. In 2022, 48% of Prince George's County residents lived in HFPAs. Reasons for these disparities are complex and comprise factors at the individual, provider, community, and systemic levels. Evidence-based interventions that improve CKM health include personalized dietitian coaching, home blood pressure monitoring (HBPM), and culturally tailored messages. Digital interventions could improve access to dietitians and fruits/vegetables (f/v) through digital ""FARMacy"" (akin to a virtual farmers market). Implementation strategies for the delivery of these digital interventions are critical gaps, and clinic integration remains unclear. Digital FARMacy platforms offer potential for increased reach and engagement-relative effectiveness and implementation approach have not been explored. The investigators propose to test the effects of iTHRIVE using a randomized controlled trial among 100 adult participants living in HFPAs in MD counties with uncontrolled BP defined as systolic blood pressure (SBP) ≥130 milimiters of mercury (mmHg) and diabetes or moderate risk chronic renal disease. Participants will be randomized to either iTHRIVE (digital FARMacy, personalized dietitian coaching with produce prescription \[PRx\], and HBPM) or enhanced usual care (EUC, general dietary advice, standard food bags). The investigators will assess the effectiveness of iTHRIVE in improving systolic blood pressure at 6 months and evaluate the reach, adoption, implementation, maintenance, and budget impact of iTHRIVE" NCT01219803,Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes,"Inclusion Criteria: * Clinical diagnosis of type 2 diabetes mellitus * 30-65 years old * HbA1c≥7.0%, and FPG\>7.0 mmol/L, but \<13.9 mmol/L or 2hPG\>11.1 mmol/L * Informed consent has been signed * Dampness and Heat in Spleen Exclusion Criteria: * The patients accepted diabetic treatment for more than a month continuously * The patients were treated by drugs in 3 week before they were given test drugs * Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month * The contractive pressure \>160 mmHg or diastolic pressure \>100 mmHg * Pregnant, preparing for pregnancy or breast-feeding women * Mental patients * The patients whose ALT or AST are \>100U/L,and BUN or Cr are abnormal. * The patients who have serious heart, lung, liver, kidney and brain or other primary complications * Allergic persons * The patients who are attending other clinical trial * The patients who have serious diabetic complications * The patients who ever attended this clinical trial * Alcohol and / or psychoactive substances, drug abuse and dependency * The person maybe loss for some reason such as work or life condition according to the investigator's judgement * The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable * The patients who are eating some drugs or health food which can affect the body weight","two hundred and forty primary diabetic patients will be expected to be recruited, which were divided into different groups in a randomized, doubled blind, dose-paralleled-control multi-centre clinical design. The patients were randomly taken with high-dosage(5 times of low-dosage),mild-dosage(3 times of low-dosage), low-dosage,placebo(4.5% of low dosage) by 2 times every day for 12 weeks. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG),postprandial 2 hours plasma glucose(2hPG),insulin(0h,1h,2h),syndrome,symptoms,body mass index (BMI),waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week." NCT07357415,A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight,"Inclusion Criteria: * Have a Body Mass Index (BMI) at screening * ≥ 30 kilogram per square meter (kg/m2) OR * ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease * Have at least one unsuccessful attempt to lose weight by dieting Exclusion Criteria: * Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening * Have a prior or planned surgical treatment for obesity * Have type 1 diabetes or type 2 diabetes * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had within the past 90 days before screening: * heart attack * stroke * hospitalization for unstable angina or heart failure * Have New York Heart Association Functional Classification Class IV congestive heart failure * Have a history of chronic or acute pancreatitis * Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening",N/A NCT03524625,Sensitivity and Specificity of a Mobile Lead-one ECG Like Device for the Detection of Atrial Fibrillation (AF),"Inclusion Criteria: Patients with AF or suspected AF referred or admitted to hospital (secondary care setting). Able to hold the impulse device with both hands. Able to give informed consent. Exclusion Criteria: Patients who are unable to give informed consent either through lack of capacity or lack of ability to understand study documentation. Patients who are unable to hold the impulse device for 2mins. Presence of artificial pacemaker or cardioverter defibrillator.",N/A NCT06390189,Inflammatory Resolution in Cardiometabolic Health and Disease,"Inclusion Criteria: * Informed signed consent has been obtained from the volunteer. * The volunteer has a BMI greater than 18.5 kg/m2 * Men and women over the age of 18 are included. Exclusion Criteria: * The study staff contacting a potential participant perceives that the individual has difficulty understanding the information. * An MD determines that the individual is on too many medications to participate. * The individual takes a medication that is approved by the MD, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw. * The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication. * The individual has some form of chronic inflammation. * The individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin). * The individual uses immunosuppressive drugs (e.g., methotrexate). * The individual regularly consumes fish oils (omega 3). * The individual has significant gastrointestinal problems. * The individual smokes or uses chewing tobacco. * The individual has been drinking alcohol two days before the study visit. * The individual has tattoos or body piercings on the forearms and / or the stomach that can affect the examination. * The individual does not follow instructions given in the research study.",N/A NCT02690168,Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy,"Inclusion Criteria: * Male * BMI 20.0-24.9 kg/m2 * 18-40 years old * Willing to reside at Pennington Biomedical for 4 days Exclusion Criteria: * Type 1 diabetes mellitus * Type 2 diabetes mellitus * Fasting glucose ≥ 110 mg/dL (determined at screening visit) * Hyperketonuria \>15 mg/dL, (determined at screening visit) * Contraindication to MRI * History of or current eating disorder * History of obsessive compulsive disorder * Current use of any medication (excluding over-the-counter pain medication) * Contraindication to prolonged fasting * Consume \>10 alcoholic drinks/week","Following the detection of severe hypoglycemia by the central nervous system (CNS), a series of physiological countermeasures are triggered which return serum glucose to euglycemic levels. This vital homeostatic response frequently becomes dysfunctional in both type 1 and type 2 diabetics, leaving them particularly vulnerable to life threatening bouts of hypoglycemia. This dysfunction, often termed hypoglycemia-associated autonomic failure (HAAF), is thought to be caused by maladaptive changes in the CNS. Currently, progress towards rectifying this HAAF is severely hindered by a lack of knowledge regarding the exact nature of these maladaptive changes and the antecedent events which cause them. Previous work by the PI, as well as others, has identified altered glial metabolism as a potential biological substrate driving HAAF. The alterations in glial metabolism associated with HAAF are strikingly similar to those induced by prolonged dietary restriction in rodents. This raises the intriguing possibility that HAAF may be driven by glial adaptations, normally induced only by prolonged starvation, which are triggered in diabetic individuals by treatment-induced exposure to severe hypoglycemia. The primary goal of our pilot project is to conduct a prospective observational study in humans to test the hypothesis that prolonged fasting will induce changes in glial metabolism similar to those previously measured in individuals with HAAF. The investigators will accomplish this goal via the following specific aims: Aim 1: Using a prospective observational study design in humans, test whether a 72 hour fast will induce acute alterations in glial metabolism, Aim 2: Determine if changes in plasma glucose and leptin levels following prolonged fasting are correlated with changes in glial adaptation. The investigators will utilize innovative 13C magnetic resonance spectroscopy to measure alterations in glial metabolism and substrate preference following acute dietary restriction in healthy young individuals. By demonstrating that metabolic adaptations of glial cells induced by prolonged fasting are similar to those previously associated with HAAF, the investigators can provide key insights into the precursors that may lead to the development of HAAF in diabetic individuals." NCT02713568,Estimation of Fetal Weight by MR Imaging to PREdict Neonatal MACROsomia (PREMACRO Study),"Inclusion Criteria: * Subjects is ≥ 18 years of age and able to provide a written informed consent. * Subject is a pregnant woman carrying a live singleton fetus at the 36+0-36+6 weeks scan, with no major abnormalities appearing during prenatal imaging with no major abnormalities appearing during prenatal imaging potentially affecting the correct use of the Hadlock formula for US-EFW. Conditions such as congenital diaphragmatic hernia with decreased abdominal circumference could be underestimated by the Hadlock USEFW. Another example is a massive sacro-coccygial teratomas. * Subject is planning a delivery at our maternity at the University Hospital Brugmann, in Brussels, Belgium. * Subject is known not to have any contra-indication to undergo an MR imaging examination. Exclusion Criteria: * Subject is known to have a contra-indication to undergo an MR imaging examination such as: Carrying a pacemaker or a metallic cardiac valve, having metallic material inside the head, having metallic fragments inside the eye following an accident, having any type of implant including ear implant, having a hip prosthesis * Subject presenting with painful regular uterine contractions or history of ruptured membranes. * Subjects who are unconscious, severely ill, mentally handicapped or under the age of 18 years. * If birth occurs before MR and US evaluation. * If patients delivers outside our local maternity unit. * If the neonate's weigh is not measured within 6 hours after birth for any reason, including the need for emergency care immediately after delivery","Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates of fetal weight are poor. Historically, ultrasound has been used as a second line in such cases but the accuracy of this imaging modality in the mid- to late third trimester is also limited. Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to guide obstetric interventions, when a fetus is small or large for dates. When a diagnosis of intra-uterine growth restriction (IUGR) is made, the decision-making process is complex, particularly at very early gestations and involves multiple different factors, including maternal status, cardiotocography, liquor volume and dopplers. However, a large body of research is now available to assist with the management of both early and late-onset intrauterine growth restriction (IUGR) but there is a paucity of evidence to guide clinical practice, once macrosomia has been diagnosed, therefore the EFW is frequently the single most important component guiding interventions, such as induction of labour or Caesarean section. Fetal macrosomia is associated with a higher incidence of perinatal morbidity, including shoulder dystocia and brachial plexus injury in the fetus and anal sphincter tears, uterine atony and haemorrhage in the mother. A recent multicentre randomised controlled trial appears to confirm the advantages of a policy of induction of labour for suspected macrosomia, demonstrating a clear reduction in the rates of shoulder dystocia and composite perinatal morbidity. However, some earlier but lower quality, observational studies have questioned the benefit of EFW made by ultrasonography in the last trimester, for suspected macrosomia, demonstrating that this practice can increase the risk of caesarean and instrumental delivery, without reducing perinatal morbidity. Despite this conflicting data and a lack of evidence to support routine third trimester ultrasound, the absence of specific guidance, coupled with concerns regarding perinatal outcomes,mean that obstetricians will increasingly request an ultrasound at around 34-36 weeks gestation to identify foetuses above the 90th or below the 10th centiles. This practice will inevitably lead to increased and potentially harmful interventions based on relatively inaccurate data. Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected macrosomia in the 3rd trimester, the investigators believe that these estimates should not be used to make important obstetric decisions regarding mode and timing of delivery and that a more accurate method of assessment could produce better outcomes by restricting interventions to those foetuses at greatest risk. Some publications have already demonstrated that magnetic resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound, with a mean percentage error superior to that of ultrasound and a recent meta-analyses has confirmed this promising accuracy. The goal of the present study is thus to compare the performance of magentic resonance imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the prediction of neonatal macrosomia." NCT06155591,Case Management of Complex Pluripathology in Primary Care,"Inclusion Criteria: * Dependent complex and pluripathological chronic patients (CPCP) with associated cardiac and/or respiratory pathologies and/or diabetes mellitus * Frail ≥1 point * Require a main caregiver to perform basic activities of daily living (ABVD) * Barthel ≤60 points and/or grade II or III dependency recognised by Social Services * Are immobilised at home and/or require social resource management * Agree to sign (themselves or their legal guardians) the informed consent for participation in the study Exclusion Criteria: * Patients with other pathologies associated with complex pluripathology * With non-habitual caregivers * Barthel ≥60 points or grade I dependency recognised by Social Services * Who reside outside the area assigned to the Garrido Sur and Miguel Armijo health centres despite being assigned to them",N/A NCT05920291,Carotid Doppler Findings of High Risk Group of Stroke,"Inclusion Criteria: * Adults. * People with risk factors for cerebrovascular stroke such as diabetics, hypertensive, smokers and obese person. Exclusion Criteria: * Children. * People with no risk factors for cerebrovascular strokes. * People with past history of cerebrovascular stroke.","Atherosclerosis of carotid arteries is a common serious condition that develops when sticky plaque builds up inside carotid arteries that deliver blood to brain, so carotid artery diseases cause about 10-20 percent of strokes which is a medical emergency that can leave the brain with permanent damage. Doppler sonography of the cervical segment of carotid arteries is a popular non-invasive tool for evaluation of anatomy and hemodynamics of carotid artery (1), its ability to measure intimal media thickening and characterizes the morphology of carotid atheroma makes it a reliable modality to determine the etiology and severity of stroke (3), (4). Carotid intimal media thickening is measured as the distance between the leading edges of the two echogenic layers of the wall using the posterior wall (5), in addition color Doppler ultrasonography permits measurement of flow based on reflection of ultrasound waves utilizing both pulse Doppler and color Doppler ultrasound. Visualization of color coded flow information about direction and velocity, so with high grade lesions are more easily detected with color than with pulsed Doppler ultrasound although the later allows direct estimation of flow velocity The peak systolic velocity (PSV) is used for quantification of stenosis, however end diastolic velocity (EDV), carotid index and spectral wave form analysis are also used for assessment of stenosis (6). Also, color integration is used to identify areas of abnormal flow. There are a number of pitfalls when using velocity based estimation of ICA stenosis, such as higher velocities in females, and elevated velocities where there's contra lateral carotid artery occlusion .(7\_9) If there is a severe tortuosity of an artery, high carotid bifurcation, obesity, or extensive calcification of the vasculature, these will reduce the sonographic accuracy; if carotid artery stents are already in situ , vessel wall compliance can be diminished accelerating flow velocity.(10) Ultrasound may also be unable to distinguish between partial and complete vessel occlusion, despite the distinction being critically clinically important. (10-12). In this study we present analysis of findings of carotid ultrasound examination among patients with clinical suspicion and risk for cerebrovascular diseases in New Valley. Ultrasonography in this study is used to measure intimal thickening as well as flow characteristics of carotid artery with focus on internal carotid artery. Extra cranial vessels represent vessels outside the brain and the skull. The most common configuration is the three-vessel arch anatomy, where the first branch is the brachiocephalic artery which further branches into the right common carotid artery (CCA) and right subclavian artery. The second branch is the left common carotid artery, with the left subclavian artery as the third branch. (13) The most common variant to this anatomy is the common origin of brachiocephalic and left CCA from aortic arch. The common carotid arteries bifurcate into the external carotid artery (ECA) and internal carotid artery (ICA)at the upper border of the thyroid. The carotid bulb is the location of a bifurcation and the ICA origin. (14) ICA is generally posterior and lateral to ECA and is usually bigger in caliber compared to ECA. ECA supplies the musculature of face and neck and tapers distally giving off extra cranial branches. (15). Coloured Doppler sonography using 5-10 MHZ multifrequency linear transducer, the scan is performed in both transverse and longitudinal dimensions. The patients are scanned in supine position on the examination table, the patient's head is turned away from the side and the neck a little extended. The examination is carried out either from the patient's Side or sitting at the patient's head. Coupling gel is applied on each side of the neck. Gray scale imaging, which is also Called B (brightness) mode is usually performed first where the carotid arteries are evaluated in their entirety from the jugular notch to angle of the mandible (16).B\_mode imaging evaluates the coarse and caliber of the vessel with evaluation of intimal media thickness and quality of the plaque , the morphology of the plaque is associated with the severity of atherosclerotic diseases (17). At the jugular notch the transducer angulated caudally, while at the mandible it's cephalic angulated. This is followed by Doppler examination (18,19) Many parameters should be adjusted to achieve reliable results, Doppler angle should be less than 60 degrees (as close as possible to parallel) to improve accuracy of measurements. (20) The calculated velocity will be incorrect if calculated using inaccurate angle, the velocity of CCA is usually 30-40 cm/sec but may vary in diseased vessel. (21) Gain is adjusted so that color is seen only within the lumen of the vessel to avoid bleeding artifact. (22) Sample volume should be placed in to center of the lumen and should be moved along the entire vessel. Any abrupt change in the systolic velocity or area of slow flow should be carefully evaluated and documented.1(23) Spectral analysis including peak systolic velocity (PSV), peak diastolic velocity (PDV), main maximum velocity, and pulsatiliy index can be obtained. Spectral Doppler wave form evaluation gives critical information about flow dynamics at the point of sampling, which depends on hemodynamic factors affect proximal and distal portion of the vessel. (24) ICA demonstrates low resistance flow, ECA has high resistance flow, while CCA has a hybrid of ICA and ECA. The resistive index is used to describe wave form, which signifies resistance of the vessel distal to the examined vessel. (25) Spectral Doppler should be evaluated at minimum at (a) proximal, mid, and distal common carotid artery (b) proximal, mid and distal internal carotid artery (c) proximal carotid artery (d)vertebral artery, any significant stenosis should be carefully evaluated and documented distal and proximal to the stenosis.(26,27) Peak systolic velocity (PSV) greater than 125cm/S correlates with 50%or higher ICA stenosis (28) PSV greater than 230cm/s correlates with 70% or higher stenosis a potential indication for surgical endarterectomy." NCT07186218,Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease,"Inclusion Criteria: * Adults (age ≥ 18 years) * Advanced CKD, defined as at least two measurements of creatinine-based or cystatin C-based eGFR ≤ 30 mL/min/1.73m2 separated by at least 90 days in the preceding 12 months * Able to provide consent to participate in the study * Able to read and write in English * Under the care of a nephrologist at a Mass General Brigham nephrology clinic Exclusion Criteria: * Terminal illness likely to lead to death within 6 months of participation * Patients receiving dialysis treatment at the time of enrollment or scheduled to start dialysis therapy in the next 4 weeks * Patients scheduled to receive a kidney transplant in the next 6 months * Patients having their initial clinic visit (i.e., new to the clinic) * Cognitive deficits that would preclude understanding of consent form and/or questionnaires","This is a single-center, open-label, two-arm, randomized pilot trial of 70 individuals with advanced chronic kidney disease (CKD; eGFR\<20 mL/min/1.73 m2). This pilot study will assess reach, feasibility, acceptability (implementation) and preliminary efficacy of patient use of IPOS-Renal (Integrated Patient Outcome Scale-Renal, primary exposure of interest), an instrument designed to assess symptoms among patients with CKD, which will be electronically completed monthly for 12 months. Randomization will occur in a 1:1 ratio at the level of the individual; therefore, 35 individuals will be randomized to the IPOS-Renal electronic patient-reported outcome measure (ePROM) intervention arm, and 35 individuals will be randomized to the control arm (standard of care). The ePROM intervention has three core components: 1) patient self-reporting of CKD-related symptoms at regular intervals using the Integrated Patient Outcome Scale (IPOS)-Renal survey, 2) feedback of patient responses to clinicians; and 3) provision of guidance for symptom management to clinicians. Patients randomized to the ePROM intervention arm will receive instruction on how to self-report symptoms using an electronic version of the IPOS-Renal instrument. Clinicians will be provided instruction on how to view patient symptom responses and given guidance regarding symptom management strategies; however, treatment decisions will be left entirely to the discretion of the clinician. Whenever a patient has a clinic visit, a symptom report will be generated and printed by the research team and will be given to the treating nephrologist. All participants will complete two PROMs over the course of participation. At baseline, participants will complete the Kidney Disease Quality of Life-36 (KDQOL) instrument (primary efficacy outcome) and the IPOS-Renal to assess symptom burden at baseline. Participants will be given a choice to complete questionnaires online, via mailed paper forms, or over the telephone. The KDQOL questionnaire will be completed at baseline and months 6 and 12 (+/- 4 weeks each). All study questionnaires will be available in English. Chart abstraction will be conducted by a member of the study team at baseline, 3, 6, 9, and 12 months (+/- 1 months each) to collect demographic and clinical data. Additional information on clinical events (progression to CKD requiring kidney replacement therapy, emergency room visits, hospitalizations, and death) will be abstracted at 24 months. Patient and clinician participants (target n=20 patients and n=10 clinicians) will be invited to participate in semi-structured interviews for qualitative data collection. Qualitative data will be used to explore patient and clinician perspectives on symptom management in the ambulatory nephrology setting and the feasibility and acceptability of the ePROM intervention." NCT06376890,Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico,"Inclusion Criteria: * Must be eighteen years or older, * Fasting blood glucose of 100mg/dl to 125mg/dl * BMI of 24 or higher * Must be willing to ingest powdered chili pepper * Must be able to swallow tablets Exclusion Criteria: * Insulin dependent diabetes * Thyroid disease * History of metabolic disease * Allergic to chili peppers * Pregnant",N/A NCT01352390,The Effect of a Coloring Prompt on Health Engagement,"Inclusion Criteria: * Indications according to Spring 2011 CDC criteria for a Pap smear * Indications according to Spring 2011 CDC criteria for a blood pressure check * Indications according to Spring 2011 CDC criteria for a cholesterol test * Indications according to Spring 2011 CDC criteria for a fasting plasma glucose test * Employee at partner corporation that implemented the study","The investigators will randomly assign some individuals with 4-9 year old children to receive colorful reminders to engage in a given health behavior. Others will receive identical reminders along with a prompt to share the reminder sheet with their child so it can be turned into a piece of art. The investigators are interested in whether the coloring prompt will lead the reminder to stay in the home for longer, be placed on the refrigerator, etc. and thus result in an increase in compliance with the recommended health behavior." NCT02175810,Impact of Bariatric Surgery on Cardiorespiratory Function,"Inclusion Criteria: * Ages 18 years to 50 years * Patients enrolled in the bariatric surgery program of St George's Hospital with BMI \> 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes Exclusion Criteria: * Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing * Weight \> 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies) * Cognitive impairment * Patients unable to follow instructions in English",N/A NCT06185413,Children's Cooperation Denmark: a 3-year System Dynamics Trial,"Inclusion Criteria: * All children from grade 1 (aged 6-7 years) to grade 6 (aged 11-12 years) at the participating schools Exclusion Criteria: * No","The Child-COOP trial was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. Two feasibility studies were initiated in 2021 and still running - and Child-COOP was subsequently adapted and adjusted. INTRODUCTION Lack of physical activity (PA) and sedentary lifestyle in Danish children is a major challenge. New strategies are needed to combat this development. Early awareness and promotion of healthy PA behaviour is important, as PA behaviour in childhood often is manifested across adolescence and into adulthood. Social inequity in health is also mirrored in PA behaviour among children. Children in families with few resources are known to be less physically active compared to peers in more affluent families. One way to promote healthy PA behaviour in children, which also considers inequity challenges, is to develop more health-enhancing active leisure communities. Unfortunately, dropout from active leisure communities is common in the transition from childhood to adolescence. These high dropout rates call for identification of initiatives that encourage children to engage in active leisure communities throughout childhood and youth. However, both sedentary behaviour and moderate-to-vigorous PA have been found to be independent predictors for health status, and they are not mutually related. Hence, focussing solely on reaching the recommended levels of daily PA is not sufficient. Instead, a comprehensive strategy is warranted to ensure that more time is spent on light, moderate and vigorous PA and less time on sedentary activity. Promoting (initiating and sustaining) a healthy PA behaviour is not an easy task because PA behaviour is shaped by a complex interplay between a wide range of factors at individual, family, community and society levels. Interventions building on a participatory system dynamics approach has been suggested as a feasible way to address such complex problems as they combine the current evidence base on prevention, best practice and local wisdom to achieve new knowledge and create solutions. A participatory system dynamics approach implies that a variety of engagement and solutions at different system levels may occur at both the interpersonal and organisational levels. This strategy has already proven successful in several international childhood obesity prevention interventions. The participatory system dynamics approach remains to be tested in a large-scale Danish context. During the past year, our research group has tested the participatory system dynamics approach in different settings in Denmark. We propose to conduct a participatory system dynamics trial across ten communities in five municipalities to create local solutions to promote healthy PA behaviour in Danish schoolchildren through Child-COOP. AIM The overall aim is to evaluate a participatory system dynamics approach to promote (increase and sustain) healthy PA behaviour in 6- to 12-year-old schoolchildren in local communities in Denmark through the following sub-aims: * Measuring the effectiveness on the children's PA behaviour by assessing changes in time spent sedentary and time spent at light, moderate and vigorous intensity at three-year follow-up * Estimating changes at system level such as assessing changes in community systems, community networks structure, policy and practice at three-year follow-up * Identifying health-economic implications by assessing both a cost consequence analysis and an explorative analysis of the derived effects at three-year follow-up * Conducting a process evaluation to map a final systems program theory on ""what works for whom under what circumstances"" to be used as a framework in future recommendations and up-scaling. TRIAL COMPONENTS The Child-COOP trial consists of three stages: Stage 1: Preparation: selection of communities, training and monitoring (12 months) Selection of communities: The communities will be selected and defined by the municipalities based on their local challenges related to children's PA behaviour, socially deprived areas and motivation. Training: Employees from all participating municipalities will receive training in how to run local community initiatives based on a participatory system dynamics approach. The target group for the training is Child-COOP municipal coordinators and other employees in the municipality taking part in the project. The training will consist of seminars and homework. The purpose of the training is to build capacity for municipal employees to understand and act within the framework of the participatory system dynamics approach and to solve complex health challenges regarding children's PA behaviour. Monitoring: A local childhood health profile will be generated to outline daily PA behaviour, sleep patterns and leisure time activities at baseline (based on survey and objective data) and factors associated with PA behaviour in children, e.g. mental health, screen use and parental support. This profile will be generated at baseline based on survey and objective data (see details in ""Individual level: data collection and measurements""). Stage 2: Recruitment, group model building (GMB) and systems mapping (9 months) Recruitment of key leaders and local stakeholders: A coordinator from each municipality will together with the research team identify and recruit key leaders (e.g. local politicians, department heads, municipality leaders) and local stakeholders (e.g. school board members, school principal, school nurse, sport club representatives). Key leaders and local stakeholders will be selected based on authority and capacity to initiate actions that are likely to influence the children's PA behaviour across sectors and organisations. During this stage, key leaders must commit to allocate resources to ensure subsequent implementation. The aim is to recruit 12-15 key leaders and local stakeholders from each community. GMB process and systems mapping: During this stage, three workshops (WS1, WS2 and WS3) will be held at each participating community. WS1 and WS2 will engage the key leaders and stakeholders, and local childhood health data will be presented to provide the first critical engagement step. In these two workshops, the key leaders and stakeholders will map the system by building a causal loop diagram (CLD) to understand how the perceived local system affects the children's daily PA behaviour in their community. In WS3, all community members willing to engage in changing the local system will be invited to identify priority areas for action based on the developed CLD from WS1 and WS2. Stage 3: Implementation of actions, support and monitoring (24-30 months) Actions and support: The output of WS3 is the formation of local working groups that will focus on implementing the chosen actions. The working groups will be supported and supervised by a backbone office consisting of the Child-COOP municipality coordinator(s) and the research team. A follow-up workshop (WS4) will be held with the key stakeholders six months after completion of WS3 to review the consolidated priority actions. To increase and maintain motivation and actions in the local community, subsequent follow-up meetings will be held with the working groups when needed during the 24-30 months after WS3. Monitoring: Survey childhood health data will be collected from the study population on an annual basis and from the newly enrolled schoolchildren (first grade) every year (see details in ""Individual level: data collection and measurements""). At an annual meeting in each community, these data on the children's health and well-being in the local community will be presented to actions groups, key leaders and stakeholders to sustain and promote engagement. RESEARCH PLAN Child-COOP will be evaluated through an assessment of outcomes at individual and systems level, process and economic implications. Combined, these three elements will give an essential understanding of what it would require to upscale Child-COOP to regional or national level. Few guidelines exist on how to evaluate public health programs in complex adaptive systems. Child-COOP is inspired by both the Medical Research Council recent evaluation guidelines for process evaluations of complex interventions and the newly developed ENCOMPASS framework aiming to generate a comprehensive, yet practically realistic evaluation. The evaluation will be structured along the realist research cycle, and a critical first step is to develop an initial program theory to inform how the participatory system dynamics intervention is expected to produce change. Given the participatory approach in Child-COOP, the exact outcomes and actions are unknown in advance. Consequently, the evaluation will be constructed to allow for systematic documentation of processes and outcomes. A final systems program theory on ""what works for whom under what circumstances"" based on the participatory systems dynamic approach will be made, including recommendations for large-scale implementation across different settings. System level: data collection and measurements Engagement and commitment will be measured by a survey to document changes at community and organizational level. The survey will be distributed to all participants attending workshops and will enrol new workings groups' members continuously at base line (defined as first attendance) after one year and at two-year follow-up. Participatory mapping of communities will be assessed through online workshops with the participants attending the workshops. The online workshops will supplemented by survey data provide evaluation and formative insight into the local network of each community. Actions implemented will be evaluated by using Ripple Effects Mapping method which asses the number of actions and where they have been initiated in the system. Action Scales Model is used to asses leverage point of each action implemented. Both methods will be used in workshops with working groups every 6 months for a two-year period. Change in local systems will be understood through Causal loop diagrams (CLDs) built during the GMB workshops, which will be enriched with observation data from the workshops and survey data to quantify actions, collaborations and system changes over time and to assess the impact of actions and networks on variables in the system. To support the GMB method, the software program ""Systems Thinking in Community Knowledge Exchange"" (STICKE) will be used together with internationally developed, tested and standardised scripts. Process evaluation: data collection and measurements Quantitative data for the process evaluation will be collected with the same procedures as described at system level (to assess reach). Moreover, we will also use the results of ""ripple effect mapping"" (REM) to understand the solutions and actions developed in the local communities. Additional data will be collected through interviews, focus groups, structured observations and follow-up interviews before, during and after the GMB workshops to access the overall process. The process evaluation will also include structured observations/checklists collected during workshops (to assess dose). Interviews or focus group discussions with workshop participants and participants dropping out of the GMB processes will be used to assess participant responsiveness. These data will be used to understand the mechanisms in Child-COOP. Furthermore, adherence to the participatory system dynamics approach will be assessed by routinely (every 6 months) collected information regarding implementation, engagement and actions of key leaders and stakeholders, political will and advocacy. In addition adherence, dose, quality of delivery, participant responsiveness and reach will be assessed to gain knowledge on how the participatory system dynamics approach was delivered and implemented and to inform a final program theory." NCT00516620,"Fruits, Vegetables, and Whole Grains: A Community-based Intervention","Inclusion Criteria: * residents of households within the City of Toronto 416 calling area * respond to advertisements in newspaper, on radio, and from flyers * Eligible households will include at least one willing adult 18 years or older; able to communicate in English, at least one adult with BMI \>/= 25 * Pregnant and breastfeeding mothers who fit the criteria above are eligible to join the study 6 months post-partum or 6 months after the cessation of breastfeeding * Individuals who fit the inclusion criteria but recently (past 6 months) started blood pressure medication are eligible for the study once their blood pressure is under control * Individuals who fit the inclusion criteria but recently started hypothyroid medication or diuretics will be eligible after 1 month of treatment Exclusion Criteria: * Residing outside of the 416 area code * under 18 years of age * actively following a special diet or weight-loss program * major cardiovascular event in the previous 6 months * recently (past 6 months) started blood pressure medication * diabetes, liver disease, renal failure, cancer (or a history of malignancy), inflammatory bowel disease, individuals with acute or chronic infections, either bacterial or viral, or individuals suffering from chronic inflammatory diseases, irritable bowel syndrome, peanut or nut allergy, major surgery in the previous 6 months * blood pressure greater than 145/95 on repeated measurements will be excluded","Governments and major national agencies throughout the western world concerned with chronic disease prevention (heart disease, stroke, diabetes, and cancer) uniformly advocate increased intakes of fruit, vegetables and whole grain cereals. All also agree that body weight reduction is central to reducing the risk of heart disease, stroke, type 2 diabetes, and certain cancers. Nevertheless, there is no official advice encouraging increased consumption of these foods in order to achieve and maintain a healthy body weight. Most importantly, there are no intervention studies that have tested the assumption that increased intake of fruit, vegetables and whole grain cereals will promote a healthier body weight. Our study will therefore address this issue to determine the effect of an increased intake of fruit, vegetables, and whole grain cereals on body weight, the intensity of effort required to achieve compliance, the durability of this habit, genetic determinants, and the effect on biomarkers of chronic disease risk. We will ask approximately 780 families to take part in this study. We will invite households to take part if there is at least one adult who is eligible for our study, and who agrees to participate. To be eligible for this study, participants must be at least 18 years old and have no medical conditions that would make it unsafe for them to take part. Before beginning the study, the medical history and other measures will be checked to ensure participant safety and suitability for participating in the study. This study consists of three parts. If agreement to participate is given, the first part is to make an appointment to come to our study clinic to give a fasting blood sample (baseline measurements), about 40mL of blood. The clinic visit will last approximately 40 minutes. All participants will be asked to complete a short checklist about their medical history, which includes information to make sure that they and their household are eligible for participation. Body fat measurements will also be made using a non-invasive, very simple machine called Futrex as well as height, weight, waist-to-hip ratio, and blood pressure. Part of the blood sample will be used for a health screen to ensure subject safety and suitability for participating in the study. Blood samples will be stored in a secured location and analyzed at the end of the study for cholesterol levels and other risk factors for heart disease. Part of the blood sample will be used in DNA analysis to help us understand the genes related to food intake and metabolism. We will also ask all participants to complete a questionnaire package about their eating habits and their physical activity either prior to the clinic visit or at the end of the clinic visit. Once the questionnaires are completed and returned to the study office, the second part of the study will commence. The second part is the intervention itself, lasting six months. If households are deemed to be eligible, they will be 'randomized' into one of eight study groups with all groups receiving Canada's Food Guide \& Physical Activity Guide. The study groups involve a combination of different kinds of dietary advice and provision of fruit, vegetables, and whole grain cereals. * Treatment 1: no food provision or dietary advice. * Treatment 2: food delivery. * Treatment 3: counseling on fruit, vegetables and whole grains. * Treatment 4: counseling to reduce soft drink intake. * Treatment 5: food delivery AND counseling on fruit, vegetables and whole grains. * Treatment 6: food delivery AND counseling to reduce soft drink intake. * Treatment 7: counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake. * Treatment 8: food delivery AND counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake. All food boxes are prepared and delivered by Food Share, a Toronto-based non-profit organization that has an existing system for home delivery of nutritious food boxes. If participants do receive dietary counseling, it will involve a phone call once a week for the first month (for about 20 minutes) then a phone call once a month for the next 5 months. At the end of six months, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures. The third part is a follow-up 12 months after the end of the intervention. Again, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures." NCT01861860,OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA,"Inclusion Criteria: * Age \> 18 years * Patients who have had a coronary angioplasty with implantation of a TAXUS™ Element™ stent of 28, 32 and 38 mm in length and up to 3 stents per patient in the case of acute occlusive dissection deployed using IVUS * Patients with indication of Taxus™ Element™ stent included in the List of Reimbursable Products and Supplies (LPPR): * diabetes, * small vessel (less than 3 mm in diameter), * long lesion(s) (more than 15 mm long), * chronic total occlusion \> 1 month, * intra-stent restenosis with the exclusion drug eluting stent(s), restenosis of * people with a lesion that is accessible to IVUS after stenting * people who have provided consent for collection of medical data for this trial. Exclusion Criteria: -Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up",N/A NCT03154060,Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites,"Inclusion Criteria: * Patients with a diagnosis of T1D for more than 6 months * Adult patients ≥ 18 years * Signed informed consent form Exclusion Criteria: * Pregnancy * Patients with severe cognitive dysfunction or other disease which makes FGM use difficult. * History of allergic reaction to any of the FGMs materials or adhesives when in contact with the skin. * History of allergic reaction to chlorhexidine or alcohol anti-septic solution. * Abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo). * Presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR \< 45 ml/min).",N/A NCT06133660,Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular,"Inclusion Criteria: * ① Patients undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases; * Patients who underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes; ③ Intraoperative BSS was used for fill the vitreous cavity; ④ Before treatment, inform the patient that the clinical data may be used in clinical research, and the patient and his family are informed and sign the informed consent. Exclusion Criteria: * ① The operation eye was intraocular lens or cataract extraction during operation; ② Suspensory ligament relaxation or rupture, ciliary body detachment or transaction, lens dislocation, endophthalmitis, traumatic cataract; * intraoperative lens injury; ④ patients who refused to participate in the study.",N/A NCT04861324,Effects of a Lifestyle Intervention on Gestational Diabetes Management,"Inclusion Criteria: * high risk for gestational diabetes * willing to make lifestyle changes * history of diabetes Exclusion Criteria: * carrying more than one fetus * history of chronic conditions except diabetes and hypertension","Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery." NCT02027259,Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits,"Inclusion Criteria: * Clinical diagnosis of type 2 diabetes * Clinical diagnosis of depression * PHQ-9 score ≥10 for depressive symptoms * \>= 18 years old * a most recent HbA1c ≥8.0% within the previous 12 months in the chart; and * have 1 or more of the following modifiable CVD risk factors not at target goals, defined as: * current smoker (any cigarette smoking \<30 days), * blood pressure \>130/80 mm Hg, documented at least twice in the last 6 months * LDL cholesterol \>100 mg/dL within the last 12 months. Exclusion Criteria: * Inability to attend the group sessions * active psychosis of any type or organic brain injury that precludes DM self- care * type 1 diabetes as documented in the medical chart * pregnancy * actively suicidal and /or * end-stage medical illness (e.g. metastatic cancer, awaiting organ transplant) * Patients currently enrolled in DM group programs that include medication titration within the group setting would not be eligible due to co- intervention.","BACKGROUND Nearly 33% of the 24.5 million people in the US with diabetes mellitus (DM) have co-morbid depression. Since 65% of patients with DM die from cardiovascular disease (CVD), concomitant control of CVD risk factors along with glycemic control is crucial to prevent adverse outcomes. However, co-morbid depression makes DM and CVD risk factors harder to control. We demonstrated that a pharmacist-led group visit model consisting of: 1) pharmacotherapy management for DM, hyperlipidemia and hypertension, 2) self-management education, 3) case management and 4) behavioral strategies for DM and CVD self-care behaviors, was more efficacious in improving hyperglycemia and CVD risk factors compared to standard primary care controls in a general DM population and also for patients with DM and co-morbid depression. For participants with DM and depression there was also a non-significant trend toward improvement in depression despite the lack of depression treatment. OBJECTIVE: Our objective is to determine whether group visits with added behavioral activation (BA) for depression (cases) will have a greater clinical impact than our standard group visits without BA for depression (active control) in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months. RESEARCH PLAN/METHODS: The goal is to conduct a randomized-controlled pilot trial (n=25 in each arm) to evaluate the clinical effect of added BA to our group intervention in patients with DM and depression who have a Hemoglobin A1c\>=8% and a PHQ-9 depression score \>=10 and at least one additional CVD risk factor such as tobacco use, hyperlipidemia or hypertension not at American Heart Association and American Diabetes Association guideline recommended goals. The interventions in both arms will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse. The primary aims are: * 1\) To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 6 months * 2\) To examine the acceptability and adherence to our group visit model with and without added BA therapy by way of focus groups and attendance The secondary aim is * 1\) To explore mediating factors of our group visit model with added BA therapy that are associated with improvement in CVD risk and depression" NCT04472962,The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.,"Inclusion Criteria: * Age 18-70 years. * Type 1 diabetes ≥ 5 years. * Insulin pump use ≥ 1 year. * Use of flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) ≥ 3 months. * Body mass index 18.5-30 kg/m2. * HbA1c ≤ 64 mmol/mol (8.0%). * Self-reported hypoglycemia awareness * Ability to carbohydrate count for all meals. * Familiarity with the insulin pump bolus calculator for all meals. * Moderate to vigorous level of physical activity Exclusion Criteria: * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start. * Use of Metronic Minimed 670G insulin pump system. * Allergy to paracetamol or nuts * Females who are pregnant, breast-feeding or intend to become pregnant. * Heart disease. * Severe asthma. * Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation.","Background: People with type 1 diabetes practicing a low-carbohydrate diet can increase the fat and/or protein content of the diet to cover their energy needs. In relation to physical activity, ingestion of protein is preferable for muscle protein synthesis and enhances structural changes in non-muscle tissues such as tendons and bones. Furthermore, addition of ≥ 28 g of protein to a meal is likely to result in significant and sustained postprandial hyperglycemia commencing in the late postprandial period (2-3 h) and continuing beyond 5 h in people with type 1 diabetes. The protein-induced change in the postprandial glucose response could be beneficial in relation to prevention of exercise-induced hypoglycemia. Hypoglycemia is a common fear in people with type 1 diabetes and makes many abstain from exercising. This study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content. This study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia. The study may add new aspects to current guidelines for glucose management during exercise in people with type 1 diabetes. If the strategy has a positive effect on preventing exercise-induced hypoglycemia it will be useful to all people with type 1 diabetes irrespective of diet strategy. Study design: The study is a randomized, two-arm crossover trial including one screening visit, two study days and a short visit after each study day, where the participants must meet to upload research data. The study will include adults with type 1 diabetes on insulin pump therapy using flash glucose monitoring (FGM) or continuous glucose monitoring (CGM). 15 participants have to complete the study. The study days are identical except for the content of the pre-exercise meal (low-carbohydrate-high-protein meal versus high-carbohydrate-low-protein meal) and the size of the meal bolus. Meals are isocaloric. The participants will complete two study days in random order with a 10-14 days washout period between. 48 hours prior to each study day blood glucose will be monitored by CGM and activity level will be monitored by an activity monitor wristband. Each study day is divided into an in-clinic period, which takes place at Steno Diabetes Center Copenhagen (SDCC), and a home period, which takes place in the participants own homes. The participants will arrive at the research facility in the morning following an overnight fast. A pre-exercise meal with either low-carbohydrate-high-protein content or high-carbohydrate-low-protein content will be served. To estimate the gastric emptying 1g paracetamol will be added to the meal. After ingesting the meal and 90 min of resting the participants must perform 45 min of exercise on an ergometer cycle equaling to 60 % of their peak oxygen consumption or until hypoglycemia (plasma glucose \< 3.9) or unbearable symptoms of hypoglycemia. Throughout the in-clinic study day the participants must use their insulin pumps. The basal insulin rate and meal-bolus will be adjusted according to international guidelines. Blood samples for analysis of glucose, insulin, glucagon, cortisol, adrenalin, noradrenalin, growth hormone, ketones, lactate, free fatty acids, GLP1, GIP and inflammatory markers will be collected. Indirect calorimetry will be performed before, during and after exercise to measure energy expenditure, respiratory exchange ratio and carbohydrate and fat oxidation rates. The Borg Scale will be used to assess perceived exertion during the exercise and a visual analog scale will be used to assess the feeling of satiety during the study day. Leaving SDCC the home period begins. Throughout the home period the blood glucose and activity level will be monitored by the CGM and the activity monitor until the next morning, where the study day ends. From the research facility the participants will be provided a standard evening meal and a bedtime snack. The participants will also be provided dextrose tablets, which they must ingest in case of hypoglycemia. Within one week after both study days, the participants must meet at the clinic to upload research data." NCT03274362,Headspace Mindfulness App Trial,"Inclusion Criteria: * Provides full informed consent to participate in the study * Established diagnosis of diabetes mellitus according to Canadian Diabetes Association criteria at the time of screening for the study * Has an age ≥12 years * Has a most recent HbA1C measurement of ≥8% * Has access to an electronic device that supports Headspace (i.e., tablet or smart phone) Exclusion Criteria: * Has a most recent HbA1C measurement of \<8% * Has a physical disability or psychiatric diagnosis which would limit the ability to adhere to the study regimen, as judged by the investigator","Stress has been associated with diabetes mellitus, and is believed to both precipitate the onset and disrupt the control of diabetes. The overall quality of life, measured as physical and social functioning and perceived as physical and mental well-being, has been shown to be adversely impacted in those living with diabetes compared to people with no chronic illness. Both the physiological effects of poorly managed diabetes and the psychological stress of dealing with chronic illness can have negative tolls on the physical, social and mental well-being of the patient. Although the emotional problems in diabetic patients have received increasing attention in the recent decade, these issues often remain unrecognized in clinical practice and untreated. Previous research suggest that antidepressant medication and cognitive behavioral therapy can be effective in the treatment of major depression in a proportion of diabetic patients; however, the use of these medications is often accompanied by side effects, lack of response to medication, or relapse. One accessible group intervention that proved successful in reducing emotional distress and improving quality of life in nonpatients and patient groups is mindfulness-based cognitive therapy. The central component of such intervention is the cultivation of mindfulness. Mindfulness, the mental state of awareness of internal and external experiences, has been used as a technique in numerous types of therapies. Previous studies suggested that increased levels of mindfulness through mindfulness-based cognitive therapy mediated the effects of inventions on depressed and angry mood and stress in diabetes outpatients. Practice of mindfulness, such as meditation, has indicated correlation with well-being and perceived health, and that dispositional mindfulness may buffer against the negative impact of perceived stress on psychological well-being. Furthermore, mindfulness may be associated with better glucose regulation in diabetics, as individuals with higher levels of mindfulness may have a lower likelihood of obesity and greater sense of control. Hence, the role of mindfulness in the management of diabetes warrants further investigations. A promising digital health platform, Headspace, provides guided meditation sessions, mindfulness training, meditation resources via a software application. Headspace has already been used in a number of clinical trials exploring the effects of mindfulness training. For instance, one study examining the impact of mindfulness on workplace stress found significant increases in well-being and perceived job control, and reductions in anxiety, depressive symptoms, diastolic blood pressure and sleep problems. The objective of this study is to determine the effectiveness of using the Headspace mindfulness application compared to the standard care of providing resources on mindfulness to patients with diabetes. Specifically, the study will test the hypothesis that participants randomized to the Headspace app group will exhibit greater improvement in HbA1C and quality of life measures compared to those randomized to standard care. Participants randomized to mindfulness app group will be given 3 months of free access to Headspace, a digital service that provides guided meditation sessions and mindfulness training. Headspace consists of video sessions on the foundations of mindfulness, health, relationships and performance. Participants randomized to standard care will not receive Headspace, but instead, a list of resources on mindfulness and health, until the 3-month study is complete. At the 3-month visit, participants in both groups will have HbA1C taken and quality of life questionnaire completed. No further data will be collected after the final 3-month visit. At this time, participants in the control group will receive the same 3-month access to Headspace as if the participants had been randomized to the treatment group, for equality purposes." NCT07199946,A Phase I/II Trial to Preserve Residual Insulin Secretion in Children With Recent Onset Type 1 Diabetes by Giving Verapamil,"Inclusion criteria: • Informed consent given by patients and caregivers/parents * Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening * Age 4.00 -9.99 years at Diagnosis of Type 1 diabetes * Fasting C-peptide \>0.12 nmol/ml * Elevated levels of any diabetes-related antibody/ies (eg GADA, IAA, IA-2A, ZnT8A ) is/are present. Exclusion criteria: • Cardiac disease/problems, abnormal ECG, or history of abnormal blood pressure * Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted) * Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted) * Treatment with any oral or injected anti-diabetic medications other than insulin * A history of anaemia or significantly abnormal haematology results at screening * Participation in other clinical trials with a new chemical entity within the previous 3 months * Inability or unwillingness to comply with the provisions of this protocol * A significant illness other than diabetes within 2 weeks prior to first dosing. However treated celiac disease and hypothyroidism with adequate treatment will be accepted. * Deemed by the investigator not being able to follow instructions and/or follow the study protocol","Type 1 diabetes (T1D) is by far the most common chronic, serious, life-threatening disease in Sweden, and tends to become an extremely serious global problem. Residual insulin secretion is of crucial importance to facilitate treatment, prevent acute and late complications and improve quality of life. Primary objective: To evaluate the effect on preservation of residual beta cell function but treatment with Verapamil Secondary objectives: To evaluate safety, but also clinical efficacy of Verapamil treatment such as blood glucose control and prevention of acute complications, and immunological effect on the disease process Primary outcome: • Change in C-peptide AUCmean 0-120 min) during an MMTT from baseline to month 24. Secondary outcome: * Change in C-peptide fasting and 90 minute value during an MMTT from baseline to month 24 * Proportion of patients with peak C-peptide \> 0.20 nmol/l at month 24 * Hemoglobin A1c (HbA1c), change between baseline and subsequent visits * Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits * Safety and tolerability Trial population: Patients must be 4.0 - 9.99 years old, and diagnosed with type 1 diabetes (T1D) within the previous 3 months at the time of screening. Number of subjects: Part A: 6 Part B: 30 (In total 36) Inclusion criteria: * Informed consent given by patients and caregivers/parents Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening * Age 4.00 -9.99 years at Diagnosis of Type 1 diabetes * Fasting C-peptide \>0.12 nmol/ml * Elevated levels of any diabetes-related antibody/ies (eg GADA, IAA, IA-2A, ZnT8A ) is/are present. Exclusion criteria: * Cardiac disease/ problems * Abnormal ECG * history of abnormal blood pressure * Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted) * Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted) * Treatment with any oral or injected anti-diabetic medications other than insulin * A history of anaemia or significantly abnormal haematology results at screening * Participation in other clinical trials with a new chemical entity within the previous 3 months * Inability or unwillingness to comply with the provisions of this protocol * A significant illness other than diabetes within 2 weeks prior to first dosing. However treated celiac disease and hypothyroidism with adequate treatment will be accepted. * Deemed by the investigator not being able to follow instructions and/or follow the study protocol Intervention: The study is a Phase I/II trial, with two parts: A. 6 patients participate in an open controlled study without any placebo with the primary aim to evaluate safety. After a baseline evaluation including ECG, physical examination, mixed Meal Tolerance Test evaluating residual beta cell fuction, these patients will be treated for 12 months with Verapamil 3-6 mg/kg body weight/24 hrs, divided into two daily doses. When these 6 patients have been followed for 6 months, and safety and tolerability is regarded as good, part B will start: In part B the next 30 patients will be randomized 1:1 in a double-blind placebo-controlled study into two arms: 15 patients will receive active treatment for 12 months with Verapamil 3-6 mg/kg body weight/24 hrs divided into two daily oral doses, while 15 patients will receive placebo in two daily doses for 12 months. Efficacy will be evaluated with MMTT and clinical response ( insulin dose/kg body weight/24 hrs, HbA1c, and CGM data on Glucose Time in Range), from baseline and after 12 and 24 months. Investigational medicinal product(s), dosage, administration: 3-6 mg/kg body weight/24 hrs of Verapamil ( Isoptin) is given per os two times per day Ethical considerations, benefit/risk: There is a great benefit of preservation of residual insulin secretion, and therefore therapies aiming at preservation of this function justifies treatments that are quite heavy, even dangerous and expensive. Thus it has been regarded as justified to treat even children with Type 1 diabetes at onset with drugs like monoclonal antibodies against the CD3-receptor, which causes adverse events in principally all patients, some even quite serious adverse events and risks. Even cytostatics have been used. The investigators will here use oral Verapamil, a drug which is used as antihypertensive treatment in different ages, even in children in the neonatal period, with limited adverse events and risks. Verapamil treatment has shown encouraging results preserving beta cell function in Type 1 diabetes in adults, and the investigators expect to get similar positive effects also in young children, in whom so far no immune intervention has shown efficacy. Thus, there is a clear possibility of therapeutic benefit, whereas the risk is very small, which makes the trial ethically justified." NCT04905589,Medium Chain Triglycerides (MCT) and Whey Protein Isolate (WPI) for Type 2 Diabetes Patients (Combine),"Inclusion Criteria: 1. Male or female subjects, 25 to 65 years of age, inclusive. 2. Subjects with a BMI of ≤ 40kg/m2. 3. Established diagnosis of Type 2 diabetes mellitus (T2DM), documented by either HbA1c 6.5 -10.0% or active therapy with metformin at a daily dose of up to 3000 mg at screening. 4. Willing and able to sign written informed consent prior to study entry. 5. Subjects with laboratory parameters within normal range, or showing no clinically relevant deviations, as judged by the investigator. 6. Willing and able to comply with the requirements of the study protocol. Exclusion Criteria: 1. Fasting blood glucose \>11mmol/L at screening. 2. Elevated liver transaminases \> 3 Upper limit of normal at screening. 3. Ongoing or recent (i.e. \< 3month) insulin therapy. 4. Ongoing or recent (i.e. \< 3month) GLP-1 therapy. 5. Ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin. 6. Ongoing or recent weight loss interventions (e.g. dietary weight loss programmes) or any history of bariatric surgery. 7. Ongoing treatment with anorectic drugs, steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption. 8. Major medical/surgical event requiring hospitalization in the last 3 months. 9. Known allergy and intolerance to product components. 10. Alcohol intake higher than 4 units per day in line with National Health Service guidelines. 11. History of regular smoking (daily or most days in a week) or use of nicotine products (3 or more nicotine containing products). 12. Have a hierarchical link with the research team members. 13. Subjects who have been dosed in another clinical trial with any investigational drug/new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to screening, or subjects currently participating in any investigational trial. 14. Positive pregnancy test at screening for women of child-bearing potential. 15. Subject who, in the judgment of the investigator, is likely to be noncompliant or uncooperative during the study due to language barrier, poor mental development or any other reason. 16. Subjects with fasting blood glucose that is not within 20% of the value at the previous study visit. Note: In such cases, subjects can come in on another day within the visit window at the discretion of the investigator, however, subjects will be discontinued if the same observation is made at the new visit. 17. Evidence of eating disorders and regularly skipping breakfast and dinner. 18. Current or recent history (in last 3 months) of clinically significant gastrointestinal, liver, cardiovascular, clotting, metabolic or endocrine disorders, apart from T2DM, that in the opinion of the investigator might put the subject at risk by entering the study or interfere with the aims of the study. 19. Total score of ≥ 20 on the Eating Attitude Test (EAT-26) at the screening visit.",The purpose of this study (Combine) is to evaluate the effects of Combined Intake of Medium chain triglycerides (MCT) at breakfast and whey protein isolate (WPI) preload at lunch and dinner for patients with type 2 diabetes NCT05958368,Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes,"Inclusion Criteria: * Participant reported diagnosis of Type 2 diabetes * HbA1c between 5.7%-11% (inclusive) and / or fasting blood glucose of ≥ 100 mg/dL * BMI 27-50 kg/m2 (inclusive) * Age range - 18 - 65 years (inclusive) * On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) * Willing to follow all requirements of study protocol including blood draws * Under the care of a physician who will be responsible for managing the subject's diabetes * Willing to give release to provide their treating MD with information about the trial Exclusion Criteria: * Not willing or unable to consume study foods including avocados * Participation in a weight control program within the past 3 months or weight loss of ≥ 5 kg in the previous 3 months * Taking prescription or OTC weight loss medications within last 4 weeks * History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve) * History of major surgery within three months of enrollment * Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (including rosiglitazone and pioglitazone) * Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL * Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL) * ALT \> 3 (IU/L) times the upper limit of normal (normal range is 7-56) * Evidence of more than 1 severe hypoglycemic event (episode requiring emergency medical services) in the past 12 months, unless the participant's treating physician provides written clearance for participation. * Those on higher doses of diuretics (furosemide 40mg or higher or comparable) * Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia) * Presence of implanted cardiac defibrillator * Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test. * Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable * Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea, or active gallbladder disease * Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled. * Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year) * Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control * Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to stop intake during study participation * Participation in another clinical trial within 30 days prior to enrollment * Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial",N/A NCT05482789,Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes,"Inclusion Criteria: * Pregnant women (singleton) * Gestational diabetes not requiring medical therapy * Between 18 and 50 years of age * Able to give written informed consent Exclusion Criteria: * Women in the first trimester of pregnancy * Hematocrit less than 30% * Current or past treatment with any hypoglycemic agent * Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment. * Women with high triglyceride levels, history of gallbladder or pancreatic disease. * Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)",N/A NCT03220750,University Hospital Advanced Age Pregnant Cohort,"Inclusion Criteria: * Female aged ≥ 35 years * Less than 14 gestational weeks * Planning to receive prenatal healthcare and delivery service at the study hospital Exclusion Criteria: * Inability to provide informed consent * Women with mental disorders","The UNIHOPE Cohort is set up to provide comprehensive evidence for the prevention and treatment of gestational complications in pregnant women with advanced maternal age, and therefore, to meet the growing clinical challenges of increasing pregnant women with advanced age in the two-child era. The UNIHOPE Cohort is planning to recruit 22,000 pregnant women aged ≥35 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between July 2016 and December 2020. All women will be enrolled prior to 14 wks of gestation, followed up at 24-28 wks, 32-34 wks of gestation, delivery, and 42 days postpartum. Data including demographics, medical history, reproductive history, prenatal health care, gestational complications, and pregnancy and birth outcomes will be collected via electronic data capture system. Venous blood of the pregnant women will be collected at enrollment and each follow-up visit during pregnancy, and placental tissue, cord blood and hair of the newborn will also be collected." NCT01113918,Expression of CVD and HA Between Obesity and Non-obesity Polycystic Ovary Syndrome (PCOS) Women in Taiwan,"Inclusion Criteria: * women who had visited the Reproductive Endocrinology Clinic at Taipei Medical University - Wan Fang Medical Center during April 2004 - March 2007 with the chief complaints of menstrual irregularities, infertility, acne/or hirsutism. Exclusion Criteria: * women who had been diagnosed with androgen-secreting tumors. * girls who had their menarche less than 3 years prior to the study, or who older than 40. * women with inadequate clinical/biochemical records.",N/A NCT04948918,Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension,"Inclusion Criteria: * informed consent of participation in the study; * systolic BP \> 140 or diastolic BP \> 90 mm Hg; * type 2 diabetes mellitus (glucose tolerance test \> 11.0 mmol/l, HbA1c\>6,5%); Exclusion Criteria: * secondary hypertension; * type 1 diabetes mellitus; * acute renal failure; * traumatic kidney injury; * toxic kidney injury; * CKD G4 and G5 according to the KDIGO 2012; * infectious diseases requiring active antibacterial and/or antiviral therapy; * other severe diseases and conditions","Detailed Description: Diabetes mellitus and hypertension are two major causes of chronic kidney disease (CKD) that starts as subclinical decline in renal function that silently progresses to symptomatic advanced stages associated with irreversible significant damage of the kidney structure. Recent major improvements in pharmacotherapy of hypertension and diabetes have substantially reduced the prevalence of cardiovascular complications, yet, the frequency of CKD remains largely unchanged. Renal denervation is a new minimally invasive method to create regional blockade of the renal sympathetic nerves that is currently used as non-pharmacological therapy of hypertension. The CKD is likewise mediated by overactivity of renal sympathetic system so that RDN has strong potential to prevent development or progression of CKD. The new anatomically optimized distal RDN may have additional benefit in this regard. Denervation of the distal vessels involved in tonic regulation of renal blood should cause a significant drop in renal vascular resistance and proportional increase in blood and oxygen supply to the kidney preventing/reducing chronic hypoxia of renal tissue that is major mechanism of CKD. The aim of this study is to prove the aforementioned concept. For this purpose the eligible patients with type 2 diabetes mellitus and hypertension will undergo distal renal denervation performed using dedicated radiofrequency catheter Symplicity Spyral. The changes in the kidney function and structure as well as BPs (office and ambulatory) will be assessed at baseline, 6 and 12 months post-procedure" NCT05806190,Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure,"Inclusion Criteria: for test group: * Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year. * Adults aged above 18 years for matched control group: * Diabetes mellitus excluded on baseline blood review * Adults aged above 18 years Exclusion Criteria: * Measured eGFR ≤ 30 * Acute illness * Abnormal thyroid function * Admission to hospital * Pregnant or planning pregnancy * Breastfeeding * Enrolled in other clinical trials, except at the discretion of the chief investigator * Have active malignancy or under investigation for malignancy * Severe visual impairment * Reduced manual dexterity * Unable to participate due to other factors, as assessed by the Chief Investigators","PURPOSE OF THE STUDY The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars throughout the day and night. This study will assess how often hypoglycaemia occurs, especially at night, and whether the type of steroid tablet people take affects how often hypoglycaemia happens. STUDY AIMS 1. To measure how often low blood sugars occur at night in people with both AI and insulin-treated diabetes using CGM, and in people without diabetes who are matched in age, sex and steroid replacement (hydrocortisone or prednisolone). 2. To compare the frequency of low blood sugars in people taking prednisolone for their AI versus those taking hydrocortisone. 3. To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone. STUDY DESIGN This study will observe 16 adults with both insulin-treated diabetes and adrenal insufficiency and 16 adults without diabetes who are matched for age, sex and steroid replacement. The investigators will aim to recruit 32 participants in total. Participants will spend 30 days in the study. RECRUITMENT Recruitment will be undertaken in endocrinology and diabetes clinics at Imperial College Healthcare NHS Trust. Participant information sheets will be given to potential participants and following any questions, informed consent will be taken. Participants will be given as much time as they require (at least 24 hours) to decide whether or not to take part - this can vary on a per participant basis." NCT01870713,Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus,"Inclusion Criteria: * patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass * age:18-65yr * HbAlc\>8% Exclusion Criteria: * diabetes (applies for control patients) * chronic inflammatory disease * malignant disease * pregnancy * prior gastric, duodenal, proximal jejunal surgery or pancreas resection * current use of thiazolidinediones * treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months * HbAlc\<8% * any condition felt by the investigator to interfere with ability to complete the study","Diabetes Mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. Recently，researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. However, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures. This study will enroll type 2 diabetes mellitus patients follwing Roux-en-Y gastric bypassing surgery and obese persons without type 2 diabetes surgery. The defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. Blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. The long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated." NCT01859013,Topiramate in Adolescents With Severe Obesity,"Inclusion Criteria: * BMI ≥1.2 times the 95th percentile (based on gender and age) or BMI ≥35 kg/m2 * 12-18 years old * Tanner stage IV or V by physical exam Exclusion Criteria: * Tanner stage I, II, or III * Type 1 or 2 diabetes mellitus * Previous (within 6-months) or current use of weight loss medication (patients may undergo washout) * Previous (within 6-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics) * Previous bariatric surgery * Recent initiation (within 3-months) of anti-hypertensive or lipid medication * Previous (within 6-months) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout) * Major psychiatric disorder * Females: Pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study * Tobacco use * Liver/renal dysfunction * ALT or AST \>2.5 times the upper limit of normal * Bicarbonate \<18 mmol/L * Creatinine \>1.2 mg/dL * Glaucoma * Obesity associated with genetic disorder (monogenetic obesity) * Hyperthyroidism or uncontrolled hypothyroidism * History of suicidal thought/attempts * History of kidney stones * History of cholelithiasis * Current use of other carbonic anhydrase inhibitor","The prevalence of severe pediatric obesity is on the rise and youth with this condition are at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Lifestyle modification therapy alone is ineffective for most adolescents with severe obesity and few patients qualify for bariatric surgery. Many patients would likely benefit from pharmacotherapy but only one medication (orlistat) is approved for use in adolescents but notable side effects and limited efficacy impede its clinical use. Topiramate, a medication approved by the Food and Drug Administration (FDA) for the treatment of seizures in adults and children, is associated with weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However, the weight loss effect of topiramate has never been evaluated among children and adolescents. Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with severe obesity. This will be a 28-week, randomized, double-blind, placebo-controlled, pilot clinical trial of meal replacement therapy (4 weeks) followed by topiramate (24 weeks) vs. meal replacement therapy (4 weeks) followed by placebo (24 weeks) for BMI reduction and cardiometabolic risk factor improvement in 36 adolescents (ages 12-17 years old) with severe obesity. Monthly lifestyle modification/behavioral counseling will be delivered by trained study coordinators to patients in both groups. The lifestyle modification education materials will be given to patients and selected sections will be discussed at each monthly contact (five face-to-face sessions and three phone sessions)." NCT04616482,Therapeutic Nutrition With Technology in Primary Care,"Inclusion Criteria: * Overweight or obese (BMI \>25 kg/m2) * At risk for T2D as deemed by physician * Diagnosed with T2D * Able to read and speak English (in order to communicate with the technology platform/app * Over the age of 18 Exclusion Criteria: * Unable to read or speak English (due to the app being provided in English) * Unable to access a computer or mobile phone that has access to the internet. * Currently compliant with a very low carbohydrate ketogenic diet or very low calorie commercial weight loss program * Planning to change doctors in the next 12 months.","The study is a non-experimental feasibility study to explore the acceptability, practicality and demand for the use of a 12-week, personalized, online program to teach and coach patients about therapeutic carbohydrate restriction for individuals with obesity and/or at risk for type 2 diabetes/with type 2 diabetes. The program is intended to enhance the usual clinical care provided for patients with these conditions and will allow for physicians to monitor patient progress through the program. Both physician and patient perspectives will be explored." NCT00961324,A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes,"Inclusion Criteria: * Male or female aged 18-65 years (both inclusive) * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index 18.0-28.0 kg/m\^2 (both inclusive) Exclusion Criteria: * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period",N/A NCT00971659,Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes,"Inclusion Criteria: * male or female subjects aged between 35 and 70 years, inclusive * type 2 diabetes with duration \>6 months and \<10 years * for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas * HbA1c \>=7.0% and \<=10.0% * if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start * written informed consent Exclusion Criteria: * history or presence of cancer or any clinically relevant diseases * chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months * recurrent hypoglycemia * abnormal lab tests at screening (ALAT and/or ASAT \>=3 times ULN), creatinine \>1.6 mg/dL in males and \>1.4 mg/dL in females * clinically relevant ECG findings at screening * treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months * treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months * any systemic or topical treatment with drugs known to influence glucose metabolism","Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c \< 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts." NCT02935179,The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity,"Inclusion Criteria: * 24≦ BMI≦30 Exclusion Criteria: * Pregnant and lactating women * Patients within six months after surgery * Mental illness or depression * Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases * Those who have taken ""additional nutritional supplements"" habit","All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination." NCT02181062,Culturally Tailoring a Stroke Intervention in Community Senior Centers,"Inclusion Criteria: * age 60 years and older * reported history of high blood pressure Exclusion Criteria: * younger than 60 years of age * not self-identifying as the racial-ethnic group for the intervention planned at that site * inability to communicate verbally in the appropriate language in a group setting (either due to lack of language skills, hearing impairment, or other disability) * inability to sit in a chair and participate in a 1-hour discussion session * inability to walk (the use of assistive devices such as canes and walkers is not an exclusion criterion) * not available to attend the baseline data collection session and subsequent weekly intervention sessions * plans to move away from the region during the next 6 months * lacking cognitive capacity to provide informed consent to participate","As many as 30% of ischemic strokes in the U.S. population can be attributed to physical inactivity. With the goal of eliminating racial/ethnic stroke disparities, this interdisciplinary team proposes to develop, implement, and test a culturally-tailored behavioral intervention to reduce stroke risk (primary prevention) by increasing physical activity (walking) for 4 different racial/ethnic groups (Korean-Americans, Chinese-Americans, African-Americans and Latinos) in Los Angeles community senior centers. The intervention combines stroke and stroke risk factor knowledge (using materials developed by the American Heart Association and American Stroke Association) with theoretically-grounded behavioral change techniques and focuses on reducing stroke risk by increasing physical activity (walking). The study team will conduct focus groups (n=144) to identify culture-specific beliefs about stroke and stroke risk factors, to assess the feasibility and acceptability of the intervention, and will work with Community Action Panels to culturally-tailor the intervention. The intervention will consist of 4 weeks of twice-weekly 1-hour group sessions implemented at 4 community senior centers by trained case managers who are part of the regular senior center staff and supported by congressionally-mandated Older Americans Act Title III funding. The project team will test the effectiveness of the intervention in a randomized wait-list controlled trial (n=240) testing the hypothesis that the intervention will increase mean steps/day (measured by pedometer) at 1 and 3 months, and that the increase will be mediated by changes in stroke/stroke risk knowledge and self-efficacy. Blood pressure will be examined as a secondary outcome. In collaboration with the SPIRP Biomarker Collection \& Analysis Core, the team will collect biological specimens (finger pricks) to explore the relationship between the intervention and biological markers of health; they will also explore the relationship between the intervention and healthcare seeking or taking medications to control stroke risk factors. The team will evaluate the barriers and facilitators of successfully integrating the intervention into the senior centers in order to inform large-scale implementation of the culturally-tailored stroke risk factor reduction/walking intervention." NCT04874246,Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy,"Inclusion Criteria: * Informed consent * Age: 19-60 year-old women * Plan of myomectomy for uterine leiomyomas * Leiomyoma Subclassification System 2-7 (robot-assisted laparoscopic myomectomy is possible) * American Society of Anesthesiologists Physical Status classification 1 or 2 * A person who understands the contents of the clinical trial, is cooperative with the trial, and is judged to be able to participate until the end of the study Exclusion Criteria: * Pregnancy or breastfeeding * A single diameter of uterine leiomyoma is greater than 12 cm or more or multiple leiomyomas with more than five * Suspicious disease of uterine malignancy * Patient with has a history of pelvic surgery (cesarean section, myomectomy, etc.) and is expected to have severe pelvic adhesion * A person who is hypersensitive or contraindicated to vasopressin * A person who is hypersensitive or contraindicated to tranexamic acid * Considered as inappropriate by the researcher's judgment","This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study. Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial." NCT00671346,NORVIT and WENBIT - Long-term Follow-up,"Inclusion Criteria: * Randomised in the Norwegian Vitamin Trial (NORVIT) or in the Western Norway B-Vitamin Intervention Trial (WENBIT) Exclusion Criteria: * Withdrawn consent to participate in study cohort for post-trial observational follow-up","The ""homocysteine-hypothesis"" of vascular disease has attracted considerable interest, as total plasma homocysteine levels can be easily lowered by folic acid and vitamin B12, raising the prospect that cardiovascular disease could be lowered by such B-vitamin supplementation. Two large B-vitamin intervention trials have been performed in Norway during the period 1998 to 2005, NORVIT and WENBIT, both registered at ClinicalTrials.gov, identifiers NCT00266487 and NCT00354081, respectively. The main objective in these trials was to study the effects of homocysteine-lowering therapy with folic acid and vitamin B12 to reduce the risk of cardiovascular events in patients with established coronary artery disease. The B-vitamin intervention, which included vitamin B6 in a 2x2 factorial design, was identical in the two trials. Follow-up was terminated for NORVIT on March 31st 2004 and for WENBIT October 5th 2005. Results from the NORVIT trial was published April 2006 {Bonaa, 2006} and preliminary results from the WENBIT trial were presented at the annual congress of the European Society of Cardiology September 4th 2007 {Zegers, 2007}. The WENBIT trial is completed and submitted for publication early in year 2008. So far, none of the B-vitamin intervention trials have shown any statistically significant favourable effect of homocysteine-lowering therapy with folic acid with or without concomitant vitamin B12 on cardiovascular events {Bazzano, 2006}. In NORVIT there was even a trend towards an increased risk of cardiovascular events (myocardial infarctions) in patients receiving the combination of folic acid, vitamin B12 and vitamin B6. This trend was not observed in WENBIT. However, the treatment with folic acid / B12 was associated With a more rapid progression of angiographic coronary atenoses {Løland, 2010}. Thus, the ""homocysteine-hypothesis"" of vascular disease has been attenuated through the emergence of these negative trial results, whereas a potential harmful effect of the B-vitamin intervention has been revealed. There is so far no data on possible long-term effects following years of B-vitamin supplementation. By combining analyses and follow-up in the NORVIT and WENBIT cohorts, we will probably have some more answers both considering possible subgroup and long-term effects of the B-vitamin intervention. Current data indicate that folate prevents cancer, especially breast and colorectal cancer. However, during the last few years several reports have challenged this assumption. Swedish observational studies found increased risk of colorectal cancer at high blood folate levels {Van Guelpen, 2006} and increased risk of prostate cancer at high levels of folate and vitamin B12 {Hultdin, 2005}. In a randomised trial with folic acid versus placebo to prevent colorectal adenomas, one found increased risk of cancer in the group receiving folic acid, especially of prostate cancer {Cole, 2007}. In a long-term follow-up of women taking high doses of folic acid throughout pregnancy one found a doubled risk of deaths attributable to breast cancer {Charles, 2004}. Recently it has been hypothesized that the implementation of folic acid fortification of foods may have been wholly or partly responsible for the observed increase in colorectal cancer rates in the USA and Canada in the mid to late 1990s {Mason, 2007}. This has led to new hypotheses that folate may prevent carcinogenesis but may enhance the growth of established cancer cells {Ulrich, 2007}. The question of possible adverse effects of folic acid supplementation will be of major importance when public health administrations decide whether to implement or enhance programs folic acid fortification of foods. The effect of the B-vitamin intervention will also be studied in relation to other life-style diseases like diabetes and osteoprosis. Additionally, the combined NORVIT-WENBIT cohort will used for observational studies evaluating new risk phenotypes or genotypes and their potential effect modification by the B-vitamin interventions." NCT04009603,"Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS","Inclusion Criteria: * The patient will be included according to the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine sponsored a PCOS consensus criterion which says the presence of any two of the following three features must be present for the patient to be diagnosed as a case of PCOS: * Oligomenorrhea and/or amenorrhea (Oligomenorrhea\>45 days or \<8 cycles per year and amenorrhea \>3 months in women with previous periodic menses) for a period of 6 months * Clinical and/or biochemical hyperandrogenemia, the presence of acne, hirsutism (FG score\>8), and alopecia * Polycystic ovaries on sonography (\>12 follicles in one or both ovaries, 2-9 mm in diameter and/or increased ovarian volume \>10 mL). Exclusion Criteria: * History of chronic diseases * Allergic to probiotic or metformin * Current or previous (within the last 6 months) use of chemotherapy or other drugs. * History of smoking * Individuals with autoimmune disease * Individuals with autoimmune disease.","Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries. The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most common cause. Metformin has been considered as the first line agent for the treatment of non-insulin dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS. Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like for ovulation clomiphene citrate must be given etc. So there is a need of novel and comprehensive agent that can prove to be effective in improving maximum symptoms of this disease. Probiotics have received renewed attention in the 21st century through research studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host. In recent year it has shown tremendous promising effect in treatment of different diseases like diarrhea, gingivitis and obesity etc with negligible side effects. In this context the investigators are going to evaluate and compare the effects of probiotics, metformin and their combination therapy in treatment of various symptoms of PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical trial. As mentioned above patients will be divided into three groups with 20 patients each. In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care Hospital" NCT04768127,Adipositas Care & Health Therapy,"Inclusion Criteria: relevant for all groups: * patients who have already approved to have their data entered into the National Registry of metabolic and bariatric diseases (StuDoQ, DGAV) * Sufficient knowledge of the German language to use the app, to communicate with the obesity case manager (obesity guide) and to fill out the questionnaires * signed consent form group specific criteria: Intervention group I (""early aftercare""): * Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern * Consent to participate in the selective contract * The bariatric metabolic operation (sleeve gastrectomy, Roux-en-Y-gastric bypass) was carried out 3 weeks (+/- 10 days) before the entrance examination * iOS or Android smartphone (operating system: iOS 11 or higher or Android 6 or higher) with internet access can be used for study * Sufficient mobility to get to the aftercare practice regularly and to complete an exercise program Intervention Group II (""medium-term and late after care"") recruited from control group I: * Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern * Consent to participate in the selective contract * The bariatric-metabolic operation (sleeve gastrectomy or Roux-en-Y-gastric bypass) was carried out 18 months (+/- 2 months) before time of recruitment Control group I (compared to early intervention): * Insured with the Allgemeine Ortskrankenkasse (AOK) Bayern * The bariatric metabolic operation was carried out 18 months (+/- 2 months) before time of recruitment * Sufficient mobility (see intervention group, so that groups are comparable) Control group II (compared to late intervention): * The bariatric metabolic operation was carried out 36 months (+/- 2 months) before the recruitment date * Sufficient mobility (see intervention group, so that groups are comparable) * The health insurance is irrelevant in this group Exclusion Criteria: * State after a revision operation * Planned two-stage surgical procedure","In Germany, every second adult is overweight and almost one in four is obese - the trend is rising. Obesity is a chronic illness which significantly increases the risk of developing co-morbidities such as cardiovascular and joint diseases, cancer and diabetes. In addition to those functional and health limitations, many people are stigmatised which can lead to social exclusion and a reduced quality of life. Available conservative therapies do not always lead to sufficient, long-term weight loss. In those cases and if the disease is very pronounced, an obesity surgery (bariatric-metabolic surgery) can help. In order to ensure its success, patients require long-term after care following surgery. Currently, there are no necessary outpatient care standards and provisions. Inpatient obesity centres try to compensate for this with their own structures and limited resources, but are already reaching their limits. The aim of the ACHT project is to ensure long-term therapeutic success after an operation. This is done through a digitally supported, structured, cross-sectoral and close-to-home aftercare program. Obesity case managers (obesity guides) coordinate the aftercare process and monitor the therapy goals. A digital case file links patients, case managers, resident doctors and obesity centers. Individual exercise goals, nutritional advice and psychological support are part of ACHT. ACHT is connected to quality assurance measures of a medical society. Four groups are compared in the ACHT study. One group begins their 18 months ACHT aftercare program directly after the operation, another group 18 months after the operation. These two groups are compared to patients who receive standard care. Through these two intervention groups, we hope to examine the long-term effects of the program within the given time constraints of the study. ACHT is funded for three and a half years by the Federal Joint Committee as part of the Innovation Fund with approx. 4.5 million euros." NCT00645827,Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients,"Inclusion Criteria: * Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled. * Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU). Exclusion Criteria: * At time of enrollment, patients with type I diabetes mellitus, * active acute or chronic pancreatitis, * history of pancreatic surgery, * use of a self-titratable insulin pump, or * history of β-islet cell transplantation were excluded. * At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of \> 20% in previous 24 hours, or * those without caloric intake while on IV insulin were excluded.",N/A NCT04642261,Effect of Empagliflozin on Liver Fat in Non-diabetic Patients,"Inclusion Criteria: * Potential study subjects will first be screened by transient elastography for the presence of hepatic steatosis (defined as a measurement of controlled attenuation parameter \[CAP\] \>= 248 db/M). * They will be recruited into study if steatosis is \>= 5% as confirmed by MRI-PDFF Exclusion Criteria: * DM (defined as hemoglobin A1c \[HbA1c\] \>= 6.5% or fasting glucose \>= 7.0 mmol/L) * alcohol intake \> 20g within past 2 years * concurrent chronic liver diseases (including chronic viral hepatitis infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, congestive hepatopathy, primary biliary cholangitis, primary sclerosing cholangitis, biliary tract obstruction) * drug-induced liver disease * usage of drugs that can lead to hepatic steatosis (e.g. steroids, amiodarone, valproate, methotrexate, tamoxifen) * decompensated cirrhosis (including ascites, hepatic hydrothorax, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome) * history of malignancy including HCC * recreational substance abuse * pregnancy * contraindications to empagliflozin use (estimated glomerular filtration rate \[eGFR\] \<45mL/min/1.73m2 as measured by the MDRD equation, history of recurrent genitourinary tract infections, gangrene, or allergy) * contraindications to MRI (e.g., claustrophobia, certain cardiac pacemakers, implanted medical devices with ferromagnetic properties).","Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25%. Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that reduce hepatic fat content in patients with DM, which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by transient elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy. The novelty of utilizing the concept of ""drug repositioning"" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration. The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of empagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients without DM. A total of 98 adult patients will be randomly sampled from the liver clinical in our local hospital. Empagliflozin 10mg daily will be given to the treatment arm. The placebo pill will be manufactured to be identical in appearance to the study drug. Eligible subjects will be followed up until week 52, and will undergo clinical, anthropometric and laboratory assessments (including liver function test and fasting blood) at baseline, week 6, 12, 26, 40 and 52. They will undergo LSM at baseline, week 26 and 52, and MRI-PDFF at baseline and week 52. The primary outcome will be a difference in change of liver fat content (measured by MRI-PDFF) at week 52 from baseline between the two groups. The secondary outcomes will be remission of steatosis (MRI-PDFF \<5%) at week 52, reduction of liver fibrosis (LSM) at week 26 and 52, improvement of laboratory results (including liver transaminases and ductal enzymes, fasting glucose, HbA1c, lipid profile), improvement of anthropometric measurements, and combined cardiovascular and cerebrovascular events. The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis and regress fibrosis in NAFLD patients without DM." NCT04261361,Community-based Cognitive Behavioral Therapy for Type 2 Diabetes,"Inclusion Criteria: * Patients have to meet the following criteria: 1) aged between 25 to 60 years; 2) living with Type 2 DM, 3) community dwelling, 4) independent in their activities of daily living as indicated on the Barthel Index and 5) obtained on screening a score of 5 to 9 on the Patient Health Questionnaire Depression Scale (PHQ-9). Exclusion Criteria: * Patients will be excluded by a clinician/ investigator for major depression within the past 6 months, lifetime history of other psychiatric disorder including psychosis, schizophrenia ad bipolar affective disorder, serious suicidal risk, alcohol or substance abuse and medical illnesses with prognosis of less than 12 months to live (as identified by reviewing their medical history), already taking medication or receiving psychological intervention for depressive disorders or related symptom, bedridden, having memory loss, not being able to understand or communicate in Chinese language, or refusing to give consent.","A community-based CBCBT is tested for patients living with diabetes(DM) and subclinical depression. The program includes both face-to-face group sessions and individual telephone sessions. The aim of the current study is to evaluate the efficacy of a mixed mode CBCBT in reducing depressive symptoms and enhancing adherence among adults with DM and subclinical depression. The intervention program consists of three components: 1) eight weekly sessions of face-to-face interventions, 2) four weekly consolidation individual telephone calls and 3) three monthly individual follow-up phone calls. This is a prospective randomized two-armed intervention study. The CBCBT intervention will be compared with enhanced treatments usual (ETAU) using a single blinded randomized design. The intervention will be delivered by qualified health care professional (e.g. clinical psychology/ social worker/ nurse counsellor) who have had some training in CBCBT in the initial training." NCT03894761,Night Pain in Patients With Rotator Cuff Syndrome,"Inclusion Criteria: * To be diagnosed with rototor cuff pathology by magnetic resonance imaging * Age range between 18-65 years old * To be literate and cooperative Exclusion Criteria: * Having shoulder pathology other than rototor cuff pathology (Glenohumeral instability, Bisipital tendon lesions, Glenohumeral joint osteoarthritis, Acromioclavicular joint osteoarthritis, Milwaukee shoulder) * Having complete rotator cuff tear * Patients with a history of shoulder or cervical surgery * The presence of cervical pathology * Patients with a history of fracture in the shoulder with pain * Local corticosteroid injection history for the shoulder (over the last 6 months) and using painkiller regularly * Physical therapy history for the shoulder (in the last 3 months) * The presence of systemic inflammatory disease * Malignancy * Pregnancy * A history of any psychiatric disorders","Patients who were diagnosed as rotator cuff syndrome by clinical examination and magnetic resonance imaging will be included in this prospective study. Demographic data (gender, age, education level, occupation), shoulder pain duration, history of trauma to the shoulder, smoking, dominant arm and diabetes will be questioned and body mass indexes will be calculated. Active shoulder range of motion of the patients will be measured by goniometer and recorded . Specific tests, which are important for rotator cuff lesion, will be performed to determine whether they are positive or not. Magnetic resonance imaging of the patients with shoulder pathology will be recorded. A visual analog scale will be used to determine the intensity of day and night pain. Shoulder Shoulder Pain and Disability Index to assess shoulder disability of patients, SF-36 form will be filled by patient to evaluate the effect of shoulder pathology and Kinesiophobia Score to assess the avoidance of pain induced movement." NCT04970108,Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension,"Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years; * Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months; * Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies. Exclusion Criteria: * Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * History of alcohol abuse or illicit drug use; * Participation in a clinical trial in the year prior to this study; * Pregnancy or risk of pregnancy and lactating patients; * Known hypersensitivity to any of the formula compounds; * Type 1 diabetes mellitus; * Known or suspected secondary hypertension.",N/A NCT00491725,Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs,"Inclusion Criteria: * Type 2 diabetes for at least 12 weeks * HbA1c: 8.0-10.0% * Current treatment with OAD on monotheray or OAD on combination therapy * Body mass index (BMI): 21.0-35.0 kg/m2 Exclusion Criteria: * Known or suspected allergy to trial product(s) or related products * Recurrent major hypoglycaemia as judged by the Investigator * Uncontrolled hypertension * Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator",N/A NCT03843840,Dual Wavelength OCT,"Inclusion Criteria: * Age\>18 * Ability to consent * Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine * clinical care Exclusion Criteria: * Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of * the retina and/or choroidal substructures in the opinion of the investigator * Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.","Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material." NCT01934140,Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination,"Inclusion Criteria: All subjects must satisfy the following criteria at study entry to the persistence phase: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between and including 17 and 66 years of age at the time of entry into the present study. * Has completed the vaccination phase of the vaccination study MENACWY-TT-015. * In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects ≥18 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent. * Healthy subjects as established by medical history and history-directed physical examination before entering into the study. All subjects must satisfy the following additional criteria prior to entry of the booster phase: * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: * Child in care. * Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015. * History of meningococcal disease due to serogroup A, C, W-135 or Y. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination. * Major congenital defects or serious chronic illness. * Family history of congenital or hereditary immunodeficiency. * History of chronic alcohol consumption and/or drug abuse. Additional exclusion criteria for booster phase at Month 120 study entry (to be checked at Month 120) for all subjects * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. Inhaled and topical steroids are allowed. * Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination (with the day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * Previous vaccination with tetanus toxoids within the last month. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. * Acute disease and/or fever at the time of enrollment. * Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.",N/A NCT03682250,Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes,"Inclusion Criteria: * Men and women ≥ 18 years old; * Be able to give informed consent; * Diagnosis of type 1 diabetes for ≥ 6 months; * Treated with intensive insulin therapy (multiple injections of insulin or insulin pump) AND EITHER * A history of CV disease defined as: 1) Established diagnosis of atherosclerotic coronary artery disease (example: previous history of infarction); 2) Previous cerebral Vascular Stroke or Transient Ischemic Accident; 3) Anterior revascularization of the coronary arteries, carotid artery or peripheral arteries; 4) At least one coronary stenosis, carotid artery or lower extremity arteries \> 50%; 5) History of symptomatic coronary heart disease confirmed with hospitalization or a positive stress test result or by any cardiac imaging result, or unstable angina with changes observed at the ECG; 6) Asymptomatic cardiac ischemia confirmed by a nuclear imaging test, an exercise test, a dobutamine stress echo; 7) NYHA II-III class chronic heart failure; 8) Amputation of limb or foot due to circulatory insufficiency. * Or more than 20 years duration of T1D and at least 2 of the following risk factors or associated condition: 1) Chronic renal failure eGFR \<60 ml / min / 1.73 m2); 2) Presence of micro or macro-albuminuria (albumin / creatinine ratio \> 2); 3) Hypertension or treatment for hypertension; 4) Hyperlipidemia or treatment for hypolipemia; 5) Abdominal obesity (Waist circumference\> 94 cm for men and \> 80 cm for women); 6) Smoking ; 7) Significant retinopathy (pre-proliferative, proliferating, laser or intravitreous injection); 8) Body mass index \> 30 kg /m2; 9) Erectile dysfunction; 10) Left ventricular hypertrophy; 11) Positive family history of early MCAS (H \< 55 years old and F \< 65 years old) Exclusion Criteria: * Definitive criteria: 1) QRS \> 120 ms on the baseline ECG; 2) Presence of atrial fibrillation at inclusion; 3) Current intake of any drug that may prolong QT according to the judgment of the investigator and the update of the list available on www.professionsante.com. * Transient criteria (the patient can be included once the anomaly is corrected): 1) Hypokalemia (\< 3.5 mmol/L); 2) Hypocalcemia (ionized calcium \< 1.10 mmol/L); 3) Hypomagnesemia (\< 0.7 mmol/L)",N/A NCT00944450,Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027),"Inclusion Criteria: * Subject is in good health * Female subjects must have a negative pregnancy test * Subject is within 30% of ideal body weight * Subject does not smoke * Subject agrees to follow the study guidelines Exclusion Criteria: * Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject * Subject has a history of hypoglycemia * Subject has a history of any hepatic disease * Subject is taking any oral, parenteral, topical or implantable contraceptives",N/A NCT06415097,Benefits of Smart Pens in Type 1 Diabetes,"Inclusion Criteria: * Individuals aged 18 or above * Individuals diagnosed with type 1 diabetes * Individuals receiving multiple daily doses of insulin * Individuals using a glucose monitoring device * Individuals who use or have used smart insulin pens since their introduction to the market Exclusion Criteria: * Individuals with other types of diabetes * Individuals utilizing continuous subcutaneous insulin infusion devices * Individuals using automatic insulin delivery systems","Rationale: Despite ongoing advancements in type 1 diabetes management, a significant number of patients continue to struggle in attaining recommended control goals, posing an elevated risk of complications and a diminished quality of life. Hence, there is a need for innovative interventions that genuinely improve diabetes management and associated clinical outcomes. Smart insulin pens, coupled with glucose monitoring devices, emerge as a promising treatment option for individuals on multiple daily insulin injections who may not be suitable candidates for continuous subcutaneous insulin infusion (CSII) therapy. These easy-to-use devices offer significant advantages, such as automated tracking of administered insulin doses along with information other relevant diabetes-related data, facilitating treatment optimization, and helping overcome barriers to achieve better glucose control where both patients and healthcare professionals can implement treatment plans with agility, adopting a more proactive and personalized approach to diabetes care. While certain recent studies have shown positive outcomes in glycemic control and quality of life linked to the utilization of these devices, there is still a gap in understanding their impact under real-life conditions. Hence, conducting clinical studies within the framework of routine clinical practice becomes imperative to thoroughly assess their application and effects on individuals with type 1 diabetes undergoing multiple daily insulin injections. The purpose of this study is to provide real-world evidence on the effectiveness of smart pens in enhancing glycemic control and identify specific patient subgroups for targeted interventions. Hypothesis: Our hypothesis suggests that the use of smart pens in patients with type 1 diabetes receiving multiple daily insulin doses and utilizing glucose monitoring devices is associated with improved glycemic control. It is expected that the use of these devices is linked to a significant increase in time in range, a reduction in time below the target range, and a decrease in glucose variability during the usage period, compared to a control group. Primary objectives: * To describe the clinical characteristics of individuals with type 1 diabetes using smart pens for multiple daily insulin doses in the Valencia Clínico-Malvarrosa Health Department, comparing it with a control group. * To evaluate changes in glycemic control parameters (HbA1c and continuous glucose monitoring parameters) as well as the incidence of adverse events with the use of smart pens in patients with type 1 diabetes, comparing it with a control group in real-life conditions. Sample size: The sample will include all adults (≥ 18 years) with type 1 diabetes who attend or have attended the Diabetes Unit of the University Clinical Hospital of Valencia, using or having used smart insulin pens, along with a control group matched for age, sex, diabetes duration, and HbA1c value at the study's outset (1:1). Data and study procedure: Data for this study will be sourced from the electronic health records of adults (≥ 18 years) with type 1 diabetes who attend or have attended the Diabetes Unit of the University Clinical Hospital of Valencia. The medical records of all participants using or having used smart insulin pens and glucose monitoring devices, as well as a control group (1:1), will be reviewed. Retrospective data will be collected on participant characteristics, the type of smart insulin pen used, and individual changes in glycemic control (HbA1c and glucose monitoring device parameters), as well as daily insulin doses, starting from the date of smart pen prescription. Additionally, all adverse events occurring during the use of smart pens will be documented, specifying their type and frequency for each individual. All data will be compiled in an anonymous Microsoft Excel database, which will be deleted upon completion of the study. Anonymization will be performed by an individual external to the clinical research team. Ethical aspects: The study database will not contain any information allowing the individual identification of study participants. The data will be used exclusively for the purposes described in this project. The information will be considered confidential and will be stored and processed in accordance with EU Regulation 2016/679 of the European Parliament and the Council of April 27, 2016, regarding personal data and the free movement of this data, as per Organic Law 3/2018 of December. Although there are objectives related to medication use, being a retrospective study makes it impossible to alter the prescription habits of any physician in the unit under study." NCT01570660,Phielix et al.: Hepatic Fat Content and Adipokines,"Inclusion Criteria: * well controlled patients with type 2 diabetes (Hb1Ac \< 8%) * no insulin therapy * no co-morbidities * stable medication use for the last 6 months * stable body weight the last 6 months * no diet in the last 6 months Exclusion Criteria: * Hb1Ac \> 8% * insulin therapy * diabetes-related co-morbidities, like cardiovascular disease, neuropathology * unstable medication use * unstable body weight in the last 6 months (\> 5 kg) * following a diet in the last 6 months",N/A NCT01880060,Tailored Worksite Weight Control Programs,"Inclusion Criteria: * Employed full time at an eligible worksite * Access to the internet * BMI \> 25 Exclusion Criteria: * BMI \< 25 * no internet access","This study will test the utility of a social ecological theory, individually-targeted internet-based intervention with monetary incentives to reduce the weight of overweight and obese employees (INCENT) when compared to a low-intensity, internet-based weight loss program without incentives (Livin My Weigh). Participants in INCENT will receive daily e-mail support that facilitates goal setting, regular assessments of body weight, and incentives based on percent of original body weight lost at the end of each quarter over the 12-month program. The e-mail supports will target improving perceptions of self-efficacy and outcome expectations related to weight loss or maintaining a healthy weight. In addition e-mail support will facilitate participant problem solving and identification of resources for healthful eating and physical activity at home, in their neighborhoods, and at their worksite. Participants in Livin My Weigh (LMW)will receive evidence-based physical activity and nutrition information to facilitate weight loss through quarterly newsletters and quarterly educational sessions." NCT05368220,Translating Genetic Knowledge Into Clinical Care in Non-Autoimmune Diabetes,"Inclusion Criteria: * Any case of non-T1D defined as debut \>30 years of age, OR debut \<30 years of age AND negative autoantibodies * Any case of diabetes diagnosed in pregnancy (obstetric departments) Exclusion Criteria: * Age \<18 years * Inability to provide informed consent","The TRANSLATE project is an integrative project with multifaceted goals, that can be broken down into two main columns. The foundation for both columns is the WGS analysis in a clinical diagnostic setting in order to guide patient treatment. Patients are not randomized and the inclusion and exclusion criteria are deliberately broad and minimal, respectively. The first column is the clinical development project, which seeks to complete a novel diagnostic process. This column will develop new pipelines and uncover barriers and challenges associated with gene-based precision medicine to facilitate sustainable implementation of gene-based precision medicine beyond the TRANSLATE project. During the project, we wish to focus on potential barriers against a broad application of gene-based precision medicine in a common disease. These may include: * Challenges pertaining to the selection of variants that are deemed clinically actionable, automation of genetic interpretation/translation, and the feasibility of large-scale precision medicine implementation * Ethical concerns of patients, clinicians, and other technicians with regard to the application and utility of genetic information * Validity and limitations of current computational pipelines for variant calling including the calling of structural variants and aggregate genetic tools * Challenges regarding the interoperability of IT systems and databases nationally in Denmark, specifically how central databases can be linked to clinical end-users * How implementation of genetic analyses affects clinical decision-making and/or clinical trajectories, both qualitatively and quantitatively The second column is a register-based research project in which we will utilize data from the patients to advance gene-based precision medicine. In this column we will both address how to establish comprehensive research infrastructure, as well as answer specific research questions. We will address how to combine and harmonize genetic data with other Danish registry sources. We will use the newly established methodologies to focus on the following research areas with respect to patient stratification, clinical trajectories, complication development, and other clinically relevant outcomes: * Polygenic risk scores * Machine learning algorithms * Combined polygenic and monogenic traits * Non-coding variation * Structural variation, specifically exon deletions and duplications, which have previously been shown as a cause of monogenic diabetes" NCT05307120,Lifestyle Monitoring and Coaching Using the Mobile DIAMETER Application in Secondary Care,"Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus * Being familiar with using a smartphone * Being treated in ZGT hospital or primary care Exclusion Criteria: * Dependence on renal replacement therapy * Severe general diseases or mental disorders make the participation in the study impossible * Insufficient mastery of the Dutch language * Other CGM device than Freestyle Libre.","INTRODUCTION Type 2 Diabetes Mellitus (T2DM) is a major chronic lifestyle-related disorder with a significant impact on quality and costs of care. As patients with T2DM often have insufficient knowledge about proper self-management and are insufficiently motivated for lifestyle change, interventions with more motivational strategies and personalization are needed. The use of real-time monitoring of glucose values, nutrition and physical activity in combination with coaching aimed at lifestyle-related behavior change may improve patients' diabetes management. It is hypothesized that a technology-supported lifestyle intervention is effective and a step forward in T2DM management. In the Twente region of the Netherlands, a personalized treatment strategy to improve lifestyle in T2DM patients is being developed by providing coaching and feedback in daily life through a mobile application, the Diameter. The development of the Diameter is a collaboration between ZGT hospital, University of Twente and Roessingh Research and Development Institute. The Diameter monitors food intake, physical activity and glucose values; it gives individual patients and healthcare professionals insight into lifestyle, blood glucose levels, as well as into the effect of lifestyle behavior on glucose values in daily life. Furthermore, the Diameter offers evidence-based coaching aimed at improving lifestyle, i.e. physical activity and nutrition. The coaching content offered in the Diameter comprises the e-supporter which is developed by the UT, ZGT and TNO within the E-Manager project. It consists of goal setting, daily lifestyle coaching via short messages and a weekly exercise that supports people to achieve selected goals for a period of ten weeks. An innovative and unique coaching strategy is the feedback on blood glucose levels through continuous glucose monitoring (i.e., FreeStyle Libre). This continuous feedback is considered to be a very powerful tool for behavior modification and offers great potential. The development of the Diameter is an iterative process. Since 2017, the monitoring and coaching elements of the Diameter have been developed, extended and validated in several studies. In a blended-care setting, the Diameter combines face-to-face counselling of usual T2DM care with the Diameter and continuous glucose monitoring through the FreeStyle Libre. OBJECTIVE The Diameter as a blended-care intervention has only been evaluated in a small pilot study (phase 1) in ZGT hospital to test the proposed research protocol for phase 2 with T2DM patients treated at the outpatient clinic. Therefore, information about the intervention usage and acceptability are not yet available, as well as proper data for sample size calculation in future effectiveness testing. The next step is to implement and evaluate the Diameter in practice regarding intervention usage and acceptability (e.g. effort expectancy, pleasure), and to explore its effect on clinical outcomes (e.g. glycemic control), physiological (e.g. body composition), behavioural (e.g. physical activity), and psychological outcomes (e.g. health-related quality of life). Phase 2, which is registered in this trial system, concerns a feasibility study in ZGT hospital to evaluate intervention usage and acceptability of the Diameter as part of usual care. Usual care includes traditional diabetes care, possibly for a subgroup of participants, supplemented by the combined lifestyle intervention ""Gecombineerde Leefstijl Interventie"" (GLI) COOL which will be offered by ZGT to their T2DM patients. STUDY DESIGN The Diameter will be assessed using a mixed-methods prospective longitudinal design among 80 patients with T2DM. Approximately 20-40 of them will also follow the COOL program as part of usual care. During the study, 3 rounds of measurement will be performed. Additionally, for participants who started the COOL program next to the use of the Diameter, an extra measurement moment after 8 months (T3) is included. The data for this measurement will be collected as part of usual care and will be extracted from the participants' health record with the patients' consent. The measurements will be performed at the following time points: * T0 (week 1-2): All participants will start with a two-week period of baseline measurements, including blinded glucose measurement (using the Freestyle Libre Pro IQ sensor), blinded nutrients intake measurement (using the Diameter app), a non-blinded physical activity measurement (using a Fitbit), other clinical and physiological outcomes and some questionnaires. * Use of the Diameter (week 3-12): All study participants use the Diameter for 10 weeks to receive digital personalized coaching with a maximum of 2 coaching messages per day and one exercise per week about goal setting and achievement. Also, they use the Diameter to monitor their physical activity and nutrition. They receive 2 Freestyle Libre 2 sensors with which they can measure their glucose values continuously for in total 4 weeks, using the LibreLink app. * T1 (week 13-14): All participants will perform a two-week period of measurements of all clinical, physiological, and behavioral outcomes, will fill in a number of questionnaires and 10-15 participants will be asked to participate in an interview about their acceptability of the Diameter. * Use of the Diameter ""light"" (week 15-24): The participants will use a ""light"" version of the Diameter, consisting of all functionalities of the Diameter except the daily coaching messages as they will stop automatically after 10 weeks. They receive 2 Freestyle Libre 2 sensors with which they can measure their glucose values continuously for in total 4 weeks. * T2 (week 25-26): All participants will again perform a two-week period of measurements of clinical, physiological and behavioral outcomes and will fill in some questionnaires. The follow-up measurement is performed after 6 months because it is assumed that there is a permanent change in behavior when the healthy behavior is maintained for a period of six months or longer. * T3 (week 34): Only applicable for participants who are also following the COOL program. After 6 months of using the Diameter, participants who also follow COOL will continue their trajectory with the lifestyle coach in ZGT. In the context of the COOL program, after 8 months some measurements are taken that are part of regular care, consisting of medication use, HbA1c, BMI and waist circumference. These data will be obtained with consent of the participant from the patient record. No additional measurements will be conducted for this purpose. These data will be used as a final follow-up measure to assess the extent to which these participants can maintain any progress in clinical and physiological outcomes after 8 months which is the end of the basic part of the program that focuses on behavioral change. STUDY POPULATION In phase 2, patients will be recruited in ZGT hospital. The patient population will consist of 80 T2DM patients (18+, male and female) visiting the outpatient clinic for T2DM at ZGT hospital. Patients who are already participating or participated in the DIALECT cohort will be recruited. The remaining number of patients will be recruited from the outpatient clinic in ZGT. Some of the T2DM patients recruited from the outpatient clinic also follow the COOL program within ZGT in addition to receiving regular diabetes care. People who will participate in the COOL program and want to participate in the study will start using the Diameter at the beginning of the COOL program. Patients who use blood glucose-lowering medication independent of their gender and socio-economic status will be included. STUDY SETTING This research project will be conducted within the outpatient clinic for diabetic care in the ZGT hospital. Patients will participate in the pilot study for 5 weeks and in the feasibility study, phase 2, for half a year. Research appointments will be combined with regular outpatient clinic or COOL visits as much as possible. Currently, 17 healthcare professionals are working in this specific outpatient clinic. The team consists of 8 internists, 7 T2DM nurses, one nurse practitioner and one technical physician specialist together treating 2500 patients with T2DM a year. The current patient population consists of 450 T2DM patients, they are on average 63 years old with a mean duration of 11 years, and most of them are male (58%). Their average BMI is 32.9 ± 6.2; almost all patients (95%) have a BMI higher than 25. In addition to traditional diabetes care, ZGT starts to offer the Combined Lifestyle Intervention (Gecombineerde Leefstijl Interventie; GLI) COOL to their T2DM patients. During the COOL program in ZGT, a professional lifestyle coach who is also a diabetes nurse will counsel adults with T2DM treated in ZGT who are obese or at high risk of obesity to achieve a healthier lifestyle. COOL consists of a basic part that focuses on behavioral change (8 months) and a maintenance part (16 months). In the first 8 months of the COOL program, participants follow 8 group sessions of 90 minutes and 4 individual sessions (2 sessions of 60 minutes, 2 sessions of 45 minutes)." NCT01786720,Analysis of the Time Taken to Triple Therapy (NOVARTIS),"Inclusion Criteria: * Aged ≥40 years at initial date of COPD diagnosis * COPD diagnosis with Quality Outcome Framework (QoF) approved read code * has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted) * Patient has one year of data prior to initial date of COPD diagnosis * Patient has a minimum of two years of data post initial date of COPD diagnosi Exclusion Criteria: * Patients whose initial date of COPD diagnosis is before 1997","Triple therapy consists of long-acting beta agonist (LABA) + inhaled corticosteroids (ICS) + long-acting muscarinic antagonist (LAMA) and typically should be reserved for patients who have severe to very severe (FEV1 \<50%) COPD symptoms or for patients who have two or more exacerbations per year. However previous research from RiRL indicate that 50% of patients at GOLD stage II (moderate) receive ICS of which half were on triple therapy. To allow for multiple analysis regarding the factors that influence the likelihood of being prescribed triple therapy, a bespoke COPD dataset will be created to include: 1. Disease severity markers: 2. Confirmation of a COPD diagnosis at initial date of COPD diagnosis 3. Standard co-morbidities fields 4. Demographic fields This retrospective, observational study using data of COPD patients will assess treatment pathways (changes/step up) from initial date of COPD diagnosis with the prescription of triple therapy as the endpoint. Specific questions that will be asked are: 1. Does the percentage of COPD patients prescribed triple therapy vary dependent on time of initial date of COPD diagnosis? 2. Does the time taken to the prescription of triple therapy vary dependent on initial date of COPD diagnosis?" NCT01487382,Special Survey for Paediatric Subjects,"Inclusion Criteria: * Requiring insulin therapy * No treatment history of NovoRapid® (insulin aspart)",N/A NCT04522882,Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1,"Inclusion Criteria: * Patient with T2D treated with insulin pump for at least 6 months * Patient with a body mass index (BMI) between 27 and 40 kg/m2 * Patient treated with a total daily dose of insulin between 40 and 300 U/24 h * Patient with CGM * Patient with Social security or beneficiary * Patient able to read and understand the procedure, and able to express consent for the study protocol Exclusion Criteria: * Patient with T1D * Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion * Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)","T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin. Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life. These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics. The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop." NCT01175824,Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies,"Inclusion Criteria: * Present with type 2 diabetes mellitus * Have been taking metformin and/or pioglitazone * Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days * Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5 * Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter \[mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)\], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons * Not pregnant or breastfeeding Exclusion Criteria: * Have Type 1 Diabetes * Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country * Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2). * Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks * Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study * Have cardiac disease with a functional status that is Class III or IV * Have a history of renal or liver disease * Have had a blood transfusion or have a blood disorder",N/A NCT05207059,Healthy Early Life Moments in Singapore,"Inclusion Criteria: 1. Women aged 21-40 years 2. BMI 25-40 kg/m2 3. Intention to reside in Singapore for the next 4 years 4. Chinese, Malay, Indian or any combination of these 3 ethnic groups 5. Planning to conceive within 1 year 6. Able to understand English 7. Able to provide written, informed consent Exclusion Criteria: 1. Currently pregnant 2. Known type 1 or type 2 diabetes 3. On any anticonvulsant medication in the past 1 month 4. On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron) 5. On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month 6. On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month 7. On HIV or Hepatitis B or C medication in the past 1 month.","Maternal Child Health (MCH) in Singapore is currently entering a new phase to address the twin challenges; a burgeoning (i) Metabolic and (ii) Mental Health Challenge for Singapore which have shown to have adverse effects on childbearing and child outcomes. To tackle these challenges, we are establishing a new Model-of-Care (MOC) with a life-course approach at KK Women's and Children's Hospital (KKH) through the Healthy Early Life Moments in Singapore (HELMS) cohort. Over the course of five years, HELMS will enroll 500 overweight or obese women aged 21-40 years planning for pregnancy, with an estimated 170 completing their pregnancies where they will be followed for another 18 months as a mother-child dyad. HELMS leverages on building a healthy mental model of life-course events through preconception to postpartum life. Components of intervention will focus on preconception-pregnancy-postpartum care and lifestyle guidance on diet, physical activity, emotion and sleep, complemented by health nudges to promote sustainable change. Various questionnaires and testing will be carried out at relevant time points. Biosamples including blood, cord blood and stool will be collected. Through the application of HELMS, there is potential to improve metabolic and mental health, break vicious transgenerational cycles of obesity transmission and promote virtuous life cycles of health in the population." NCT02098980,Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar,"Inclusion Criteria: * male or non-pregnant, non-lactating females, aged 18-75 * volunteered to participate by signing the consent form * BMI ˂ 40kg/ m2 * serum 25(OH) vitamin D3 (25(OH)D) concentration ˂75nmol/L * fasting serum glucose \<7.0 mmol/L * HOMA insulin resistance index ≥1.3 * presence of any ONE OR MORE of the following risk factors for type 2 diabetes: * high BMI (\>23) * high waist circumference according to IDF ethnic specific values for non- Caucasian (females \>80cm; males \>90cm) * family history of diabetes in first-degree relative (parent or sibling) * previous history of gestational diabetes * history of high blood glucose, high triglycerides and/or low HDL cholesterol Exclusion Criteria: * fasting serum glucose ≥7.0mmol/L * history of renal failure or liver disease * serum urea or creatinine \>1.8 times upper limit of normal (ULN) * serum aspartate or alanine transaminase (AST,ALT) \>1.5 times ULN * current use of drug or drugs to treat diabetes or which influence glucose metabolism * medical or surgical event requiring hospitalization within 3 months of randomization * presence of any condition affecting nutrient absorption","Epidemiologically, there is an association between elevated T2DM risk and low serum levels of vitamin D and suggest that it may protect against the diseases through the improvement of insulin sensitivity as well as secretion and reducing chronic inflammation. Although some of these effects were shown in clinical studies, no study permitted the inference that vitamin D can reduce blood glucose and attenuate inflammation. Post-prandial glucose is the most sensitive to alterations in insulin sensitivity. Therefore, it is rational to examine whether vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM and to elucidate the mechanism by which this occurs, i.e. via improved insulin sensitivity or improved insulin secretion, or both. Furthermore, identifying a distinct proteomics-based signature that can be used to distinguish responders to supplementation from non-responders is critical to define the bases for inter-individual variation in response and the effect of vitamin D on the prevention of T2DM. Identification of this proteomics-based signature will enable us to tailor alternative preventive measures to adjust the vitamin D dose to non-responders, leading to more effective and precise intervention protocols." NCT02131896,"The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes","Inclusion Criteria: * Parents/guardian are willing and able to sign an informed consent form * Age 5-18 years * Diagnosis with type 1 diabetes for up to 2 months prior to screening * Peak C peptide \> o.2 pmol/mL Exclusion Criteria: * The patient has any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator might interfere with patient's compliance or ability to complete the study * Any concomitant disease that might impact body composition, physical activity level and/or eating habits * Active celiac disease, hashimoto thyroiditis or uncontrolled Graves' disease * Down syndrome, Turner, inflammatory bowel disease * Patients treated with antipsychotic drugs, steroids, or other drugs that might affect body weight and appetite. * Patient who suffers from eating disorders * Patients participating in other device or drug studies",N/A NCT04219462,Effect of ESWT on ED in Type 2 Diabetics,"Inclusion Criteria: 1. Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function. 2. Patients who will have erectile dysfunction ( ED) from 6 months. 3. Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl. 4. Body mass index ( BMI) will be \< 30 kg/m² 5. The age of patients will be between 40- 60 years. Exclusion Criteria: * History of pelvic trauma, pelvic surgery, psychiatric disease. * Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries. * Vascular surgical intervention that recommended for the patients. * Other renal conditions, respiratory disease, liver failure. * Prostatectomy and patients with prostatic disease. * Patients lacking complete follow-up data. * hypogonadism.","ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups: Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg" NCT01735903,"Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression","Inclusion Criteria: * Patient has been diagnosed with diabetic peripheral neuropathy and has nerve deficit in all proposed surgical areas, sensory and/or motor * Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees. * Patient is between 18 years and 85 years of age * Patient is a type I or type II diabetic that is currently under medical treatment * Patient has a Hgb A1C lab value of 8.0% or less * Patient symptom based VAS scale is 6 or above for at least one of the following: pain, burning, numbness, tingling, weakness or instability * Patient is scheduled for surgery and has been cleared for outpatient surgery per anesthesia guidelines established for the Foot Surgery Center of Northern Colorado * Patient is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site for all required office visits and CSU visits * Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent Exclusions Criteria: * Patient has a BMI of greater than 40 or body weight greater than 300 pounds * Patient has untreated hypertension (systolic blood pressure \> 160 and/or diastolic \> 100) * Patient's ASA is 4 or greater * Patient has blood glucose greater than 200 the day of surgery * Patient has Raynaud's Syndrome * Patient is a current smoker * Patient is a woman who is considering pregnancy or who is pregnant * Patient has history of recent nerve or lumbar disc surgery, untreated thyroid disease, B12 or Folate deficiency, hepatic disease, renal disease, and/or Parkinson's disease, or neuropathy due to chemotherapy or radiation therapy * Patient is being treated with chemotherapeutic agents * Patient has ankle edema greater than mild - (Moderate to Severe) * Patient is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint","Nerve decompression (ND)as treatment for the foot complications of diabetic sensorimotor peripheral neuropathy (DSPN) is a controversial topic although many patients find it provides gratifying relief of pain and numbness. Neural electrical monitoring has been used intra-operatively to diagnosis nerve abnormality, monitoring for ongoing normal nerve function and confirm nerve integrity for spine surgeries and thyroid surgeries with success. Presently there is not objective data to indicate the the use of neural electrical monitoring is reliable or effective. The goal of this study is to measure objectively and quantifiable clinical surgical outcomes of nerve decompression surgery in diabetic neuropathy patients. The study is designed to measure changes in nerve function, gait, balance and blood flow in the lower limb." NCT02155127,Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study,"Inclusion Criteria: * Male and female patients over the age of 60 years * Diagnosed with moderate to severe CKD (stage 2-4) * Ambulatory (with or without use of an assistive device such as a cane or walker) * Living in the community, cognitively able to provide consent and understand directions for the tests * Cognitive ability to understand and carry out an independent home walking program * Access and ability to communicate with study staff on a weekly basis and available for follow-up testing. Exclusion Criteria: * Inability to carry out a program of walking independently at home * Unavailable for follow-up testing, estimated GFR \>60 ml/minx1.73m2 and \< 15 ml/minx1.73 m2 * Recent cardiac event (within the past 6 months) * Uncontrolled hypertension * Uncontrolled diabetes * Pulmonary disease that may limit the ability to progress with walking * Progressive neuromuscular disease * Any orthopedic or neuromuscular condition that may be exacerbated by increased walking activity * diabetic foot ulcer.",N/A NCT05352425,Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension,"Inclusion Criteria: 1. Age 21 years or above 2. End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure 3. Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes 4. Deemed an acceptable candidate for the implant procedure by the investigator 5. Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography Exclusion Criteria: 1. Known or clinically suspected baroreflex failure or autonomic neuropathy 2. History of intradialytic hypotension within the past 3 months 3. Secondary cause of hypertension except treated obstructive sleep apnea syndrome 4. BMI ≥ 45 kg/m2 5. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex","Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery. Following implantation of the device, subjects will be followed for 60 months." NCT03462017,Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus,"Inclusion criteria : * Male and female stable Type 2 diabetes mellitus (T2DM) patients. * Body Mass Index between 18 and 35 kg/m\^2. * Stable T2DM patients, but otherwise healthy as assessed by a clinical and laboratory assessments and detailed medical history. * Diagnosis of T2DM for at least 6 months at the time of the screening visit. * Glycosylated hemoglobin (HbA1c) \< 8.5%. * estimated glomerular filtration rate ˃60 mL/min/1.73 m\^2. * Flow-mediated dilatation (FMD) ≤7% at screening. * Treatment of T2DM with lifestyle interventions or stable oral antidiabetic treatment for at least 3 months prior to inclusion. * No clinically significant abnormality detected in cardiac echography, as assessed by certified Cardiologist, performed at screening. Exclusion criteria: * Any history or presence of clinically relevant or symptomatic gastrointestinal, hepatic, metabolic (except stable T2DM and controlled dyslipidemia), hematological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), or infectious disease, or ongoing cancer (including basal cell skin carcinoma), or signs of acute illness which as judged by the Investigator, may affect the patient's participation in or the outcome of this study. * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥30 mmHg within 3 minutes when changing from 10 min supine to standing position, at screening. * History of symptomatic bradycardia, fainting, collapse, syncope, or vasovagal reactions in the last 6 months. * Presence or history of drug hypersensitivity and/or allergy to any ingredients of the investigational product and/or non-investigational product diagnosed and treated by a physician. * Any subject who cannot be treated with sildenafil because of conditions mentioned in the contra-indication, warning and precautions sections of sildenafil product information notably subjects with anatomical deformity of the penis. * Loss of vision due to non-arteritic, neuro-optic, anterior ischemia assessed in ophtalmologic examination at screening. * If female, pregnancy (defined as positive β-human chorionic gonadotropin blood and urine test), breast-feeding. * Generally any medication which has a potential to interfere with the safety, pharmacokinetics of SAR247799 and sildenafil, or with study measurements is not allowed, and in particular: * Nitrates, all calcium channel blockers, phosphodiesterase type 5 inhibitors (except investigational medicinal product \[IMP\]), guanylate cyclase stimulators use or anticipated during the study; * Beta-blockers; * Glucagon-like peptide-1 agonists; * Insulins (all types); * Anticoagulants, antithrombotics except aspirin; * Any drugs which decrease heart rate; * Antiarrhythmics; * Digoxin; * Cholinergic agents eg pilocarpine or cholinesterase inhibitors eg neostigmine, guanidine; * Recent (≤3 months) use of systemic immunosuppressive or corticosteroid therapy; * Any inactivated vaccination (eg, seasonal influenza) during study treatment, any attenuated vaccination within 2 months before inclusion, and any biologics (antibody or its derivatives) given within 4 months before inclusion; * Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 3 days before inclusion as weak inhibitor of CYP3A4 gut wall metabolism. * Any severe dyslipidemia with fasting triglycerides \> 450 mg/dL. * Any hyperosmolar hyperglycemic episode with severe neurological symptoms (eg, coma, aphasia) in the last 3 months before screening. * Weight change of ≥5 kg during the last 2 months prior to screening. * History or presence of clinically relevant or symptomatic pulmonary disease, such as asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary fibrosis, pulmonary hypertension which as judged by the Investigator, may affect the patient's participation in or the outcome of this study. * Cardiovascular history such as: * History or presence of a clinically relevant or symptomatic cardiovascular disease such as acute coronary syndrome (ACS), stroke, transient ischemic accident (TIA), obstructive or congestive heart failure, or structural heart disease (e.g., valvular disease) which as judged by the Investigator, may affect the patient's participation in or the outcome of this study. * History of elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the past 6 months. * History of clinically relevant or symptomatic cardiac arrhythmia such as sustained ventricular arrhythmia, non-fixed supra-ventricular arrhythmia which as judged by the Investigator, may affect the patient's participation in or the outcome of this study or which occurred within the past 6 months * History of clinically relevant or symptomatic cardiac conduction abnormalities (any type of atrioventricular (AV) block, sick sinus syndrome, sinus node disease). * Patients with a pacemaker or implantable cardioverter defibrillator. * Known history of autoimmune disorders. * Any severe viral, systemic, fungal, bacterial or protozoal infection within the past 6 months or chronic severe infection (hepatitis, HIV infection, tuberculosis). * Presence of macular edema at fundus examination performed within 6 months before the first study drug administration. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",Study duration per patient is approximately 10 weeks including a 4-week treatment period. NCT06607068,Assessment of Taurine Concentration in Older Women With/Without Obesity And With/Without Type 2 Diabetes Mellitus,"Inclusion Criteria: Have not exercised regularly for at least 3 months; Exclusion Criteria: 1. use of insulin; 2. consumption of multivitamin supplements or antioxidant vitamins; 3. consumption of mineral supplements such as Copper, Zinc and/or Manganese; 4. liver disease; 5. chronic kidney disease; 6. coronary disease; 7. thyroid disorders; 8. infectious diseases; 9. regular consumption of alcoholic beverages; 10. smoking; 11. the Mini Mental State Examination (MMSE) will be applied, which has a total score ranging from 0-30 points. For the elderly women to be included in the study, they must have a score greater than or equal to 13 points","The aim of this study is to investigate whether health status (women with obesity, T2DM and no comorbidities) promotes changes in plasma taurine concentration and to correlate this concentration with biochemical markers (e.g. blood glucose, total cholesterol, insulin, glycated hemoglobin, triglycerides and HDL cholesterol). As well as to evaluate and compare the physical capacities of the different groups. Methods: Forty older women will participate in the cross-sectional study and will be allocated into four distinct groups, and will be classified as follows: older women with obesity and T2DM, older women with obesity and no T2DM, older women without obesity and with T2DM; eutrophic older women, with 10 older women in each group. The following will be performed: body composition assessment by total and regional body scanning using iDXA, anthropometry, tests to assess physical performance, peripheral blood collection for analysis of biochemical markers and the Physical Activity Level will be assessed using the Modified Baecke Questionnaire for Olders. For statistical analysis, One-way ANOVA will be used to verify the differences and compare the four groups. Expected results: It is expected that older women with obesity and T2DM will have lower plasma taurine concentration and also lower performance in physical tests, compared to the other groups." NCT02497768,Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils,"Inclusion Criteria: * Must be generally healthy * Must have eaten nuts within the last month with no adverse effects Exclusion Criteria: * Must not be allergic to nuts of any kind * Must not have any teeth missing (apart from unerupted wisdom teeth) * Must not have bleeding gums * Must not have had dental treatment (other than checkups) in the last 3 months * Must not be currently suffering from any infectious disease that may be passed on via saliva e.g. Glandular fever, flu",N/A NCT03598374,Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women.,"Inclusion Criteria: * Women with PCOS diagnosed by Rotterdam criteria in couple that desire to conceive. Exclusion Criteria: * Male infertility factor that require in vitro fertilization technique. * Women with infertility factors that require in vitro fertilization technique. * Couple with infertility factors that require in vitro fertilization technique. * Diabetes mellitus that require insulin or oral drugs treatment. * Any other pre-pregnancy or pregnancy-induced/related disease. * Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial.",N/A NCT05066997,A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1),"Inclusion Criteria (selection) - Stage 1: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening). Inclusion Criteria (selection) - Stage 2: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening). Exclusion criteria (selection) - Stage 1 and Stage 2: 1. Have macular edema considered to be because of a cause other than DME. 2. Have a decrease in BCVA because of causes other than DME. 3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.","A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME. Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME." NCT07187713,"ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases","Inclusion Criteria: * Adults (≥18 years) with nephropathy of any degree (microalbuminuria, overt proteinuria, CKD stages 1-5 not on dialysis, or post-transplant with proteinuria). Stable background therapy with ACEi/ARB, SGLT2i, or MRA allowed. Exclusion Criteria: * Recent kidney transplant (\<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.","Study Objectives Primary Objective: To evaluate the effect of ACE Reno on urinary albumin-to-creatinine ratio (ACR) after 12 weeks of treatment in patients with nephropathy of diverse etiologies. Secondary Objectives: To assess the effect of ACE Reno on estimated glomerular filtration rate (eGFR) slope. To evaluate changes in proteinuria, blood pressure, and patient-reported outcomes. To assess safety and tolerability. Exploratory Objectives: To explore biomarker changes (e.g., TGF-β, cGMP, NGAL, KIM-1). To assess durability of response up to 6 months in responders. Investigational Product (IP) ACE Reno is a sublingual solution (1 mL four times daily for 12 weeks) containing a standardized panel of low-molecular-weight bioactive peptides and amino acids. Key peptide domains include: BMP-7-like sequences countering TGF-β-driven fibrosis. HGF-like fragments supporting epithelial repair. Klotho-like motifs antagonizing profibrotic pathways and RAAS/Wnt activity. Natriuretic-peptide-like domains enhancing cGMP signaling, with anti-fibrotic, vasodilatory, and endothelial-protective effects. No genetic material is present; formulation is peptide-based only. Study Design Type: Prospective, multicenter, interventional, open-label. Model: Single-arm with within-patient comparisons. Duration: 12 weeks treatment + 4 weeks post-treatment safety follow-up. Visits: Screening, Baseline (Day 0), Week 4, Week 8, Week 12, and Week 16 safety call. Participants Inclusion: Adults (≥18 years) with nephropathy of any degree (microalbuminuria, overt proteinuria, CKD stages 1-5 not on dialysis, or post-transplant with proteinuria). Stable background therapy with ACEi/ARB, SGLT2i, or MRA allowed. Exclusion: Dialysis at baseline. Recent kidney transplant (\<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components. Categories (Strata: 17 Subgroups) Diabetic nephropathy - microalbuminuria Diabetic nephropathy - macroalbuminuria Diabetic nephropathy - CKD Stage 3 Diabetic nephropathy - CKD Stage 4-5 (non-dialysis) Hypertensive nephropathy - microalbuminuria Hypertensive nephropathy - proteinuric CKD Hypertensive nephropathy - advanced CKD (3-5) Autoimmune nephropathy - Class II-III Autoimmune nephropathy - Class IV-V Reflux nephropathy - mild/moderate scarring Reflux nephropathy - severe scarring Chronic glomerulonephritis - nephrotic range proteinuria Chronic glomerulonephritis - CKD \<60 mL/min/1.73m² CKD of unknown etiology - Stage 1-2 CKD of unknown etiology - Stage 3-4 ESRD pre-dialysis (eGFR \<15) Post-transplant CKD with proteinuria Sample Size and Rationale Primary endpoint powering (paired design): Detect 30% reduction in ACR (δ = ln(0.70) = -0.357), assuming σ = 0.8, r = 0.6 → \~32 analyzable patients needed. Planned enrollment (pooled cohort, with 17 categories): \~182 analyzable patients (\~214 enrolled allowing for 15% attrition). Each category will include a minimum of 8-12 patients (more for common etiologies such as diabetic proteinuria). Total enrollment stratified by prevalence across categories. Endpoints Primary Endpoint: Change in urinary ACR from baseline to Week 12 (log-transformed). Secondary Endpoints: Change in eGFR slope. Change in 24-h proteinuria (selected patients). Blood pressure change. Patient-reported outcomes (KDQOL-36, EQ-5D). Safety (hyperkalemia, creatinine rise, liver tests, hematology). Exploratory Endpoints: Biomarker profiles (TGF-β, cGMP, NGAL, KIM-1). Hospitalization rate. Extended follow-up outcomes at 6 months. Follow-Up Plan Monthly Visits (Week 4, 8, 12): Clinical: BP, vitals, weight, adherence. Labs: creatinine/eGFR, electrolytes, liver panel, CBC, urine ACR. Safety: hyperkalemia, creatinine rise. PROs brief (fatigue, QoL). Final (Week 12): Primary endpoint assessment (duplicate ACR). PROs full set. Investigator global assessment. Safety Call (Week 16): AE/SAE resolution, concomitant therapy updates. Statistical Analysis Primary analysis: Paired t-test and mixed model for repeated measures (MMRM) on log(ACR). Secondary: eGFR slope via linear mixed model, BP change via ANCOVA, responder rate (≥30% reduction in ACR). Subgroups: Category-by-time interaction analysis; forest plots for effect estimates. Multiplicity: Subgroup effects exploratory; overall primary endpoint tested at α=0.05." NCT00860613,Medical Nutrition Therapy Program for Pregnant Women With Diabetes,"Inclusion Criteria: * pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes. * less than 30 weeks of gestation * women who plan to attend their pregnancy at the institution (INPerIER) Exclusion Criteria: * women with type 1 pregestational diabetes or gestational diabetes type A1. * women with multiple pregnancies * women with renal or hepatic disease * women who could not follow the dietary recommendations within the study",N/A NCT01648582,A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus,"Inclusion Criteria: * Have type 2 diabetes mellitus for at least 6 months * Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks * Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0% * Adult men or adult non-pregnant, non-breastfeeding women * Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m\^2) * Stable weight (±5%) ≥3 months prior to screening Exclusion Criteria: * Have type 1 diabetes mellitus * Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic * Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide * Have gastric emptying abnormality * Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke * Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury\[mmHg\] or diastolic blood pressure above 95 mmHg) * Have impaired liver function * Have impaired kidney function * Have history of chronic pancreatitis or acute pancreatitis * Have a serum calcitonin ≥20 picograms per milliliter (pg/mL) * Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)",N/A NCT02552823,Effects of Peas on Blood Glucose Control,"Inclusion criteria 1. Generally healthy male or female, between the age of 18-40 years; 2. Body mass index (BMI) 18.5-34.5 kg/m2; 3. HbA1c \<6.0%; 4. Willing to provide informed consent; 5. Willing/able to comply with the requirements of the study. Exclusion criteria 1. Pregnant or lactating; 2. Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L or use of insulin or oral medication to control blood sugar; 3. Medical history of cardiovascular disease 4. Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg; 5. Fasting plasma total cholesterol \>7.8 mmol/L; 6. Fasting plasma HDL \<0.9 mmol/L; 7. Fasting plasma LDL \>5.0 mmol/L; 8. Fasting plasma triglycerides \>2.3 mmol/L; 9. A change in blood glucose concentration less than 1 mmol/L between baseline and 30 minutes after consumption of white bread at visit 1; 10. Maximum blood glucose concentration occurs after 60 minutes after consumption of white bread at visit 1; 11. Major surgery within the last 3 months; 12. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months; 13. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN)); 14. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)); 15. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use with the past 6 weeks; 16. Active treatment for any type of cancer within 1 year prior to study start; 17. Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol; 18. Shift worker; 19. Tobacco use current or within the last 3 months; 20. Allergies to peas; 21. Aversion or unwillingness to eat study foods; 22. Consuming \>4 servings of pulses per week; 23. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia; 24. Participation in another clinical trial, current or in the past 4 weeks; 25. Unstable body weight (defined as \>5% change in 3 months) or actively participating in a weight loss program.","A randomized, controlled, cross-over study designed to examine the PPGR to peas will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. The study will be divided into 2 groups of 24 healthy volunteers each. In Group 1, eligible participants who have provided consent will be asked to attend 6 clinic visits in a fasted state. Participants will be given white bread at their first and last visits, peas with rice at 3 visits and rice at 1 visit. At each visit participants will provide 7 blood samples via finger poke, 6 questionnaires about their appetite and a questionnaire about the acceptability of the test food. Each visit will last approximately 2.5h and be separated by 3-10 days. Group 2 will undergo the exact same study procedures as group 1, but rice will be replaced with potato." NCT00454623,Normal Serum Adiponectin Levels in Females,"Inclusion Criteria: 1. Age: 15 - 40 years old. 2. BMI: 18.5 - 24.9 3. No medical or chronic health problems. 4. If pregnant, singleton. 5. First blood sample can be obtained before 13 weeks gestation. 6. Plans to continue pregnancy till term and deliver at our hospital Exclusion Criteria: 1. Hypertension. 2. Diabetes Mellitus. 3. Ischemic heart disease. 4. Metabolic disorders e.g. hyperlipidemia, hypercholesterolemia. 5. Endocrinological diseases e.g. thyroid or adrenal diseases. 6. Chronic Debilitating diseases e.g. SLE, or Cancer. 7. BMI less than18.5 or greater than 25. 8. Anorexia or Bulimia. 9. Polycystic ovarian disease. 10. In pregnant group: 1. Multiple gestations. 2. Hyperemesis or dehydration. 3. History of Gestational Diabetes, Preeclampsia, or other complications with previous pregnancies 4. If abnormal weight gain during pregnancy, will continue in the study but would not be included in establishing normal levels.","The prevalence of obesity has increased dramatically in recent years . It is commonly associated with type 2 diabetes, coronary artery disease, and hypertension, and the coexistence of these diseases has been termed the metabolic syndrome. White Adipose Tissue (WAT) has been increasingly recognized as an important endocrine organ that secretes a number of biologically active ""adipokines"" . Of these adipokines, adiponectin has recently attracted much attention because of its antidiabetic and antiatherogenic effects and is expected to be a novel therapeutic tool for diabetes and the metabolic syndrome . Adiponectin directly regulates glucose metabolism and insulin sensitivity by activation of AMPK. Adiponectin expression is reduced in obese, insulin-resistant rodent models. Plasma adiponectin levels are also decreased in an obese rhesus monkey model that frequently develops type 2 diabetes. Levels have also been reported to be reduced in obese humans, particularly those with visceral obesity, and to correlate inversely with insulin resistance. Prospective and longitudinal studies have shown that lower adiponectin levels are associated with a higher incidence of diabetes. Hypoadiponectinemia has been demonstrated to be independently associated with the metabolic syndrome. Reduced plasma adiponectin levels are also commonly observed in a variety of states frequently associated with insulin resistance, such as cardiovascular disease, ischemic heart disease, and hypertension. In women, lower adiponectin levels were associated with breast cancer, endometrial cancer, and polycystic ovarian syndrome. By establishing normal serum levels of Adiponectin, researchers will be able to demonstrate deviations from the norm associated with investigated diseases and variables. When applied to pregnancy, it will help identify obstetrical complications associated with abnormal levels." NCT03421379,A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus,"Inclusion Criteria: * Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D) * Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D * Hemoglobin A1c (HbA1c) ≤10% Exclusion Criteria: * Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month * Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg)",N/A NCT05180396,A Study on Disease Awareness and Treatment Compliance of Heart Failure Patients,"Inclusion Criteria: 1. Male or female patients aged 18 and over 2. Patients diagnosed with acute or chronic heart failure 3. Patients who agreed to participate in the study Exclusion Criteria: 1. Patients who stated that they did not agree to participate in the study 2. Patients who were not diagnosed with Heart Failure or whose diagnosis was changed or not confirmed during the index application 3. Pregnancy","Data entry personnel to be assigned at the centers throughout the study will apply a questionnaire consisting of different questions to patients referred to them by clinicians with the diagnosis of HF. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG, most recent echocardiography , coronary angiography report, if any) will be recorded. No additional examination/procedure will be performed for the study, only the data of the examinations requested by the clinician in routine clinical practice will be entered. A total of 200 patients from 3 centers will be included in this study over a six-month period." NCT05290246,TRE in Type 2 Diabetes (See Food Study 3),"Inclusion Criteria: * Overweight/obese adults with metformin-only treated type 2 diabetes * 18-65 years old * BMI:25-45 kg/m2 * HbA1c: 6.5-8.5% * Self-reported weight must be stable \[±5 pounds\] for at least 3 months prior to the study * Owns a smartphone. Exclusion Criteria: * Active or anticipated pregnancy during the study * type 2 diabetes treated with medications other than metformin * presence of eating disorders as noted by screening survey.",N/A NCT02018627,Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon,"Inclusion Criteria: * Age 21 to 80 years old with type 1 diabetes for at least one year. * Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment. Exclusion Criteria: * Unable to provide informed consent. * Unable to comply with study procedures. * Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject. * Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception. * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * Hemoglobin \< 11.5 gm/dl. * History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension). * History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache. * Inadequate venous access as determined by study nurse or physician at time of screening. * Liver failure or cirrhosis. * Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.","This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly)." NCT00213070,Double-Blind Trial of Miglitol in Type 2 Diabetic Patients With Insulin Treatment,"Inclusion Criteria: * Type2 diabetes * Criteria of postprandial plasma glucose and HbA1c are met Exclusion Criteria: * Type1 diabetes * Patients with antidiabetic drugs * The other exclusion criteria are met",N/A NCT07281170,Xinqiao High-risk Cohort of Diabetes(NICE),"Inclusion Criteria: * Individuals who provide written informed consen * Have access to a smartphone * Hamily history of diabetes or abnormal microglucose level detected once * Age ≥18 years at the time of consent Exclusion Criteria: * Diabetes mellitus * Any other condition which, in the judgment of the investigator, would make the subject unsuitable for enrollment in the study * recently surgical histories, trauma, acute cardiovascular complications, or infectious diseases",N/A NCT00298740,Medtronic MiniMed Implantable Insulin Pump,"Inclusion Criteria: * People with type 1 diabetes previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins may join this study. Exclusion Criteria: * Anyone not previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins.","If the participant joins the study and chooses to have a new pump implanted, the study is expected to last 12-15 months for each participant, and each participant will continue to be followed, with 3-monthly refills and research visits for as long as the pump lasts, until the participant chooses to withdraw, until the FDA approves the pump for regular care, or until the company stops supporting the pump. During the first 12-15 months of the study, there will be an estimated 13 clinic visits and one hospital stay for 2-3 days. The data collection visits will take about 30 minutes, and a continuous glucose monitor will be started. The participants will have a brief visit 3-4 days later to drop off the monitor. After this phase of the research, the participants will still be cared for with the implanted pump, having visits for refills and tests every 3 months. This long-term follow up will last until the participants choose to withdraw, the pump malfunctions, the FDA approves the pump for regular care, or the company no longer supports the pump. If the participants are no longer taking part in the study, the investigators will have the pump removed from their body." NCT00321789,A Patient-Spouse Intervention for Self-Managing High Cholesterol,"Inclusion Criteria: * veteran * elevated baseline low-density lipoprotein cholesterol level * married Exclusion Criteria: * no telephone number; * spouse unwilling to participate; * patient or spouse cognitively impaired, unable to communicate via telephone, living in nursing home or receiving home health care, or refuses to provide informed consent; * hospitalized past 3 months; * survival prognosis less than 1 year; * active psychosis or dementia; no primary care physician at VA; * no medical visit to VA in past year; * enrolled in another study focusing on lifestyle changes","Background: Background/Rationale: Coronary heart disease (CHD) is the leading cause of death in the United States, resulting in more than 500,000 heart attacks and another 500,00 deaths per year. More than 80% of veterans have \> 2 risk factors for CHD, underscoring the need for intervention. One major modifiable risk factor for CHD is elevated low-density lipoprotein cholesterol (LDL-C). Despite the proven success of diet, exercise, and medication, LDL-C frequently is not at the optimum level, due in part to patient nonadherence. Therefore, interventions are needed to increase adherence, thereby lowering LDL-C. Objectives: Objectives: We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. The primary hypothesis was that patients enrolled in a telephone-based, spouse-assisted intervention will experience a clinically meaningful 7% reduction in LDL-C. The secondary hypotheses were that patients who receive the intervention would show a significant increase in adherence to medication, diet, and exercise. Methods: In a 3-year study, a randomized controlled trial compared a 10-month, telephone-based, spouse-assisted intervention to usual care. Married patients with above-goal LDL-C and their spouses were consented, completed a baseline assessment, and then were randomly assigned to the intervention or usual care arm. Month 1 involved an educational call delivered to patients and spouses. Months 2-10 (except month 6) involved monthly goal setting calls delivered to patients and calls focused on increasing social support to spouses. The patient phone call will always preceded the spouse phone call. At 6 and 11 months, LDL-C and adherence were re-assessed. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months. Descriptive statistics were computed for all study variables within each study arm. Mixed effects models were used to evaluate the intervention's effect on the primary and secondary outcomes at 11 months. We also calculated intervention cost. Status: Enrollment began in Fall, 2007 and was completed in July of 2009. Impact: Elevated LDL-C is a major risk factor for CHD, stroke, and peripheral vascular disease, all of which are common among veterans. The expected increase in prevalence of CHD over the next several decades will result in an increased burden for both veterans and the VA health care system. Despite the known risk of hypercholesterolemia, many veterans have suboptimal LDL-C levels. As the latest evidence and recommendations suggest that these goals should be even lower, interventions to assist patients to lower LDL-C increasingly will be needed. The VA considers the reduction of LDL-C an important goal, as indicated by the major effort of the Ischemic Heart Disease Quality Enhancement Research Initiatives (QUERI). This study is important because (1) it addresses a highly prevalent risk factor for CHD among veterans; (2) it proposes a potentially low-cost method for improving LDL-C levels, which in turn could reduce VA healthcare costs; (3) the intervention is practical and could be disseminated easily in the VA healthcare system if proven effective; and (4) this intervention provides a model for self-management of other chronic diseases, such as diabetes and hypertension." NCT05614089,Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings,"Inclusion Criteria: 1. Children and young adults (age 7-25) 2. Have a clinical diagnosis of type 1 diabetes (T1D) Exclusion Criteria: 1. Prior use of any insulin analogue 2. Patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent 3. Who are currently pregnant or plan to become pregnant over the next year 4. Who have previously used a continuous glucose monitor (CGM) for glucose monitoring 5. Who were first diagnosed with T1D less than 12 months ago 6. Who is diagnosed with severe malnutrition","Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO's Model List of Essential Medicines (EML) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., NPH insulin and premixed 70/30 insulin). In 2021, long-acting insulin analogues were added to the EML but the decision remains controversial since the WHO concluded that ""magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small."" Moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings. To address this unmet need, Pitt has partnered with Brigham and Women's Hospital, The London School of Hygiene and Tropical Medicine, the Clinton Health Access Initiative and Life For a Child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with T1D in a lower resource setting. Note: In preparation for results submission, we made minor changes to the outcomes sections to reflect what is listed in the protocol. For Primary Outcomes #1 and #2, and Secondary Outcomes #3,#4, #5, #7, #8: we added 12 months measurements (in addition to the 6 months measurement). We updated Secondary Outcome #9 to specify the PedsQL Diabetes Symptoms Score. We added Secondary Outcome #10 to include the PedsQL Diabetes Management Score. We added Secondary Outcome #11 for ITSQ scores." NCT07432620,Artificial Intelligence Stress Echo (FINESSE) Project,"Inclusion Criteria: * Age 18 years or older at the time of the index stress echocardiography. * Referred for pharmacological (dobutamine) stress echocardiography at Milton Keynes University Hospital for assessment of suspected coronary artery disease / chest pain. * Stress echocardiography report available in the hospital dataset for data extraction and conversion into a structured database. Exclusion Criteria: * Age under 18 years at the time of the index stress echocardiography. * No available/usable stress echocardiography report for extraction into the study database. * Unable to link the record to follow-up outcome information using routine hospital systems (with attempted supplementary checks where needed). * Patients who have registered a National Data Opt-out and are therefore not eligible for use of their confidential patient information for research/secondary purposes in this study.","This is a single-centre, retrospective observational study using an existing dataset of pharmacological (dobutamine) stress echocardiography (SE) reports generated within Milton Keynes University Hospital over approximately 15 years, starting from 2002. The SE dataset comprises reports/letters produced by a single, experienced clinician, which reduces inter-observer variability and supports consistent interpretation across the cohort. Data sources and cohort construction SE reports (in document format) will be converted into a structured research database. A computer science team will develop a generalisable approach to extract structured variables from the clinical SE reports, building on prior proof-of-concept work demonstrating feasibility of converting these reports into a database. The dataset includes clinical variables (e.g., cardiovascular risk factors, comorbidities, prescribed medications, and anthropometrics) alongside SE-derived measures (including ischaemia detection and wall motion scoring at rest and peak stress). Stress echocardiography technique (context for imaging-derived variables) The study dataset reflects contemporary dobutamine SE practice at MKUH, with contrast-enhanced imaging used in the majority of cases (SonoVue contrast with rota pump infusion equipment). Studies were performed predominantly on Philips echocardiography systems, with image acquisition across standard stages (resting, intermediate, peak stress, and recovery) and standard views (apical 4-, 2-, and 3-chamber; parasternal long- and short-axis). Reporting used dedicated platforms enabling stage-by-stage comparison. Outcome ascertainment and linkage Following database completion, a research nurse will query the hospital Electronic Data Management system to ascertain major adverse cardiovascular events (MACE) for the cohort. Where outcomes cannot be confirmed from hospital systems (e.g., patients no longer served by the hospital), missing outcome information will be explored via primary care physician contact and/or patient contact as appropriate. Data processing, quality checks, and handling missingness Extracted data will undergo cleaning prior to analysis. Natural Language Processing (NLP) and feature engineering approaches will be used to transform extracted information into model-ready features. As part of preprocessing, data fields will be checked for completeness and consistency before modelling. Missing outcome data will be addressed through the external outcome checks described above. Statistical / machine learning approach and internal validation After preprocessing, subset feature selection methods will be applied to identify the most informative predictors for risk classification. Supervised learning will be used to discriminate between lower-risk cases and cases requiring further investigation, with additional modelling approaches (including regression techniques) planned to support quantification of disease stage in abnormal cases. Overfitting will be mitigated through use of techniques robust to overfitting (e.g., ensemble methods) and internal validation using k-fold cross-validation (five folds), ensuring separation of training and validation data. Sample size and additional analyses The study will utilise the available full dataset (approximately 3,000 patients) to maximise model development and internal validation. A cost analysis is also planned using the available data." NCT03687320,Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers,"Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or Female 4. Age:18-90 years old at the time of Informed Consent (Adult, Senior) 5. Type 1 or type 2 Diabetes Mellitus 6. Presence of a diabetic foot ulcer located in the ankle area or below that has persisted a minimum of 3 months prior to the screening visit 7. Ulcer grade classified as ≤3 according to Wagner grading system or IA according to University of Texas Classification of Diabetic Foot Ulcers. 8. Area of ulcer (after debridement) is at least 4 cm2 9. Arterial perfusion: Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.7 or that have documented confirmation of adequate arterial perfusion 10. Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes 11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation Exclusion Criteria: 1. Pre-existing conditions - evidence of gangrene on any part of affected limb, active Charcot's foot on the study limb; infection at time of screening, deep vein thrombosis (DVT), active malignancy, being on dialysis, anemia (Hb\<9 gr/dL) 2. Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings 3. Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 10 weeks of screening 4. History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization 5. Taking immunosuppressive medication 6. Received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening 7. Used oral, or IV antibiotic/antimicrobial agents or medications within 7 days of baseline 8. Has serum albumin level of\<3 mg% 9. Presence of ulcers due to other causes not related to diabetes 10. HbA1c \> 12% (uncontrolled hyperglycemia) 11. A documented history of alcohol or substance abuse within 6 months of screening 12. Currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results 13. Pregnant at the time of screening 14. Has any Photobiomodulation (low level laser) device at home","Patients with diabetic foot ulcers will receive standard treatment and in addition will be randomly allocated to receive either active or sham laser device to self-treat at home. The patient's wound will be evaluated every 2 weeks. Adverse events will be documented. The study hypothesis is that B-Cure laser treatments as an adjunct therapy to standard treatment, applied, at home, by the patient or personal care-giver, can accelerate diabetic foot ulcers healing compared to standard treatment alone." NCT06156020,Outcome Analysis of Endoscopic Resection of Pituitary Adenomas,"Inclusion Criteria: * Adult patient * Pathological diagnosis of pituitary adenoma * Underwent endoscopic endonasal resection Exclusion Criteria: * Age \< 18 or \> 80 years * Non-pituitary adenoma pathologies * Underwent non-endoscopic surgery",N/A NCT00645424,A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol,"Inclusion Criteria: * Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol * Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of \<400 mg/dL Exclusion Criteria: * Type I diabetes mellitus * Secondary causes of high cholesterol * Elevated liver enzymes",N/A NCT01316224,Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment,"Inclusion Criteria: * Participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator * Participant has indication of psoriasis systemic therapy * If female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: * Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) * Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration * A vasectomized partner * Total abstinence from sexual intercourse * Able and willing to give written informed consent and comply with the requirements of the study protocol Exclusion Criteria: * Participants who have active infections * Participants enrolled in another study or clinical trial * Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk * History of active tuberculosis (TB), histoplasmosis or listeriosis","Psoriasis is a chronic inflammatory disease affecting 1% to 3% of the population worldwide. A significant portion (5%-40%) of participants with psoriasis develop PsA, a chronic inflammatory arthritis that causes progressive joint damage, reduced functionality and increased mortality risk. Skin disease typically manifests before arthritis in more than 80% of PsA participants, and psoriasis symptoms usually precede joint symptoms by an average of 10 years. Participants with psoriasis who have comorbid PsA incur substantially increased cost of care and experience greater impairment of physical functioning and quality of life compared with participants with psoriasis alone." NCT06487962,Pilot RCT: FQHC Intervention for Uptake of CGM in Low-Income Adults With T1D,"Inclusion Criteria: * Low-income status * Documented diagnosis of T1D * 18 years of age or older * Federally Qualified Health Center (FQHC) primary care provider * English or Spanish-speaking And at intervention sites * Willingness to wear a CGM sensor * Adult family member or friend, who will give consent to participate in the study and co-attend the 4-week intervention sessions * Reported difficulty in using CGM if current or past use of CGM Exclusion Criteria: * Pregnancy or planning to become pregnant * Lactation * Serious illness that may prevent study participation (e.g., severe depression) * Less than 6 months life expectancy * Alcohol abuse or dependence * Uncorrected hearing or vision impairment","Low-income adults with T1D experience a disproportionate burden of life-threatening, acute complications with high rates of related emergency department visits, hospitalizations, and death. Use of CGM may mitigate these inequities. Yet, low-income adults with T1D have exceptionally low levels of CGM use. This reflects social determinants of health (SODH), as framed by the multiple levels of the Socio-Ecological Model (SEM). The SEM's healthcare provider level is a main driver in Hispanic disenfranchisement from CGM. With a severe shortage of endocrinologists, primary care providers are increasingly managing T1D although many report inadequate confidence in titrating insulin and using CGM. With limited access to endocrinology, low-income, Hispanic adults with T1D thus often receive diabetes management in FQHCs with scant or no access to CGM. Hence, to foster equitable uptake of CGM in the most vulnerable adults with T1D, a 4-year, mixed-methods, feasibility study with a pilot randomized controlled trial (RCT) is underway to primarily assess the feasibility of the SEM-guided, 6-month intervention (targeting the individual, family/social networks, and healthcare provider levels). The SEM-guided intervention was refined by our Community Advisory Board. Refinements were informed by qualitative research exploring SDOH barriers to CGM uptake in low-income adults with T1D from the perspectives of four stakeholder groups. The individual level of the intervention, guided by the Information-Motivation-Behavioral-Skills Model, fosters essential acquisition of information, motivation, and behavioral skills for CGM uptake through two principal approaches: (1) 4-week, personalized, CGM sessions with a RN/ certified diabetes care and education specialist (CDCES); and (2) subsequent virtual peer educator-led support groups, integrating CGM education, through study month six. The family/social networks level leverages social support to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement in peer-led support group sessions, respectively. The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes). A total of 11 FQHC sites were randomized to deliver the intervention (n=6) or control (n=5) conditions with a total enrollment goal of 30 low-income adults with T1D (sites having roughly equivalent enrollment rates). The feasibility of the study protocol (e.g., recruitment and retention yields, data collection procedures, intervention implementation, and intervention acceptability, among others) will be routinely assessed. Significant intervention signals in terms of physiological (e.g., A1C and time within, above, and below range glucose range), psychosocial (e.g., quality of life and family support), and behavioral (CGM adherence) outcomes from baseline to 3- and 6-months post-baseline will be assessed. The long-term goal of this study is to inform a large, multi-site RCT, and with successful results, provide a model for CGM uptake in low-income adults with T1D for FQHCs nationally" NCT05692388,Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus,"Inclusion Criteria: 1. self- report as AA/Black 2. age ≥18 3. screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool 4. self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD) 5. able to communicate in English. Exclusion Criteria: 1. cognitive impairment at screening visit 2. active psychosis 3. active alcohol or drug abuse/dependency","Health-related social needs (HRSN) including loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN. Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing HRSN using in-depth patient and stakeholder interviews. Aim 2 (Quantitative): Examine the effect of increasing burden of HRSN on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing HRSN. Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN." NCT03191188,A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients,"Inclusion Criteria: * Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level. Exclusion Criteria: * Hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.",N/A NCT05598203,Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes,"Inclusion Criteria: \- Adult patients with a previous diagnosis of type 2 diabetes mellitus Exclusion Criteria: * Patients with other types of diabetes * With HbA1C within the therapeutic target or with values greater than 12% * Severe neuropathy * Chronic kidney disease \[glomerular filtration rate \<30mL/min/1.73m²\] * Life expectancy \<6 months * Chemical dependence/alcoholism or use of antipsychotics * Autoimmune disease or chronic steroid use * Gastroparesis * Pregnant or lactating women * Patients who have had an Episode of Acute Coronary Syndrome (ACS) in the last 60 days * Wheelchair users * Cognitive, neurological or psychiatric condition","The estimate of patients with diabetes increases every year and for their treatment, a change in lifestyle is essential, so there is a need to seek strategies that increase patient adherence in the long term. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes. An open randomized clinical trial will be performed. Patients = patients with type 2 DM; Intervention = food (nutritional) education based on operative groups added the usual care; Control = usual care; Outcome/Outcomes = glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations. In order to detect a mean difference of 0.59 in HbA1c between patients randomized to the intervention (patient-centered group) and those in the control group (traditional education intervention), with a standard deviation of 1.39%, a type I error of 5%, and a type II error of 20%, a total of 88 patients in each group were deemed necessary (1:1 ratio at randomization, n= 176). Considering a dropout rate of 30% over the long term (12 months), it will be essential to include a total of 252 participants." NCT03799185,"Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population","Inclusion Criteria: * All subjects Exclusion Criteria: * Prescribed treatment for cancer * Organ transplantation * Known auto-immune disease * Severe liver disease * Chronic renal failure * Pregnant women","ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South East and South West. The screening is being assessed using surveys covering socioeconomic, nutritional and anthropometric measures in addition to biological assessments. The target population is being recruited by random sampling drown by the National Institute of Statistics (Tunisia). The estimated number of participants at the end of recruitment amount to 10 000. The frame sampling uses a two stage cluster sampling (district and household). Interview with each eligible participant will be conducted mainly during assessment visit and after consenting the subject, it will be notified all the demographic, behavioral history, family history, cardiovascular risk factors and medical history. During the assessment visit, Physical examination/anthropometry data and Diet survey will be filled up by the investigator. Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)" NCT01255085,Yellow Pea Protein and Fibre and Short Term Food Intake,"Inclusion Criteria: * male 20-30 years old healthy weight Exclusion Criteria: * smoking restrictive eating metabolic diseases breakfast skippers dieters","A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 30 minutes after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period." NCT05526443,Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC),"Inclusion Criteria: * 18 years, female and male * ECOG (Eastern Cooperative Oncology Group) Scale 0-2 * Diagnosis of histologically confirmed locally advanced inoperable and/or metastatic PDAC * Patients undergoing palliative 1st line therapy with a platinum- or gemcitabine- based chemotherapy in case of previous (neo)adjuvant therapy also patients who receive nal-Irinotecan/5-FU/Leukovorin as palliative first line are eglible * Signed informed consent for prospective patients, for retrospective cases no informed consent is required Exclusion Criteria: * Patients with locally advanced operable PDAC who do not receive palliative chemotherapy * Patients with locally advanced borderline resectable PDAC who do not receive palliative chemotherapy",1500 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy NCT00001625,Methods for Measuring Insulin Sensitivity,"* INCLUSION CRITERIA: Normal Volunteers: Adults between the ages of 21 and 55 in good general health with no significant underlying illnesses, on no medication, and a normal body mass index (20-26 kg/m(2)). Obese Subjects: Adults between the ages of 21 and 55 in good general health with no significant underlying illnesses, on no medication, and a body mass index between 30 and 35 kg/m(2). Hypertensive Subjects: Adults between the ages of 21 and 55 in good general health except for mild to moderate hypertension (blood pressure between 140/95 and 170/109 off medication), on no medication except for antihypertensive agents. Subjects will be taken off all antihypertensive drugs for at least one week prior to study. If a subjects blood pressure exceeds 180/110 on three determinations over a period of at least 15 minutes, the subject will be withdrawn from the study and appropriate antihypertensive therapy resumed. Diabetic Subjects: Adults between the ages of 21 and 65 in good general health except for non-insulin dependent diabetes mellitus controlled with oral hypoglycemic agents. Subjects on no other medications. If fasting blood glucose exceeds 300 mg/dl, the subject will be withdrawn from the study and appropriate therapy resumed. EXCLUSION CRITERIA: Pregnancy, liver disease, pulmonary disease, end-organ damage such as renal insufficiency, coronary artery disease, heart failure, peripheral vascular disease, proliferative retinopathy, diabetic neuropathy, or HIV infection.","We hypothesize that the majority of the information needed to accurately estimate insulin sensitivity is contained in the fasting insulin and glucose levels as well as the insulin and glucose levels obtained shortly after an intravenous glucose load. We propose to test this hypothesis by performing both hyperinsulinemic euglycemic glucose clamps as well as intravenous glucose tolerance tests on normal volunteers and groups of patients with diabetes, hypertension, or obesity (diseases known to be associated with insulin resistance). Data from these studies will be used obtain estimates of insulin sensitivity by the glucose clamp method, minimal model method, and a novel analysis that utilizes only fasting and peak levels of glucose and insulin. We hope to devise a simpler method for determining insulin sensitivity in vivo that is suitable for testing large populations. This method will require only a few blood samples, take less than one hour to perform, and correlate with glucose clamp estimates at least as well as the minimal model method." NCT02455076,Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes,"Inclusion Criteria: 1. A known history of Type 2 Diabetes receiving either diet alone or oral antidiabetic drugs (OAD) including insulin secretagogues, pioglitazone, DPP4 inhibitors, or metformin as monotherapy or in combination therapy, or low-dose insulin at \<0.5 unit/kg/day. 2. Males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-Intensive Care Unit setting). 3. Subjects with an admission / randomization BG \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 mEq/L or positive serum or urinary ketones). 4. Admission HbA1c between 7% and 10% 5. BMI range: \> 25 Kg/m\^2 and \< 45 Kg/m\^2 Exclusion Criteria: 1. Age \< 18 or \> 80 years 2. Subjects with increased blood glucose (BG) concentration, but without a history of diabetes (stress hyperglycemia) 3. Subjects with a history of type 1 diabetes (suggested by BMI \< 25 Kg/m\^2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria). 4. Treatment with high-dose (\>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3 months prior to admission. 5. Patients that required ICU care during the hospital admission. 6. Recurrent severe hypoglycemia or hypoglycemic unawareness. 7. Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction. 8. Patients with clinically relevant pancreatic or gallbladder disease. 9. Patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance \< 30 ml/min) 10. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease), 11. History of hypersensitivity to exenatide 12. Treatment with oral or injectable corticosteroid (equal to a prednisone dose \>5 mg/day), parenteral nutrition and immunosuppressive treatment. 13. Patients with history of heavy alcohol use (female \> 2 drinks per day, male \> 3 drinks per day) or drug abuse within 3 months prior to admission. 14. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 15. Female subjects who are pregnant or breast feeding at time of enrollment into the study.","The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established. Data from previous trials in hospitalized patients have shown a strong association between hyperglycemia and poor clinical outcomes, such as mortality, morbidity, length of stay (LOS), infections and overall complications. Basal bolus insulin regimens improve glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin (SSRI). However, the use of basal bolus is labor intensive, requiring multiple daily insulin injections, and has a significant risk of hypoglycemia. The investigators will study if treatment with exenatide alone or in combination with basal insulin will result in similar glycemic control and a lower frequency of hypoglycemia than treatment with basal bolus in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes." NCT01652040,Resistance Training and Testosterone After Spinal Cord Injury,"Inclusion Criteria: * Male with Spinal Cord Injury * Between 18-50 years old * BMI \< 30 Kg/m2 * Traumatic motor complete C5-L2 level of injury * American Spinal Injury Classification (A and B; i.e. motor deficit below the level of injury) Exclusion Criteria: * Cardiovascular disease * Uncontrolled type II DM and those on insulin * Pressures sores stage 2 or greater * Supra-physiological T level * Hematocrit above 50% * Urinary tract infection or symptoms","Individuals with spinal cord injury (SCI) are at a lifelong risk of increasing obesity and several chronic metabolic disorders such as glucose intolerance, insulin resistance and dyslipidemia secondary to deterioration in body composition. Within few weeks of injury, there are significant decrease in whole body fat-free mass (FFM), particularly lower extremity skeletal muscle mass and subsequent increase in fat mass (FM). Resistance training (RT) is an important type of exercise that has been shown to induce positive physiological adaptations such as increasing lean mass and reducing metabolic disorders in other clinical populations. In a pilot work, the investigators provided evidence that evoked RT using surface neuromuscular electrical stimulation (NMES) for knee extensor muscle group resulted in significant increase skeletal muscle cross-sectional area (CSA), reduction in % leg FM and a trend towards decrease in visceral adipose tissue (VAT) CSA. The favorable adaptations in body composition were associated with decrease in plasma insulin area under the curve and plasma triglycerides. The investigators attributed the adaptations in body composition and metabolic profile to an associated increase in plasma insulin-like growth factor (IGF-1). The investigators concluded that twelve weeks of evoked RT targeted towards evoking skeletal muscle hypertrophy could result in significant body composition and metabolic adaptations in individuals with SCI. It is unclear if a longer RT program greater than 12 weeks would provide additional benefits to Veterans with SCI. It is also unknown whether enhancing the decline anabolic homeostasis by providing testosterone (T) replacement therapy (TRT) would reverse body composition and metabolic profile changes in Veterans with SCI. The major research goal of this proposal is to investigate the effects of 16 weeks of evoked RT+TRT vs. TRT on body composition (muscle CSA, VAT, %FM) and the metabolic profiles (glucose and lipid metabolism) in individuals with motor complete SCI. To address this goal, surface NMES accompanied with ankle weights will be conducted twice weekly to exercise the knee extensor skeletal muscle groups from sitting position. After 4 weeks of delayed entry approach, participants (n =24) will be randomly assigned into RT+TRT (n =12) or TRT (n =12) groups. The TRT will be provided via transdermal T patches that will be alternated on both shoulders over the course of the study. The investigators also propose to study the effects of detraining on body composition and metabolic profiles. The research plan includes three specific aims Specific aim 1 will demonstrate the effects of NMES RT and/or Testosterone patches (Tp) on the CSA of thighs and legs skeletal muscle groups, percentage FFM, and the CSA of VAT, intramuscular fat and percentage FM after 16 weeks of training+Tp and 16 weeks of detraining. Specific aim 2 will determine the changes in metabolic milieu (resting energy expenditure, glucose homeostasis, lipid profile, free fatty acids, serum total and free testosterone and IGF-1), and cytokines (c-reactive protein, tumor necrosis factor alpha and IL-6 as inflammatory biomarkers) after 16 weeks of training+Tp and detraining. Specific aim 3 will determine if 16 weeks of evoked RT and Tp will increase GLUT-4 concentration, muscle IGF-1 and peroxisome-proliferator-activated receptor-gamma co-activator 1 (PGC-1) expressions, altered fiber type distribution and enhance the mitochondrial enzymatic activities (electron transport chain) compared to Tp only." NCT07088640,Single Step Protocol and Multi-step Warming Protocol for Blastocyst FET,"Inclusion Criteria: * Women aged from 18 * Undergoing no more than 3 previous IVF/ICSI cycles * Had at least a single good-quality blastocyst frozen. * Endometrium preparation using artificial cycle * Agree to single blastocyst transfer * Not participating in any interventional studies at the same time Exclusion Criteria: * Embryos from cycles after in-vitro maturation, pre-implantation genetic testing (PGT) * Having contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease) * Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx or endometrial polyp)","Nowadays, vitrification is the gold standard method in freezing human embryos, using different commercial brands of ready-to-use kits. Removing cytotoxic cryoprotectants and rehydration to prevent osmotic shock has been a fundamental principle in cryobiology. This minimized damage during the vitrification/thawing (V/T) process. However, the entire process is time-consuming and labor-intensive in the IVF laboratory. Especially, some laboratories have difficulty ordering the same brand of medium for V/T kits. Because of the long period of cryopreserved embryos, it may be that embryos were vitrified and warmed with different kits with a potentially different kind and concentrations of cryoprotective agents. Recently, the combinations of the two different V/T commercial kits have shown comparable survival, blastulation, and implantation rates in both own and donor oocyte cycles. Additionally, there remains an opportunity and a necessity to continue improving the warming protocol. The key factors for thawing require a fast warming rate, a gradually decreasing concentration of intracellular cryoprotectant, and embryologist skills to secure the survival rate. Based on previous work, one option would be shortening the time necessary to rehydrate. A study by Seki and Mazur has shown that embryo survival is almost entirely dependent on the warming rate rather than the extracellular cryoprotectant concentration used. A recent study by Liebermann showed that simplifying warming procedures in one step by using 1M sucrose only is possible with an encouragingly higher ongoing pregnancy rate and comparable clinical outcomes when compared to the same conventional multi-step warming protocol, showing a significantly lower miscarriage rate (4.0% vs. 7.6%). These results lead to a faster, safer, and more cost-effective procedure. This study aims to investigate the effectiveness and safety of a new combination of V/W solutions-single and multi-step thawing protocol- on live birth rate (LBR), as well as embryo transfer, obstetric, and neonatal outcomes." NCT03484689,MBCT for DM Distress: a Pilot Qusai-experimental Study,"Inclusion Criteria: * received a clinical diagnosis of type II DM * aged \>=18 * can provide valid consent * can speak Cantonese * can read and write simple Chinese * HbA1c \>7% * have CDDS score \>=3 Exclusion Criteria: * diagnosed active mental illness * have severe hearing loss * non-Chinese * have active suicidal ideation as screened by Q9 of PHQ-9 * unwilling to join at least 6 out of 8 session of MBCT * received mindfulness training in the past year or having regular mindfulness practice * received psychotherapy last year * severe physical illness limiting them from coming repeatedly to the group",N/A NCT07128368,Mechanisms of Resistance Exercise Training for Improved Muscle Insulin Sensitivity,"Inclusion Criteria: * Sedentary (≤30min of physical activity on ≤1 day/week) * Weight stable for ≥3 months prior to study Exclusion Criteria: * Active coronary artery disease or heart failure. * Participation in a structured exercise program \> 1 day/week. * A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * Abnormal liver function test results (Transaminase \>2 times the upper limit of normal) * Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study * Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise * Abuse of alcohol or recreational drugs * Active tobacco usage * Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis). * Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening. * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol * Active pregnancy * Menopause (defined as absence of menstruation for 12 consecutive months) * Restrictions on Use of Other Drugs or Treatments: * Any other medication believed to be a contraindication to the subject's participation.",N/A NCT04971174,Outcomes of Periodontal Regenerative Treatment,"Inclusion Criteria: Inclusion criteria for part 1 of the study: * Patient age 18 and older * Patients that received periodontal regenerative surgical treatment at Barts RLDH from January 2017 to January 2019 with and without the use of any biomaterials, bone graft/substitute and membrane or combinations of those. * Available full periodontal examination records after non surgical therapy to serve as a baseline for the study and not beyond 12 months before surgery * Available radiographic examination of the tooth treated with surgical regenerative procedure at initial examination or after non surgical therapy to serve as a baseline for the study. Additional inclusion criteria for part 2: -Patient able and willing to give informed consent Exclusion Criteria: Exclusion criteria for part 1: * All the patients that do not match the inclusion criteria will be excluded from part 1. * Patients that received regenerative surgical treatment for the management of gingival recession. Exclusion criteria for part 2: * Unable or unwilling to give consent * Pregnant women","This study will be divided in two parts: Part 1: a retrospective analysis of short-term outcomes of periodontal regenerative procedures undertaken at the Barts Royal London Dental Hospital (RLDH); Part 2: a single recall visit study in which patients identified through part 1 and willing to consent for the study will be reassessed for medium-term outcomes of the regenerative procedures previously undertaken. For part 1 historic data will be collected from available dental records at RLDH and divided in: * Timepoint 0: the latest available full mouth periodontal assessment before surgery and x-ray of site/s needing surgical intervention * Timepoint 1: the latest available full mouth periodontal assessment after surgery and x-ray of same site/s at Timepoint 0 For part 2 data will be collected from patients identified through part 1 and willing to give consent for a single study recall visit: •Timepoint 2: single study outcome recall visit (full mouth periodontal assessment and x-ray of same site/s at Timepoint 0). Due to the nature of the study, the time elapsed between Timepoint 0 and Timepoint 2 can vary between 1 and 4 years." NCT01349374,Skin Samples of Diabetic Patients and Healthy Volunteers Collection,"Inclusion Criteria: * Diabetic patients diagnosed for type 2 diabetes, with a BMI between 20 and 25, without familial history and known genetic cause of diabetes. * Diabetic patients diagnosed for MODY diabetes (1, 2, 3, 4, 5 or 6), with a BMI between 20 and 25. * Healthy volunteers, siblings of MODY patients (1, 2, 3, 4, 5 or 6). * Healthy volunteers without familial history of diabetes. * Patients over 18 years old. * Patients with social insurance coverage * Patients who signed a consent form Exclusion Criteria: * Type 1 diabetic patients. * Pregnant women or women who might get pregnant",N/A NCT06931210,Study of AI-based Prediction Models for Exercise-Induced Gut Microbiota Alterations in Patients With Type 2 Diabetes,"Inclusion Criteria: -1. Diagnosed with type 2 diabetes; 2. Taking ≤3 types of antidiabetic medications; 3. On a stable medication regimen for at least 6 weeks prior to the intervention and maintaining the same regimen during the study period; 4. Aged between 35 and 65 years; 5. Abdominal obesity: waist circumference \>90 cm for men and \>85 cm for women; 6. Body mass index (BMI) ≤35 kg/m²; 7. Waist-to-thigh ratio (WTR): ≥1.7 for men and ≥1.6 for women; 8. Sedentary lifestyle (engaging in moderate-intensity exercise for ≤60 minutes per week). Exclusion Criteria: -1. Glycated hemoglobin (HbA1c) \<6.5% or ≥9%; 2. Use of insulin; 3. Presence of one or more of the following complications: advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or renal dysfunction (estimated glomerular filtration rate \[eGFR\] ≤60 mL/min/1.73 m²); 4. History of cardiovascular events (e.g., myocardial infarction, stent implantation, unstable angina, heart failure, or cardiac dysfunction); 5. History of cerebrovascular disease (e.g., cerebral hemorrhage or ischemic stroke); 6. Muscular, skeletal, or neuromuscular injuries that hinder exercise training; 6. Severe osteoporosis or failure to meet bone mineral density criteria despite treatment; 7. Pregnancy; 8. Inability or unwillingness to undergo MRI examination (e.g., due to claustrophobia, implantable cardioverter-defibrillator \[ICD\], or pacemaker); 9. Diagnosed depression or any psychiatric disorder that prevents the patient from understanding the nature, scope, and possible sequence of the study; 10. Patients taking antihypertensive or lipid-lowering medications are excluded if their medication regimen is unstable or affects glucose metabolism.",N/A NCT00250510,Reimbursement Effects on Enrollment in Obesity Treatment,"Inclusion Criteria: * Adults with obesity (BMI at least 30 kg/m2) * Commitment of the full EatRight Weight Management Program fee Exclusion Criteria: * None","This is a prospective study to determine whether a reimbursement incentive (the prospect of reimbursement of half of the out-of-pocket fee for participation in the UAB EatRight Weight Management Program, when it is contingent upon consistent Program participation and loss of 6% of initial body weight) is associated with (1) a higher rate of Program enrollment and (2) greater percent weight loss, greater reductions in medication dosages and costs, and fewer visits to health care providers after 12 weeks and 9 months." NCT00700960,Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose Control,"Inclusion Criteria: * Type 2 diabetes * HbA1c level greater than 7% despite treatment with two (or three) oral antidiabetic drugs (OADs) at an optimal dose level * Patient agreeing to take part in the study and capable of completing a self-questionnaire. Exclusion Criteria: * Hypersensitivity to insulin or to one of the excipients * Treatment with insulin for at least 6 months * Participant in a clinical trial for diabetes on entry into the observational study",N/A NCT00810420,EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes,"Inclusion Criteria * 18-60 year old subjects * Type 1 diabetics with complete or partial hypoglycemia unawareness. * Ability to comprehend and a willingness to sign an informed consent form Exclusion Criteria: * Neurological or psychiatric disease. * Current use of neuroactive medication or recreational drugs. * Pregnancy. * Patients with known heart disease, former myocardial infarction or cardiac arrhythmia * Patients with known epilepsy or in treatment with anti-epileptic drugs for all purposes * Patients treated with drugs that are known to influence the EEG, including benzodiazepines and other anxiolytics, anti-depressants and beta-blocking agents * Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation * Cancer of any kind","The near-normalization of glycemic control has become an established treatment goal in diabetes in order to reduce late complications such as nephropathy, neuropathy, retinopathy and cardiovascular disease (1,2). However, the frequency of insulin-induced hypoglycemia increases several-fold during intensified insulin therapy (2,3). Thus, hypoglycemia is the most common acute complication in the treatment of diabetes with insulin. During hypoglycemia the cognitive function is disturbed, and may progress to unconsciousness and seizures. This can lead to high-risk situations, e.g. while driving or operating a machine. Estimates of deaths in patients with type 1 diabetes attributed to hypoglycemia vary between 2% and 6% (4,5). Moreover, the risk of hypoglycemia limits everyday activities of diabetic patients decreasing their quality of life. It is therefore not surprising that hypoglycemia is the most feared acute complication of insulin therapy in diabetic patients. This fear of hypoglycemia discourages diabetic subjects from attempting to maintain tight glycemic control, which in turn leads to a higher incidence of late complications and consequently increased mortality rate (1,6,7) In the first years of type 1 diabetes, most patients are able to sense the characteristic symptoms of hypoglycemia, which can then be relieved by consuming appropriate food. The symptoms of hypoglycemia can roughly be classified as autonomic (warning) symptoms caused by the release of catecholamines, and neuroglycopenic symptoms caused by the lack of glucose in the brain. In many patients symptoms are often compromised at night (nocturnal asymptomatic hypoglycemia) due to impaired glucose counterregulatory response by adrenaline and glucagon. The chronic form of hypoglycemia unawareness is very common. A quarter of all insulin-treated diabetic patients have some degree of diminished symptomatic awareness, but this proportion increases to almost 50% in patients who have had diabetes for more than 20 years (8). Strict control of diabetes by intensive insulin therapy is associated with increased risk of the hypoglycemia unawareness syndrome with loss of autonomic warning symptoms (2,6,9). This seems to involve diminished hormonal glucose counterregulation due to recurrent hypoglycemic episodes (6,9). For these reasons, a number of studies have been carried out with the aim of developing automatic detection systems, which can warn the diabetic patients before blood glucose levels are reduced to the level at which severe neuroglycopenia develops, typically about 2.0-2.5 mmol/l. Most studies have evaluated the potential of continuous glucose monitoring (CMG) to decrease the frequency of hypoglycemia. Although, smaller studies have reported a lower risk of hypoglycemia using CMG compared with conventional glucose measurements (10,11), larger multi-center studies have failed to reproduce these findings (11-14). This could be explained by a low accuracy in the low range of glucose values and delay in detection time during rapid changes using CMG (11,13,14). In fact, CMG only recognizes less than 50% of hypoglycemic events (15). Thus, even with a marginal improvement compared with conventional glucose measurements, CMG is far from the goal of completely avoiding severe hypoglycemic episodes. The EEG signal reflects the functional state and metabolism of the brain. The brain is almost totally dependent on a continuous supply of glucose, and when this is lower than the metabolic requirements of the brain, its function deteriorates. Indeed, neuroglycopenic hypoglycemia in insulin-treated diabetic patients is associated with characteristic changes in EEG with a decrease in alpha activity, an increase in delta activity, and in particular an increase in theta activity (16-19). These changes are clearly seen at \~2.0 mmol/l (16,17), but may be present already at higher glucose levels (\~3.0 mmol/l), in particular in type 1 diabetic patients with hypoglycemic unawareness (19,20). It has been shown that the most characteristic changes, the increase in theta activity, appears 19 min before severe cognitive impairment (20). This suggests a ""window"" between hypoglycemia-induced EEG changes and severe neuroglycepenia, which is an important prerequisite in developing an automatic detection system capable of warning the patient. A number of studies have characterized the changes in the EEG that results from hypoglycemia (16-20), but none have proposed a method of processing and testing in real-time. With a device, which can perform real-time monitoring and processing of EEG signals and automatically detect and warn the patient of hypoglycemia-induced EEG changes, it would be possible for the patient to avoid severe neuroglypenic symptoms e.g. by ingestion of carbohydrates. The construction of an EEG-based hypoglycemia alarm system must fulfill the following criteria. First, the device should be able to distinguish hypoglycemia-induced EEG changes from normal changes in EEG, noise and artifacts with high sensitivity and specificity using a mathematical algorithm that classifies the EEG in real-time. Second, these EEG changes should be observed in the majority of insulin-treated diabetic patients during hypoglycemia. Third, there should be a ""window"" between hypoglycemia-induced EEG changes and severe cognitive impairment. Moreover, the device should be fully compatible with normal everyday activities. Thus, the electrodes should be thin and implanted subcutaneously, and the monitoring and processing unit should be small, have sufficient battery power, and capable of communicating with a PDA or cell phone." NCT06862180,Effect of Meal Replacement Therapy on Glucose Control and Metabolic Parameters in Patients With Uncontrolled Diabetes,"Inclusion Criteria: 1. Patients between ≥ 30 to ≤ 65 years old 2. Diagnosed as having type 2 diabetes mellitus base on CPG Malaysia Clinical Practice Guidelines (CPG) for Type 2 Diabetes Mellitus (T2DM) 6th edition 2020. 3. On oral hypoglycaemic agent(s) 4. HbA1c 7- 10 % (result 3 months from the date of recruitment) 5. Agree not to take other beverages, herbal or nutritional supplements for the duration of the study. Exclusion Criteria: 1. Severe diabetic complication(s) including end-stage renal disease and proliferative retinopathy. 2. Pregnancy or plan to get pregnant during the study period 3. Newly diagnosed diabetic less than 3 months from the date of recruitment 4. Currently involve in any weight loss program 5. Currently consuming any meal replacement product 6. Patients with chronic kidney disease with eGFR ≤ 25 ml/min. 7. Patients with advanced liver disease, such as non-alcoholic steatohepatitis (NASH) with significant fibrosis (e.g., liver stiffness measurement \> 9.5 kPa by FibroScan) or cirrhosis. 8. Patients with significantly elevated liver enzymes (e.g., ALT or AST ≥ 3 times the upper limit of normal), which may indicate more severe liver damage.","General objective To determine the effect of Contro Eazy NOW (CEN) as meal replacement therapy on HbA1c, fasting plasma glucose, fasting lipid profile, body mass index (BMI) and body composition in patients with uncontrolled type 2 diabetes on oral hypoglycemic agents vs control group. Hypotheses 1. There are significant improvement in HbA1c over a 12-week period between type 2 diabetes mellitus patients taking meal replacement Contro Eazy Now vs the control group (between-group). 2. There are significant improvement in HbA1c among type 2 diabetes mellitus patients at baselines and 12-week after taking meal replacement Contro Eazy Now (within-group). 3. There are significant improvements in fasting plasma glucose, fasting lipid profile, body mass index (BMI), blood pressure body composition (muscle mass(kg), fat mass (kg), fat percentage (%) and diabetes quality of life over 12-weeks between type 2 diabetes mellitus patients taking meal replacement Contro Eazy Now vs control group (between-group). 4. There are significant improvements in fasting plasma glucose, fasting lipid profile, body mass index (BMI), blood pressure, body composition (muscle mass(kg), fat mass (kg), fat percentage (%) and diabetes quality of life at baselines and 12-week after taking meal replacement Contro Eazy Now? (within-group). Study procedure Participants will be recruited from KRK. Potential participants will be identified from the case notes of patients or being referred by the medical officers in charge. Participants will be screened to determine their eligibility criteria. Those who are willing to participate in this study will be given information regarding the study. Informed consent will be obtained. Their latest blood result within the last 3 months will be checked such as hemoglobin A1c (HbA1c), Liver function test (LFT), renal function test (RFT). If there is no blood result within the last 3 months, blood will be taken and sent to the private lab. If all the inclusion criteria are fulfilled, they will be given an appointment for the next visit for recruitment. During recruitment, the participants' socio-demographic data will be collected, and the medical record will be assessed to fill in their medical and diabetes profiles. They will also answer the Diabetes Quality of Life (Rv-DQoL) questionnaire. The physical examination includes measurement of height, weight, calculated Body Mass Index (BMI), body composition (muscle mass, fat mass and fat percentage) and blood pressure during sitting will be done. Blood taking 8ml of fasting venous blood will be taken for measurement of hemoglobin A1c (HbA1c), fasting blood sugar(FBS), full blood count(FBC), renal function test(RFT), liver function test(LFT) and fasting lipid profile(FLP) as a baseline. All participants were advised not to consume any special supplement or other replacement meal throughout the study. They then will be given an appointment date for visit 2 for randomization. During visit 2, The participants will be randomized to either intervention or control group. Both groups will receive diet consultation and dietary assessment using a 24-hour diet recall form from the dietitian in the study team at the Dietetic Clinic, Hospital USM. Those in the intervention group will receive diet consultation and meal replacement therapy (Contro Eazy Now (CEN)). The control group will get a diet consultation. The participants will be seen 6 weeks after taking the product. During this visit, they will be assessed for any side effects or adverse events and compliance with meal replacement product (food record form). Blood pressure, weight, height, calculated Body Mass Index (BMI) and body composition (muscle mass, fat mass and fat percentage) also will be measured. Supply of Contro Eazy Now (CEN) will be given for another 6 weeks for the intervention group. For the control group, blood pressure, weight, height, calculated Body Mass Index (BMI) and body composition (muscle mass, fat mass and fat percentage) also will be measured. Lastly, the participants will be assessed in week 12. During this visit, the same measurement will be taken as visit 1, including answering the Diabetes Quality of Life (Rv-DQoL) Questionnaires. Adverse events and compliance will be assessed. Blood taking 8ml of fasting venous blood same as baseline will be taken for measurement of HbA1c, FBS, FBC, RFT, LFT and FLP. The duration for visit 1 and visit 4 (at 12 weeks) is about 50-60 minutes for each visit since it will involve blood taking procedure. Duration for visit 2 and 3 (at 6 weeks) is about 30 minutes since it will not involve blood taking. Meal replacement arm group. At baseline, both the meal replacement and control group will receive diet consultation from a research Dietician. On top of that, the MR group will receive a meal replacement product (Contro Eazy Now) to replace one meal daily for 5 days a week. Participants in the MR group then will be briefed about meal replacement therapy using Contro Eazy Now (CEN) covering its benefits (on glucose control, weight, body composition and quality of life), dosage, method of preparation and suggested meal replacement time. The meal replacement time suggested by the Dietitian must be agreed by participants first, to allow good compliance with meal replacement therapy. The duration of the intervention will be 12 weeks. All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment. Dietary compliance towards advice on diabetic diet and meal replacement therapy given at baseline will be assessed on the 6th and 12th week intervention in 30 minutes follow up session. Control group Participants will receive one session of dietary consultation at baseline. The 45 to 60 minutes session will be conducted on a one-on-one basis by a research Dietitian. The dietary consultation session mirrors usual/standard practice for diabetes patients at Dietetic Clinic Hospital USM, including topics on calorie intake and carbohydrate requirements, carbohydrate food sources, carbohydrate exchange counting, sucrose intake, fat intake, Healthy Food Plate Malaysia, physical activity recommendation, and individualised menu plan. Upon completion of the dietary consultation session, participants in the control group will be advised to continue their daily lives and routine medical care without extra intervention. They will be given a 24-hour diet record form to record the 24-hour diet recall before coming in for follow-up at 6-week and 12-week. The duration of the intervention will be 12-weeks, the same as MR group. Dietary compliance advice on diabetic diet given at baseline FRF will be assessed on the 6th and 12th week. Follow up There will be two follow-ups during this study. 1st follow-up will be on the 6th week and 2nd follow-up (final follow-up) will be during 12th week of the study. During the 6th week follow-up, participants will be checked for their weight, height, calculated Body Mass Index (BMI), body composition and Compliance Form, any adverse effect will be documented and collect the balance of six-weeks supplements. During this visit also the participants will be asked to bring their Food Record Form, and the researcher will check the form before handing over the balance of 6-weeks MR product. A final visit (12th week) to the clinic will be conducted on the 12th week. During these visits, assessment of the outcome measures will be carried out to determine the effect of meal replacement interventions." NCT00727779,Mechanisms by Which Strength Training Ameliorates the Metabolic Syndrome,"Inclusion Criteria: obese family history of diabetes Exclusion Criteria: non-obese diabetes","Life style alterations can be powerful deterrents to developing type 2 diabetes and are cornerstones of the treatment of this condition. Both aerobic and resistance exercise improve diabetes blood glucose control and insulin resistance. These two types of exercise appear to exert their effects on different muscle fiber types - red for endurance and white for strength. Similar to the effects of endurance exercise training, strength training increases muscle glucose transporter isoform 4 (GLUT4), but in contrast, mitochondria numbers do not increase. We hypothesize (1) that strength training in persons with pre-diabetes may be effective in reversing insulin resistance by novel mechanisms that are distinct from the endurance training-induced mitochondrial biogenesis. We further hypothesize (2) that resistance exercise training enhances whole body insulin action primarily by increasing the white fiber size via the protein kinase mammalian target of rapamycin (mTOR) and improves insulin-stimulated glucose uptake by increased GLUT4 expression primarily in white fibers of the trained muscles. In this proposal, we will perform eight weeks of progressive strength training on ten subjects with the Metabolic Syndrome who are at high risk for developing type 2 diabetes and on ten sedentary control subjects. This project builds on our experience with a study of focused resistance training whose results are presented in this application. In this pilot study, subjects exercised on stationary bicycles for six weeks causing muscle GLUT4 and phopho-mTOR to increase substantially, but maximal oxygen uptake (VO2max), phospho-AMP-activated protein kinase (AMPK), peroxisome proliferator-activated receptor-γ co-activator (PGC-1α), and mitochondrial markers did not change. Our hypotheses will be tested by two Specific Aims. (1) Subjects at high risk for diabetes will undergo progressively increasing intensity resistance exercise training and increased strength and improved insulin responsiveness will both be quantified to demonstrate significant benefit, and (2) quantify the effect of resistance exercise training on anatomic and functional adaptation in muscle. We will characterize fiber type, fiber size, fiber-specific changes in mitochondrial DNA and enzymes, fiber-specific changes in the principle glucose transporters in muscle (GLUT4, GLUT5, and GLUT12), and evaluate changes in two distinct intramuscular pathways (AMPK, mTOR) and regulatory factors (PGC-1α, PPARγ, PPARδ) using immunoblots of muscle subcellular fractions and immunohistochemical techniques. These evaluations of molecular mechanisms will also include assessing changes in full human Affymetrix gene array data that may move us to new potential resistance training-regulated gene targets. It is the long-term goal of this team of investigators to understand the interplay between life style changes and pharmacological agents in the prevention and treatment of diabetes. Our results will facilitate the development of more effective clinical options to turn back the epidemic of obesity and diabetes in the United States." NCT04876079,Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes,"Inclusion Criteria: 1. Males and females ≥ 18 years old 2. Clinical diagnosis of type 1 diabetes for at least one year 3. Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin) 4. A glycated hemoglobin A1c ≤ 10% Exclusion Criteria: 1. Clinically significant microvascular complications: nephropathy (eGFR \< 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis) 2. Recent (\< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery) 3. Known significant cardiac rhythm abnormality based on investigator's judgement 4. Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement 5. Ongoing pregnancy or breastfeeding 6. Severe hypoglycemia episode within 1 month of screening 7. Known uncorrected hypokalemia within the past 3 months (potassium \< 3.5 mmol/L)",N/A NCT06523179,Evaluation of Risk of hEpatocellular Carcinoma,"Inclusion Criteria: * Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\<60/40 g/day in M/F), so as to also include subjects with a moderate alcoholic component of liver disease, an important factor given the high epidemiological burden of this group * Age between 45 and 75 years * Any of the following criteria: * F3-F4 fibrosis, determined histologically, or by non-invasive techniques (stiffness \> 7.9 kPa at Fibroscan and positivity at the NAFLD fibrosis score or at APRI or at FIB4), or evidence of cirrhosis deriving from biochemical tests or imaging methods; * Family history of primary liver cancer in first degree parentage, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT) * Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7. * Willingness to sign the informed consent. Exclusion Criteria: * Alcohol intake \>60/40 g/day in M/F * Chronic viral or autoimmune hepatitis * Any previously diagnosed genetic liver disease associated with increased risk of HCC (such as hereditary hemochromatosis, Wilson's disease, Alpha-1 Antitrypsin deficiency) * Use of drugs known to induce steatosis and liver disease * HCC diagnosed before the study start date. * Other pathological conditions with a prognosis of less than two years.","The mechanisms linking NAFLD to liver disease progression towards HCC have not yet been identified. Anyhow several pathways may be activated in obesity and diabetes favoring a tumor-promoting environment distinguishing the pathogenesis of NAFLD-HCC from that of other etiologies. First of all, increased cancer risk is associated with a low-grade of chronic inflammation, a manifestation typical of obesity and metabolic syndrome. Indeed, adipose tissue expansion promotes the release of pro-inflammatory cytokines, namely tumor necrosis factor alpha (TNFα) and interleukin 6 (IL6) both potent activators of key oncogenic signaling pathways. Furthermore, obesity alters the release of adipokines reducing the level of those with anti-inflammatory effects such as adiponectin and arising the level of those with pro-inflammatory and fibrogenic effects, such as leptin. Overall the factors listed above collectively induce hyperinsulinemia, resulting in increased bioavailability of insulin-like growth factor-1 (IGF1) which in turn promotes cellular proliferation and inhibits apoptosis. The activation of hepatic stellate cells (HSCs) is also a major step in the development of cirrhotic HCC, however these cells not only secrete collagen that results in liver fibrosis, but may even produce several growth factors which stimulate oncogenic pathways contributing to the expansion of neoplastic clones. Genetic factors have been shown to influence disease progression in NAFLD, and family history remains the main risk factor for HCC development. The common genetic polymorphism rs738409 C\>G encoding for the I148M variant in Patatin-like phospholipase domain-containing protein 3 (PNPLA3 or adiponutrin) has been established as the main common genetic determinant of hepatic fat content and of progressive NAFLD. The mechanism is related to accumulation of the mutated protein, which interferes with lipid droplets remodeling in hepatocytes, and with retinol release by hepatic stellate cells. The PNPLA3 variant predicts HCC development in European patients with NAFLD. This evidence suggests that this genetic risk factors may be helpful to select high-risk individuals for screening, but it has a low sensitivity to be used as single prognostic biomarker. The rs58542926 E167K variant in Transmembrane 6 superfamily member 2 (TM6SF2) also predisposes to progressive NAFLD by altering the secretion of very low-density lipoproteins, but its direct role in HCC predisposition is disputed. More recently, it has been found that the rs641738 C\>T sequence variant in the Membrane bound O-acyltranferase domain containing 7/ Transmembrane channel like 4 (MBOAT7/TMC4) locus, involved in phospholipids remodeling, predisposes to cirrhosis development in individuals with excessive alcohol intake, and to the development and the progression of NAFLD in individuals of European descent. We recently reported in a cross sectional cohort that the rs641738 variant is also associated with HCC risk is patients with NAFLD . Moreover, loss of function germline mutations in the telomerase reverse transcriptase (hTERT) can predispose to a spectrum of familial liver diseases characterized by steatosis and possible evolution to cirrhosis and HCC. Furthermore, it has also been reported that rare mutations inducing Mendelian diseases due to severe derangements in the function of encoded proteins may predispose to NAFLD-HCC. Indeed, mutations in Apolipoprotein B (APOB) may explain some familial cases through predisposition towards development of severe steatosis caused by hepatocellular retention of lipids." NCT06623396,A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer,"Inclusion Criteria: * Aged ≥18 years * Diagnosis of pathologically confirmed EG adenocarcinoma * Diagnosis of metastatic or recurrent disease * ECOG performance status of 0-1 * Life expectancy of ≥4 months Inclusion Criteria for Leukapheresis: * Written informed consent for the study (from participant) * Life expectancy of ≥4 months * ECOG performance status of 0-1 * Histologic diagnosis that \& \>25% of the tumor expresses MSLN by IHC analysis. Archival tissue obtained up to 2 years before study enrollment is acceptable. IHC testing of a cell block from cytology (e.g., ascitic fluid) is acceptable if approved by the study pathologist. If adequate archival tissue is not available at screening, a fresh tumor biopsy should be obtained * Stage IV disease with gross peritoneal carcinomatosis on imaging and/or microscopic peritoneal involvement by cytology or noted during diagnostic laparoscopy * Disease progression or treatment intolerance after receiving at least 1 treatment regimen in the metastatic setting; patients with disease recurrence within 6 months of completing curative systemic therapy (chemotherapy, chemoradiation or adjuvant immunotherapy) are also eligible * Patients with Her2 positive disease must have received ≥1 line of anti-Her2 based therapy * At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 6 weeks of signing the informed consent form * Completion of systemic therapy at least 7 days before leukapheresis o Immune checkpoint inhibitor therapy must be completed at least 14 days before leukapheresis * Lab requirements (hematology): * Absolute neutrophil count ≥1.0 K/mcL * Hemoglobin ≥9 gm/dL * Platelet count ≥75 K/mcL * Blood product transfusion or growth factor support cannot occur within 7 days of testing * Lab requirements (serum chemistry): * Bilirubin ≤1.5× upper limit of normal (ULN) * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) level ≤3× ULN * Calculated clearance of ≥50 mL/min by Cockcroft-Gault equation * Negative screen for infectious disease markers, including hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, HIV 1-2 antibody, HTLV antibody and syphilis antibody o Note: Patients with a history of hepatitis B virus infection are eligible if the hepatitis B viral load is undetectable. Patients with a history of hepatitis C virus infection who were treated for hepatitis C and cured are eligible if the hepatitis C viral load is undetectable * Serum pregnancy test with negative result at screening and preconditioning and must be willing to use effective and reliable contraception for at least 12 months after T cell infusion (for female participants of childbearing age) * Resolution of all acute toxic effects of any previous therapeutic or palliative chemotherapy, radiotherapy, or surgical procedures to grade ≤1 (CTCAE v5.0), except for neuropathy and alopecia Inclusion Criteria for lymphodepleting chemotherapy/CAR T cell infusion * Life expectancy of ≥4 months * ECOG performance status of 0-1 * At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 4 weeks before the date of lymphodepletion * Completion of systemic therapy at least 14 days before lymphodepleting chemotherapy o Immune checkpoint inhibitor therapy must be completed at least 28 days before lymphodepleting chemotherapy * Lab requirements (hematology): * Absolute neutrophil count ≥1.5 K/mcL * Hemoglobin ≥8 gm/dL * Platelet count ≥75 K/mcL * Lab requirements (serum chemistry): * Bilirubin ≤1.5× upper limit of normal (ULN) * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) level ≤3× ULN * Calculated clearance of ≥50 mL/min by Cockcroft-Gault equation * Serum pregnancy test with negative result within 7 days of planned lymphodepletion date and must be willing to use effective and reliable contraception for at least 12 months after T cell infusion (for female participants of childbearing age) * Resolution of all acute toxic effects of any previous therapeutic or palliative chemotherapy, radiotherapy, or surgical procedures to grade ≤1 (CTCAE v5.0), except for neuropathy and alopecia Participant Exclusion Criteria Exclusion Criteria for Leukapheresis or Lymphodepleting chemotherapy/CAR T cell infusion: Participants are excluded from enrollment if any of the following criteria apply: * Pregnant or lactating * HIV, active hepatitis C virus, or active hepatitis B virus infection, as determined by quantitative PCR (patients who have undergone negative testing prior to leukapheresis do not require repeat testing) * Receiving therapy for concurrent active malignancy * Note: Patients receiving treatment for in situ skin malignancies are not excluded. * Patients with any malignancy diagnosed \>3 years before that is thought to be curatively treated and/or has a low risk of recurrence are eligible. Patients may continue to receive adjuvant therapy at the time of study enrollment (e.g., adjuvant hormonal therapy for curatively treated breast cancer). * Known hematologic malignancy requiring treatment in the preceding 5 years or a known history of lymphoid malignancy * Previous receipt of CAR T cell therapy or any other cellular therapy * Previous mesothelin-directed therapy Any major abdominal surgery (laparotomy with resection of gastrointestinal tract or organ resection) that is completed \<28 days before study enrollment. Patients who have undergone diagnostic laparoscopy can be included in the study without regard to timing * Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible if all of the following criteria are met: * Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study * Completion of radiotherapy ≥4 weeks before the screening radiographic study * Active autoimmune disease that has required systemic treatment within 1 year before leukapheresis (with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) o Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Receiving daily systemic corticosteroids ≥10 mg of prednisone daily or equivalent or receiving immunosuppressive or immunomodulatory treatment * Any of the following cardiac conditions: * New York Heart Association stage III or IV congestive heart failure * Myocardial infarction ≤6 months before enrollment * History of myocarditis * Serious uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled infection * Left ventricular ejection fraction ≤40% * Active interstitial lung disease/pneumonitis or a history of interstitial lung disease/pneumonitis requiring treatment with systemic steroids * Baseline pulse oximetry \<90% on room air at the screening time point * Known active infection requiring antibiotic treatment 7 days before leukapheresis o Note: Treatment can be delayed at the discretion of the treating physician to allow the patient to recover from the infection. * Any other medical condition, e.g. fever \>38.0 degrees C, that, in the opinion of the PI, may interfere with the subject's participation in or compliance with the study * Receipt of live, attenuated vaccine within 8 weeks before the planned lymphodepleting chemotherapy date * Deemed to be noncompliant by the study team for administration of a high-risk treatment agent and for close follow-up after treatment as required by the protocol",N/A NCT03253562,Metformin Versus Vildagliptin for Diabetic Hypertensive Patients,"Inclusion Criteria: * Patients suffering from moderate HTN and DM, their HbA1c ≥ 7 and age range between 40-60 years, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission Exclusion Criteria: * Clinical evidence of ischemic heart disease, chronic obstructive pulmonary disease, presence of diabetic ketoacidosis (DKA), patients admitted to intensive care unit (ICU), subjects expected to undergo surgery during the study period, patients with clinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0 mg/dL), systemic infections or pregnancy. Also, patients on medications known to interfere with the blood glucose level (either increasing or decreasing) were excluded from the study.","Several studies indicated that type 2 diabetes mellitus and hypertension are associated with increased cardiovascular complications. Recently, studies suggest that metformin and vildagliptin can reduce cardiovascular complications in diabetic patients with unclear mechanisms. This work aimed to determine the effect of metformin and vildagliptin on diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy volunteers, groupII: patients recently diagnosed with their hypertension and diabetes, groupIII: patients treated with captopril (25mg once daily) for their hypertension in addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period, then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial growth factor (VEGF) levels in serum will be measured for different groups to estimate the benefits of one drug over the other one in protecting against cardiovascular risks for diabetic hypertensive patients.." NCT03920462,Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers (PROTOVELIS),"Inclusion Criteria: * Capacity to ride a bike * Volunteer without a contraindication to moderate physical activity or cycling (acute coronary artery disease less than 2 years old, musculoskeletal problem of the spine or lower limbs incompatible with cycling). * weight \< 125 kg * volunteer available for an intervention of 2-3 hours twice a week during 1 month. Exclusion Criteria: * Person deprived of liberty or legal protection measure","The investigators propose to validate the technical and organizational feasibility of workshops using the intelligent electric bike for health with different devices such as two connected vests (non-invasive) measuring on the one hand the cardiological and respiratory parameters (connected vest named : Etisens) and the other hand the kinetic energy of movement (connected vest named : Optimove). The development of this ambulatory physiology platform and the engine brake create perspectives for an outdoor rehabilitation tool that for example could stimulate, on an altitude free-excursion, a mountain pass of Alpes doing the link of health, sport and well-being." NCT07158762,Blood Glucose Levels After Bread Consumption Between Participants With Normal Weight and Overweight/Obesity,"Inclusion Criteria: • healthy adults of 18 - 50 years Exclusion Criteria: * participants with diabetes * digestive system diseases * BMI \< 18.5 kg/m2 * coeliac disease * other chronic diseases * blood clotting issues * those who could not consume the study meals due to food allergies or other reasons","Introduction Postprandial glycaemic response (PPGR) is an independent risk factor for type 2 diabetes mellitus (T2DM), and postprandial hyperglycaemia is the first detectable metabolic alteration in the progression from prediabetes to T2DM. T2DM is a multifactorial disease, with overweight and obesity being major risk factors. Previous evidence shows inconsistent results regarding the association between BMI (few studies used BF%) and PPGRs. Some studies found no significant difference in the incremental area under the curve (iAUC) of PPGRs between participants with normal weight and overweight/obesity after bread consumption or glucose solution ingestion. Other studies similarly reported no differences after processed orange juice ingestion or a high-fat meal. Bread is a staple food in the UK, with white bread being the most consumed, followed by wholemeal bread. Wholemeal bread is generally considered healthier than white bread due to its higher content of dietary fibre, phytochemicals, and some minerals and vitamins. Interestingly, some studies found no significant differences in PPGRs between wholemeal and white breads, despite the higher fibre content of wholemeal bread. This may be due to the predominance of insoluble fibre in wholemeal flour, which does not affect postprandial glycaemia, whereas soluble, viscous fibre is known to slow gastric emptying and glucose absorption, thereby attenuating glycaemic spikes. However, few studies have tested commercially available breads, which typically contain around 7 g (wholemeal) and 2.9 g (white) of dietary fibre per 100 g. The primary aim of this study is to determine whether individuals with overweight or obesity exhibit higher PPGRs compared to individuals with normal weight following the consumption of commercially available white and wholemeal breads sold in UK supermarkets. The secondary aim is to assess whether wholemeal bread consumption attenuates PPGRs compared to white bread, irrespective of BMI or BF%. Methods Ethics approval The study was approved by the Coventry University Ethics Committee (Ref P136390). Participants Twenty participants will be recruited using purposive and convenience sampling via a recruitment advert circulated by email and word of mouth among university staff and students. Normal weight (BMI 18.5-24.9 kg/m²) and overweight/obesity (BMI ≥ 25 kg/m²) were defined according to National Institute for Health and Care Excellence (NICE). Inclusion criteria: healthy adults aged 18-50 years. Exclusion criteria: diabetes, digestive system diseases, BMI \< 18.5 kg/m², coeliac disease, other chronic diseases, blood clotting disorders, or inability to consume the study meals due to food allergy or other reasons. Eligibility will be screened via a health and lifestyle questionnaire. Study design This is an acute, randomised, non-blinded crossover trial. Eligible participants will attend two visits (at least 48 hours apart). They will be asked to fast for 8-12 hours (water only) prior to each visit. On each visit, participants will be provided with meals containing either white bread (WB) or wholemeal bread (WMB) in random order. The bread type for the first visit will be determined by coin toss: heads = WB, tails = WMB. Participants will consume two slices of bread (white or wholemeal) alongside 150 ml of pure orange juice and 10 g of butter to mimic a real-life scenario and enhance palatability. All food and drink items will be purchased from TESCO supermarket (Welwyn Garden City, United Kingdom). Postprandial blood glucose will be measured at 0 (fasting), 30, 60, 90, and 120 minutes by finger prick, performed by the researcher using the BIOSEN Blood Glucose/Lactate Analyser (EKF Diagnostics, Cardiff). Participants will be instructed to consume the meal within 10 minutes, remain sedentary, and refrain from eating or drinking during the study period. Mobile alarms will be used to ensure blood samples are collected on time. Participants will also be asked to follow a similar dinner, avoid intensive physical activity and alcohol, and obtain adequate sleep the night before each visit. Names, email addresses, and mobile numbers will be collected for appointment purposes, and self-reported demographic variables (age, gender, and ethnicity) will also be collected. The treatment allocation (bread type) will not be blinded to AC and YX, who conducted the study, or to participants (non-blinded), but will be blinded to HD, who analysed the data. Outcome measures PPGRs will be reported as iAUCs and peak values (PVs) after the meals for up to 2 hours. iAUC will be calculated using trapezoidal numerical integration, including only the incremental area above the fasting level. Body height will be measured with a stadiometer, and body weight and BF% will be measured using the TANITA MC-980MA PLUS (TANITA Company, Tokyo) before the meal on the first visit only. Data analysis The sample size was informed by a similar study design and calculated using G\*Power software (version 3.1.9.7, Düsseldorf, Germany), selecting F-test, ANOVA: repeated measures, within-between interaction. Twenty participants were required to detect an effect size of 0.3 with 90% power at a significance level of 0.05. Categorical data will be presented as frequency (n) and percentage (%). Continuous data will be presented as mean ± standard deviation (SD). Differences in age, BMI, and BF% between the two groups will be analysed using independent-samples t-tests. Gender and ethnicity distributions between groups will be analysed using the Chi-squared test. Differences in iAUC and PVs between the two body weight groups (between-subject factor) and between WB and WMB conditions (within-subject factor) will be analysed using a two-way repeated-measures ANOVA. Pearson's correlation will be used to analyse associations of BMI and BF% with iAUCs and PVs after white and wholemeal bread consumption separately. Normality of continuous data will be assessed using the Kolmogorov-Smirnov test. Statistical significance is set at P ≤ 0.05 (two-tailed)." NCT03792646,"Protein Supplementation: Body Composition, Muscle Strength and Postural Balance","Inclusion Criteria: * Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin or combination of both) for three months or more. * Glycated hemoglobin between 6 and 8.5% * Renal function assessed by MDRD above 60 ml / h * AST and ALT up to 2.5 times the upper limit of the * No involvement of the musculoskeletal system with pain and any type of incapacitating disease or previous surgeries. * No chronic non-communicable disease not treated properly and decompensated * Renal function assessed by MDRD equal to or above 60 ml / h Exclusion Criteria: • Impossibility to conduct evaluation and training efficiently","Eligibility Criteria: Diabetes mellitus type 2 with stable dose of medication (oral antidiabetic or insulin or combination of both) for three months or more. Glycated hemoglobin between 6 and 8.5% Renal function assessed by MDRD above 60 ml / h AST and ALT up to 2.5 times the upper limit of the No involvement of the musculoskeletal system with pain and any type of incapacitating disease or previous surgeries. No chronic non-communicable disease not treated properly and decompensated Renal function assessed by MDRD equal to or above 60 ml / h" NCT05067088,Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness,"Inclusion Criteria: 1. Age of \>18 years 2. Newly diagnosed OSA naïve to CPAP 3. Apnea hypopnea index (AHI) ≥5/hr on in-laboratory polysomnography or home sleep test acquired and scored using standard criteria(59) 4. Referred for CPAP adherence management at Yale New Haven Hospital Sleep Center Exclusion Criteria: 1. Need for supplemental oxygen 2. Central apnea index comprising \>50% of the AHI 3. Treatment recommendation with another modality (e.g., Bilevel PAP, Adaptive Servo-Ventilation, Automatic Volume Pressure Assured Pressure Support) 4. A referral for a sleep disorder other than OSA (i.e., narcolepsy, sleep related movement disorder, circadian rhythm sleep-wake disorder) 5. Prior CPAP or Auto-CPAP use over the past 3 years 6. Unstable medical or mental health condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end stage renal disease, psychosis) 7. Inability to participate in the informed consent process (e.g., cognitive impairment) 8. Pregnancy 9. Non-English language use as only means of communication (because the research budget does not provide adequate resources to ensure that the needs of non-English speaking patients can be adequately addressed)","Most patients with OSA who are prescribed the gold-standard therapy, CPAP, are ineffectively treated. This is due to 1) poor CPAP adherence, 2) high residual apnea in 20% of users (low efficacy) and 3) inconsistent symptom improvement. To improve CPAP effectiveness, we propose to address novel physiologic targets that cause OSA in each individual: arousability (arousal threshold), ventilatory control sensitivity (loop gain) and pharyngeal muscle compensation. Our overall objective is to determine the contribution of these traits to CPAP effectiveness independently of established biological, psychological and social predictors. This study leverages state-of-the art sleep study analysis tools and validated measures of the determinants of CPAP effectiveness to create a pragmatic, prospective cohort (n=267) of OSA patients. This unique dataset will help determine whether physiologic causes of OSA influence CPAP adherence, efficacy, sleep quality, symptoms, function and quality of life. The results will inform design and conduct of a randomized clinical trial designed to modify physiologic traits such as easy arousability to improve CPAP effectiveness and other patient-centered outcomes in OSA patients." NCT02042664,Effect of GLP-1 Receptor (GLP-1R) Agonists on Cardiac Function and on Epicardial Adipose Tissue (EAT) Volume and on Myocardial TG Content in Obese Diabetics,"Inclusion Criteria: * \- Patients with type 2 diabetes according to WHO criteria * Age\> 18 years * BMI ≥ 30 kg/m2 * HbA1c\> 7% and \<10% * Processing by ADO (Metformin and Glimepiride) * Effective contraception (for women) * Signed informed consent by the patient before inclusion in the protocol Exclusion Criteria: * Ongoing pregnancy or become pregnant within six months of the study protocol * Breastfeeding * Recent weight loss (\> 5% of total weight) * Treatments changing the distribution of adipose tissue as corticosteroids or glitazones * Acute coronary syndrome or unstable angina during the last three months * Contraindications to cardiac MRI (mechanical heart valve, pacemaker, metallic intraocular foreign body, claustrophobia) * Contraindication to cold test: Raynaud's syndrome * Contraindication to exenatide: * Neoplasia active or untreated or in remission for less than 5 years (except for basal cell carcinoma or in situ cervical or prostate) * Contraindication to ADO (depending on specific product) in combination with exenatide. * History of kidney transplant or dialysis or plasmatique creatinine\> 1.5 mg / dL for men and\> 1.2 mg / dL for women * Digestive diseases, including gastroparesis * plasma triglycerides\> 1000 mg / dL * History of pancreatitis confirmed biologically * contraindication or hypersensitivity to Exenatide or one of its social coverage composantsAbsence",N/A NCT07225998,Oral N-acetylglucosamine in Crohn's Disease,"Inclusion Criteria: 1. Age 18 and 80 years of age 2. Diagnosis of CD involving ileum (L1) or ileocolonic disease (L3) of any disease behavior 3. On stable dosing of any CD therapy for \>/= 8 weeks (inclusive of biologics, small molecules, immunomodulators) 4. CDAI \<450 5. Willing to undergo genetic testing for ZIP8 genotype 6. No steroids within the past 4 weeks 7. No antibiotics within the past 2 weeks 8. Willing to provide informed consent 9. Willing to participate in all at-home and clinic-based follow-up 10. Willing to provide most recent endoscopy and imaging results; when possible, access to prior pathology specimens 11. Willing to use all forms of ""highly effective"" contraception throughout the study period and for 30 days after the last dose of study drug (all subjects of child-bearing potential) Exclusion criteria 1. Have taken GlcNAc or glucosamine in the previous 3 months 2. Allergy to shellfish 3. Severely-active CD defined as CDAI \>450 AND/OR 4. Simple Endoscopic Score for Crohn's Disease (SES-CD) score \>/= 16 (or \>/= 8 for isolated ileitis) on colonoscopy within 8 weeks of screening, if available 5. Steroids within the past 4 weeks 6. Antibiotics within the past 2 weeks 7. Stricture with high-grade obstruction, significant fistulizing disease, presence of intra-abdominal or perianal abscess, perforation, or fulminant colitis requiring imminent surgical management 8. Surgery within 12 weeks 9. Recent initiation or escalation of immunosuppressive therapy (\<8 weeks) 10. Any clinically significant abnormalities on routine clinical labs, including unexplained white blood cells (WBC) \>16,000, hemoglobin \<7, AST/ALT \>2x ULN, alkaline phosphatase \>2x ULN, eGFR \<60, ferritin \<30 ng/ml2 11. History of type 1 diabetes, inadequately controlled type 2 diabetes (HbA1c\>6.5%), type 2 diabetes on insulin 12. History of peripheral vascular disease, coronary artery disease, stroke, transient ischemic attack 13. History of cancer 14. History of organ transplant 15. History of bleeding disorder 16. History of chronic respiratory disorder, including asthma 17. History of chronic renal failure 18. History of chronic liver disease, including primary sclerosing cholangitis 19. History of seizure disorder 20. Pregnant, less than 6 months postpartum, breastfeeding, or attempting to conceive","While many new medications improved care for patients with Crohn's disease, clinical remission is only achieved in \~40% of patients - a therapeutic ceiling that has not changed in 20 years. These data underscore the need for new treatment strategies and (the investigators hypothesize) greater focus on personalized medicine using factors like genetics. This study is a clinical trial of oral N-acetylglucosamine (GlcNAc) in patients with Crohn's disease. The investigators are aiming for approximately half of the participants to carry a genetic variant in a gene called ZIP8. ZIP8 regulates levels of manganese and the variant lowers levels of manganese; manganese levels may also be reduced for reasons other than just ZIP8 genetics - including variation in dietary intake, water sources, and inflammation - therefore, the investigators are also enrolling participants who do not have the ZIP8 variant. Manganese is a nutrient absorbed from food that is required for glycosylation, but direct supplementation of excess manganese may carry risk of neurologic side effects. An alternative approach is to supplement with GlcNAc, the critical building block of glycosylation that regulates intestinal health and inflammation. GlcNAc is preferred given its positive safety profile and prior small studies in patients with inflammatory bowel disease that showed promising results. Key study information: * The investigators will check if the participant carries the ZIP8 variant at study enrollment. The participants can choose to be informed of ZIP8 genetics. * This is a randomized, double-blind, placebo-controlled, cross-over study. This study design provides the most power to determine if there is a beneficial effect of GlcNAc. * This means the participant will receive the study drug (GlcNAc), but will also have a period of placebo. The sequence in which the participant receives the GlcNAc or placebo is randomized. The study is blinded, meaning that the participant and the investigator will not know if the participant is receiving active drug or placebo unless there are safety concerns. * GlcNAc or placebo is provided to the participant as a powder that the participant will mix in a small amount of water 3 times per day. * GlcNAc is a naturally-occurring substance found in nature and tastes sweet when mixed with water. * The study runs for 18 weeks. There are brief, weekly check-ins and 7-8 in-person visits. * Participants will be asked to provide blood, stool, and saliva samples for a total of 7-8 times. * If it is possible at the participant's site, intestinal ultrasounds will be performed over the course of the study. * Participants will be paid to participate in the study. There are no direct costs to the participants." NCT06518798,Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans With Prediabetes,"Inclusion criteria: * Identify as Asian American * Diagnosed with prediabetes according to at least one of the following: * HbA1C 5.7%-6.4% * Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L ) * Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours Exclusion criteria: * Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions * Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin * Individuals who are pregnant or breastfeeding * Individuals with anaphylaxis food allergies * Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac * Individuals who have completed the FMD in the past year",N/A NCT00331487,Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia,"Inclusion Criteria * Type 2 diabetes mellitus according to the World Health Organization criteria and have diabetes-associated dyslipidemia (fasting triglycerides level between greater than or equal to 150 mg per dL and less than or equal to 600 mg per dL, and a fasting direct low-density lipoprotein cholesterol less than or equal to 130 mg per dL). * Fasting serum C-peptide greater than or equal to1 ng per * Glycosylated hemoglobin greater than or equal to 7% and less than or equal to 11% if naive to oral antihyperglycemic medications, or greater than or equal to 9.5% if previously treated with oral antihyperglycemic monotherapy Exclusion Criteria * Investigator site personnel and their immediate families. Immediate family defined as a spouse, parent, child or sibling, whether biological or legally adopted. * Treatment with a drug within 30 days of Visit 1 that had not received regulatory approval. * Treatment within 60 days of Visit 1 with any of the following: * insulin * systemic glucocorticoid therapy (excluding topical and inhaled preparations) * combination glycemic therapy (two or more oral anti-diabetes medications) * any lipid-lowering agent (including nicotinic acid, fibrates, bile acid resin binders, statins, d thyroxine or neomycin) * any weight loss agent (prescription or over the counter) * Pregnant, breast feeding, or intending to become pregnant during the study. * Serum creatinine greater than or equal to 176.8 μmol per L or greater than or equal to 2 plus per dipstick. * Proteinuria at Visit 1. * Alanine transaminase or aspartate transaminase greater than or equal to 1.5 times the upper limit of normal at Visit 1 or had significant clinical signs or symptoms of liver disease. * History of signs or symptoms of liver disease, such as jaundice or alanine transaminase greater than or equal to 1.5 times the upper limit of normal, while treated with any thiazolidinedione * Hemoglobin less than 10.5 g per dL for females and less than11.5 g per dL for males at Visit 1. * Clinically or biochemically based on thyroid stimulating hormone at Visit 1 hypothyroid or hyperthyroid. * History of myocardial infarction, acute cardiovascular event, or heart surgery within 6 months of Visit 1. * Functional New York Heart Association Cardiac Class III or IV disease. * Receiving renal dialysis or has had received a renal transplant. * Undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer. * Clinical signs or symptoms of drug or alcohol abuse. * History of HIV infection. * Allergy to any glitazone drug. * Medical history or the presence of any clinically significant or unstable medical condition that made the patient unlikely to complete the study. * Any condition or situations that precluded adherence and completion of the protocol or a precluding ability to voluntarily give informed consent.","At least two metabolic defects contribute to the development of type 2 diabetes mellitus: relative insulin insufficiency and insulin resistance. The majority of patients with type 2 diabetes mellitus demonstrate some degree of insulin resistance. Even in the absence of hyperglycemia (high blood sugar), insulin resistance is associated with a cluster of metabolic abnormalities that increase the risk for cardiovascular disease, including dyslipidemia (unhealthy blood fat), increased expression of inflammatory markers, activation of pro-coagulants (pro-clotting), hemodynamic changes, and endothelial dysfunction. The dyslipidemia associated with insulin resistance and type 2 diabetes mellitus is characterized by elevated triglyceride levels and decreased high-density lipoprotein (good) cholesterol levels. Although low-density lipoprotein (bad) cholesterol levels may not be significantly elevated in patients with type 2 diabetes mellitus, an increase in the proportion of small, dense low-density lipoprotein cholesterol particles of increased atherogenicity (increased formation of lipid deposits in the arteries) is observed. When compared with individuals without type 2 diabetes mellitus, the risk of cardiovascular disease is 2- to 4-fold greater in patients with type 2 diabetes mellitus, and the dyslipidemia of diabetes is an important contributor to the increased risk in this population. By targeting the insulin resistance underlying type 2 diabetes mellitus, the thiazolidinedione class of oral antihyperglycemic medications possesses both a glucose-lowering effect and the potential to alter lipid/lipoprotein metabolism. Two thiazolidinediones are currently available for the treatment of type 2 diabetes mellitus: pioglitazone hydrochloride (ACTOS, Takeda Pharmaceuticals North America, Inc, Lincolnshire, IL) and rosiglitazone maleate (Avandia, GlaxoSmithKline, Research Triangle Park, NC). The purpose of this study is to evaluate the triglyceride-lowering effects of pioglitazone to rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia who are not receiving any other glucose- or lipid-lowering therapies at the same time as the study medications. Individuals who participate in this study will provide written informed consent and will be required to commit to a screening visit and approximately 7 additional visits at the study center. Study participation is anticipated to be about 39 weeks (or approximately 8 months). Multiple procedures will occur at each visit which may include fasting, blood collection, physical examinations and electrocardiograms. Participants will be required to follow a diabetic diet, self-monitor their blood glucose and maintain a study diary for the duration of the study." NCT00486187,Effects of ROSIglitazone on Inflammatory Markers and Adipokines in Diabetic Patients Using an Angiotensin Receptor Blocker (TELmisartan) - The ROSITEL Study,"Inclusion Criteria: * Type 2 diabetes * Hemoglobin A1c (HbA1c) level greater or equal to 0.075 * Treatment naïve (no current oral anti-diabetic therapy) or on monotherapy with either metformin or any sulfonylurea * Must meet one of the following: * Already on an angiotensin receptor blocker (ARB for hypertension and/or microalbuminuria OR * If not on an ARB: SBP\>129 mm Hg and/or DBP \>79 mm Hg And/Or albumin to creatinine ratio (ACR) \> 2.0 mg/mmol in men or \> 2.8 mg/mmol in women Exclusion Criteria: * Women who are pregnant, breast feeding, or not using a reliable method of contraception * Clinical signs of congestive heart failure or measured left ventricular ejection fraction \<40% * Hemodynamically significant valvular heart disease or hypertrophic obstructive cardiomyopathy * Insulin-dependent diabetes mellitus * Use of any PPAR-ỵ agonist (Rosiglitazone or Pioglitazone) * Renal dysfunction (creatinine \> 1.8 x ULN) * Hepatic disease (liver function test \>1.5 x ULN \[upper limit normal\]) * Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study * History of systemic inflammatory disease (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous), myositis/myopathic process, or cancer) * HIV * Use of steroids or chemotherapy drugs within the past year or chronic use of nonsteroidal anti-inflammatory drugs besides aspirin (use for \> 2 weeks within the past year); * Patients on potassium sparing-diuretics * Treatment with excluded medications prior to or at the time of randomization * Known hypersensitivity to Rosiglitazone, or ARB's * Participation in another clinical study concurrently or within the 30-day phase prior to screening for entry into the present study * Unwilling to provide written informed consent for study participant and/or * Unreliability as a study participant as based on the investigator's prior knowledge of the patient, such as the inability or willingness to participate in or complete the study or the presence of concurrent physical or psychological disorders that may make it impractical for the patient to participate in or complete the study.","Type 2 diabetes is a chronic and progressive disease that is strongly associated with all-cause and cardiovascular mortality. The United Kingdom Prospective Diabetes Study (UKPDS) demonstrated that glycemic control alone only modestly reduces the risk of macrovascular disease among type 2 diabetic patients . Insulin resistance, which has been identified as an important underlying or associated factor in the pathogenesis of type 2 diabetes, is the main proposed mechanism responsible for the accelerated atherosclerosis noted in this population. Evidence continues to accumulate supporting the role of chronic subclinical vascular inflammation as a central component in the development of atherosclerosis, insulin resistance and type 2 diabetes. Markers of subclinical inflammation, in particular C-reactive protein (CRP) and interleukin-6 (IL-6), have been shown to be independent predictors of both diabetes and cardiovascular risk. More recently, the visceral adipocyte has been recognized to produce a number of metabolically and hormonally active substances, collectively called adipokines. The adipokine adiponectin may have antiatherogenic and anti-inflammatory properties. High levels of adiponectin seem to be associated with protection against type 2 diabetes and atherosclerosis via anti-inflammatory pathways. Unlike adiponectin, leptin and resistin are examples of adipokines that seem to be associated with the development of both atherosclerosis and insulin resistance. Rosiglitazone is a thiazolidinedione drug that is approved for the treatment of type 2 diabetes. As a nuclear peroxisome proliferator-activated receptor-γ agonist, rosiglitazone reduces insulin resistance, thereby sensitizing the liver, muscle, and adipose tissue to the actions of circulating insulin. Treatment with rosiglitazone has been demonstrated to favourably modify levels of inflammatory biomarkers and adipokines, to attenuate endothelial dysfunction, and to reduce coronary events following percutaneous coronary intervention. Diabetes and hypertension co-exist in approximately 75% of patients and this combination synergistically augments cardiovascular risk. In fact, blood pressure control seems to be of greater importance in the prevention of macrovascular disease than is glycemic control. Therefore, in patients with diabetes, dual targeting of insulin resistance and blood pressure is essential to reduce overall atherosclerotic risk. Recent evidence suggests that angiotensin receptor blockers (ARB) in addition to their antihypertensive efficacy may directly improve insulin sensitivity. These unique attributes of ARB's may prove particularly beneficial when combined with an insulin sensitizer, such as rosiglitazone, in the treatment of diabetic patients. The rationale therefore of the ROSITEL study is to compare the effects of rosiglitazone to usual therapy on adipokine levels, inflammatory markers, and insulin sensitivity in ARB-treated diabetic patients with suboptimal glycemic control." NCT02099214,Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis,"Inclusion Criteria: Patients : * Adults older than 18 ; * Newly diagnosed with HFE hereditary haemochromatosis by genetic testing (homozygous for the C283Y mutation on HFE gene); * Treatment-naive; * Showing a ferritin level higher than 200µg/l for women and higher than 300µg/L for men; * Affiliated to French Social Security; * Having given a written informed consent. Healthy volunteers: * Adults older than 18; * Presenting all the following criterions: * Normal cardiovascular physical examination: no signs of cardiac insufficiency, no pathological cardiac murmur, normal EKG (regular sinus rhythm, no high degree AV nor ventricular blocks, no rhythm anomaly), * Body Mass Index \<27 kg/m², * Normal routine blood biology (blood count, MCV, serum iron, ferritin, transferrin saturation); * Affiliated to French Social Security; * Having given a written informed consent. Exclusion Criteria: Patients : MRI-related criterions : * Cardiac pacemaker or implanted defibrillator ; * Non MRI-compatible prosthetic cardiac valve; * Non MRI-compatible clips/stents/coils/etc.; * Cochlear implant; * Peripheral or neuronal stimulator; * Intra-ocular or brain metallic foreign bodies , foreign body in the eyes' vicinity, shrapnel or firearm wound; * Less than 4 weeks-old stents, less than 6 weeks-old osteosynthesis materials; * Claustrophobia; * Pumps, tattoos, permanent makeup, intrauterine device, patches; * Non-removable metallic or magnetic material in the vicinity of the analysed field. Other criterions : * Haemodynamic instability / Acute respiratory insufficiency / Altered general status / Need for continuous monitoring incompatible wih MRI confines; * Pregnancy, breast feeding; * History of blood transfusion or iron supplementation; * Blood donation in the last 3 months; * Infection in the 7 days prior to the first visit; * Stay in altitude (\>1500m) in the past 2 months; * Adults under legal protective regimen or deprived of liberty. Healthy volunteers * Alcohol abuse (\>20g per day for women, \>30g per day for men); * Active tobacco intoxication or smoking cessation in the 6 last months; * Personal cardiovascular medical history; * Cardiovascular functional signs.","Since the wide use of phlebotomy was implemented the incidence of congestive heart failure in HHC became quite low. As such, the interest towards the initial diagnosis and cardiological follow-up has been lesser. A subclinical myocardial iron overload can nevertheless exist and eventually lead to functional consequences in the medium and long term if neglected, even evolve into heart failure and preserved ejection fraction. The expected aftermath of this study is : * The estimation of the frequency of myocardial iron overload measured by 3 Tesla MRI in patient with HFE hereditary haemochromatosis; * The assessment of its consequences on heart function; * The appreciation of a cardiological assessment strategy in patients with HFE hereditary haemochromatosis." NCT05814406,To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM,"Inclusion Criteria: * Type 2 Diabetes Mellitus Exclusion Criteria: * Type 1 Diabetes Mellitus * The subject not meet the specified HbA1c and FPG","A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study" NCT07400133,Assessing Feasibility of a Digital Health Intervention for Multiple Long-Term Condition Care in Primary Health Settings in India and Nepal,"Inclusion Criteria: * Adults aged 40 years or above * Attending the Primary Health Centre (PHC) during the enrollment period * Diagnosed with two or more of the following chronic conditions: 1. Hypertension 2. Diabetes mellitus 3. Depression 4. Anxiety 5. Chronic obstructive pulmonary disease (COPD) 6. Asthma 7. Vision impairment 8. Hearing impairment 9. Osteoarthritis 10. Chronic back pain Exclusion Criteria: * Age \< 40 years * Presence of only one or none of the listed chronic conditions * Pregnant or breastfeeding women * Severe cognitive impairment or dementia that prevents informed consent or or reliable participation * Bedridden or terminally ill individuals with a life expectancy \< 6 month * Current participation in another clinical or interventional research study may interfere with study outcomes * Severe psychiatric illness (e.g., psychosis or bipolar disorder) other than depression or anxiety * Unable or unwilling to provide written informed consent * Severe communication barriers that prevent participation in interviews or questionnaires, even with assistance","\- Implementation framework and study design: The pilot study uses a cluster-based, non-randomized design in rural primary health centres (PHCs) to implement an integrated digital health intervention for people with multiple long-term conditions (MLTC). It is conducted over \~3 months at selected PHCs (for example, two in Andhra Pradesh and two in Rajasthan, India, plus sites in Nepal). The intervention package comprises: (i) an Electronic Decision Support System (EDSS) to incorporate evidence-based MLTC management into PHC workflows; (ii) assisted telemedicine (a fixed PHC ""hub"" model and a portable ""backpack"" kit) to link patients and health workers with remote specialists; (iii) a patient-facing mobile application to support self-management (education, medication/appointment reminders, and messaging); and (iv) trained community health champions to bridge the health system and community. * Co-Design and intervention development: The core intervention components were iteratively co-designed with stakeholders across three sites in India (Jodhpur, Rajasthan; Anakapalli, Andhra Pradesh) and one in Nepal. Over 15-18 co-design workshops were conducted between December 2024 and early 2026, culminating in a national synthesis workshop in New Delhi. Participants were stratified into stakeholder groups to ensure broad representation: Group A (patients with MLTC and their caregivers/community representatives), Group B (primary healthcare providers, technical experts, and researchers), and Group C (policy makers/district/state officials). Workshops were held in accessible community venues (and online for policy makers) with careful advance mapping and consent of participants. Trained facilitators guided semi-structured discussions using journey mapping, brainstorming, voting/prioritization exercises, and live demonstrations of prototype technologies. These activities elicited user needs and system requirements which directly shaped the intervention package. Group A workshops (patients/caregivers) identified critical user preferences (e.g. trusted provider communication, self-care support, and community champions) and barriers (disappointment with fragmented care, out-of-pocket costs). Group B workshops (providers/experts) yielded practical design recommendations, such as integrating clinical guidelines into workflows, incorporating drug-interaction alerts, and defining standard teleconsultation formats with language and trust considerations. A joint workshop with both Groups A and B validated and prioritized intervention features: for example, ""must-have"" features included an editable EDSS dashboard, simple app navigation in local languages, offline data entry, and a reliable telemedicine referral pathway. Feedback on the patient-facing application emphasized low-literacy formats (audio/video, SMS/IVR options) and event-triggered reminders. Throughout, emerging insights were documented and fed back into design cycles (""design"" and ""adapt"" phases of the ADAPT framework), ensuring that the EDSS algorithms, telemedicine workflows, and mHealth app reflected local context, language, and health system realities. In summary, the co-design process ensured that the intervention components are grounded in stakeholder experience and health system constraints. The final intervention package consists of an Electronic Decision Support System (EDSS), assisted telemedicine models (facility-based and portable ""backpack"" models), and a patient-facing mobile application, complemented by trained community champions and strengthened referral pathways. The co-design phase also produced stakeholder engagement structures (e.g. community advisory boards) and preparatory materials (training modules, user manuals) that will underpin implementation. All technical specifications (algorithm logic, user interfaces, data flows) will continue to be refined through iterative feedback during the pilot phase. * Workflow Integration at PHC Level: The EDSS is used as part of routine outpatient management rather than an add-on. Nurses and officers are instructed to use the system during normal clinical hours (e.g. during patient intake and consultation). For each patient encounter, PHC staff complete all mandatory fields in the EDSS before submitting the encounter. Usage logs (timestamps of logins, data entries, referral triggers) are captured continuously on the DigiSetu back-end and synchronized daily, creating an audit trail. Supervisors review log data weekly to ensure adherence to protocol. To support these workflows, standard operating procedures (SOPs) have been developed for each task. SOPs detail: (a) Case identification and case-mix classification (how to use the screening tool and record diagnoses); (b) Data collection protocols (guidance on REDCap and EDSS data entry, use of unique patient IDs); (c) Telemedicine workflow (criteria for tele-referral, scheduling process, documentation of consult notes); and (d) Patient app enrolment . These SOPs were co-created with implementers and iteratively refined during pilot workshops. For example, telemedicine SOPs explicitly define ""who to refer"" (e.g. uncontrolled hypertension or diabetes after 3 medication trials) and ""when not to refer"" (e.g. acute emergencies). All staff nurses and MOs receive printed job aids summarizing key steps for each component (screenshots of EDSS pages, referral algorithms, consent checklists), which are reviewed during training. * Training and capacity building: All healthcare providers in intervention PHCs (medical officers, staff nurses, auxiliary nurse-midwives) will undergo comprehensive training on the intervention components. The initial training consists of a 3-4 day in-person workshop, co-facilitated by clinical, public health, and digital health experts. The curriculum was co-developed by a multi-disciplinary Course Advisory Committee (45 members including clinicians, technologists, and community representatives) to cover: MLTC care principles, EDSS operation, telemedicine processes, and patient app overview. Training methods include lectures, interactive demonstrations of EDSS and app mock-ups, hands-on practice in simulation labs, and case scenario role-plays. Pre- and post-tests assess knowledge and confidence. A cascade training model will be employed: initially, ""master trainers"" (e.g. site investigators, district NCD programme officers) receive intensive instruction, then they train the PHC teams locally. State health authorities are engaged from the outset to embed the training into routine NCD programme capacity building. Custom training manuals and quick-reference job aids (in local languages) were developed and distributed to all trainees. For example, printed flowcharts outline the step-by-step process of a telemedicine consult or patient enrollment in the app. Training attendance and performance are tracked via checklists. In the initial pilot phase, 27 PHC staff (mostly nurses) completed the pilot training with post-training evaluation; similar numbers will be trained in Nepal. Refresher sessions are scheduled at 3 months, supplemented by on-site mentoring visits from research staff. Beyond initial implementation, ongoing capacity building is integrated into the project. Primary Health Centre teams participate in monthly learning sessions with research staff, sharing challenges and solutions. A district-level supervisory structure is in place: each PHC is paired with a mentor (a senior nurse or physician) who conducts quarterly site visits to review fidelity checklists, observe practice, and provide feedback. In parallel, research field coordinators receive training in Good Clinical Practice (GCP), data management, and participant engagement, with continuous skill-building over the course of the study. Community Champions and members of newly formed Community Advisory Boards (CABs) at each site (60 members across 6 pilot PHCs) also undergo training in MLTC awareness and community engagement strategies, ensuring local ownership and sustainability. * Intervention Components and digital architecture: The EDSS is built on the CCDC's DigiSetu platform, expanding prior modules (hypertension, diabetes, CVD) to cover MLTC-relevant conditions (e.g. asthma, osteoarthritis, mental health, sensory impairments, substance use). It provides a structured clinical workflow at the PHC: nurses enter patient vitals, history and lab results into the EDSS; the system generates guideline-based treatment plans; and medical officers review, override if needed, and finalize management. The EDSS features an at-a-glance dashboard showing key diagnoses, risk status, pending follow-ups and alerts for missed visits or deterioration. Key design features include offline data entry with automatic syncing (for low-connectivity settings), state-aligned essential-drug databases (with the ability for PHC staff to update availability), and risk-stratification algorithms that flag high-risk patients and guideline-based referral criteria. The EDSS is explicitly designed as an assistive tool - clinicians retain full override authority to exercise their judgment. Back-end audit trails log every action and decision for monitoring. The assisted telemedicine component has two models: a facility-based model providing real-time specialist consultations within the PHC (via teleconference) and a portable ""backpack"" model enabling outreach to remote community settings. In both models, nurses or mid-level providers collect structured clinical data and basic investigations prior to the teleconsult, reducing physician cognitive burden. The telemedicine platform integrates electronic health records (EDSS data), point-of-care diagnostics (e.g. glucometer, digital stethoscope), and decision support summaries. Care pathways are defined by SOPs (e.g. which patients qualify for tele-referral, how consultations are scheduled and documented). Quality features include offline scheduling with sync (to avoid cancelled consults), and a PPP-based pool of specialists to improve availability (with defined incentives and schedules). All teleconsult requests and outputs (prescriptions, specialist recommendations) are logged and routed back into the PHC workflow to reinforce continuity of care. Importantly, prescriptions are automatically checked against PHC stock - the system will flag if a specialist-recommended drug is unavailable, minimizing patient out-of-pocket costs. The patient-facing mobile application (the Ai.M Healthy app by ClinAlly) supports MLTC self-management. Core functions include linkage with the national ABHA Health ID (to import health records securely), personalized medication and visit reminders, symptom tracking, and a content library of lifestyle and adherence support. Based on co-design feedback, the app uses audio-visual, low-literacy content (short videos and interactive prompts) in local languages. Users can log self-reported behaviors via simple yes/no/tick inputs, triggering context-specific feedback. The app is ""event-triggered"" rather than continuously burdensome: notifications occur around clinic visits, medication changes, or scheduled follow-ups. For patients without smartphones, the system falls back on SMS/IVR reminders and engages caregivers or frontline workers (ASHAs/ANMs) to relay key messages. Critically, the app is interoperable with EDSS and telemedicine records - for example, it displays the patient's current care plan and follow-up dates, so reminders align with the PHC's instructions. Overall, the intervention is implemented on a secure, cloud-enabled platform compliant with national digital health standards. Data entry at PHCs and in the patient app is encrypted end-to-end and stored on secure servers. The architecture follows the WHO digital health evaluation framework: it is assessed for technical/infrastructure fit (offline sync, data security, interoperability) and workforce/workflow fit (user interface design aligned with OPD routines). System readiness was confirmed in a prior phase: health facility assessments at 20 PHCs (using IPHS 2022 standards) highlighted gaps which the intervention explicitly addresses (e.g. provision of digital tablets, training on record-keeping). In sum, the digital tools are fully integrated into PHC workflows rather than operating in parallel, with APIs linking EDSS, telemedicine, and patient app data to minimize duplication. * Quality Assurance and Supervision: A robust quality assurance (QA) system is established. Supervision protocols require real-time monitoring of key processes. At each PHC, a designated study coordinator conducts weekly reviews of enrollment logs and EDSS entries to verify completeness. Monthly centralized monitoring by the research center includes data audits: for example, random records are cross-checked between REDCap and EDSS to detect missing or discrepant entries. The EDSS platform automatically generates backend audit trails for every user action. These logs feed into structured fidelity checklists developed from Carroll's framework. Performance indicators (e.g. % of EDSS encounters with all mandatory fields, % of patients referred per protocol) are compiled into dashboards for review. Supervisors observe at least 10 patient encounters per PHC during the pilot to assess ""quality of delivery"" - e.g. whether MOs appropriately justify any EDSS plan modifications. Third-party oversight is provided by periodic audits from the independent data monitoring committee. They review processes such as consent procedures, data security, and adherence to SOPs. Automated data integrity checks (e.g. range and logic checks in REDCap) flag any out-of-range values or missing data, prompting immediate queries to site staff. Key QA tools and indicators include: SUS and MAUQ questionnaires capturing system usability, Theoretical Framework of Acceptability (TFA) interviews capturing provider attitudes, and Acceptability of Intervention Measure (AIM) surveys of participants. The Carroll fidelity domains provide pre-defined thresholds: e.g. ≥80% of EDSS steps completed per encounter, ≥80% of eligible patients exposed to each component, and ≥75% of sampled encounters rated ""high-quality"". Any deviations trigger retraining or process corrective action. * Data management and sample size: All quantitative data are collected using secure electronic systems with audit trails. Baseline and survey data are entered into REDCap at point-of-care. EDSS and telemedicine encounter data are logged in DigiSetu with unique participant IDs. The patient app usage data (log-ins, reminder responses) are capture. A single codebook defines all variables across platforms. To minimize missing data, all critical fields are mandatory in the digital forms; research staff are trained to resolve missing items immediately by direct inquiry. At the central office, periodic data checks identify missing or inconsistent values; statistical imputation (e.g. multiple imputation for random missingness) will be applied if needed during analysis to ensure valid inferences. This pilot will enrol approximately 30 participants per PHC (total \~180 participants). This sample size was chosen pragmatically to test implementation processes and provide estimates of uptake/fidelity rather than to power clinical outcomes. Loss-to-follow-up is expected to be low given the 6-month duration; all efforts (e.g. multiple contact methods, community follow-up) will be used to minimize attrition. Recruitment and retention rates will be monitored monthly. * Evaluation and Outcomes: Effectiveness will be assessed through a mixed-methods evaluation framework. Acceptability among providers is measured using the TFA: after completing prescribed tasks, MOs and nurses will undergo think-aloud sessions and semi-structured interviews to probe affective attitude, burden, coherence, perceived effectiveness and self-efficacy. Providers will also complete the 10-item System Usability Scale (SUS) - a validated tool yielding a 0-100 score (target ≥70). Acceptability among patients/caregivers is assessed via in-depth interviews at study end, exploring perceived usefulness, barriers, and satisfaction with the app and care pathway. Usability of the patient app is quantified using the Mobile App Usability Questionnaire (MAUQ), an 18-item instrument with subscales for ease-of-use, information quality, and usefulness. A mean score ≥5.0 (on 1-7 Likert) will be considered acceptable. Additional usability data (navigation patterns, time per session) will be extracted from app analytics. Telemedicine usability will be inferred from completion rates and satisfaction surveys of both PHC staff and specialists. Feasibility is continuously monitored: backend logs are analyzed for intervention exposure (e.g. proportion of eligible patients actually entered in EDSS, completed teleconsults per schedule, app-engaged participants). Key operational metrics include average screening and consultation times, system uptime (frequency of app crashes), and teleconsult success vs dropout rates. These inform real-time troubleshooting and are summarized at 3- and 6-month intervals. The logic of telemedicine referrals is audited: we track the proportion of specialist suggestions that align with EDSS and availability at PHC (to evaluate integration). Evaluation findings (both quantitative metrics and qualitative insights) will be triangulated to refine the intervention. For example, app content will be iterated based on SUS/MAUQ scores and user suggestions, and telemedicine SOPs adjusted if too few referrals occur. An intention-to-treat analytic approach will be used for primary analyses, with sensitivity checks for missing data. A mixed-effects model will be planned (with cluster PHC random effects) for any exploratory impact outcomes (e.g. change in risk factor control), though hypothesis testing is outside this pilot's scope. In sum, this registry entry describes a comprehensive implementation of a co-designed, digital health intervention for MLTC at the PHC level. It emphasizes participatory design, rigorous training, standardized workflows, and embedded evaluation to ensure the intervention is feasible, acceptable, and scalable within existing health systems." NCT06817252,How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes,"Inclusion Criteria: * Men and postmenopausal women within the Las Vegas/Henderson NV area * Ages 45-80 years * BMI between 25-40 kg/m2 * HbA1c between 5.7-6.4% * Individuals from different demographic backgrounds (i.e., American Indian or Alaska Native, Caucasians, Asian, Black or African-American, Native Hawaiian, Hispanic, Latino or Pacific Islander) * Individuals who are considered ""non-frequent"" white potato consumers (\<2 servings of baked potatoes/week) * Individuals from all races, genders, sexual identities, and religions will be included * Individuals must follow certain guidelines, including avoiding new medications during the study or significant changes to lifestyle factors (e.g. beginning to smoke or exercise more or less than usual) Exclusion Criteria: * Individuals with uncontrolled hypertension (≥160/100mmHg), active cancer, asthma, thyroid, kidney, liver, or pancreatic diseases * Individuals who are currently using insulin, on dialysis, changing/adding hypoglycemic, anti-hypertensive, and hypocholesterolemic medication within ≤3 months (or throughout the study) * Individuals participating in weight loss programs or another clinical trial * Individuals who start smoking * Individuals who have unstable metabolic or chronic diseases * Individuals who may have allergies to potatoes * Woman who are currently pregnant, think they may be pregnant, or who is nursing cannot participate (women must be postmenopausal)","Study Overview: Investigators will recruit 60 adults with pre-diabetes from different demographic backgrounds, between the ages of 45 and 80 years to participate in a 12-week randomized controlled trial (RCT) examining baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) compared to MEDNE alone. Potential participants will be recruited from the metropolitan Las Vegas area through campus and community advertisements including flyers, newspaper articles, social media, and public events. Investigators will randomize eligible, consenting participants to receive either the BP+MEDNE or MEDNE in a 1:1 ratio. Investigators will use a computer-generated randomization method to manage the random assignment of either group. Prescreen Interview: Potential participants who inquire about the study by calling the recruitment phone line, will be given a brief overview of the study and will be pre-screened by telephone interview to determine whether they should be invited for the in-person screening visit. Eligibility will be based on inclusion/exclusion criteria and responses to questions about medical history and dietary habits. Potential participants will be invited to report to the clinical facilities in the Health Sciences Building at UNLV (study site) for their first on-site visit (and all subsequent visits if the participant qualifies) to ascertain eligibility (screening study visit). This pre-screening interview will occur prior to participants consenting (which occurs at the in person screening study visit). Screening Study Visit: Potential participants who inquire about the study by calling the recruitment phone line will be given a brief overview of the study and pre-screened by telephone to determine whether they should be invited for the in-person screening visit. Eligibility will be based on inclusion/exclusion criteria and responses to questions about medical and diet history during the pre-screen phone interview. Potentially eligible participants will be invited to report to the study site for their first on-site visit for screening (and all subsequent visits if the participant qualifies) to ascertain eligibility (Screening Study Visit). During the first in-person study visit for screening, the potential participants will be provided with verbal and written explanations of the project and will have any questions regarding the study answered by trained research personnel during the informed consent process. Consenting participants will be asked to sign an informed consent document (with a copy provided to the participant to take home). To confirm eligibility, the Screening Study Visit will consist of measurements of HbA1c (Afinion HbA1c Point of Care) via finger stick blood draw to confirm pre-diabetes, in addition to anthropometrics, blood pressure, and questions regarding medical history and medication use (fasting blood glucose via ACCU-CHECK Glucometer will be assessed but not as an eligibility criteria). Potential participants will also complete a 7-day food frequency questionnaire, to indicate whether individuals frequently consume baked white potatoes. If participants are considered ""non-frequent"" white potato consumers, they will be included in the study and asked to come for subsequent visits and study visits. Participants who are not eligible will be thanked for their time and participation and told the specific reasoning for why they do not meet the inclusion criteria. Eligible participants will be asked to complete a three-day food record using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool to assess typical dietary intake and dietary quality (Healthy Eating Index \[HEI\]-2020 scoring), prior to their Baseline Study Visit at participants homes via a computer, ipad, or smartphone. The Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) is a web-based dietary recall system developed by the National Cancer Institute. It allows participants to self-report their dietary intake over the past 24 hours using a user-friendly interface that prompts for detailed food and beverage consumption. The tool can be distributed via a unique web link provided to participants, enabling remote data collection without requiring in-person visits. Pre Baseline and 12-Week Visits: One week prior to the Baseline and 12-Week Study Visits, eligible participants will be asked to come to the study site to have placement of a continuous glucose monitor from training research staff (Dexcom G7) and wearable devices (ActiGraph Accelerometry) for assessments of real-time blood glucose levels, physical activity, and sleeping patterns. At their Baseline and 12-Week Study Visits, trained research staff will remove the Dexcom CGM from the participant and discard it. Similarly at their Baseline and 12-Week Study Visits, the Actigraph wearable device will be removed from trained research staff. Baseline, 6- and 12-Week Study Visits: At the Baseline, 6-, and 12-Week Study Visits participants will be asked to come fasted to the study site (between 7:00-10:00 A.M., 12 hours after the abstinence from caffeine and 24 hours after the last bout of moderate/heavy physical activity); vascular assessments (blood pressure, Pulse Wave Velocity, Pulse Wave Analysis) will be measured followed by body composition (Bioelectrical Impedance Analysis), finger prick blood draw (fasting blood glucose and HbA1c), venous blood draw (lipid profiles, inflammatory, and oxidative stress biomarkers), anthropometrics (height, weight, and waist/hip circumference), assessment of fruit and vegetable intake via Raman Spectroscopy, assessment of physical activity patterns (Five-City Project Physical Activity Recall), nutrition knowledge (General Nutrition Knowledge Questionnaire), MD adherence (Mediterranean Diet Adherence Screener), barriers to Mediterranean Diet Adherence (Barrier Analysis Questionnaire), and sleep quality (Pittsburg Sleep Quality Index). After assessments of outcome measurements at Baseline and 6-Week Study Visits (not at the 12-Week Study Visit), participants will be provided with BP+MEDNE or MEDNE (comparative control). All participants will be provided with MEDNE. In addition to all assessments mentioned for all study visits, at the 12-Week Study Visit there will be assessment of dietary and/or nutrition education acceptability and feasibility. Dietary Assessments Throughout The Study Period (at week 1, 4, 8, and 12): Participants will be asked to complete a three-day food record using NCI's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool to assess typical dietary intake and diet quality (using HEI-202075) during week 1, 4, 8, and 12 of the study period. This food record can be completed at participants' homes via a computer, ipad or smartphone." NCT07038252,The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients,"Inclusion Criteria: * Age between 18 and 75 years,. * Hypertension controlled under pharmacological or non-pharmacological treatment, defined as office BP\< 140/90 mmHg at the Inclusion visit, * BMI \> 30 kg/m², * Stable antihypertensive treatment one month before inclusion (V1), * Signed informed consent, * Social security affiliation. Exclusion Criteria: * Secondary hypertension on the basis of medical history, * History of stroke on the basis of medical history, * Myocardial infarction on the basis of medical history, * Severe hepatic insufficiency on the basis of medical history, * Chronic kidney disease (DFG \< 30 ml/min 1.73 according to MDRD method), * Pregnancy or breast feeding, * Regular treatment with NO-donors or phosphodiesterase inhibitors, * Inability to comply with protocol requirements, * Patient under tutorship or / guardianship or/ safeguard of justice, and incapable to give informed consent, * Patient on AME (state medical aid), * Participation in another interventional study involving human participants , * Allergy to the ultrasound gel, * Hypersensitivity , allergy, or idiosyncratic reaction to omega-3 acids, fish or soya allergies. * Chronic inflammatory diseases, on the basis of medical history, * Chronic anti-inflammatory treatment administered within the past month preceding the Inclusion visit, * Any supplementation with omega-3 or omega-6 polyunsaturated fatty acids within the past month, * Life expectancy less than one year.",N/A NCT00955747,Naturlose (D-Tagatose) Efficacy Evaluation Trial,"Inclusion Criteria: * Type 2 diabetics in accordance with WHO. * Male and female patients, between 18 and 75 years of age. * Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise. * Normal blood creatine clearance and normal liver function test results. * BMI less than or equal to 45kg/m2. Exclusion Criteria: * Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide, Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta, insulin, and any antidiabetic medications within the prior 3 months. * Therapy with beta-blockers or thiazide diuretics within the prior 3 months. * Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure. * Documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption. * Receiving any investigational drug within 30 days of the baseline visit.","This was a Phase 3, prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy, safety, and tolerability of D-tagatose (as compared to placebo). Prior to the start of treatment, subjects participated in an 8-week run-in period during which diabetes education was provided and diet and exercise treatment stabilized. Efficacy analyses were conducted on data from 4 and 6 months. Screening Visit Based on the inclusion and exclusion criteria, eligible subjects underwent a basic physical examination, pregnancy test for females, and hematology, clinical chemistry, and urinalysis tests. Basic physical examination included physical measurements, general examination by observation, palpation, percussion, auscultation, blood pressure measure, and heart rate check. The clinical laboratory tests included: 1) hematology (hematocrit, hemoglobin, MCH, MCHC, MCV, total white blood cells, platelets, and differential); 2) clinical chemistry (sodium, chloride, potassium, CO2, BUN, uric acid, albumin, creatinine clearance, SGOT, SGPT, bilirubin (total and direct), phosphorus, calcium, alkaline phosphatase, total protein, and glucose (fasting); 3) HbA1c; 4) serum lipid profile including total cholesterol, HDL, LDL, and triglycerides; 5) urinalysis (appearance, volume, specific gravity, pH, glucose, protein, and microscopic evaluation of urinary sediment). Run-in Period Subjects deemed potentially eligible on the basis of their medical records were to continue on their previously established diet and exercise treatment program under physician's recommendation for 8 weeks. Patients were to record their food intake and exercise in nutrition diaries. Treatment Period The treatment period consisted of 12 monthly visits, the first of which was used to gather the baseline data for the efficacy and safety parameters and also included the first distribution of test and placebo treatments. Subjects who received study drug for more than 6 months were evaluated for safety and efficacy the first 6 months and then for safety only thereafter. Baseline and Distribution of Test and Placebo Treatments Approximately 550 enrolled subjects were to be randomized into the study. Subjects were randomized to one of the two treatments in a 1:1 ratio. Each eligible subject was randomized to a group assignment on the basis of a randomly generated number. Randomization was stratified by the screening HbA1c values (\<7.5% and ≥7.5%) to ensure an even distribution of subjects between the two treatments. Randomization was to take place through an Integrated Web-based Randomization System (IWRS) which sites accessed in order to make randomized treatment assignments. After the 8 weeks run-in period, subjects returned (Visit 2) to the study sites and underwent medical history review, and the same examination and clinical laboratory tests as those performed during the screening visit. In addition, subjects received their randomized study treatment and detailed instructions about its use. There were two treatment groups in this trial: 1. Drug (D-tagatose), and 2. Placebo (Splenda). The dose of tagatose was 15 g in solution in a final volume of approximately 4 ounces of water (\~250 mL) taken 3 times daily (tid); the dose of placebo (Splenda) was to be 1.5 g. Treatments were dispensed by an unblinded staff member who had no other role in the trial; all other clinical center staff were blinded to treatment. If the patient was outside the +/- 7 day window, the investigator/site staff would document the information in the subject chart and provided the Sponsor with a note to file. Procedures Visits Every other month after Visit 2 subjects returned to the study site and underwent the same comprehensive testing that they underwent at Visit 2. Drug and dietary compliance was to be verified by sachet counts at each visit and by nutritional diaries. DATA QUALITY ASSURANCE A study initiation meeting was held at each investigative site before enrollment of the first subject to review study design, study procedures, data collection, and investigator responsibilities. During interim field monitoring visits, the monitor verified CRF entries against available source documents and ensured that appropriate data were collected and documented. Independent GCP audits of selected study sites were performed. Prior to data entry, CRFs were checked for completeness and consistency by a monitor and verified against source documentation that was maintained at each study site. Data from CRF were reviewed and queries to the study sites were generated by the clinical and data management staff of the CRO. Discrepancies were reconciled with the study site and the respective laboratory. Prior to data lock a final audit report and memo was generated summarizing the audit findings and given to the Data Manager Data analyses were performed primarily with Statistical Analysis System (SAS®) software, version 9.2. SAS analysis datasets were crosschecked against the locked database and/or CRF. Data summary tables were crosschecked against SAS analysis datasets. All identified inconsistencies were reported to the lead statistician and resolved prior to production of this report. This clinical study report was checked for accuracy and consistency before sign-off. Statistical and Analytical Plans Amarex LLC, Germantown, MD prepared a statistical analysis plan (SAP) for the efficacy and safety data before database lock. Analysis Populations Intent-to-Treat Population The intent-to-treat (ITT) population was defined as all randomized subjects who received at least one dose of double-blind study medication and had a least one post-treatment visit evaluating efficacy. The ITT population was used for the main efficacy evaluation. Per Protocol Population The per protocol (PP) population was defined as all subjects in the ITT population who had 80% compliance with medication for 75% of the dosing time points and who had no major protocol violations or eligibility violations. Safety Population The safety population consisted of all randomized subjects who received at least one dose of double-blind study medication and had at least one post treatment visit evaluating safety. This population was used for all of the safety analyses. Handling of Duplicate, Missing and Outlier Data For data that were identified by the Sponsor's Medical Monitor as clinical outliers, two separate analyses were conducted, one including the outlier and one from which the outlier was excluded. The impact of all possible combinations of the outliers was to be treated in the context of the parameter. For the ITT population, missing data (including missing values at intermediate visits) were imputed from scheduled visits using the last-observation-carried-forward (LOCF) method. A blind review of the data was conducted prior to statistical analysis to determine data accuracy. Safety data were compiled on all subjects without exclusion, and in the case of AEs, the relationship to study product was made. The determination that a subject was to be excluded from an analysis population was jointly made by the sponsor and the investigator in the blind review meeting. Covariates, Stratification Factors, and Subgroups To improve the precision of the analysis, covariate analyses were conducted. The respective baseline values were used as covariates in the analysis models for all the continuous variables; along with the pre-specified stratification factor, screening HbA1c values (\<7.5% and ≥7.5%). The adjusted least squared (LS) means at each time point were reported. Other clinically meaningful baseline covariates and stratification factors were examined; if statistically significant, these factors were included in the analysis models. Interim Analyses Two blinded interim analyses (IAs) were planned, one when approximately 40% of subjects had been randomized and completed through month 6, and the other when over 60% of the subjects had been randomized and completed through month 6. The ITT population was used for the analyses conducted in each IA. The IA was directed and conducted by an independent statistician, who was not involved in the trial conduct other than this IA. The main purpose of the IAs was to assess the assumption made concerning the standard deviation in the sample size calculation for the primary end-point (mean change in HbA1c). Two such IAs were planned because the trial started earlier in the USA than in India, so the first IA was more likely to reflect the results from the USA population, while the second IA was more likely to reflect the results from the India population. For each IA, the independent statistician used the blinded data, the observed pooled standard deviation, and the other original assumptions noted in the sample size determination (e.g. Power, Type I error rate) to recalculate the sample size. Based on the documented sample size re-calculation and the observed dropout rate, the intent was that the independent statistician could recommend a new, larger sample size to the sponsor; however, in neither IA was this necessary. Statistical Methods Subject Characteristics The subject population enrolled in this trial was characterized according to * the disposition of subjects within the trial; * the demographics, baseline clinical laboratory assessments, and previous and concomitant medical history; * concomitant medications; and * treatment duration and compliance characteristics. Demographic and baseline characteristics were summarized and also provided as data listings. Continuous data variables were summarized according to the number of observations, mean, standard deviation, median, and minimum and maximum values, while categorical data variables were summarized according to frequency counts and percentages. Treatment duration and compliance characteristics were summarized by treatment group and analysis population with the duration of dosing (days) being calculated as date of last dose minus date of first dose plus 1. Percent compliance was calculated as \[(total units of drug returned minus the total units of drug dispensed) divided by the total dispensed\] times 100%. Efficacy Analyses Statistical tests for the efficacy analyses were to be two-sided, with no p-value adjustment, and were to focus on the responses of the ITT population with the PP population being used in supportive analyses. To assess the primary end-point of change in HbA1c level from baseline, the general linear model (analysis of covariance) adjusted for baseline and important stratification factors, e.g., baseline HbA1c and site, was used. In this analysis, in order to protect the statistical degrees of freedom, sites were pooled according to location and other factors. The closed test procedure was to be used for the secondary end-points in order protect the Type I Error rate of α = 0.05. For this procedure, the secondary end-points were to be analyzed in the following order: 1. Body Mass Index 2. Triglycerides 3. LDL 4. Total cholesterol 5. Fasting blood glucose 6. Proportion of subjects achieving HbA1c \<7% and/or ≤6.5% 7. Insulin 8. HDL" NCT06800638,"Comprehensive Review of Retinal Pseudo-Holes: Clinical Presentation, Diagnosis, Pathophysiology, and Management","Inclusion Criteria: * Studies that directly addressed retinal pseudo-holes, their clinical presentation, diagnostic modalities, pathophysiology, or treatment. * Peer-reviewed clinical trials, case reports, observational studies, and reviews. * Studies that utilized OCT or other imaging techniques (such as fluorescein angiography or fundus photography) to diagnose retinal pseudo-holes. * Studies that were published in English and provided full-text access. Exclusion Criteria: * Studies that did not specifically focus on retinal pseudo-holes but instead dealt with other retinal conditions (e.g., full-thickness macular holes, retinal detachment). * Studies that were not peer-reviewed (e.g., conference abstracts, opinion pieces). * Non-English language studies or those without available full texts.",This is a REVIEW study on Retinal pseudo-holes. NCT01101438,A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer,"Eligibility Criteria: * Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. A core biopsy interpreted as invasive cancer meets this criterion; otherwise, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy). Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery. Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither violates the eligibility criteria. * All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. Sentinel lymph node biopsy alone is allowed in the following instances: 1. sentinel lymph node biopsy is negative: pN0 2. sentinel lymph node biopsy is positive for isolated tumour cells only: pN0 (i+) 3. \* clinically node negative, T1-2 tumours with sentinel lymph node biopsy positive in ≤ 2 lymph nodes without extra-capsular extension or matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation (\* excludes subjects treated with neo-adjuvant systemic therapy) Definitive surgery and/or chemotherapy have been completed at least 4 weeks prior to randomization. Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumour bed is delivered. In situ lobular disease at the margin is acceptable. Adjuvant subjects with the following pT pN combinations are eligible: * pT1c, pN0 AND negative estrogen and progesterone receptors AND HER2 negative OR * pT2N0 and at least one of the following tumour characteristics: histologic grade 3, lymphovascular invasion, negative estrogen and progesterone receptors, HER2 positive, Oncotype Dx recurrence score ≥ 25 (or if Oncotype Dx recurrence score is not available, Ki67 \> 14%) OR * Subjects with pT3, pN0 OR * Subjects with pT1-3, pN1-3 The eligibility of neo-adjuvant subjects is assessed on the basis of cTNM. The same eligible TNM combinations apply. * HER2 status must be known. (Positive = 3+ over-expression by IHC in \> 30% of invasive tumour cells OR HER2 gene amplification by FISH/CISH \> 6 HER2 gene copies per nucleus, OR a FISH/CISH ratio: HER2 gene copies to chromosome 17 signals of ≥ 2.2. All other results will be considered negative). * Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies and no mammogram within 12 months prior to randomization must, instead, have a physical examination of the chest wall to ensure there is no residual or recurrent disease at the time of randomization. The date of this examination is used in place of the mammogram date on the eligibility checklist.) * Investigations, including chest X-ray or CT chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of randomization. * Chest X-Ray, 2 view (or Chest CT) is mandatory * Bone scans (with x-rays of abnormal areas) are required only if there are signs or symptoms of metastatic disease * Abdominal imaging is required only if there are signs or symptoms of metastatic disease * Hematology investigations (WBC, Granulocytes, Platelets, Hemoglobin) have been completed within 28 days prior to randomization and results are available. * Biochemistry investigations have been completed within 28 days prior to randomization and values are within the parameters required by the protocol. AST \< 1.8 X ULN; ALT \< 1.8 X ULN; Alkaline Phosphatase \< 2 X ULN; Serum Creatinine \< 115 μmol/L (1.3mg/dL) Serum Bilirubin \< institution ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level) * ECOG Performance Status of 0,1 or 2 (at baseline evaluation visit within 28 days prior to randomization). * Age ≥ 18 and \< 75 and life expectancy of at least 5 years (18 years of age was used as a cut-off due to the lack of data indicating that breast cancer is a health issue in the \< 18 years age group and metformin safety in pediatric patients has not been confirmed. Age \> 80 carries increased risk of lactic acidosis and study intervention is for 5 years). * Subjects must be accessible for treatment and follow-up. Investigators must assure themselves the subjects randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * In accordance with NCIC CTG policy, protocol treatment is to begin within 10 working days of patient randomization. * Subject consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization or registration. Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records (see Section 16 for further details). For the first 888 eligible English or French-speaking subjects only (sub-set enrollment completed 2011NOV04): * Subject is able (i.e. sufficiently fluent) and willing to complete the Quality of Life (EORTC QLQ C-30 and Trial Specific Checklist) in English or French. The baseline assessment must already have been completed at the time of enrollment. Inability (illiteracy in English or French, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible. (Once the target number of 888 subjects is achieved, this criterion will no longer need to be fulfilled.) \[See Appendix VI\]. Sub-set enrollment completed 2011NOV04. * English-speaking subjects who have completed the Quality of Life Questionnaire who are able (i.e. sufficiently fluent) and willing to complete Nurses Health Study II Physical Activity Questionnaire and Block Alive Screener in English. The baseline assessment must already have been completed at the time of enrollment. Inability (illiteracy in English, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible. (This component of the study will close at the same time as the Quality Of Life sub-study.) Closed to new patient enrollment as of 2011NOV04. Ineligibility Criteria: * Subjects with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. * Subjects with locally recurrent or metastatic breast carcinoma. (Subjects with prior invasive breast cancer at any time are not eligible. Subjects with prior DCIS only in either breast are eligible provided the DCIS has been curatively treated including surgery, radiotherapy and/or Tamoxifen). * Subjects whose axillary node status is unknown. * Known diabetes (type 1 or 2) or baseline fasting glucose \> 7.0 mmol/L (126 mg/dL). (Sampled and assayed according to local institution's procedures.) * Known hypersensitivity or intolerance to metformin. * Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status \[see Appendix IX\], history of acidosis of any type; habitual \* Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason. * Current or planned pregnancy or lactation in women of child-bearing potential. Men should not father a child. (An effective method of birth control should be used while on study treatment which could include abstinence, IUD, condoms or other barrier methods of birth control because the safety of metformin in pregnancy or in male fertility has not been established). * Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or involving P13K inhibitors (at the time of randomization)\*. * These interventions would interfere with the primary endpoint. (Also, in general, double randomizations in breast cancer trials for MA.32 patients are permitted only if the patient meets all the eligibility criteria for MA.32 and the sponsor of the previous trial has no objection to the patient also being enrolled in MA.32).","This is a multicenter study. Patients are stratified according to hormone-receptor status (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body mass index (≤ 30 vs \> 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Blood and tumor samples are collected periodically for correlative studies. Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients). After completion of study treatment, patients are followed annually." NCT04646252,The Role of Glycocalyx Integrity in the Primary Prevention of Major Cardiovascular Events,"Inclusion Criteria: We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital. Exclusion Criteria: * History of Coronary artery disease, * History of Peripheral Arterial Disease, * History of Heart failure * History of Stroke * hepatic failure * renal failure, * active neoplasia * poorly controlled DM, defined as Hba1C\>7%","Blood pressure is measured in each subject with the aid of a digital oscillometric sphygmomanometer (TensioMed, Budapest Hungary, Ltd). Each subject rests in a quiet room at 25°C for 30 minutes before the examination. The cuff is placed in the right arm, while the subject is seated. The diagnosis of hypertension is made on the basis of:1) systolic blood pressure ≥140 mmHg/diastolic blood pressure ≥90 mmHg after 3 consecutive measurements or 2) the participant is receiving antihypertensive treatment. Moreover fasting blood samples are drawn to identify the presence of diabetes mellitus and hyperlipidemia in our sample. Specifically, DM is determined by either plasma glucose ≥ 126 mg/dl measured by the enzymatic in vitro test (Roche, automatic chemistry clinical analyzer) or treatment with antidiabetic agents . Similarly, hyperlipidemia was defined by either Total Cholesterol ≥230 mg/dl, and/or LDL ≥160 mg/dl, and /or TGs ≥200 mg /dl measured by the colorimetric spectrophotometry (Roche Diagnostics) or the use of lipid lowering agents according to the running guidelines held during the initial examination. Additionally, smokers are considered only those participants who are actively smoking at the time of enrollment . Also, the presence of positive family history of coronary artery disease is defined as coronary disease in a first degree female relative before 65 years or a male relative before 55 years of age. BMI is calculated as the ratio of weight (kg) to the square of height (m2). Furthermore, SCORE estimation system is used to calculate the 10-year cardiovascular risk for each participant. As far as ethnicity is concerned, an individual is not considered Greek in case he/she was born abroad and also has at least a foreigner parent or he/she is born in Greece but both parents were foreigners. Inversely, a subject was considered Greek if they and simultaneously both parents were born in Greece. Exclusion criteria are the history of Coronary artery disease (CAD), Peripheral Arterial Disease (PAD), Heart failure (HF), Stroke, hepatic or renal failure, active neoplasia and poorly controlled DM, defined as Hba1C\>7%. ENDOTHELIAL GLYCOCALYX EVALUATION The researchers quantified the perfused boundary region (PBR, measured in μm) of the sublingual microvasculature by using Sideview Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA) . Briefly, SDF camera utilizes green reflected light emitting diode (LED) light (540 nm) from hemoglobin molecules to depict the radial displacements of RBCs within the microvessels . The camera is inserted under the tongue and captures more than 3000 vascular segments of vessels with diameter ranging from 5 μm to 25 μm. The images are obtained automatically by the Glycocheck software . Afterwards the system checks the quality of the recordings and selects the valid frames (contrast enhancement greater than 60%), which are going to be further analyzed . The RBC column width, as well as the total perfused diameter of microvessels is estimated by the software with high accuracy. Then PBR is calculated by the formula \[Perfused Diameter- RBC column width\]/2.The software also provides the PBR of vessels with diameter 5-9μm, 10-19μm, 20-25μm and the mean 5-25μm As a result, PBR expresses the outer area of the vessels' lumen that is vulnerable to RBC penetration and is consistent with the integrity of glycocalyx layer. Thus, high PBR values are considered as indicator of damaged endothelial glycocalyx with affected barrier properties, which allows high spatio-temporal distribution of RBCs. On the other hand Conversely, low PBR values are associated with robust thick glycocalyx layer. The whole procedure lasts for approximately 3 minutes, does not require high expertise, is operator independent, has satisfactory reproducibility and thus is highly recommended as a validated technique for the assessment of endothelial glycocalyx function . The PBR measurements are independent of red blood cell filling of the vessels segments (hematocrit), because the software only includes vessel segments that have a filling percentage of more than 50%. Hence, vessel segments are only selected when at least 11 of the 21-line markers have a positive signal for the presence of an erythrocyte. Thus, PBR values are independent of hematocrit, reflecting a damaged glycocalyx that is more accessible for circulating erythrocytes . In the current study the evaluation of PBR takes place between 9:00 and 11:00, after 8 hours fasting and abstinence from alcohol and smoking and temporary discontinuation of medications for 48 h before the examination as well. PULSE WAVE VELOCITY Pulse wave velocity carotid to femoral and Augmentation Index were estimated non-invasively using a dedicated technique (Complior, Alam Medical, Vincennes, France). FOLLOW UP A follow up assessment is performed 6 years after the recruitment via telephonic contact and planned appointment at the outpatient clinic. Briefly, at the reevaluation the participants or their legal representatives - in case of inability or death- are asked for the incidence of major cardiovascular events or death attributed to any cause. The primary composite outcome of major adverse events consists of death, myocardial infarction (ICD-10: DI20-22), stroke (ICD-10: DI60-68; DG45) and hospitalization for heart failure (ICD-10: DI50-51; DI42; DI11). Each of the forenamed events is documented by hospital medical records or attending phycians' letters and confirmed by the national security electronic records using the appropriate ICD10. STATISTICAL ANALYSIS Statistical analysis is performed by SPSS version 25 (IBM SPSS Statistics, Inc., Chicago, IL) and Stata version 16 (StataCorp LP, College Station, TX). Scale variables are presented as mean ±SD in case of normal distribution, as determined by the normality tests Kolmogorov-Smirnov test and Shapiro-Wilk, or as medians and interquartile ranges in case of non-normal distribution. Nominal variables are expressed as frequencies and percentages. Scale variables are compared using independent samples Student's t tests or Mann-Whitney tests as indicated, whereas categorical variables are compared using Chi-square tests or Fisher's exact tests, as appropriate. In addition, patients are dichotomized based on the mean values of PBR for the sublingual microvessel diameter 5-25μm, 5-9 μm, 10-19 μm, and 20-25 μm . Cox proportional hazard models are built for each variable to decide whether any of mean values of the above PBR categories can serve as an independent predictor of major cardiovascular events or death at a significance level of p value\<0.05. Cumulative event rates are calculated using the Kaplan-Meier survival analysis for subjects with lower vs higher mean PBR value. The log-rank test for time-to-event data with respect to the total events is used for comparison of these two groups. Cox proportional hazard models are built for each possible risk factor in relation to the study endpoints. Estimated hazard ratios and their respective 95% confidence intervals are obtained. P value\<0.05 are considered significant. Multivariate analysis include factors with proven clinical value or p value ≤0.1 at univariate analysis. Moreover, chi-square values of multivariate models were comparedbefore and after adjusting for PBR. Chi square change with p value\<0.05 is considered significant. Furthermore, the net reclassification index (NRI) and Harrell's C were calculated to evaluate improvement in risk prediction by PBR and p value\<0.05 is considered significant." NCT03898349,eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System,"Inclusion Criteria: * Starting HCV treatment at a VA clinic * Have access/ability to text messaging Exclusion Criteria: * Not being treating for HCV * No access/ability to use a cell phone","The investigators examined patient and provider experiences with VA's automated text messaging system, named ""Annie"". The investigators aimed to describe early experiences using Annie and subsequently pilot and evaluate an augmented implementation strategy to improve implementation of the system. Then, seven new facilities implemented Annie. The investigators focused on specialty clinics serving patients with hepatitis-C virus (HCV). Working in collaboration with clinical team members and other Office of Connected Care stakeholders, the investigators developed a texting protocol for Veterans with HCV that included motivational messages, medication and lab appointment reminders. This protocol was made available to the seven new facilities. Four facilities were randomized to serve as intervention sites to receive augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance, described below. An additional three comparison sites received usual implementation of Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls run by the Office of Connected Care. Two control sites did not receive Annie. The investigators conducted a mixed-methods evaluation including pre and post patient and provider surveys and semi-structured interviews, medical chart abstraction, and process measure analysis. The investigators collected data on patient and clinician experiences with the Annie system, including usability, clinical workflow fit, and clinical benefits such as improved HCV medication adherence and rates of appropriately timed lab tests." NCT05109949,Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes,"Inclusion Criteria: * Diagnosis of T2DM * HbA1c \> 7 y \< 10 * BMI 25 - 34.9 kg/m2 * Signature of consent under information Exclusion Criteria: * Hypertension * Treated with insulin and / or loop diuretics and thiazides * T1DM * Hypotension * Any autoimmune disease * Liver disease * Women whitout birth control method * Women taking oral birth control or under hormone replacement therapy * Woman pregnant or breastfeeding * Untreated thyroid disease * Patients with a cardiovascular disease that contraindicates the use of this pharmacological class * Glomerular filtration rate \<60ml/min (Cockcroft-Gault)","Measure basal carotid-femoral Pulse Wave Velocity through a Pulse Pen tonometer by DiaTecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again." NCT02796248,"STigma and Its Impact on Glucose Control aMong Youth With diAbetes, a Canada-Wide Study","Inclusion Criteria: * type 1 diabetes * Canadian citizen * Aged between 14 and 24 years Exclusion Criteria: * other forms of diabetes","Stigma in diabetes has been understudied. Some recent investigations have examined stigma in adults with type 1 diabetes through in-depth interviews. Such qualitative evaluations provide important insights into the roots and experiences of stigma, but cannot capture the prevalence of the problem. This is a key gap that we will address through a national sample. We will also assess the relationship of stigma to both glycemic control and patient-reported outcomes (PROs) such as mood, self-efficacy, and sense of well-being. PROs are increasingly recognized as critical outcome measures. Finally, we will explore potential solutions with participants. Methods 1. Selection of questions to capture stigma: As a starting point, we will consider the questions included by Mulvaney and colleagues in their validated Barriers to diabetes adherence in adolescents questionnaire. This 21-item tool includes 6 questions on stigma and 4 other components (stress and burnout, time pressure and planning, social support, parental autonomy support) and showed good overall internal consistency (Cronbach's alpha 0.88). We will also consider additional questions proposed by our team, related to lived experiences with type 1 diabetes and to managing young people with type 1 diabetes (e.g., stigma within social media networks). 2. Creation of on-line questionnaire Based on (1), we will create an online questionnaire through FluidSurveys™ (www.fluidsurveys.com). Participants will be able to fill the survey directly online or offline on tablets, laptops or cell phones. The survey platform also allows participants to upload documents (pictures, videos, text). The questionnaires will be available in both French and English and will include close-ended and open-ended questions. Participants will be allowed to interrupt survey completion as needed and continue at a later time, as convenient. In addition to stigma, we will query peer support, quality of life and well-being, diabetes history and current treatment, and socio-demographic information.Overall well-being will be assessed with the WHO-5 well being index, a validated 5-item questionnaire. It is the most widely used questionnaires assessing subjective psychological well-being and has been used in people with type 1 diabetes. Demographic factors including age, sex, and ethnocultural background will be queried to ascertain if the prevalence of diabetes-related stigma is more common in some demographic subgroups (e.g., teens vs. young adults, females vs. males, ethnocultural groups). Similarly, we will query sexual orientation/gender identification in order to ascertain, for example, if being LGBT (i.e., Lesbian, Gay, Bisexual, Transgender), or subgroups thereof, is associated with higher prevalence of diabetes-related stigma. Owing to their potentially sensitive nature, however, the questions on sexual orientation/gender orientation will be explicitly optional Following completion of close-ended questions, participants will respond to open-ended questions that seek to capture experiences and perceptions of stigma as well ideas as to how stigma may be effectively addressed. They will be permitted to upload explanatory materials (e.g., videos, testimonials, pictures, drawings). 3. Following survey completion, participants will receive a kit for A1c testing (DTILaboratories, Inc.) with a pre-paid envelope for mailing the sample back to Montreal. The kit includes a sample vial that contains EDTA preservative, a vial holder, a single use lancet, a capillary tube device to draw up a small amount of blood after lancing, and a Ziploc bag. Participants will receive instructions to place the vial on the vial holder, wash their hands, lance a finger tip (they are familiar with this, as type 1 diabetes patients), draw up the blood with the capillary tube, and then release the blood into the vial. The instructions include pictures. They will then place the vial into the Ziploc bag, then into the prelabelled and postage paid box, and then mail the package through a Canada Post mail box. The samples are stable for 2.5 months without refrigeration. The AccuBase A1c Test Kit is a non-fasting, finger stick, whole blood mail-in test requiring a very small blood volume (0.001ml). Samples are stable for 45 days un-refrigerated once collected. They are analysed using a two step process. The screening step detects hemoglobin variants and/or disturbed erythrocyte kinetics by ion-exchange high performance liquid chromatography (HPLC). The second step includes the use of an interference-free procedure HPLC-boronate affinity, that provides a hemoglobin A1c value free of possible interferences including chemically modified derivatives. It is considered one of the most accurate and comprehensive A1c tests available. Recruitment Adolescents and emerging adults with type 1 diabetes aged ≥ 14 and \< 25 years will be recruited. The study will be publicized through Facebook©, Twitter© , and other forms of social media as well as websites of organizations such as Canadian Diabetes Association, Juvenil Diabetes Research Foundation, Diabète Québec and the Quebec Diabetic Children's Foundation. These organizations may be asked to mail out flyers or send email messages through any patient contacts. Specifically, the study will be publicized through posters at diabetes clinics, Facebook© pages and websites of diabetes organizations and messages on Twitter©. As in previous studies, we will include a description of the STIGMA study with a link on the websites of diabetes organizations. We will also ask the organizations to contact their members directly to inform them about the study, with a link embedded in the email message." NCT04893148,Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes,"Inclusion Criteria: * Age ≥ 18 years old * Patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks * Patient accepting to participant to this study Exclusion Criteria: * Pregnant or breastfeeding woman * severe renal dysfunction (eGFR \<60 ml/min/1.73m2) * chronic or acute hepatic disorder (HBV or HCV hepatitis, liver cirrhosis etc.) (AST/ALT \> 2.5\*ULN) * Prescription such as immunosuppressant agents, glucocorticoids * Active anti-cancer treatment","Fixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin glargine plus dulaglutide constitute treatment intensification in type 2 diabetes mellitus (T2D). The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials. Treatments were compared in terms of glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) change from baseline, and variables from continuous glucose monitoring (CGM) system; in addition to safety issues on hypoglycemia and changes in weight." NCT00221455,The Potential of Technology to Improve Chronic Disease Management and Quality of Care,"Inclusion Criteria: Diabetic patients 18 years of age or older with an established primary care physician at the Cleveland Clinic Foundation Exclusion Criteria: An individual not meeting the inclusion criteria","To date, limited research has been conducted to determine if health information technology (HIT) is effective in improving the outcomes for patients with chronic diseases. Research is required to determine if interventions facilitated by an institutional EMR platform can be implemented such that they support patients with chronic diseases to achieve improved outcomes in a cost effective fashion. At the Cleveland Clinic Foundation (CCF) an ambulatory EMR has been implemented to foster patient safety and institutional best practice guidelines, to facilitate research, and to achieve efficiencies in practice management. Our EMR is the foundation of the CCF patient portal. One of the functions of the portal is to allow patients to enter specific data elements that become part of their permanent medical record. Diabetics can enter and review their home glucometer readings, and view alert messages based on their entries. The entries are transferred to the patient's primary care physician's EMR In-Basket for review. We recognize that some patients will be more predisposed to technology adoption and some will be more health behavior compliant than others. Therefore, in addition to studying our portal's efficacy in positive diabetic behavior change, we will test if interventions can assist less predisposed and less compliant patients to become more compliant and more inclined to adopt the technology. The goals of the proposed study are: 1\) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens." NCT04524078,Lleida TIA Intervention Study,"Inclusion Criteria: 1. Patients with transient ischemic attack (reversible episode of neurological deficit of ischemic origin that resolved completely within 24 hours) or minor stroke (established neurological deficit of ischemic origin with US National Institutes of Health stroke scale \[NIHSS\]score of 3 or less at the time of randomization) 2. All subjects will be clinically evaluated by a stroke neurologist 3. All subjects will be evaluated with CT scan or MRI to exclude other causes of neurological symptoms different than brain ischemia 4. Patients with independence: modified Rankin score\<3 5. Patients with a critical carotid stenosis will be included after revascularization therapy 6. Written informed consent Exclusion Criteria: 1. Having serious comorbidities: dementia, advanced Cancer, excessive intake of alcohol (\> 280 gr/week), severe renal or hepatic insufficiency and severe cardiac failure 2. Currently receiving an investigational drug or device 3. Age\<18 years 4. Patient or family declining to take part 5. Pregnant or breastfeeding 6. Transient neurological deficit for \< 5 minutes",N/A NCT05459285,A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects,"Inclusion Criteria: 1. Sign the informed consent form before the trial, understand and comply with the research process, and participate the trial voluntarily 2. Healthy male subjects aged 18 to 45 (including the critical value) 3. Weight \> or = 50 kg, and 19.0 kg/m2 \< or = BMI (body mass index) \< or = 28.0 kg/m2 4. Vital signs, physical examination, laboratory examination, electrocardiogram, thyroid color Doppler ultrasound, abdominal color Doppler ultrasound and chest X-ray (anteroposterior) and other test results during screening are normal or have no clinical significance as judged by the investigator 5. Subjects agree to use effective contraceptive methods from signing the informed consent form to the end of the trial drug use within 3 months, and there is no sperm donation plan. Exclusion Criteria: 1. The investigator judges that the subjects have the following clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) 2. Have a medical or family history of medullary thyroid cancer (grandparents, parents, brothers and sisters), or a genetic disease that lead to medullary thyroid cancer; or a history or family history of multiple endocrine neoplasia syndrome type 2 3. Past or current history of pancreatitis (chronic or acute pancreatitis) 4. Past or current history of habitual constipation or intestinal obstruction 5. Clinically significant history of drug allergy or specific allergic disease (asthma, urticaria) or known allergy to the investigational drug and any component or related excipient components 6. Those who have difficulty with venous blood collection, a history of needle sickness, haemorrhage, or a known tendency to severe bleeding 7. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and Treponema pallidum antibody (TPAb) 8. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products (except vitamin supplements) within 2 weeks before the first dose 9. Those who have a history of vaccination with live attenuated vaccine within 3 months before screening or a history of vaccination with inactivated vaccine within 1 month before screening 10. Those who have previously received dulaglutide or any other glucagon-like peptide-1 (GLP-1) analog 11. Those who donated blood or lost blood \> or = 400 mL within 3 months before screening, or those who plan to donate blood 12. Those who smoked more than 5 cigarettes per day within 3 months before screening or who could not give up smoking during the period from signing the informed consent to the subjects leaving the group 13. Those who have a history of alcohol abuse, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) , or those who have a positive alcohol breath test during the screening period 14. Those who have a history of drug abuse or poison use within 2 years before screening, or those who have a positive test results for urine drug abuse screening during the screening period 15. Participated in other clinical trials within 3 months before screening (subjects who are not randomized or not receiving treatment withdraw from the study before treatment, they can be enrolled in this study) 16. Acute illness or concomitant medication occurred from the time of signing the informed consent to the first administration 17. Those who have special requirements for diet and cannot obey the unified diet 18. Others judged by the investigator to be unsuitable to participate in this trial 19. Subjects who may not be able to complete this trial for other reasons",N/A NCT01182935,Elevated Triglyceride Levels and Later Type 2 Diabetes,"Inclusion Criteria: * participants in the 4 Tromso study 1994 and with elevated serum triglyceride levels Exclusion Criteria: * type 2 diabetes",N/A NCT01784211,A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes,"Inclusion Criteria: * Are males or females that have had a diagnosis of Type I Diabetes Mellitus (T1DM) for at least 12 months and are receiving multiple daily insulin injections. Total daily insulin dose \<1.2 units per kilogram per day (U/kg/day); daily basal dose \>0.2 U/kg/day * Female participants: are women of child-bearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study * Have a body mass index (BMI) of 18 to 30 kilograms per meter squared (kg/m\^2), inclusive * Have a fasting c-peptide \<0.3 nanomoles per liter (nmol/L) * Have a hemoglobin A1c (HbA1c) \<9% at screening Participants with T1DM are eligible for enrollment in Part B of the study only if they meet all of the following criteria: * Have a maximal oxygen uptake (VO2 max) of ≥25 milliliters (mL) of oxygen per kilogram per minute (O2/kg/min) (for women) or ≥30 mL O2/kg/min (for men) * Perform regular physical cardiorespiratory activity to achieve an average total energy expenditure of ≥500 metabolic equivalent of task (MET)-minutes per week during the last 3 months prior to screening Exclusion Criteria: * Have known allergies to LY2605541, insulin glargine, related compounds or any components of the formulation * Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data * Have had episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party) * Have a history of hypoglycemia unawareness * Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that may affect blood glucose, the body's sensitivity to insulin, or that promote weight loss within 14 days prior to dosing * Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to comply with study requirements regarding alcohol consumption * Currently smokes \>5 cigarettes per day, or are unwilling to comply with study requirements regarding smoking or use of tobacco products * Have a hemoglobin level \<8.0 millimoles per liter (mmol/L) (male) or \<6.4 mmol/L (female) at screening * Are currently participating in a weight loss program or plan to do so during the course of the study * Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and intra-ocular preparations) or have received such therapy within the 4 weeks before dosing * Have fasting triglycerides \>400 milligrams per deciliter (mg/dL) (4.52 mmol/L) * Have previous history or family history of deep vein thrombosis",N/A NCT05623111,Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities,"Inclusion Criteria: * Are 18 years or older * Are diagnosed with diabetes type I or II * Score 3 or above on the Doleur Neuropathique 4 interview section * Suffer from pain of the lower extremities which * is considered by the participant as their dominant overall dominant pain * is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days) * is present in both feet, roughly symmetrically. * has been present for at least 6 months * Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40. * Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study * Are using an approved, safe contraceptive (for premenopausal women) * Speak, read, and understand Danish Exclusion Criteria: * • Have a known allergy or hypersensitivity to BonT-A * Have been treated with BonT in the last 6 months. * Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Have a known malignant condition * Have an ongoing infection in the area of injection * Are expecting to change their pain medication during the study period * Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion * Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as: * spinal stenosis * claudication * previous trauma or nerve injury * cancer related pain * Have a psychiatric condition that affects their completion of the study, as assessed by the investigator. * Are active abusers of alcohol or illegal substances * Are using or receiving treatment with cannabis products of any kind * Are pregnant or planning pregnancy during the study period * Score more than 12 on the Charlson Comorbidity Index","This study is a randomized, double-blind, placebo-controlled trial, investigating the safety, efficacy, use of rescue medication, and impact on NPSI scores, health-related QoL, activities of daily living (ADLs) and levels of physical activity of perineural incobotulinumtoxin-A (iBonT-A) or placebo injections, in persons with DNP of the lower extremities. Participants will be randomly assigned via simple block randomization to receive either 100 units of iBonT-A in each leg (total of 200 units), or a placebo in each leg, injected perineurally around both distal sciatic nerves once every 12 weeks, for a total of 24 weeks. Injections are performed with sonographic guidance by an experienced operator. Contents of the blinded vials, containing either 100 U of iBonT-A or a placebo consisting of small amounts of sucrose and albumin are diluted in 5 ml of sterile saline. The injection point is just distal to the sciatic nerve bifurcation. The skin is penetrated from the lateral side using a non-cutting needle (Pajunk, SonoBlock, 22G x 80 mm, Facet S Tip). With the needle in plane in relation to the ultrasound probe, the nerves are visualized in short axis. The needle tip is placed inside the common sheath surrounding the tibial and peroneus communis nerves. The location of the needle tip is verified with small boli of sterile saline solution in combination with ultrasound. Correct distribution of the injectant is confirmed with dynamic scanning. Fluid distention must be seen around both components. When confirmation of optimal needle placement the 100 units iBonT-A or placebo is injected. The procedure is repeated for both legs. Participants will be asked to rate their neuropathic pain once a day, as well as register their daily use of rescue medication. Secondary outcome measures will be rated at baseline and at 4, 12, 16 and 24 weeks. Safety information consists of adverse events recording, as well as motorfunction and sensory changes over time." NCT04023734,A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Diabetes Patients,"Inclusion Criteria: * At least 18 years old. * Diagnosed with type 2 diabetes for at least one year based on patient's medical record. * Using at least one antihypertensive drug in the last three months. * Provision of signed informed consent. * Have sub-optimal medication adherence to antihypertensive drugs according to the MARS (\<20). Exclusion Criteria: * Patients with severe mental or physical constraints. * Pregnancy or in the lactation period. * Illiterate in Indonesian language. * Enrollment in another intervention study. * Those not responsible for taking their own medication","Adherence to chronic medication is often suboptimal. However, existing interventions to improve adherence are either too complex or expensive for implementation and scale-up in low-middle income countries and/or not particularly effective. A cluster randomized controlled trial with 3-months follow-up will be conducted in 10 Community Health Centers (CHCs) in Indonesia. Patients aged ≥18 years, diagnosed with type 2 diabetes and reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in the five CHCs randomized to the intervention group will receive a targeted and tailored pharmacist intervention at baseline (first session) and at 1-month follow-up (second session). The intervention will be low-cost, align with the current CHC workflow and will not require a substantial change to the current system. Before dispensing antihypertensive drugs during the first session, the pharmacist will discuss patient-specific barrier(s) for medication adherence based on their responses on MARS and three additional questions, which are derived from the Brief Medication Questionnaires. The intervention strategies will then be tailored to their identified adherence problems. Based on current literature, the investigators defined four non-adherence problems that can be addressed by the community pharmacist, i.e. (1) forgetfulness, (2) lack of knowledge, (3) lack of motivation or (4) other drug-related problems. Of note, patients might need a combined intervention strategy to address all experienced problems. The four non-adherence problems and recommended intervention strategies are specified below: 1. Strategies to cope with forgetfulness include reminders, habit-based strategies and/or involvement of family members. 2. The content of the counselling to cope with lack of knowledge will focus on educating patients about about the purpose of the medication, when and how to take the medication, the need for long-term use, the importance of medication adherence, and how to deal with possible side effects. To explore which education is needed, the patient will be asked whether they know why and how to take their medication. The teach-back method will be used, where the patient is asked to explain the pharmacist what he/she has understood after receiving the education. 3. The content of the counselling to cope with lack of motivation will focus on exploring and discussing the patients' concerns and necessity beliefs (motivational interviewing). 4. The content of the counselling to address other drug related problems will focus on exploring other problems underlying the non-adherence, for example experiencing side effects, costs, polypharmacy, difficulty to refill antihypertensive drugs in time, or medication intake problems, and offering solutions/alternatives when possible. The follow-up session will be conducted in one month after the baseline session, when patients refill their medication at the next regular outpatient visit. The purpose of the follow-up session is (1) to evaluate the short-term effect of the intervention and discuss the patients' implementation of and experiences with the offered information and recommendations, and (2) to address non-adherence problems that were not yet addressed during the first session. Where needed, the pharmacist, together with patient, can make changes to the coping plan and discuss additional interventions. As the quality of the intervention will depend on the competences and skills of the pharmacist, treatment integrity will be enhanced by an obligatory communication training focusing on motivational interviewing and the teach-back method, and by providing supportive material as part of the intervention. Patients in five CHCs randomized to the control group will receive pharmacist counselling based on the Indonesian guideline of pharmacy practice. At each visit, they can receive information about the quantity and dose of the dispensed drugs, when and how to use and store the drugs, side effects and how to deal with them, the importance of medication adherence, and confirming if the patient understands how to take medications correctly. Patients in the control group will complete all assessments at the same time points as those in the intervention group The primary study outcome is the difference between intervention and control group in change in total adherence scores using the MARS between baseline and 3 months follow-up. Secondary outcomes are blood pressure (BP), medication beliefs using the Beliefs about Medicines Questionnaire (BMQ)-specific, and evaluate the intervention using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance)." NCT01044134,Think AHEAD (A Healthy Eating And Drinking) Study,"Inclusion Criteria: * BMI ≥ 85th percentile for sex and age according to CDC growth charts * Access to a working telephone and cell phone * At least one parent willing and able to participate in the intervention with the subject * Residing in predominately one household (no more than one weekend every two weeks in a secondary household) * Medical clearance from a primary care provider or treating physician to rule out any major medical illness, disability, or disorder (e.g., liver disease, renal failure, cancer) Exclusion Criteria: * Intake of more than 4 cups (250 mL per cup) of water per day * BMI ≥ 40 kg/m2 * Currently smoking (\> 1 cigarette in the past week) * Major surgery within the previous 6 months * Does not have a primary care provider * Physician diagnosis of a major medical illness (e.g. diabetes) * Previous diagnosis of an eating disorder * Physical, mental, or cognitive handicaps that prevent participation * Chronic use of medications that may affect study outcomes (e.g. stimulants or diuretics) * Another member of the family (first degree relative) or household participating in the study * A friend, classmate or coworker participating in the study with whom they have contact with one or more times per week * Girls who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum","This is a 6-month randomized controlled trial. After the initial baseline screening and assessments, 60 overweight adolescents will be randomly assigned (30 subjects per group) to a standard weight-reducing diet with the advice to consume 8 cups of water per day (experimental group) or the same standard weight-reducing diet without additional advice (control group). The interventions will consist of nutrition education and behavioral counseling by a registered dietitian, during individual sessions and telephone calls. Mobile text messaging will be used to reinforce information presented at the individual sessions and thereby foster adherence to dietary advice. Diet prescriptions will differ only in regard to the specificity of recommendations regarding water consumption and physical activity recommendations will not differ between groups. The frequency and content of text messages will be consistent between the experimental and control groups, with the exception that the experimental group will receive an additional phrase with each message to encourage the ""8 x8"" water recommendation. A registered dietitian will communicate with each participant one time per month, either during an individual session or by telephone. Individual sessions will include nutrition classes, taste testing, hands-on activities, and opportunities for questions and answers. Text messages will be sent on a daily basis. Study outcomes will be assessed at baseline and at regular intervals throughout the 6 months of the study. ANALYSIS PLAN: The blinding of the randomization will be broken on or after July 28, 2014 and the data will be analyzed according to the following plan. All analyses will follow the intention-to-treat principle, attributing each subject to his or her assigned diet regardless of compliance. Baseline characteristics will be compared between the diet groups using the Fisher exact test for categorical variables and t-test for continuous variables. The 6-month change from baseline in the primary and secondary outcomes will be compared between groups using a general linear model, adjusting for baseline covariates that are potentially correlated with the outcome. These include demographics, socioeconomic status, anthropometrics, physical activity, and beverage consumption. We will further test covariates for potential interaction, i.e., differential effect on outcome in the two trial arms. The null hypothesis is that the 6-month change from baseline will not differ between diet groups." NCT00325364,Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes,"Inclusion Criteria: * Type 2 diabetes * Non smoker * Normal lung function Exclusion Criteria: * Pulmonary, hepatic, or renal disease * Congestive heart failure * Active malignancy * Systemic glucocorticoid therapy",N/A NCT06541509,Mechanisms of Semaglutide Therapy in Heart Failure Patients,"Inclusion Criteria: * Age: 20-80 years * Presence of heart failure * Body-mass index 27 kg/m2 or greater * Stable optimally tolerated dosages of heart failure therapies for 3 months * N-terminal pro B-type natriuretic peptide levels \>350 pg/mL Exclusion Criteria: * Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5% * Pregnancy or potential to become pregnant * Cancer * Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase \> 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal) * Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2) * Hospitalization in the past 3 months for reasons other than heart failure * New York Heart Association (NYHA) functional class I or functional class IV symptoms. * Prior or planned bariatric surgery * Self-reported change in body weight \>11 lbs (5 kg) within 3 months before enrollment * Acute or chronic infection",N/A NCT03568032,Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma,"Inclusion Criteria: * signed inform consent * age more than 18 years old * ECOG 0-2 * pathologic diagnosed, non-metastatic NPC * either untreated or treated by definitive IMRT 3 years ago * did not receive radiation to the head and neck region prior to the diagnosis of NPC * if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse * no prior surgery of head and neck Exclusion Criteria: * prior history of cardiovascular disease before the diagnosis of NPC * prior radiation to head and neck before the diagnosis of NPC * prior surgery of head and neck * pregnant or lactating women",N/A NCT01078532,Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR),"Inclusion Criteria: * \>=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user Exclusion Criteria: * current PHR user life-expectancy of less than 6 months dementia or disability that prevents them from being able to utilize a PHR (such as blindness)",N/A NCT01292798,Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab,"Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 18 years * Diagnosis of diabetes mellitus (type 1 or 2)Any one of the following will be considered to be sufficient evidence that diabetes is present:Current regular use of insulin for treatment of diabetes or current regular use of oral anti-hyperglycemia agent for the treatment of diabetes * Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy. * Previous history of two consecutive intravitreal bevacizumab injections for the treatment of diabetic macular edema with documented incomplete resolution of central subfield thickening by OCT (consecutive injections administered \< 7 weeks apart and within the past 12 months). * Central diabetic macular edema present on clinical examination and OCT testing with central 1mm subfield thickness greater than 300 microns as measured on SD-OCT. * Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol. * Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Exclusion Criteria: * Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception. * Participation in another ocular investigation or trial simultaneously * Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110) * Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse) * Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema * An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy) * Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas) * Evidence of neovascularization of the iris or retina * Evidence of central atrophy or fibrosis in the study eye * Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study. * History of vitreous surgery in the study eye * History of cataract surgery within 6 months of enrollment. * History of YAG capsulotomy within 2 months of enrollment. * Visual acuity \<20/400 in the fellow eye * Uncontrolled glaucoma (pressure \>30) despite treatment with glaucoma medications. * History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.",N/A NCT01876563,"the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes","Inclusion Criteria: literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention - Exclusion Criteria: people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers \-",N/A NCT00670098,Changes in Sexual Function Following Bariatric Surgery,"Inclusion Criteria: * • Age: Patients must be between 18 and 65 years of age. * Gender: Both women and men are eligible to participate. * Ethnicity and Race: Individuals from all ethnic and racial groups will be invited to participate. * Body Mass Index: 40 to 60 kg/m2 (or of \> 35 kg/m2 in the presence of co-morbid medical conditions). * Ambulation: Patients must be ambulatory, given the frequent number of assessments (and difficult arranging transportation for non-ambulatory individuals * Competent: The patient must be able to communicate with the investigator and be legally competent, provide written informed consent. Exclusion Criteria: * • Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes. * Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that significantly interferes with daily living and functioning. * Use of medications known to significantly increase body weight, such as systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and anti-psychotic agents (The use of selective serotonin re-uptake inhibitors (SSRIs) will not be excluded because of their widespread use and lesser effect on body weight.) * Patients who are not in an ongoing romantic relationship * Any current (past 12 months) substance abuse or dependence disorder. * Pregnancy or lactation (Those who are pregnant do not undergo bariatric surgery. In addition, the hormone changes induced by pregnancy are known to interfere with the hormones examined in this study, confounding the findings. Participants who become pregnant while in this study will be withdrawn from the study.)",N/A NCT05274906,Red and Processed Meat Effects on the Metabolome and Microbiome,"Inclusion Criteria: * Healthy adult, * 18-50 years of age, * able to read, speak, and understand English, and * willing to come to the Fred Hutchinson Cancer Research Center campus twice weekly during study Exclusion Criteria: * known allergy to red or processed meat, * vegetarian or vegan, * any religious or personal reason(s) to avoid red and processed meat, * pregnant an/or exclusively breastfeeding, and/or * alcohol or recreational drug abuse","This is a randomized cross-over feeding trial to test whether red and processed meat consumption, in the context of a controlled diet based on HEI-2015, will cause shifts in the metabolome and the microbiome compared to a controlled HEI-2015 diet with no red or processed meat. Twenty healthy adult volunteers will consume two diets in random order: 1) Diet A is based on the Healthy Eating Index-2015 (HEI-2015) and includes no red or processed meat; 2) Diet B is based on the Healthy Eating Index-2015 and includes red and processed meat (HEI-2015-M) as some of the protein sources. Both diet periods last 21 days and an approximately 21-day washout period occurs between diets." NCT05106933,The Effect of Carbohydrate Loading 2 Hours Before Gastroscopy on Gastric Residual Volume and Patient's Well-being Score,"Inclusion Criteria: * Patient 18 years old and above * Agree to participate Exclusion Criteria: * History of upper gastrointestinal surgery * Patient with active gastrointestinal bleeding * Unstable clinical condition * Mentally disable or who cannot give an informed consent * Patient on the nasogastric feeding tube * Pregnant patient * American Society of Anesthesiologists classification of physical status grade 3 or above * Insulin dependent Diabetes Mellitus more than 10 years * Patient who is carbohydrate intolerance","Patient planned for OGDS in HUSM will be randomized into 2 groups. Plain water is given to group A of subject and carbohydrate loading is given to group B subject 2 hours before OGDS. Gastric residual volume is visualized directly and measured through aspiration via OGDS and subject's well-being is assessed for both group of the subject prior and after clear fluid have been given. Methodology : Research design :- This is a single-blind randomized controlled trial. This is a stratified (diabetes mellitus, non-diabetes mellitus) with balanced randomization (1:1), placebo-controlled study Study area :- This study will be conducted in the endoscopy room, Hospital Universiti Sains Malaysia (HUSM) in Kubang Kerian, Kelantan, Malaysia All subjected planned for OGDS with the complaint of one or more of the following symptoms : Bothersome postprandial fullness, early satiety, epigastric pain or epigastric burning and fulfill the inclusion criteria are selected. Patients will be approached and be explained regarding the study in surgical outpatient clinic before OGDS. The patient will be approached again on the day of OGDS, if agree to participate, informed consent will be obtained. Informed consent will be obtained after explanation regarding the study and procedure again by researcher nurse. The allocation sequence is according to computer-generated random number list, it was prepared by an investigator with no clinical involvement in the trial. The allocation sequence was concealed from researcher enrolling and assessing participants. The allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and identification number of the participants will be written on a book together with the series number on the envelope. The details in the book will be kept confidentially. After enrolled subject complete all the baseline assessment, the corresponding envelope will be enclosed by the trained staff (who not involved in the study) who prepare the drink. The staff need to ensure that the envelop is still sealed when receiving it. The staff will prepare the drink into an identical container according to the assignment. The subjects are randomized into 2 groups: 1 group with 400mL plain water and another group given 1 packet carborie (400mL). Subjects need to finish the drink over 10 minutes. After that, subjects are not allowed to leave endoscope room until finish OGDS to prevent consumption of other drink or food. 2 hours after that, the subject undergoes OGDS. OGDS is performed following the standard protocol. 1. The patient lies in the left lateral position 2. Medication/lignocaine spray to numb the back of throats (spray) will be given to prevent gagging during the passage of the instrument 3. A plastic mouth guard (mouthpiece) is placed between the teeth to prevent damage to the teeth and endoscope 4. The endoscope (also called a gastroscope) will be inserted through the mouthpiece 5. A small container or yankauer suction is placed close to the mouth of a patient to collect saliva during and after the oesophagogastroduodenoscopy (OGDS) 6. The endoscope will be inserted along the middle line of the soft palate 7. Once endoscope advanced, the patient may be asked to swallow to facilitate advancement of scope 8. Throughout the procedure, no water flushing is allowed, only air inflation is allowed. Visualized pooling of fluid in the stomach is aspirated until dry via direct visualization with the endoscope. The aspirated fluid will be collected in the suction reservoir and the fluid will be measured Subject's well-being score is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and general discomfort. This scale will be used repeatedly during this study to assess the patient's well-being. The trained staff nurse will ask the patient regarding the level of 5 parameters and subject need to mark \[X\] somewhere along the horizontal line given before drink and before OGDS procedure. All subjects are advised to inform assessor if there is an adverse reaction. Medical personnel are available to manage any adverse events that might occur throughout the procedure. The possible risk that may arise in the study includes injury to the gastrointestinal wall, aspiration and bleeding which is the similar risk for all patient undergoing for OGDS procedure. The small volume of the drink will not cause psychological distress to the subject, but its taste may not be palatable." NCT06886633,The Effect of Breathing Exercise and Pressurized Cold Application on Pain and Anxiety During Sharp Debridement,"Inclusion Criteria: * Volunteer to participate in the study * Those aged 18 and over, * Those who were included in the breathing exercise group before the research and who could perform breathing exercises correctly if taught and demonstrated. * Do not have a disease that affects breathing such as Asthma, COPD, Heart failure, * Not taking any medication that suppresses anxiety symptoms, * Do not have a diagnosed disease such as Alzheimer's or Dementia that would hinder communication, * Patients included in the breathing exercise group should not have ear, nose or throat problems that may prevent them from performing breathing exercises. Exclusion Criteria: * Those who give up being a research participant at any stage of the research, * Illiterate * Having a diagnosed disease that affects breathing such as Asthma, COPD, Heart failure, * Taking any medication that suppresses anxiety symptoms, * Cold intolerance or allergy to cold","Approximately half of the diabetic population is at risk for developing foot ulcers. A prevalence study conducted in our country stated that more than 1 million of 7 million patients with diabetes developed diabetic foot ulcers (DAU) and nearly 500,000 patients had diabetic foot infections. Diabetic foot ulcers cause deterioration in the patient's quality of life, significant increase in treatment costs, lower extremity amputations and increased mortality. 50-70% of non-traumatic foot amputations are performed on diabetic foot patients . When the literature is examined, it is seen that breathing exercises have been used to support the treatment of stress, fatigue and pain since human history. Breathing exercise is a method that ensures body-mind harmony. Conscious deep and slow breathing helps develop conscious control over relaxation and increases awareness. The distracting effect of breathing can be effective in relieving pain through many different mechanisms: Breathing exercises can relieve tension and muscle spasms in the body by reducing stress. Pain is often associated with stress, tension and anxiety. The rhythmic and regular movement of breathing can help calm the mind and become less sensitive to pain. It may increase the release of natural painkillers called endorphins. Deep breathing and relaxation can trigger the release of endorphins in the brain and reduce the perception of pain. There are studies that breathing exercise increases the pain threshold, reduces the level of anxiety by allowing the person to relax, and has healing effects on vital signs. Cold application is used as an effective alternative treatment to relieve pain and is recommended because it reduces pain as a result of its effect on sensory nociceptors. Compression increases conductivity by ensuring full contact between ice and skin, and reduces blood flow and edema to the tissue by strengthening the effect of cold application in reducing tissue temperature. For this reason, it is stated that using cold and pressure together is a more effective method to reduce the level of pain than applying cold alone. It has been reported that pressurized cold application is an important application in reducing the level of pain in patients undergoing total knee prosthesis. There are studies showing that cold application reduces both the level of pain and the level of anxiety. It has been reported that cold saline application and stress ball application to reduce pain and anxiety during wound debridement in patients with diabetic foot ulcers reduce the level of pain and anxiety during debridement. According to the literature, there are limited studies on reducing pain and anxiety during debridement in diabetic foot ulcer patients. In our planned study, it is envisaged that patients who receive breathing exercises and pressurized cold application will experience a decrease in the level of pain they feel during the debridement process, a decrease in their anxiety levels, and an improvement in their vital signs, and that these study findings will constitute an important data source to reduce the pain and anxiety that occurs during the debridement process. At the same time, it is thought that using it as an alternative to the use of medication to reduce the level of pain during the procedure will make a significant contribution to reducing treatment costs." NCT00059449,Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis,"Inclusion Criteria: * Gestational Age greater than 23 weeks at birth * Birth weight greater than 500 grams * Age less than 72 hours of life",N/A NCT02692547,Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes,"Inclusion Criteria: 1. Diabetes duration \> 1 year since diagnosis 2. Sensor augmented Pump for at least 6 months 3. Age 18-25 4. A1C \<10.0 at time of screening visit 5. Willing to follow study instructions 6. Willing to perform ≥ 5 finger stick blood glucose measurements daily 7. Willing to perform required sensor calibrations 8. Patient capable of reading and understand instructions in English Exclusion Criteria: 1. Subject is unable to tolerate tape adhesive in the area of sensor placement 2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. Subject has a positive pregnancy screening test 5. Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception 6. Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit 7. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit 8. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit 9. Subject has a history of a seizure disorder 10. Subject has central nervous system or cardiac disorder resulting in syncope 11. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease 12. Subjects with hematocrit lower than the normal reference range per POC or local lab testing 13. Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias 14. Subjects with a history of adrenal insufficiency 15. Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment","This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy. Run-in Period A total of up 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (sensor augmented pump) will be used to collect sensors and insulin data and to allow the subject to become familiar. Study Period - Camp Following the run-in period subjects will participate in a 5 day, 4 night study period in an camp setting during which the CL feature will be studied. Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates. Subjects will be asked to exercise for up to 60 minutes on one day during their study period. Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)" NCT00467649,A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes,"Inclusion Criteria: * Has a clinical diagnosis of type 2 diabetes mellitus * Has an HbA1c \>7.0% and ≤10.0% * Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2 * Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy Exclusion Criteria: * Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months * Requires the use of drugs that stimulate gastrointestinal motility * Has been previously treated with Symlin (or has participated in a Symlin clinical study) * Is currently being treated with any of the following medications: \*Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat \[Xenical®\] and sibutramine \[Meridia®\]); \*Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; \*Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide \[Reglan®\]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; \*Investigational medications * Has a history or presence of any of the following: \*Eating disorders (including anorexia and/or bulimia); \*Bariatric surgery (gastric bypass, gastric banding, or gastroplasty) * Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study * Has donated blood within 30 days of study start or plans to donate blood during the duration of the study",N/A NCT03793855,Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC),"Inclusion Criteria: \>30 years old with medical diagnosis of T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who have not received or received nutritional counseling for at least 06 months. Exclusion Criteria: * Patients with type 1 DM (T1DM), latent autoimmune diabetes in adults (LADA) or HbA1C ≥ 12%; * Severe neuropathy; * Chronic kidney disease; * Active cancer or life expectancy \<6 months; * Chemical dependence or use of antipsychotic drugs; * Autoimmune disease or chronic use of steroids; * Gastroparesis; * Pregnancy, lactation, gestational DM; * Acute coronary syndrome (ACS) in the last 60 days; * Wheelchair users; * Extreme obesity (body mass index \[BMI\] ≥40kg/m²); * Cognitive, neurological or psychiatric condition that prevents participation in the study; * Participation in other clinical trials.",N/A NCT02333734,Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients,"Inclusion Criteria: * Type 2 diabetes or matched healthy controls. T2D subject only : HbA1c \> 7,3. All subjects have an age between 40-65 years and a body mass index between 25-40 kg/m2. Both genders is allowed Exclusion Criteria: * Severe diseases /immobility","Type 2 diabetes (T2D) can be defined as a bihormonal metabolic disorder characterised by insufficient insulin secretion and abnormal glucagon secretion. It is however well established that physical activity per se improves glucose and may postpone or even slow down in the diabetic population. Glycaemic control may be improved more by high intensity interval training than by intensities from existing recommended guidelines. Additionally, there seems to be accumulating evidence that high intensity interval training induces increased overall fat and abdominal fat mass loss as opposed to traditional continuous endurance training Therefore we hypothesise that 3 weekly sessions of high intensity interval training (10×60 sec. at an intensity inducing 90% of maximal heart frequency with a recovery of 60 sec. between each bout) over 8 weeks improves overall glycaemic control (glucose, insulin and glucagon), inflammatory status (interleukins, cytokines, chemokines and cell adhesion molecules) and blood flow (NO and PGI2 vasodilatory capabilities)." NCT00382564,Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease,"* INCLUSION CRITERIA: 1. Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CT or MRA), or Doppler ultrasound. Subjects at risk for atherosclerosis including: smoking, hyperlipidemia, low levels of high density lipoproteins (less than 50 mg/dl for women and less than 40 mg/dl for men), hypertension, family history (early onset atherosclerosis less than 55 year old in male and less than 65 year old in female who is first degree relative), and diabetes mellitus or metabolic syndrome. 2. Subject must be willing to participate in the protocol. 3. Subject age greater than 18 years old. 4. Subject must be clinically stable and be able to come to the Clinical Center to participate in the study. EXCLUSION CRITERIA: 1. Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions: 1. Implanted cardiac pacemaker or defibrillator 2. Cochlear Implants 3. Ocular foreign body (e.g. metal shavings) 4. Embedded shrapnel fragments 5. Central nervous system aneurysm clips 6. Implanted neural stimulator 7. Medical infusion pumps 8. Any implanted device that is incompatible with MRI. 2. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest. 3. Subjects requiring sedation for MRI studies. 4. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.). 5. Pregnant or lactating women. 6. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination. 7. Subjects who are unable to undergo a CTA within 1 month of the MRA part of this study, or are unable undergo or be scheduled for a cardiac catheterization within 1 month of the MRA. FOR GADOLINIUM BASED MRI STUDIES ONLY: 8. History of severe allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone. 9. Creatinine value greater than 3.0 mg/dl FOR CARDIAC CT: 10. Recent cardiac CT within a month. Both a coronary CTA and calcium score scan are required for this study. If any of these scans were performed at an outside facility and meet the necessary quality level, then that aspect of the cardiac CT scan (coronary CTA, calcium score scan or both) will not be performed at the NIH. Coronary CTA and/or calcium score CT obtained at the outside facility must be performed within one month of subject inclusion and acquired using a 16 slice scanner or higher and should be of good quality. The unformatted images of outside cardiac scans must be available to the primary investigator within one month of their acquisition for eligibility of inclusion in the study. FOR CORONARY CTA: 11. Contraindication to the use of CT contrast agents: 1. Creatinine value greater than 1.4 mg/dl 2. History of multiple myeloma 3. Use of metformin-containing products less than 24 hrs prior to contrast administration 4. History of significant allergic reaction to CT contrast agents despite the use of premeditation with an anti-histaminic and cortisone. 12. Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include: 1. Asthma 2. Active bronchospasm 3. Moderate or severe COPD 4. Second or third degree AV block 5. Decompensated cardiac failure 6. Allergy to beta blockers 7. Systolic blood pressure less than 100 mm Hg 8. Pregnancy or nursing","Magnetic Resonance Angiography (MRA) is a developing technique that permits the non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. While dramatic progress has been made in the last few years, there are still substantial limitations in the accuracy of MRA in the evaluation of coronary artery. The primary aim of this study is to evaluate state-of-the-art techniques for coronary MRA in subjects with known or suspected coronary atherosclerosis. The secondary aim of this protocol is to generate natural history data for future hypothesis-driven clinical trials using MRA techniques developed in this current protocol. The long-term objective of this pilot study and research initiative is to improve coronary MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of subjects with atherosclerotic disease." NCT07233434,Screening for Type 2 Diabetes by Oral Glucose Tolerance Test in the Population Groups Not Diagnosed by Fasting Blood Glucose in Guadeloupe,"o Inclusion criteria : Adult subject (over 18 years and under 65 years old) Subjects of African or Indian origin and self-declared Normal FBG levels (110mg/dL) HbA1c levels between 5.7 and 6.4% One or more of the following factors: BMI \> 25 kg/m2, family history of T2DM in the 1st and 2nd familial degree, hypertension, dyslipidemia. Affiliation to the national social health system or equivalent Informed and written consent signed by the patient and the investigator (at the latest on the day of inclusion and before the completion of any research related exam) o Exclusion criteria : Pregnant or lactating woman Women with a history of gestational diabetes Polycystic ovary syndrome Endocrine, hepatic or renal diseases affecting glycemic control Treatment that affect the metabolism of glucose or insulin Refusal to participate Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, curatorship or safeguard of justice, person participating in another research including an exclusion period still in progress, severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant","Contrary to the French recommendations, the American recommendations for the diagnosis of T2DM, include FBG, HbA1c or OGTT. These recommendations suggest that there are differences in the HbA1c levels between subjects of African origin and Caucasian subjects. The population in Guadeloupe is characterized by ethnic heterogeneity with genetic polymorphisms specific to the subjects of African and Indian origin that could justify the interest of a targeted and early screening of T2DM by another test than FBG. The main dilemma is how to confirm that subjects with risk factors of T2DM but normal FBG are not diabetic? Some of them have normal FBG levels but HbA1c levels between 5.7 and 6.4% that are not used as diagnostic criteria in France. We think that OGTT could help to better diagnose T2DM in such subjects. After identifying these subjects, an OGTT will be performed after inclusion. The diagnosis of T2DM will be confirmed in subjects who exceeded the glucose threshold of 11mmol/L (200mg/dL), 2 hours after the OGTT. The number of these diabetic subjects is evaluated to 10%, they will be treated according to the HAS recommendations and monitored during the year of the study. The other subjects without abnormalities will be followed at 12 months with OGTT repetition." NCT01751399,A Single Dose Study of LY2605541 in Participants With Liver Impairment,"Inclusion Criteria: All Participants (including those with type 2 diabetes mellitus \[T2DM\] who are controlled by diet) * Male participants agree to use a reliable method of birth control during the study * Female participants of child-bearing potential (not surgically sterilized between menarche and menopause) must have a negative pregnancy test at the time of enrollment and must be using a reliable method of birth control * Women of non-child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history, or menopause. * Menopausal women include women with either spontaneous amenorrhea for at least 12 months or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40 milli international units per milliliter (mIU/mL) * Have a body mass index (BMI) of 18.5 to 40 kilogram per square meter (kg/m\^2) * Have normal sitting blood pressure and heart rate compatible with their disease state * Have venous access sufficient to allow blood sampling * Have given written informed consent approved by Lilly and the Ethical Review Board (ERB) governing the site Participants with Normal Hepatic Function * Overtly healthy males or females with normal hepatic function * Have clinical laboratory test results within normal reference range for the investigator site, or results with minor deviations not considered to be clinically significant by the investigator Participants with Hepatic Impairment * Have stable liver impairment with no sign of recent deterioration (alcoholic, posthepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh class A, B, or C who are considered by the investigator as acceptable for participation in the study Exclusion Criteria: All Participants (including those with T2DM) * Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study * Have an acute infection with fever or infectious disease or febrile illness within 3 days prior to administration of the study medication * Have known allergies or significant hypersensitivity to LY2605541, its excipients, or related compounds, or history of relevant allergic reactions of any origin * Have previously completed or withdrawn from this study or any other study investigating LY2605541 and have previously received the investigational product * Have Type 1 Diabetes Mellitus (T1DM) or have T2DM and are receiving anti-diabetic medication * Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study * Regularly use known drugs of abuse and/or show positive findings on urinary drug screening * Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies * Have donated blood of more than 500 milliliters (mL) within the last month * Have had a liver transplant or have taken immunosuppressants following any organ transplant * Have shown signs of variceal bleeding during the last 2 weeks prior to screening * Show evidence of irritable bowel syndrome, chronic diarrhea, other symptomatic digestive problems or a known history of repeated chronic stool positive for occult blood, or be considered by the investigator to be at greater risk of acute or chronic pancreatitis * Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces \[oz\] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits) * Are on total parenteral nutrition * Take anticoagulants for therapeutic use, other than low dose acetylsalicyclic acid * Are excessive consumers of xanthines Participants with Normal Hepatic Function * Have any medically significant history of neurologic disease, cancer, or cardiac, respiratory, metabolic, hepatic, renal, gastrointestinal (except appendectomy and cholecystectomy), dermatological, venereal, hematological disorder or disease * Have creatinine clearance (CrCl) less than 80 milliliters per minute (mL/min) * Show evidence of significant active neuropsychiatric disease in the opinion of the investigator * Show evidence of hepatitis B and/or positive hepatitis B surface antigen * Show evidence of hepatitis C and/or positive hepatitis C antibody Participants with Hepatic Impairment * Show evidence of any significant active disease other than that responsible for or associated with mild, moderate, or severe hepatic impairment * Show evidence of hepatorenal syndrome as shown by CrCl \<50 mL/min calculated using the Cockcroft-Gault equation * Have shown signs of spontaneous bacterial peritonitis within 6 months prior to enrollment into the study * Have severe hyponatremia (sodium \<120 millimoles per liter \[mmol/L\]) * Show signs of hepatocellular carcinoma * Have a portal shunt * Show, in the opinion of the investigator, evidence of significant active neuropsychiatric disease other than grade 1 hepatic encephalopathy * Have hemoglobin concentrations \<9.0 grams per deciliter (g/dL) * Have a platelet count of \<30 x 10\^9 cells per liter (cells/L), unless, after consultation with the sponsor, they are considered as acceptable for participation in the study * Have total serum bilirubin concentrations \>15 milligrams per deciliter (mg/dL) (\>257 micromoles per liter \[μmol/L\]) * Take medications known to interfere with hepatic metabolism (for example barbiturates or phenothiayines) or known to alter other major organ systems * Show signs of acute cholestasis or acute cholecystitis * Have severe ascites","The study is conducted in 4 groups, based on the Child-Pugh classification of hepatic impairment as follows: Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C)." NCT03656887,Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.,"Inclusion Criteria: * written consent * diabetic patient receiving treatment which could result in hypoglycemia: insulin and/or sulfonamide and/or glinides * institutionalized patient in an EHPAD * patient over 60 years of age Exclusion Criteria: \- person not affiliated to a national health insurance",N/A NCT02241993,The Multi-Sensor Distance Accuracy Study,"Inclusion Criteria: 1. Type 1 diabetes mellitus diagnosed for at least 6 months 2. Current usage of multiple daily injections or subcutaneous insulin pump treatment 3. Age 18-65 years 4. HbA1c of 6.0 - 9.5% at screening visit 5. BMI 21-35 6. Willingness to follow all study procedures, including attending all clinic visits 7. Willingness to sign informed consent and HIPAA documents Exclusion Criteria: Subjects presenting with any of the following will not be included in the study. 1. Pregnancy or Lactation: for women of childbearing potential there is a requirement for a negative urine pregnancy test. 2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less the 3.3 g/dL; or serum bilirubin of over 2. 3. Hematocrit of less than or equal to 34%. 4. Congestive heart failure, NYHA class III or IV. 5. Visual impairment preventing reading of glucose meter values. 6. Active coronary artery disease as manifested by unstable angina, or a myocardial infarction or therapeutic coronary percutaneous procedure (e.g., PTCA, stent placement) or CABG within the past 4 months. 7. Active foot ulceration. 8. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication. 9. Cerebrovascular accident within the past 6 months. 10. Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator). 11. Active malignancy, except basal cell or squamous cell skin cancers. 12. Major surgical operation within 30 days prior to screening. 13. Seizure disorder (epilepsy). 14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. 15. Currently administration of oral or parenteral corticosteroids. 16. Use of an investigational drug within 30 days prior to screening. 17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.","An artificial pancreas system will likely require multiple glucose sensing elements to function safely. It is not yet known how close two glucose sensors can be placed and still work properly. Meaning, if one is reading inaccurately,and the other is positioned adjacent to it, will it read inaccurately also, defeating the purpose of having two sensors. Twenty adult subjects with Type 1 diabetes will wear four Medtronic REAL-Time glucose sensors during two separate 10-hour studies. The inter-sensor distances of each pair to be tested will be: 2, 10, 20, and 30mm apart. The sensors will be inserted the day prior to the study day to allow for signal stabilization and calibration. During the study day, arterialized venous blood will be drawn every 15 minutes to measure blood glucose. The sensor values and interstitial values will be recorded from each sensor receiver at each time point. Subjects will be fed two standardized meals and given pre-meal insulin based on their typical insulin to carbohydrate ratio." NCT05698693,Social Determinants of Sleep and Obesity,"Inclusion Criteria: * Not meeting Physical Activity Guidelines * age range: 21 to 65 years * body mass index range: 25.0 to 40 kg/m2 * average self-reported habitual sleep duration of ≤6 hours * self-identify as Black or African American. Exclusion Criteria: * Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder) * pregnant or less than 4 months postpartum * infant living in household less than 1 year old",N/A NCT05842993,Study of Hydrogen Inhalation Compared With Placebo in Type 2 Diabetes Patients,"Inclusion Criteria: 1. Aged 18-75 years old and gender of both sex; 2. Body mass index 18.5kg/m2 to 40 kg/m2; 3. Diagnosed as type 2 diabetes according to the diagnostic criteria of type 2 diabetes established by WHO in 1999; 4. Patients with type 2 diabetes whose blood glucose is not well controlled after diet control and exercise therapy for more than 3 months; 5. HbA1c 7% to 10%, and fasting venous plasma glucose ≤ 15 mmol/L; 6. Be able to understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent. Exclusion Criteria: 1. Type 1 diabetes, gestational diabetes, or other specific types of diabetes; 2. Screening for having received anti-diabetic drug therapy within 3 months or receiving continuous anti-diabetic drug therapy at any time before screening for more than 3 months; 3. History of diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome, lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy; 4. Hyperlipidemia patients with irregular or unstable dose of lipid-lowering drugs 5. Chronic gastrointestinal disorders with obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, hypercortisolism, acromegaly, etc.; 6. Patients with diseases that may worsen due to intestinal flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal surgery and intestinal ulcers); 7. Had transient ischemic attack, cerebrovascular accident or unstable angina in the past 6 months; History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery; Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG; 8. Subjects (taking or not taking antihypertensive drugs) had poor blood pressure control (SBP ≥ 160mmhg, or DBP ≥ 100mmhg); 9. liver disease, ALT or AST \> 2 ULN, or TBIL \> 2 ULN, and the diagnosis was confirmed within one week; 10. Patients with renal function impairment (Cr \> 1 ULN or Ccr \< 60ml / min) and confirmed by reexamination within one week; 11. Had malignancy in the past 5 years, not including basal cell carcinoma; 12. History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.); 13. Combined use of drugs that affect glucose metabolism, such as glucocorticoids; 14. Combined use of Chinese herbal medicine with the effect of regulating blood glucose within 3 months; 15. Those who have serious diseases and may be in danger of life during treatment and follow-up; 16. Mental and neurological disorders, unable to correctly express their wishes; 17. Alcoholics and drug abusers and addicts; 18. Women of childbearing age are pregnant, breastfeeding, have pregnancy intentions or have a positive pregnancy test (urine HCG or blood HCG), and should not take effective contraceptive measures during the trial (effective contraceptive measures include sterilization, intrauterine device, oral contraceptive or diaphragm method prescribed by local law); 19. Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months; 20. Patients with other diseases that the researchers believe will not be able to evaluate or are unlikely to complete the expected course of treatment and follow-up.","The objective of the study is to evaluate the efficacy and safety of hydrogen inhalation compared with placebo in patients with type 2 diabetes mellitus after 12-week treatment in a randomized, double-blind, placebo-controlled design." NCT00967993,Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease,"Inclusion Criteria: 1. Males and non-pregnant, non-lactating females 2. Age \> 18 years 3. On thrice weekly hemodialysis for at least the previous three months prior to screening 4. Serum phosphorus levels ≥ 2.5 mg/dL and \< 8.5 mg/dL at Screening Visit (Visit 0) 5. Serum phosphorus levels \> 5.5 mg/dL at Study Drug Initiation Visit (Visit 3) 6. Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening 7. Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50% 8. Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate) 9. Willing and able to give informed consent Exclusion Criteria: 1. Parathyroidectomy within six months prior to Screening Visit (Visit 0) 2. Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease 3. Serum phosphorus levels \>10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0) 4. History of multiple drug allergies 5. History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx) 6. Previous intolerance to oral ferric citrate 7. Absolute requirement for oral iron therapy 8. Absolute requirement for Vitamin C (multivitamins \[Centrum, Nephrocaps, Renaphro, etc.\] allowed) 9. Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals 10. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol 11. Inability to tolerate oral drug intake 12. Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed) 13. Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient 14. Receipt of any investigational drug within 30 days of randomization 15. Inability to cooperate with study personnel or history of noncompliance 16. Prior exposure to ferric citrate 17. Patients with hemochromatosis or Thalassemia","This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks." NCT00504816,A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers,"Inclusion Criteria: * healthy, non-smoking menstruating female age 18 to 45 years old, inclusive. * able to take a specific oral contraceptive \& KG2107494. * female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test. * female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner. Exclusion Criteria: * pregnant or a nursing female. * female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit. * Have suffered with certain infection within 4 weeks prior to the first dose of study drug",N/A NCT06687616,RCT of VR Therapy for IBS,"Inclusion Criteria: * Has been diagnosed by a physician with Rome IV IBS; all subtypes will be included * Has clinically significant abdominal pain as defined as an NIH PROMIS abdominal pain T-score ≥ 55 (0.5 standard deviation \[SD\] above the normalized population mean of 50) * Able to read/write English (SynerGI is currently only available in English) * Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to internet and email Exclusion Criteria: * Presents with a condition that interferes with VR usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions * Has cognitive impairment that would affect protocol participation * Has a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c \>=7.0, neuroendocrine tumors, microscopic colitis, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a physician believes can mimic IBS symptoms and undermine diagnostic certitude * Takes standing doses of opioid medications given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia * Previously participated in a VR clinical trial * Previously participated in talk therapy * Previously used a VR program to treat their IBS","A pilot randomized, sham-controlled clinical trial will be conducted in participants with IBS to achieve the following aims: Aim 1-collect preliminary data assessing the clinical impact of VR cognitive behavioral therapy (CBT) (SynerGI); Aim 2-establish the feasibility of using an 8-week VR CBT program among patients with IBS. The study will follow the established NIH protocol for conducting VR clinical trials, which aligns with VR-CORE clinical trial guidance. Participants will be randomized in a 1:1 ratio between two arms : (i) immersive VR CBT Program (SynerGI); and (ii) sham VR. As a pilot randomized controlled trial, it will not be powered for hypothesis testing of clinical outcomes . Instead, the focus will be on determining the plausibility and feasibility of SynerGI, with the aim to recruit 30 fully analyzable patients per arm. Patients will be randomized 1:1 to each study arm . Block randomization will be implemented, using random permuted block sizes of 6, 8, or 10, allowing for up to 15% additional participants beyond the original sample size to account for dropouts. Randomization will also be stratified by sex to ensure a balance of women and men in each arm. Assessments will take place at baseline, midway through therapy at 4 weeks, and after completing the program at 8 weeks (a standard treatment length for VR trials)." NCT04601116,The MASTER Study (MAmmary Cancer STatin ER Positive Study),"Patients must meet ALL of the following criteria to be eligible for randomization: Inclusion Criteria: 1. Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy. 2. Age \> 18 years. 3. Performance status of ECOG ≤ 2. 4. Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Patients meeting ANY one of the following criteria are not eligible: Exclusion Criteria: 1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma. 2. Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm. 3. Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range). 4. Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle - or liver disease, or excessive alcohol consumption AND creatine kinase (CK) measured to less than five times the upper limit (CK only measured in case of predisposing factors). 5. No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol. 6. Pregnancy or breast-feeding. 7. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial. 8. History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.","Cholesterol-lowering drugs such as statins are currently used to lower cholesterol levels and prevent cardiovascular events. Statins have, however, received substantial scientific attention as cancer-inhibiting drugs. Previous findings were recently supported in a large-scaled study again demonstrating the beneficial effects of statins on breast cancer outcome this time nested within a large, international, randomized clinical trial of modern adjuvant cancer therapy. Given the compelling evidence supporting a protective effect of statins on breast cancer recurrence, calls for prospective clinical trials have been expressed. In this trial - the MASTER trial - we hypothesize that the addition of statin treatment to the current breast cancer treatment will improve the prognosis of women with early breast cancer. Thus, the primary objective of the MASTER trial is to determine the clinical efficacy of the statin - atorvastatin - as measured by invasive disease-free survival among patients with primary breast cancer. The trial is nationwide throughout Denmark and a total of 3,360 women are to be included in the trial. Women eligible for the trial have been diagnosed with an estrogen receptor positive breast cancer and are candidates for systemic cancer therapy, either prior to or following breast surgery. Upon eligibility and signed informed consent, trial participants will be randomized in a 1:1 manner to either standard treatment and atorvastatin 80 mg/day or standard treatment and placebo. The randomization is blinded. The treatment with atorvastatin or placebo will continue for two years unless side effects are experienced and further treatment with atorvastatin or the placebo is deemed inadequate. The standard treatment will of course continue as planned. The trial participants will follow the standard clinical routines in terms of follow-up and in addition they are asked to fill in questionnaires, i.e. regarding potential side effects or new events or diagnoses, up to ten years following inclusion. Potential breast cancer recurrences are hereby identified and a follow-up of at least 61/2 years will be required for the trial the demonstrate the estimated clinical difference between the randomized groups of patients." NCT05414084,Aggregate Metabolic Phenotypes for (Poly)Phenols: Development of an Oral (Poly)Phenol Challenge Test (OPCT),"Inclusion Criteria: * Adult (18-74 y) * BMI 18.5-35 kg/m\^2 Exclusion Criteria: * Past cardiovascular events and metabolic diseases including diabetes * Inflammatory bowel diseases or gastro-intestinal surgery * Renal (GFR\<60 ml/min) or hepatic diseases (liver enzymes \>2.5 fold higher) * Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism) * Mental disorders * Antibiotic therapy within the last month * Food allergies * Pregnancy or lactation",N/A NCT07238933,Neurological Events and Unforeseen Risks After Locoregional-anesthesia,"Inclusion Criteria: * Age ≥ 18 years. * Scheduled to undergo a single-shot nerve or fascial plane block. * Ability to provide written informed consent. Exclusion Criteria: * Performance of more than one single-shot nerve or fascial plane block within the same anatomical region or sensory distribution during the same procedure. * Use of continuous nerve or fascial plane catheter-based anesthesia. * Presence of a language barrier that, in the investigator's judgment, would prevent adequate follow-up.","Locoregional anesthesia is generally considered safe, but rare neurological and systemic complications have been reported. Current data on the true incidence of these complications are limited and often derived from small sample sizes or registries. The NEURAL study aims to fill this knowledge gap by prospectively collecting data on complications following single-shot nerve blocks in the upper limb, lower limb, and fascial plane. In addition to incidence, the study will investigate potential risk factors for these complications." NCT01941238,Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection,"Inclusion Criteria: 1. DM type 1 2. Age ≥14 years 3. Patients on insulin pump (more than 3 months) 4. Patients on MDI (glargine or detemir combined with aspart or lispro) regimen 5. Diagnosis of type 1 DM of more than 6 months. 6. Willing to do Self Monitoring Blood Sugar (SMBG) 7. Have no other contraindication to fast Exclusion Criteria: 1. Patient with renal or hepatic impairment 2. Patient with diagnosed adrenal insufficiency 3. Pregnancy 4. Alcoholism 5. Any diagnosed psychiatric disease 6. Can not do SMBG",N/A NCT05819138,Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes,"Inclusion Criteria: * Age 18-49 years * 1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis * Insulin pump or automated insulin delivery systems * Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2 * Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics) * BMI 20-45 kg/m2 * Adequate contraceptive method for females Exclusion Criteria: * HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization * Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy * History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis * Current/planned pregnancy or nursing * Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy) * Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months * Use of atypical antipsychotics * Significant systemic illness such as cancer * Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure) * MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy",N/A NCT00516958,Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections,"Inclusion Criteria: * A patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Males and females \> 18 years of age with diabetes mellitus (type 1 or type 2, controlled). 2. Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B. 3. Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy. 4. Foot ulcers located in the plantar, dorsal or malleolar areas. 5. Ulcers 1- 9 cm2 in size. 6. An accessible infection site for culture. 7. ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg. 8. Palpable pulse on the study foot (either dorsalis or posterior tibial artery). 9. Willing and able to give informed consent. 10. Willing to comply with the requirements for participation in the study. Exclusion Criteria: Patients are excluded if they meet any of the following criteria at the time of randomization: 1. Previous antibiotic treatment received for more than 24 hours within 72 hours of study. 2. Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns. 3. Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis). 4. The patient´s ulcer is located on the stump of an amputated extremity. 5. The patient's ulcer is due to a non-diabetic etiology. 6. Infections complicated by the presence of prosthetic materials. 7. Osteomyelitis 8. Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding. 9. Known to have liver disease, with total bilirubin \> 5 times the Upper Limit of Normal (ULN); known to have neutropenia (absolute neutrophil count \<500 cells/mm3). 10. Hypersensitivity to chlorine or quinolones. 11. Need for any additional concomitant systemic antibacterial agent other than the study drug(s). 12. Concomitant glucocorticoid doses (\> 5mg prednisone a day or equivalent). 13. Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders. 14. A history of diseases of immune function (HIV, chronic granulomatous disease). 15. Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day. 16. Has received an investigational agent ≤1 month prior to the baseline evaluation.",N/A NCT01599143,Identifying Therapeutic Factors in an 8-Week (30 Hour) Mindfulness-Based Stress Reduction (MBSR) Program,"Inclusion Criteria: * over 18 years old * suffer from a chronic health problem * referred by their physician Exclusion Criteria: * acute illness (physical or psychiatric) * suicidal * problem use of alcohol or other substances * inability to do one hour of daily homework * inability to attend all 8 sessions",As above NCT07436585,CGM-Guided Acarbose for Painful Diabetic Neuropathy,"Inclusion: * Age 18-75 years. * Type 2 diabetes ≥1 year; HbA1c 7.0-10.0% within 8 weeks of randomization. * Painful DPN meeting clinical criteria; average daily pain NRS ≥4 during run-in. * High CGM variability on 7-10 day run-in (e.g., MAGE \>50 mg/dL). * Stable analgesic regimen ≥4 weeks pre-baseline. * Able to use CGM and ePRO; provides informed consent. Exclusion: * Type 1 diabetes; non-diabetic neuropathies. * Contraindications to acarbose (e.g., chronic intestinal malabsorption, inflammatory bowel disease). * eGFR \<45 mL/min/1.73 m²; significant hepatic disease (ALT/AST \>3× ULN). * Use of α-glucosidase inhibitors within 3 months. * Recent change (\<3 months) in GLP-1/GIP agonists, SGLT2i, or basal/bolus insulin strategy. * Pregnancy/lactation; other conditions compromising safety/assessments.","Adults with T2D, painful DPN, and high CGM variability (e.g., MAGE \>50 mg/dL on run-in) are randomized 1:1 to acarbose vs matching placebo for 4 weeks, on stable background analgesics. A standardized pharmacist-led algorithm escalates acarbose to target post-prandial spikes, guided by blinded CGM trend review. The primary endpoint is 4-week daily pain AUC captured via ePRO. Key secondary endpoints include changes in MAGE and time-in-range (TIR), skin microvascular reactivity (laser speckle), serum IL-6, patient global impression of change, rescue-analgesic use, and adverse events. Implementation outcomes (acceptability, feasibility, adoption, cost) are collected to inform scale-up in HIC and LMIC community settings." NCT06596863,Serum Uromodulin and DN Systematic Review and Meta Analysis,"Inclusion Criteria: * Studies were included if they met the following criteria: 1. serum level of uromodulin was determined; 2. the samples were enrolled from diabetic patients; 3. mean ± SD was reported for uromodulin between patients with and without DN; 4. the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN was determined Exclusion Criteria: * Studies were excluded according to the following criteria: 1. duplicate studies; 2. review articles; 3. non original research articles; 4. studies with insufficient data to extract; 5. non-human research; 6. studies that determined urine level of uromodulin.",N/A NCT01771887,"Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion","Inclusion Criteria: * 18 years and over, * Suffering from type 2 diabetes for at least one year, * Lebanese speak, read and write Arabic, * Have an HbA1c ≥ 7% Exclusion Criteria: * mental impairment * a psychological problem uncontrolled and medicated","1. Following the implementation of a program of education, feeling of self-efficacy participants will be higher in the experimental group than in the control group. 2. Following the implementation of a program of education, self-management behaviors: monitoring the diet, the practice of physical exercise, self-monitoring blood sugar, taking medications and care feet, participants will be higher in the experimental group than in the control group. 3. Following the implementation of a program of education, the percentage of participants who have an HbA1c less than 7 will be higher in the experimental group than in the control group." NCT00642421,Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients,"To be eligible for entry in this study, patient must: * Be greater than or equal to 18 years of age. * Have a confirmed diagnosis of acromegaly based on the following criteria: 1. Typical clinical features and 2. Mean GH concentration \> 1.0 ng/mL following an oral glucose tolerance test (OGTT) and 3. Elevated serum IGF-1 levels above gender- and age- matched values. * Fall into one of the following categories: 1. Has been treated for at least the last 12 weeks with Sandostatin LAR® 10 mg or 20 mg, every 28 days with well-controlled symptoms of acromegaly and GH concentration \< 2.5 ng/mL at screening or 2. Be naïve to prolonged release octreotide with a demonstrated tolerance response to a 7-day administration of Sandostatin® immediate release (50 µg s.c. t.i.d.) or 3. If previously treated with prolonged release octreotide, has stopped such treatment for at least 12 weeks prior to screening. * If female and of childbearing potential, must have a negative pregnancy test at screening and be using adequate means of birth control (i.e., oral or trans-dermal contraceptive drugs, intra-uterine device, diaphragm) during the study. * Have the ability to understand the requirements of the study, provide written informed consent to participate in this study and agree to abide by the study restrictions. Exclusion Criteria To be eligible for entry in this study, patient must NOT: * If female, be pregnant or lactating. * Have been treated with a GH receptor antagonist (pegvisomant) within the last 12 weeks. * Have used a dopamine agonist within the last 30 days. * Have undergone pituitary surgery within the last 12 weeks. * Have undergone radiotherapy within the last two years. * Have any contraindication (hypersensitivity to octreotide formulation) or non-responders to Sandostatin-LAR® treatment. * Be currently treated with Sandostatin-LAR® and have symptoms of acromegaly that would justify, in the Investigator's opinion, a dose modification. * Be receiving Sandostatin-LAR® administration every \< 21 or \> 35 days. * Have a liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or has persistent ALT, AST \> 2 X ULN, serum creatinine \> 2 X ULN, serum bilirubin \> 2 X ULN. * Have any other conditions that could result in altered GH or IGF-1 levels (such as anorexia nervosa, Laron's syndrome, treatment with levodopa or narcotics analgesics, heroin abuse.) * Have type I diabetes (insulin-dependent) or uncontrolled type II diabetes (non-insulin-dependent) as indicated by the presence of ketoacidosis or HbA1C greater than or equal to 10%. * Have clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator. * Have symptomatic cholelithiasis. * Have received an investigational drug or participated in a clinical trial within the last 30 days. * Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.",N/A NCT06813014,Pharmacogenetics of Response to Sitagliptin (PRS),"Inclusion Criteria: * • Age: \>18 years old * Members of Old Order Amish community in Lancaster, PA Exclusion Criteria: * • Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug) * Diabetes: HbA1c \> 6.5% or fasting plasma glucose \>126 mg/dL * Estimated glomerular filtration rates (eGFR) \<60 mL/min/1.73 m2 * Anemia: hematocrit \< 35% * Thyroid status: TSH\<0.4 or TSH\>5.5 * ALT or AST in excess of 2X upper limit of normal * Drugs that in the physician's judgment would alter response to sitagliptin * Significant health issues that in the physician's judgment could increase the risk for participants.",N/A NCT06622616,NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION.,"Inclusion Criteria: * Men and women between 18 and 65 years of age. * Adequate cultural level and understanding of the clinical study. * Agree to participate voluntarily in the study and give their informed consent in writing. Exclusion Criteria: * Subjects with dementia, mental illness or decreased cognitive function that prevents understanding of the study. * Subjects with celiac disease or serious diseases (tumour, immunological, intestinal, metabolic, cardiovascular processes, etc.). * BMI \< 18 or ≥ 35. * Pregnant or breastfeeding women. * Being a socially vulnerable person. * Subjects whit chronic pharmacological treatment for weight loss, insulin or antibiotic treatment in the month prior to the start of the intervention or during it. * Subjects with food allergies, especially to mollusks and their by-products, dust mites, chickpeas or soy (the product may contain traces of soy and gluten). * Subjects who refuse to be monitored by sensors, collect samples, draw blood and nutritional visits. * Subjects who reject the consumption of products made with alternative proteins (insect powder).","In visit 1 (basal visit), the participant will provide a stool sample (for microbiota analysis), a fasting blood sample (for biochemical, genetic, epigenetic and metabolomic analysis) and then go to the nutrition consultation where medical history data and lifestyle habits will be collected, a nutritional assessment will be made and the completed questionnaires will be corrected. In addition, they will be provided with continuous glucose monitoring sensors and an activity wristband to record lifestyle patterns. The glucose sensors will be used for the first 14 and last 14 days of the intervention. In addition, all participants will be provided with the required amount of product until the next visit, as well as how to consume, store, and ideas for consumption. In addition, a balanced (normoprotein) and varied diet and physical activity guidelines will be explained. In the second visit (final), the participant will again submit a stool sample (for microbiota analysis), a fasting blood sample will be taken (for biochemical, epigenetic and metabolomic analysis) and then they will go to the nutrition clinic where a nutritional assessment will be made and the completed questionnaires will be corrected. In addition, the glucose sensor and the activity bracelet will be removed. During the intervention phase of the study, participants will be able to come to the center for the collection of more product as well as for the review and troubleshooting of any problems with the sensors that may arise. In turn, halfway through the study (6 weeks), a telephone survey will be conducted to participants to avoid travel, in order to assess the degree of adherence and possible adverse effects." NCT06670833,Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP,"Inclusion Criteria: * Cough OR Difficulty Breathing AND, * One of the below: Fast breathing (tachypnoea) \> 50/minute (2-12 months) \> 40/minute (1-\<5 years) \> 25/minute (5-12 years) OR Lower chest wall indrawing Exclusion Criteria: * Presenting for repeat visit/follow-up of a treated lower respiratory tract infection (index illness / non-acute) or enrolled in the study within the preceding 28 days. * Received antibiotic treatment for more than 48 hours at the time of enrolment. * WHO IMCI danger signs (inability to drink/breastfeed, vomiting everything, convulsions with this illness, lethargy/unconscious). * Presence of jaundice. * Hypoxaemia with oxygen saturation (SpO2) \<88% * Oxygen saturation (SpO2) \<90% (or country-specific / altitude-adjusted thresholds) i) With signs of severe respiratory distress (such as nasal flaring, grunting, etc.) OR ii) In children \< 6 months * Requiring non-invasive ventilatory support (i.e., high-flow, bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP)) * Underlying disease associated with increased risk of severe pneumonia or pneumonia of unusual aetiology (e.g., WHO acute malnutrition requiring antibiotics as per local guidelines, severe immunodeficiency) * HIV positive participant that is either i) less than 12 months old; OR ii) requires admission for this illness; OR iii) known to be uncontrolled on treatment (with a documented VL \>1000c/ml in the previous 6 months) * Caregiver unavailable at the time of enrolment, or unwilling, to provide informed consent.","In 2019, lower respiratory tract infections (LRTI) caused 2.6 million deaths worldwide, making them the fourth leading cause of death overall. While the statistic is global the effect is concentrated in low-resource settings and among children, with pneumonia being the single largest infectious cause of death in children worldwide. LRTI (including pneumonia) are the most common reason for sick children to present for acute outpatient care and current best practice pneumonia management guidelines advocate for all cases to receive a course of antibiotics. This relies on the World Health Organization's (WHO) Integrated Management of Childhood Infections (IMCI) guidelines, first developed in the 1990s - a time when providing access to antibiotics was a major goal for public health programs. Today, antibiotics are readily available in most countries in sub-Saharan Africa (SSA) and antibiotic over-prescription has become a public health crisis. The IMCI guidelines were re-iterated in 2014 but still rely on presumptive treatment based on clinical signs alone (cough, respiratory rate, and lower costal indrawing), as evidence to include additional diagnostic tests into the IMCI approach has been lacking. However clinical features inadequately distinguish bacterial infections and complications from common, self-limiting viral infections. Furthermore, recent evidence estimates the incidence of bacterial respiratory infections in SSA, using a combination of microbiology, chest x-ray (CXR), and clinical outcomes as reference standards, is as low as 2-4% in primary, and 23.3-31.6% in secondary, care. Therefore, approximately 9 out of 10 courses of antibiotics recommended by current guidelines for children with LRTI are estimated to be unnecessary. Bacterial antimicrobial resistance (AMR), responsible for 1.27 million deaths in 2019 and with the highest burden in SSA, is thus of increasing concern; with nearly as many deaths as malaria and HIV combined. Inappropriately and excessively prescribing antibiotics represents one primary contributor of bacterial AMR. In SSA, more than 50% of children who are sick receive antibiotics when visiting health facilities with 80-90% of such antibiotics prescribed at the outpatient level and most deemed inappropriate. Most inappropriate antibiotic use occurs with respiratory infections due to systematic overprescription as outlined above. Antibiotic use and AMR are projected to increase over the next years, indicating urgent action. Accordingly, WHO declared AMR as ""one of the biggest threats to global health, food security and development today."". Effective solutions to improve antibiotic stewardship for childhood infections in SSA primary care settings remain lacking, though its well recognized improved diagnostic and management processes are essential. Lacking more effective tools to safely identify the minority of children requiring antibiotics, frontline clinicians in low resource settings therefore prescribe antibiotics to nearly every child, driving the above-described overuse and fuelling local AMR, whilst significantly overtreating cases of viral pneumonia. Besides the risk of AMR at the population level, reducing antibiotic prescriptions is also important for each individual patient. Antibiotic exposure early in life has been associated with an increased risk of health conditions, including asthma, allergic rhinitis, atopic dermatitis, autoimmune disease, obesity, and neurodevelopmental disorders. Improving IMCI diagnostic criteria to better identify children with pneumonia that would benefit from antibiotic therapy is therefore a WHO research priority. Several tools have since been proposed (currently at different stages of diagnostic development) to both improve diagnostic pathways and improve appropriateness of antimicrobial prescriptions in low and middle income countries. These include the use of point of care C-reactive Protein (CRP), Procalcitonin (PCT), comprehensive electronic decision support algorithms, and more novel applications of established technologies. Two such technologies are Lung Ultrasound (LUS) and Lung Auscultation (LAusc). LUS is a well-established, near consumable-free, and non-invasive point-of-care respiratory exam. While LUS is less ubiquitous than the stethoscope, it's new portable and affordable ultrasound-on-a-chip design, pluggable into a mobile device, has the potential to be integrated into the standard clinical exam without incurring extra costs, time, radiation, or specialist consultation. These portable ultrasound devices have reached regulatory approval and are used in medical care across SSA. This together with increasing evidence showing its ability to effectively detect lung consolidation in pneumonia have made it an increasingly attractive tool for frontline clinicians; already becoming an established practice in the outpatient case management of children with respiratory infections in many high-resource settings as well as growing steadily in popularity in SSA. A number of studies have compared LUS to CXR and/or Computerised tomography (CT) for pneumonia diagnosis. A multi-centre trial in Europe including 362 adult patients with pneumonia compared LUS performed by a specialist to a diagnosis of pneumonia made by CXR and in some cases CT. The authors reported a sensitivity of 93.4% (95% Confidence Interval (CI) 89.2-96.3%) and a specificity of 97.7% (95%CI 89.2-99.6%). Most studies in children (performed primarily in high-income countries and tertiary care settings) have found high diagnostic accuracy when comparing LUS to CXR, using either CXR, CT, or Magnetic Resonance Imaging (MRI) as reference standards, with a recent meta-analysis suggesting an overall sensitivity of 95% (91-97%) and specificity of 96% (90-99%). A smaller number of studies have investigated using LUS to assist in determining the etiological causes of the consolidations. Although these have shown a possibility of differentiating viral from bacterial infections, the reference standards used were nasopharyngeal swab carriage, clinical syndromes, and other clinically available data. A notable limitation of this study was therefore the lack of a microbiologically confirmed diagnosis, making it hard to make definitive statements about the ability of LUS to differentiate. This lack of reliable reference standards in paediatric pneumonia is a well-documented challenge, most notably discussed in the Pneumonia Etiology Research for Child Health (PERCH) study, and thus limits the value of etiology focused diagnostic accuracy studies. Although the first studies on the use of LUS to detect lung consolidation in children in LMICs are promising, as seen in Nepal, Peru, and Egypt, they remain limited in scope and context, with no evidence on the clinical impact of LUS assisted diagnoses on antimicrobial use or health outcomes, particularly in a primary care setting. This highlights the importance of the assessment of LUS integrated into care to assess for real changes in treatment outcomes through an interventional study, rather than observational diagnostic accuracy studies. Studies assessing the potential of LUS in the diagnosis of pulmonary tuberculosis (TB) in children are equally limited. With paediatric TB diagnosis remaining a huge challenge in low resource settings, many cases still remain undiagnosed and untreated - an issue being addressed though the development of pragmatic TB Treatment Decision Algorithms for settings with and without CXR. These Treatment Decision Algorithms are now included in the operational handbook accompanying the WHO guidelines on the management of TB in children and adolescents. More evidence is however needed on the potential role of LUS as an alternative diagnostic modality in the context of these TB Treatment Decision Algorithms. Regarding operability of LUS in SSA by novice health workers, LUS performance evidence shows it is possible to capture images/video with minimal training and achieve high diagnostic quality, as evidenced in both South Sudan and Bangladesh, though concerns remain regarding diagnostic quality outside research settings. Image acquisition aside, interpretation and inter-user bias remain the largest concern, this however makes them excellent candidates for automated interpretation by objective computer-aided pattern detection. Using deep learning our collaborating team at École polytechnique fédérale de Lausanne (EPFL) have found excellent preliminary results in Swiss cohorts, matching and out-performing expert evaluation for risk stratification (Area Under the Receiver Operating characteristic Curve (AUROC) \>80%) and diagnosis (AUROC \>90%) of COVID-19 pneumonia (unpublished data). As with LUS, LAsuc is another established tool being applied in a novel way. While evidence for the potential of LAusc for paediatric pneumonia is limited, some preliminary evidence on the predictive capacity of other respiratory sounds is emerging; for instance, the application of deep learning was able to predict diagnosis from breath and cough sounds collected on a mobile application with an AUC of around 80%. Another group achieved above 95% sensitivity and specificity on discriminating COVID-19 coughs from other pathologies as well as healthy patients. A study in South Africa included 33 culture-confirmed TB patients with healthy controls and found a diagnostic accuracy of 75%. This doesn't however speak much to the more pressing question of differentiating TB from non-TB pneumonia. While these are extremely promising results, no such trials have been performed in TB endemic areas, particularly challenging the specificity of LAusc for the detection of either pneumonia or TB. There is also as yet no regulatory approval for the use of AI powered LAusc devices in clinical practice. This study therefore seeks to enable adoption of LUS into the routine management of IMCI clinical pneumonia through addressing key evidence gaps for translation into policy and practice, which includes generating evidence on the possible impact on health outcomes, namely: Does the integration of LUS into IMCI-based management guidelines better identify those children that would most benefit from antibiotic treatment, thus reducing antibiotic overuse without compromising health outcomes? All paediatric patients (\>60 days - 12 years) presenting to the ER or Outpatients Department (OPD) in participating study sites will be triaged as per routine care. Study staff will screen all presenting patients and consecutive patient recruitment will be done for those meeting all inclusion criteria. Those showing signs of severe disease or WHO IMCI Danger signs on triage (and hence meeting exclusion criteria) will be referred immediately to the treating clinicians as per local policy. For those meeting inclusion criteria, sufficient time to read the informed consent form and make an informed decision will be given to the patients/parents/caregivers before inclusion in the study. Information covered will include the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail." NCT03140852,Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM),"Inclusion Criteria: * qualifying symptoms within last 3 months * able to speak English * lives independently Exclusion Criteria: * new treatment for target symptoms within last 3 months",N/A NCT01664247,The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification,"Inclusion Criteria: * Type 2 diabetes * Insulin naïve * Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID)) * Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID) Exclusion Criteria: * Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks * Calcitonin equal to or above 50 pg/mL * Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks * Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)",N/A NCT04810247,Targeting Body Image Among Women of Higher Body Weight,"Inclusion Criteria: * Female * BMI between 25-40 * EDE-Q weight concern subscale\>4 * EDE-Q shape concern subscale\>4.25 * Personal use of cell phone * Able to engage in moderate intensity activity * Desire for weight loss Exclusion Criteria: * No eating disorder history * Not pregnant * Not breastfeeding * No delivery within 9 months * No substance abuse disorder * No weight loss medication or history of bariatric surgery * No other weight loss program participation","Women with overweight or obesity, over the age of 25, who report high weight and shape concern and a desire to lose weight will be recruited from the community. Participants will be recruited and enrolled in cohorts of 5-10 individuals, with a focus on ensuring that each group has approximately 50% women of color (i.e., identify as non-white). Participants will attend, with all individuals in their cohort, the four weekly body project intervention sessions led by a trained facilitator. Each session is approximately 60 minutes long and relies on guided discussion and group activities to engage participants. In between group meetings, participants will be given exercises to complete prior to the next session. The intervention content will be modified prior to the first cohort in order to identify factors relevant for body image among women who would medically benefit from weight loss (e.g., internalized weight bias). The active ingredients will remain the same while modifying content and assignments or exercises to enhance effects among the target population. Participants will complete a baseline assessment of self-report surveys and a 7-day ecological momentary assessment period. All assessment procedures must be complete prior to the first group meeting. After the fourth and final group meeting, participants will complete a second assessment including self-report surveys and a 7-day EMA period. The data collected from the pre and post-assessments will be used to shape the focus group script. Within four weeks of the last group meeting, participants will attend a focus group meeting led by a facilitator who was not involved in intervention delivery to better understand the participant experience with the intervention content. Key changes may include expanding content to address contextual factors that cause negative weight/shape-related thoughts among women with overweight or obesity and to target weight stigma (internalized), modifying exercises that were reviewed negatively, and incorporating explicit discussion of weight management. Following the focus group, the intervention will be revised using the quantitative and qualitative data collected from each cohort. The process will be repeated to refine the intervention through iterative testing with small groups of individuals (n≤10). It is anticipated that approximately 4-6 groups will be required. Upon completion of all study procedures, participants will receive information and resources for healthy weight loss." NCT03074747,Comparison of Four Questionnaires for OSA Screening in China,"Inclusion Criteria: 1. Adult (18-60ys) 2. Male 3. ASA Ⅰ～Ⅲ grade 4. Applie to receive PSG monitor in sleep center 5. Plan to receive ophthalmological surgery under general anesthesia 6. To accept OSA correction surgery (UPPP) Exclusion Criteria: 1. Severe maxillofacial deformities, pharyngeal reconstruction surgery history ( velopharynoplasty, upper and lower jaw orthopedic surgery, cleft lip and palate surgery) 2. Disturbance of consciousness, no self-control ability, serious mental illness, long-term alcohol abuse, drug abuse 3. Took mental or nervous system drugs within 3 months 4. Sleep apnea caused by hypothyroidism, acromegaly, laryngeal spasm, vocal cord paralysis 5. Epilepsy, neuromuscular disease 6. central sleep apnea 7. Ventilator treatment before monitor for more than 1 month 8. Llliteracy 9. Non-Chinese",N/A NCT05926947,OXXYNEA® GS: Study for Glycaemia Management,"Inclusion Criteria: * Fasting Plasma Glucose 75 - 125 mg/dL * HbA1c: 5.-6.5 % * Both sexes * Overweight BMI range (25-30 Kg/m2) * Age: 20-50 years old Exclusion Criteria: * Metabolic/Chronical disease * Menopausal women * Being pregnant, breastfeeding or wanting to have a baby * Former obese with a history of yoyo effect * Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery * Having started or quit smoking, having a high alcohol consumption * Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months * Allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.",N/A NCT03451838,Prediction of Fetal Macrosomia by US,"Inclusion Criteria: * 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein ) Exclusion Criteria: 1. The presence of fetal congenital anomaly . 2. Multifetal pregnancy. 3. Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.) 4. Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation . 5. Patient who used cigarette or alcohol during pregnancy.","Estimated fetal body weight is needed especially when head measurement is impossible whenever the fetal head is positioned low in pelvic brim .A convenient method for estimating fetal body weight without head measurement was thus required . -The human placenta develop with the principal function of providing nutrients and oxygen to the fetus ,adequate fetal growth and subsequent normal birth weight depend on normal placenta ." NCT05361148,Long-term Health After Severe Acute Malnutrition in Children and Adults: the Role of the Pancreas,"Inclusion Criteria: * member of one of the 6 included cohorts * informed consent (for children, informed assent and consent of guardian) Exclusion Criteria: * lack of consent * pregnant women and chidlren will be excluded from CT scans and interavenous glucose tolerance tests","Prenatal growth retardation is associated with increased risk of adult chronic non-communicable diseases (NCDs) including diabetes. However, there is limited information regarding how postnatal malnutrition, in childhood or adulthood, affects these risks. The question of long-term effects of postnatal malnutrition is of increasing importance, because, with improved care, more children survive severe acute malnutrition and, amongst adults, drug treatments for infections, e.g. HIV and tuberculosis which frequently cause or are associated with malnutrition (MALN), have improved patient survival. Our project will focus on the role of the pancreas in the long-term consequences of MALN since both its endocrine and exocrine functions are critical for nutrition and NCDs. There is evidence that pancreatic functions may not recover fully after childhood or adult MALN and that the phenotype of diabetes in countries with prevalent MALN differs from that in high-income countries. Overall hypothesis: Severe malnutrition (MALN) at any age has medium- and long-term detrimental effects on endocrine and exocrine pancreatic function and structure. Study design and population: Cross-sectional observational study recruiting a total of 3700 participants from previous/ongoing observational cohorts in: Zambia (1 adult (N=300) and 1 adolescent cohort (N=180)), Tanzania (1 adult cohort (N=1400)), Philippines (2 adult cohorts N=600/N=420), India (1 adolescent low birth weight cohort N=800)) Specific objective 1: To determine if MALN earlier in life is associated with abnormalities of pancreas structure and function. Hypothesis 1: Prior MALN is associated with later abnormal pancreatic structure and endocrine and exocrine function. Approach: The investigators will follow up individuals from the above cohorts in which there are participants, all now adolescents or adults, who suffered from MALN at different stages earlier in life as well as age- and sex-matched individuals who have never been malnourished as a comparison. The researchers will assess in those with and without prior MALN: 1. blood glucose, insulin and C-peptide during an oral glucose tolerance test (OGTT) 2. haemoglobin A1c (HbA1c) 3. faecal elastase and plasma lipase as exocrine pancreas markers 4. pancreas size and architecture using ultrasound and computed tomography (CT) (subset) Specific objective 2: To investigate whether pancreatic abnormalities in participants with prior MALN and diabetes are compatible with a previously prescribed entity of fibro-calculous diabetes. Hypothesis 2: Prior MALN is associated with pancreatic calcifications and is common in those with diabetes. Approach: The investigators will conduct CT scans to investigate pancreatic calcification among non-pregnant adult study participants. Specific objective 3: To investigate the relative importance of decreased insulin production or increased insulin resistance in MALN associated with concurrent infections in African and Asian adult populations. Hypothesis 3: The abnormal glucose regulation seen after MALN and infection is associated with relative insulin deficiency with or without insulin resistance. Approach: This hypothesis will be investigated within the Tanzanian cohort and one Filipino adult cohort, both of whom had MALN associated with infection. 20 men and 20 women will be selected from each of two groups (MALN and non-MALN) in each cohort based on whether or not in our prior research they were recorded as experiencing MALN. In these participants the investigators will: 1. Measure in blood samples collected at 0, 15, 30, 45, 60, 90 and 120 minutes during an OGTT: glucose, insulin, C-peptide (all time points), the incretins gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) and glucagon at 0, 30, 60, 90 and 120 minutes, and proinsulin and trypsinogen at baseline only; 2. Conduct intravenous glucose tolerance tests (IVGTT) and measure in blood samples collected at -10, -1, 2, 4, 6, 8, 10 minutes: glucose, insulin, and C-peptide. Specific objective 4: To investigate whether a prior abnormal pro-insulin / insulin ratio is associated with diabetes in adults infected with HIV or previously with tuberculosis. Hypothesis 4: An abnormal pro-insulin/insulin ratio is associated with later development of diabetes in adults who had MALN and infection. Approach: For participants from the CICADA, Tanzania, cohort the reasearch team has fasting plasma samples stored from prior follow-ups up to 10 years earlier. Glucose has already been measured in these samples as well as insulin in some samples. The investigators will measure insulin in the remaining stored samples and proinsulin in all to investigate whether prior proinsulin / insulin ratio is associated with subsequent diabetes." NCT01021826,Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement,"Inclusion Criteria: * Diagnosis of osteoarthritis * Scheduled for primary hip or knee replacement Exclusion Criteria: * Arthritis other than osteoarthritis * Medication affecting glucose metabolism (excl. antidiabetic agents) * Not undergoing hip or knee replacement","Postoperative infections remain one of the most frequent reasons of failure of hip and knee prostheses. Diabetes increases the risk of infections. In other fields of surgery, hyperglycemia induced by surgical stress (stress/perioperative hyperglycemia) has been associated with higher rates of postoperative infections and complications. Such studies have not yet been performed in the field of joint replacement surgery. Unlike several other risk factors of infected joint replacements, hyperglycemia is potentially modifiable and therefore its prevalence, predisposing factors and association with postoperative infections are of interest." NCT06788743,"Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial","Inclusion Criteria: * Age ≥60 years * Elective surgery (with an expected duration of 2 hours or more) * ASA grade Ⅰ-Ⅲ * Voluntary participation and informed consent obtained * Diabetes mellitus Exclusion Criteria: * Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia) * Severe visual or auditory impairments, language barriers, or patients who cannot cooperate * Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse * Neurosurgical patients * Patients who are expected to require hepatic portal blockage during surgery * Patients who are expected to be transferred to ICU after surgery * Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome",N/A NCT00093015,Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT),"Inclusion Criteria: * Hemoglobin less than or equal to 11 g/dL * History of Chronic Kidney Disease * eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2 * Tsat (transferrin saturation) greater than 15% Exclusion Criteria: * Uncontrolled hypertension * Erythropoietic protein use within 12 weeks of randomization",N/A NCT00808535,Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction,"Inclusion Criteria: * Age 18 to 50 years * Should be able to sign an informed consent and HIPAA Agreement * 30 healthy, non-diabetic individuals * 30 diabetic individuals without documented coronary artery disease * Diagnosed diabetics less than 5 years * HbA1c less than 8.0 Exclusion Criteria: * Children under 18 years and adults above 50 years * Type 1 DM * Lactating and Pregnant females * BMI less than 35 * Contraindication to MRI such as pacemaker, defibrillator implants, etc. * Allergy to MR (paramagnetic) contrast * History of Angina, MI, or documented Coronary Artery Disease * Previous history of CHF, CABG, Angioplasty and Stenting * History of Valvular Heart Disease and Congenital Heart Disease * History of Peripheral Vascular Disease * History of Cardiac Arrythmias and anti-coagulation therapy * History of Cerebro-vascular accidents or TIA * History of active diabetic retinopathy and nephropathy * Uncontrolled hypertension (systolic \> 170 and diastolic \>100 mm Hg * End Stage Renal Disease and patients on dialysis * HbA1c of 8.0 * Creatinine greater than 1.7 mg/dl * History of active gastrointestinal bleeding * History of IV drug use * Chronic or current steroid treatment * Growth hormone treatment",N/A NCT03993132,A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA) in the Occurrence of Serious Cardiovascular Outcomes,"Inclusion Criteria: The empagliflozin-exposed population must also meet the following criteria: * Have at least one prescription for empagliflozin or fixed-dose combination of empagliflozin with another drug, with or without treatment with another glucose-lowering drug * Have no prescription/dispensing of SGLT2 inhibitors (including empagliflozin) alone or in fixed-dose combination prior to the index date * Have no prescription/dispensing of a GLP-1 receptor agonist alone or in fixed dose combination prior to the index date The population exposed to GLP1-RA must meet the following criteria: * Have at least one prescription for GLP1-RA or a fixed-dose combination of GLP1-RA with another drug, with or without treatment with another glucose-lowering drug. * Have no prescription/dispensing of a GLP-1 receptor agonist alone or in fixed dose combination prior to the index date * Have no prescription/dispensing of SGLT2 inhibitors (including empagliflozin) alone or in fixed-dose combination prior to the index date Exclusion Criteria: -Patients with type 1 diabetes T1D before the index date will not be included in the study. Exclusion criteria by outcome of interest: Different exclusion criteria will be applied to generate sets of cohorts for the analysis of the different outcomes of interest. In one main analysis, we will assess co-primary and secondary outcomes among all patients, regardless of a history of previous outcome events being present or not. In other words, we will allow a previous history of CVD events. We will adjust for the history of these events in the regression model rather than excluding patients with previous events (e.g. assess outcome rates of myocardial infarction in empagliflozine and liraglutide initiators while adjusting for previous history of myocardial infarction, unstable angina, or coronary revascularization). In another main analysis of outcomes, we will exclude patients who had a specific outcome previously. For example in the analysis of the primary heart failure outcome (heart failure admission or loop-diuretics), patients will not be included if a diagnosis of heart failure is recorded any time before or at the index date, or if a prescription for loop-diuretics has been filled within 12 months before or at the index date. For the secondary outcome of acute hospital admission with heart failure, we will include also patients with previous prescription for loop-diuretics, but exclude those with previous heart failure admission. For analysis of stroke, patients will not be included if a diagnosis of stroke is recorded any time before or at the index date. For analysis of myocardial infarction, unstable angina, or coronary revascularization, patients will not be included if any of these 3 major atherosclerotic cardiovascular events are recorded any time before or at the index date. In additional analyses, other criteria will apply (To be discussed, RWT). Thus, an additional analysis will include also patients with previous outcome events, and adjust for the history of these events in the regression model rather than excluding them (e.g. assess outcome rates of myocardial infarction in empagliflozine and liraglutide initiators while adjusting for previous history of myocardial infarction, unstable angina, or coronary revascularization).",N/A NCT05277532,Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients,"Inclusion Criteria: * BMI 25-30 * type 1 diabetes or healthy subjects Exclusion Criteria: * nicotine usage, * cardiovascular disease (CVD), * blood pressure \>160/95, * pregnancy, * treatment with other pharmaceutical drugs than insulin, stable dose of thyroid hormone, statins, and antihypertensive drugs (excluding beta blockers). Additional exclusion criteria for diabetes subjects: * diabetes duration less than 6 months, * proliferative or severe non-proliferative retinopathy, * chronic kidney disease with glomerular filtration rate (GFR) \<60 ml/min,","High intensity interval training (HIIT) is a promising intervention for lifestyle treatment in type 1 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in regulating blood glucose values in participants with type 1 diabetes and overweigt and to compare the effect in overweight but otherwise healthy subjects. Additionally, the investigators aim to to elucidate the metabolomics in the different settings. Healthy controls will be used to compare whether the effect of HIIT and interplay with circadian rhythm on organ metabolism is impaired in patients with T1D. A randomized cross-over trial with 25 participants with type 1 diabetes and 25 control subjects will be performed. The participants will be examined on three occasions on an out-patient basis . Visit 1 aim to run baseline measurements and a bicycle test to define maximum exertion . On visit 2 the participants will perform a single bout of HIIT (6 1-minute pulses at maximal exertion, interspersed with 1-minute recovery) either in the morning (09.00) or afternoon (16.00). After a 1-week washout period, the participants will return for visit 3 and an opposing exercise time. Primarily, the efficacy of the morning and afternoon HIIT will be judged by the continuous glucose monitor (CGM) -based glycaemia measurements. Additionally, during the visits the investigators will collect repeated blood samples to assess the effect of exercise timing on the diurnal hormonal rhythms. Muscle biopsies will be collected before and directly after HIIT. The hypothesis is that afternoon HIIT will be more efficacious in controlling blood glucose based on the preliminary data gathered from a 'free living' pilot study in type 2 diabetes. The current study will aim to compare the morning and afternoon exercise in controlled conditions, eliminating the effects of dietary intake, medication and sleep cycle disruption. Additionally, the tissue factors responsible for the differing glycaemic response to morning and afternoon exercise will be elucidated." NCT00892398,Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab,"Inclusion Criteria: * to have uncontrolled glaucoma * to have accepted to undergo a primary trabeculectomy with mitomycin C * to have one of the following types of glaucoma: * Normal tension Glaucoma * Chronic Open-Angle Glaucoma * Chronic Angle-Closure Glaucoma * Mixed mechanism glaucoma * Steroid-induced Glaucoma * Neovascular Glaucoma Exclusion Criteria: * to be less than 18 years old * to be unable to observe the study protocol * to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases * a history of thromboembolic events and cerebrovascular accidents * congenital glaucoma * uveitic glaucoma * to be pregnant * to be breastfeeding * surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages * to have undergone a previous conjunctival surgery * to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging * to present an active or suspected intraocular or periocular inflammation * to have a kidney failure * to have a liver failure","Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab." NCT00675987,A Randomized Clinical Trial To Study Losartan On Endothelial Dysfunction and Insulin Resistance In Obese Patients,"Inclusion Criteria: * Currently taking 1 or no antihypertensive medication * Male and female between 18 and 75 years of age * Mean trough sitting diastolic blood pressure (SiDBP) ≥80 and \< 100 mm Hg * Mean trough sitting systolic blood pressure (SiSBP) ≥120 and \<160 mm Hg * Non-diabetic patients with fasting plasma glucose ≥100 mg/dL and \<126 mg/dL * Body mass index (BMI) \>30 and \<40 * Waist circumference \>40 inches in males, \> 35 inches in females * A patient who is of reproductive potential and agrees to remain abstinent or use acceptable methods of birth control (intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, hormonal contraception, vasectomy) within the projected duration of the study Exclusion Criteria: * Secondary hypertension of any etiology (renal artery stenosis, coarctation of the aorta or pheochromocytoma, hypertension induced by oral contraceptives) * History of malignant hypertension * Any clinically significant renal disease including single functioning kidney, and known history of anuria. Any severe renal impairment, as manifested by serum creatinine more than 1.5 mg/dL, or proteinuria \>2+ by urine dipstick * Known sensitivity or intolerance to angiotensin II receptor antagonists * Type I or II diabetes * Inability or unwillingness to abstain from taking prohibited medications during the study period * History of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), congestive heart failure (CHF), unstable angina, transient ischemic attack (TIA), or cerebrovascular accident (CVA) * Concomitant cardiac conditions that would make it unsafe to participate in the trial (e.g., clinically significant atrioventricular (AV) conduction disturbance, atrial flutter, atrial fibrillation, potentially life-threatening ventricular arrhythmias, decompensated valvular disease, presence of hemodynamically significant obstructive valvular disease, or cardiomyopathy) * History of angioedema and/or organ damage from hypertension * Serum potassium \< 3.5 or \> 5.5 mEq/L * Any clinically significant laboratory value which in the investigator's judgment could be clinically significant to the outcome of this study. * History of clinically important gastrointestinal resection or malabsorption * Patient with a history or current evident of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate. (Including but not limited to: recent or current alcoholism, drug abuse within the prior 2 years, mental or legal incapacitation, any disease which could reasonably be expected to be fatal or life-threatening, or a history of malignancy ≤ 5 years prior to signing informed consent.) * Currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent. * Inability to be taken off all current antihypertensive medication and placed on placebo for up to 12 weeks. * Unwillingness or unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. * Arm circumference great than 52 cm * Smokers or former smokers who have quite less than 1 year prior to Visit 1 * Anemia (Hemoglobin \< 11) * Allergy to latex * Deformed hands and/or fingers that would interfere with the collection of pulse volume amplitude measurements * History of Raynaud's disease or any other vascular condition * Bilateral mastectomy * Aortic stenosis * Patient is taking high doses of antioxidant supplements (vitamins, minerals, or other)",N/A NCT05790421,Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy,"Inclusion Criteria: * Participants (males and females) examined with non-insulin-dependent diabetes for ≥10 years determined by neurophysiological measurements were enrolled. * The participants regularly took their diabetes medications during the assessment and treatment period. * The use of any sedatives or anticonvulsants was contraindicated for all participants. Exclusion Criteria: • Uncontrolled non-insulin dependent diabetes and diagnosed for \< 10 years, neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.",Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy. NCT06955416,REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis,"Inclusion Criteria: * Signed Informed Consent * Male and female patients aged 18-75 years, inclusive. * Confirmed diagnosis of type 1 or type 2 diabetes mellitus * Established clinical diagnosis of DKA at the time of admission * Plasma glucose \> 13.9 mmol / l * Metabolic acidosis (venous blood pH \< 7.25) * Serum bicarbonate \< 18 mmol / l * Ketonuria ≥ ++ * Possibility of randomizing the patient within 2 hours from admission to the hospital. Exclusion Criteria: * Known hypersensitivity to any component of the study drug/standard therapy p * Blood pH ≤ 6.9 or standard bicarbonate level \<5 mmol/l * Previous use of other solutions containing reserve alkalinity carriers (acetate, lactate, malate, fumarate, etc). * Conditions requiring emergency surgical intervention * Abdominal surgeries in the last 14 days * Traumatic brain injury accompanied by cerebral edema. * Chronic treatment with steroids, atypical antipsychotics, cancer chemotherapy. * Acute kidney injury * Chronic kidney disease stage C5 * Liver injury (increase in alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels by more than 5 times the established reference values). * Acute pancreatitis * Sepsis * Severe multiple or combined trauma * History of malignancy * Clinically significant cardiovascular diseases (acute coronary syndrome; acute cerebrovascular accident (CVA) or transient ischemic attack (TIA); chronic heart failure class III - IV according to the NYHA classification; severe uncontrolled arrhythmia). * Body mass index \>=40.0 * Alcohol abuse, drug use, drug use. * Other specific types of diabetes mellitus. * Previously diagnosed mental illness * Participation in another clinical trial or the use of drugs/dietary supplements containing succinic acid less than 30 days before inclusion in this study. * Pregnancy or breastfeeding. * SARS-CoV-2 infection * Low systolic blood pressure (BP) (≤70 mmHg) upon admission to hospital or at the time of inclusion in the study. * Contraindications to the infusion of REAMBERIN of 0.9% sodium chloride solution.",N/A NCT05407233,Reusing Needles for Subcutaneous Insulin Injection in Patients With Type 2 Diabetes,"Inclusion Criteria: * Patients with T2DM * Over 18 years of age * Reuses each syringe at least three times for insulin application. Exclusion Criteria: * Use of insulin pens * Pregnant women * Patients undergoing chemotherapy * Use of anticoagulants * Clotting disorders, lesions or skin changes","Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease with increasing incidence worldwide. It is well demonstrated in the literature that adequate glycemic control can reduce the incidence of chronic complications. The Brazilian Ministry of Health must provide patients with diabetes with the necessary resources for optimal glycemic control. However, this supply is often not enough and the population ends up reusing needles and lancets. According to the Brazilian National Health Surveillance Agency (ANVISA) and the manufacturers, it is recommended to use the needle for insulin application only once, but a report from the Brazilian Society of Diabetes shows that half of the patients disregard this rule - some reuse each needle up to five times. Studies show that patients do not like carrying extra needles when they are away from home, are reluctant to carry containers to dispose used needles, and decide that it is not worthwhile worth buying a new needle for each injection. Others describe that injections from reused needles are not noticeably more painful as long as they do not reuse them excessively. Finally, some patients believe that disposing of a needle after use is ecologically wasteful because metal and plastic must be incinerated. A randomized clinical trial will be carried out to compare the reuse or not of needles in patients with diabetes who use insulin. Primary outcomes as skin complications, local pain, glycemic control will be evaluated at baseline and after 4, 8 and 12 weeks and secondary outcomes will also be evaluated as quality of life, insulin application technique, frequency of capillary blood glucose tests, adherence to treatment, quality of needles, microbiological contamination and cost-utility analysis of after needle reuse." NCT00178633,"Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery","Inclusion Criteria: * The subjects in this study will represent both male and female patients with clinically severe obesity (BMI \> 40kg/m2 or 35kg/m2 with significant obesity related co-morbidities), who have chosen to undergo elective bariatric surgery. Patients are screened through the University of Texas Houston Bariatric Surgery Center (UTHBSC) and are evaluated for bariatric surgery, defined in this study as small pouch gastric bypass with Roux-en-Y (SPGB), or laparoscopic adjustable gastric banding (LAGB). Adults (\>18)from diverse ethnic backgrounds, with clinically severe obesity, are eligible to be evaluated for bariatric weight loss surgery in the UTHBSC. Candidates considered for the study are patients who not only fulfill the criteria for weight loss surgery, but also demonstrate a high likelihood of complying with the long-term follow-up that is required for a successful study. Patients who have components of the metabolic syndrome (hypertension, diabetes, and dyslipidemia) will be included if these complications do not preclude a safe operation. . Exclusion Criteria: Exclusion criteria include age over 70 years, current history of smoking, coronary artery disease, congestive heart failure, ischemic cardiomyopathy, known peripheral vascular disease, severe psychiatric disease, any medical problem or physical contraindication for surgery (as determined by the physician) and pregnancy. This study will be limited to adults since the safety of gastric bypass surgery has not been shown to be safe in children in large clinical trials \-",N/A NCT06147752,Mobile Internet Healthcare and Three Disciplines Co-management Intervention for Overweight/Obese Prediabetic Patients,"Inclusion Criteria: ①18 years≤ Age\<70 years * 5.7mmol/L≤ fasting blood glucose \<6.9mmol/L * 7.8mmol/L≤2h blood glucose \<11.0mmol/L; * 24Kg/m2≤BMI≤45Kg/m2 Exclusion Criteria: * Diagnosed diabetes * In the past 3 months, metformin, thiazolidinedione, acarbose and weight reduction drugs were used * Severe infection, severe trauma or other stress * The weight fluctuation in the past 3 months was \>5% * Aspartate Transaminase(AST) or Alanine Aminotransferase（ALT） increased the upper limit of 3 times the normal value; Creatinine greater than 1.5 times the upper limit of normal; Estimated Glomerular Filtration Rate（eGFR） 30 ml/min / 1.73 m2 or less * Serious cardiovascular and cerebrovascular disease in the past 6 months * Abnormal thyroid function not controlled; * Pregnant and breastfeeding women","Sample size estimation The sample size was calculated based on the primary clinical endpoint and previous relevant clinical studies, which met 90% detection efficacy, with an a-value of 0.05 on both sides and a follow-up rate of more than 80%. 100 overweight/obese prediabetic patients were enrolled in the Department of Endocrinology and Diabetes The First Affiliated Hospital of Xiamen University. Recruitment: The researcher informs the patient about the study; If patients agree to participate in the study, they will need to sign an informed consent form with their doctor. The study doctor will ask and record the medical history, do physical examination, such as measuring height, weight, waist circumference, blood pressure, laboratory tests, finally determine the enrollment conditions and complete the randomized grouping. A total of 140 participants were recruited, 100 participants were finally enrolled and randomly divided into control group and intervention group according to 1:1. Management mode: Informed consent was signed at the first admission, and the researcher and patients were fully communicated, so that patients could realize the importance of out-of-hospital lifestyle management in reversing prediabetes. Dietitians provide detailed one-to-one guidance to each patient, using food models, pictures and other tools to guide, including food diary recording , food intake estimation, food exchange serving, nutrition label reading. Weight managers guide patients to proficiently use mobile healthcare apps, increase their attention to online communication, increase the frequency of use of online platforms for out-of-hospital care, real-time upload diet, exercise and weight monitoring indicators, respond to patient consultation in time so as to improve interaction and compliance with patients. To give full play to the effect of service management, researchers will also remind and urge patients to use apps through telephone, wechat and other ways to improve compliance. Quality control: 1. Unified training of investigators, including program implementation, questionnaire survey, etc., to ensure unified methods in the investigation process. 2. All researcher have undergone unified training, including diagnostic standards, evaluation guidance, record norms, etc. 3. Epidata was used to build the database, and all data were entered in parallel by two people, with automatic and manual double verification." NCT01368549,"Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)","Inclusion Criteria: * New Metanx® Start * Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction. Exclusion Criteria: * Patients who do not meet ADA criteria for DPN diagnosis. * If participant indicates that he or she did not get a prescription for Metanx®, he/she will not be able to complete the survey(s). * For follow-up surveys, if the participant indicates that he/she has not been taking Metanx®, he/she will not be able to complete the survey(s).","Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Metanx® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Metanx® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Metanx® as directed. Patients will also receive educational materials about managing their diabetic neuropathy." NCT05660538,Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN),"Key Inclusion Criteria: * Diagnosis of diabetes mellitus type 1 or type 2 with * Glycosylated hemoglobin A1c (HbA1c) ≤9%; and * Presence of bilateral pain in lower extremities due to DPN for at least 1 year Key Exclusion Criteria: * Painful neuropathy other than DPN * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months Other protocol defined Inclusion/Exclusion criteria may apply.",N/A NCT00304148,SDCC - Prospective Cohort Study of Chronic Renal Insufficiency,"Inclusion Criteria: During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level: * Age Range: 21 - 79 years * Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m² * Proteinuria: varies dependent on eGRF Exclusion Criteria: * Unable or unwilling to provide informed consent * Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one month * Prior organ or bone marrow transplant * Prior renal transplant * Received immunosuppressive or other immunotherapy for primary renal disease or systemic vasculitis that affects the kidneys (i.e., anti-GCM, ANCA, SLE, IgA nephropathy, cryoglobulin, etc.) within the past six months before enrollment * Received chemotherapy or alkylating agents for systemic cancer * Known cirrhosis * NYHA Class III or IV heart failure at baseline * Previous diagnosis of multiple myeloma or renal carcinoma * Previously diagnosed polycystic kidney disease * Known HIV infection and/or AIDS * Pregnant or breast-feeding women * Currently participating in an interventional clinical trial (i.e., primarily trials of therapeutic agents that may have an effect on renal or cardiovascular outcomes). * Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility resident) * Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.","Study Visits and Participant Contact During its 5th and final phase, the 7 Clinical Centers comprised of 12 sites will extend participant follow-up for participants who have not reached ESKD before the inception of Phase 5 by conducting 2 study visits. For all participants, Visit 1 is conducted in person at the study site. Visit 2 can be conducted in person or by telephone. For participants who enrolled in one or more Phase 4 subprotocols, Visit 2 requires a blood draw for a creatinine measurement. The blood draw can be performed at the study site, at a commercial laboratory, or at the participant's home. The principal focus for these study visits is to ascertain kidney and clinical CVD outcomes, both of which are of particular importance for the participants who enrolled in the three Phase 4 subprotocols. Participants may be contacted at other times during the year to answer additional questions or to join ancillary studies. Participants who are known by the study team to have ESKD will not have any in-person visits or scheduled telephone calls. Phase 5 Visit 1 Participants without ESKD will complete one initial visit through the end of 2024 (Visit 1) and one follow up visit during the following year (Visit 2). Data collection has been streamlined in accordance with the Phase 5 objectives . At the in-person visit, informed consent will be obtained for continued participation in the CRIC Study. Blood pressure, weight, and medical history data will be obtained using standardized equipment and protocols established previously in the CRIC Study. Blood and urine samples will be collected for serum creatinine, serum cystatin C, and urine protein/creatinine, the key indicators of kidney outcomes. Serum creatinine will be measured locally using CLIA-approved laboratories, and serum cystatin C and urine protein/creatinine will be measured at the CRIC Central Laboratory (CCL) at the University of Pennsylvania. As has been done in earlier phases, the results of the serum creatinine measurement will be provided to participants. Serum and urine remaining after the centralized measurements will be stored at the CCL during the Phase 5 award period for potential analyses in the future. For participants who are unable to come to the Clinical Center for an in-person visit, informed consent and the medical history and hospitalization data will be obtained by telephone. Participants should be encouraged to get blood drawn at a laboratory or at their home if they are not able to come to the Clinical Center. Phase 5 Visit 2 The follow-up visit for participants without ESKD can take place by telephone or in person. During the follow-up visit, medical history updates and hospitalization data will be collected. The subset of participants who participated in any of the three Phase 4 subprotocols will be asked to have a second blood draw for creatinine measurement at or around the time of Visit 2. The creatinine measurement can be performed at the study site, at a commercial laboratory, or at the participant's home. Follow-up of Participants who have Reached ESKD Participants who have reached ESKD before the start of Phase 5 will not have in person visits but will be consented via a telephone visit for passive follow-up through linkages with the US Renal Data System, the National Death Index, and other national billing claims or other databases. These participants will also be asked to consent to sharing their contact information with the SDCC to facilitate potential future studies. Sharing of contact information is not required for participation in Phase 5. While participants who have reached ESKD will not undergo in-person visits as part of the core CRIC Phase 5 protocol, they may be invited to complete additional visits/activities for ancillary studies. Close Out Activities During the 3 years of the Clinical Center Phase 5 funding period, the Clinical Centers will hold local events to express appreciation to study participants for their contribution over many years and to provide them with an overview of major findings. The last 6 months of the Clinical Center funding period will focus on closeout activities including resolution of data queries, storage of study documents, and regulatory reporting and completion of outcome ascertainment." NCT03304626,Budesonide for Liver Transplant Immune Suppression,"Inclusion Criteria: * Female or male subjects aged 21-75 years old * Received a primary liver transplant within 4 days of enrollment Exclusion Criteria: * Received previous organ transplants * Undergoing multiple organ transplants * Recipients with advanced fibrosis in graft * Treatment plan for subject includes receiving immunosuppressant therapy other than standard immune suppression (SIS) as per University of Cincinnati LT immune suppression protocol (UC-ISP). * Inability to take enteral (orally or by tube feed) medications by day 4 post-transplant * Subjects with diabetes mellitus prior to transplant (diabetes mellitus defined as use of hypoglycemic agents or HbA1c \> 6.4 prior to transplant) * Subjects who have any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation. * Subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives on the investigational product, whichever is greater. * Subjects in which concomitant use of medications which are inhibitors of CYP3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) cannot be avoided during the study period. * Pregnant females * Diminished mental capacity to consent for the study as determined by attending on the record.","Enrollment of Subjects: All consecutive patients undergoing liver transplant (LT) at the University Of Cincinnati Transplant Center will be screened for enrollment upon admission for transplant surgery. Subjects will be approached after permission from attending on record by one of the members of research team. Study rationale, procedures, different interventions, potential benefits and risks as well as alternatives to study participation will be explained to the subjects in their native language in non-medical terms, as much possible. For non-English speakers, certified interpreter services will be used. Subjects meeting all of the inclusion and none of the exclusion criteria will be educated about the study and written informed consent will be obtained either 12 hours prior to undergoing LT or within 72 hours of completion of a successful transplant surgery. This time frame is proposed so that subjects have sufficient time to go over the study and are not pressured to sign the consent within a short time frame prior to LT surgery. In addition, all patients being placed on liver transplant list at our center will be provided with a copy of the consent form in the LT clinic at the time of listing for review only so that this study proposal is not completely novel to them at the time of LT surgery. A pregnancy test will be performed on all the females of childbearing potential. Enrollment of Controls: Each study subject will be matched with a control subject. Patients undergoing LT at University of Cincinnati that are not part of the study will serve as controls. Confounding and effect modifiers will be accounted for by matching the controls on multiple variables which may affect the primary outcome of ACR. These variables include: age less than 55 years, serum creatinine greater than 1.5 ng/mL, the use of antibody therapy at the time of transplant and a history of autoimmune hepatitis. To minimize the selection bias, the matched control will be selected in a manner that he/she would have undergone liver transplantation within a 24 week period (8 weeks prior or 16 weeks after) of the liver transplantation of the matched study subject. This means that data from controls will also be collected prospectively. Since outcomes are being measured at week 24 of liver transplantation, this will ensure that the investigators have no influence on selecting the controls with a known outcome. Controls will be identified through LT clinic. They will not undergo any study specific procedures, interventions, testing or evaluations. A written and informed consent will be obtained from all controls prior to their enrollment in the study. University of Cincinnati transplant program has performed 90-100 LTs each year over last 2 calendar years. Application of inclusion and exclusion criteria of our study to this database estimates that 65% of all LTs will be potential candidates for participation either as study subject or control. Based on this estimate the investigators are confident that this enrollment goal of 20 subjects and 20 controls can be achieved in 9-12 month period. Study Drug: After LT surgery, subjects will be started on SIS including intravenous corticosteroids, calcineurin inhibitor (CNI), mycophenolate mofetil (MMF) +/- thymoglobulin as per University of Cincinnati LT immune suppression protocol (UC-ISP). On post-operative day 4, intravenous corticosteroids will be discontinued and replaced by the study drug; budesonide. Based on pharmacokinetic and bioavailability studies, 3 mg of budesonide is equivalent to 10 mg of prednisone. Starting dose of budesonide will be 9 mg by mouth daily which will be equivalent to 30-40 mg of prednisone used as standard of care. Study drug will be tapered over the next 3 months as detailed in Table 1 and in line with UC-ISP. At 3 months post LT, study drug will be discontinued. Subjects with autoimmune hepatitis as an etiology for LT will be initiated on prednisone 5 mg daily in addition to SIS as per UC-ISP. Table 1: Study Drug Taper Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Budesonide 9 mg Days 31-45 SIS + Budesonide 6 mg Days 46-90 SIS + Budesonide 3 mg Days 90 onwards SIS Study Assessments (Visits 3-7): Subjects will undergo study visits in the LT clinic or inpatient transplant unit at post-LT weeks 2,4,6,8 and 12 (Figure 1). At each visit, data regarding history and physical, vital signs, concomitant medications, use of hypoglycemic agents or insulin, adverse event assessment, laboratory blood work including blood counts, chemistries, blood glucose, liver function test, and tacrolimus trough level will be recorded. Blood samples for early morning cortisol level (between 6 AM and 9 AM) will be collected at week 4 and week 8 visits only. These samples will be centrifuged at 3600 rpm for 15 minutes, appropriately labelled and stored in - 80 C freezer at Schubert Research Clinic. All the samples from the study will be analyzed for serum cortisol in 1-2 batches to ensure uniform and standardized testing conditions and reagents. No other testing will be performed on these samples. Hemoglobin A1c will be checked at week 12 (visit 7). Additionally, at each visit, the study team will perform a pill count for the study drug. Study drugs will be dispensed every 4 weeks at study visits 2, 4 and 6. Decisions regarding obtaining a liver biopsy for evaluation of abnormal liver tests will be at the discretion of treating physician. Biopsy proven ACR will be treated according to UC-Rejection protocol. Study drug will be discontinued at week 12 (visit 7) and subjects will continue routine post-LT follow up as per the current standard of care. A low dose ACTH stimulation test will be performed at Schubert Research Clinic at week 12 visit. This test comprises of intravenous injection of cosyntropin at a dose of 1 micrograms per 1.73 m2 of body surface area and checking the serum cortisol levels at baseline and 30 minutes after cosyntropin injection. This test is used to assess adrenal insufficiency with a high sensitivity." NCT04058626,TEsting for Arterial Disease in Diabetes (TrEAD) Study,"Inclusion Criteria: * All diabetic patients presenting to the diabetic foot clinics will be eligible for the study. Exclusion Criteria: * Patients unable to provide informed consent will also be excluded.","In the UK, over 7,000 amputations are performed each year because of diabetes. Most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. The most important cause of this is poor circulation to the feet. Currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. Because of this, poor circulation can be missed and its treatment delayed. A focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. It is safe, painless and I have previously proven that it can be learned and performed quickly. It may help avoid amputations by detecting poor circulation so that it can be treated quickly." NCT03851978,Pharmacist Impact on Pneumococcal Polysaccharide Vaccination Rates in Patients With Diabetes in a Supermarket Pharmacy Chain,"Inclusion Criteria: * Patients with diabetes * Patients who have filled a prescription for at least one diabetes medication in the past 90 days Exclusion Criteria: * Patients with a known history pneumococcal polysaccharide vaccination * Patients with an allergy to any component of the pneumococcal polysaccharide vaccine","Three geographically and socioeconomically diverse Kroger pharmacies will be selected in the greater Richmond area. Eligible patients include patients with diabetes between the ages of 19 and 64 and patients who have filled a prescription for at least one diabetes medication in the past 90 days. An NDC (National Drug Code) activity report will be run through Kroger internal reporting to identify patients who have filled a prescription for a diabetes medication in the past 90 days. Excluded patients include those with a known history pneumococcal polysaccharide vaccination, and patients with an allergy to any component of the pneumococcal polysaccharide vaccine. All patients who are deemed eligible will have their immunization history assessed by verifying immunization records in their Kroger medication profile, in the Virginia Immunization Information System (VIIS) or with their primary care physician. The percentage of patients vaccinated with the pneumococcal polysaccharide vaccine in the three Kroger pharmacies will be calculated prior to the start of the intervention period. Eligible patients will have a pop-up note added to their patient profile in the Kroger system. The pop-up note will indicate that the patient is eligible for education on the pneumococcal polysaccharide vaccine. When an eligible patient presents to the pharmacy for prescription pick up or drop off, the pop-up note will notify the technician to get a pharmacist for education. The pharmacist will educate the patient on the vaccine and then recommend that the patient receives the vaccine. If the patient accepts the recommendation, the pharmacist will then follow Kroger policies and protocol and administer the pneumococcal polysaccharide vaccine to the patient. Standard procedure of administering a pneumococcal vaccine at Kroger includes having the patient complete and sign a vaccination consent form. The consent form consists of questions that assess the patients current health status, immunocompromising conditions, allergies and pregnancy status This indicates to the pharmacist whether the vaccine requested is appropriate for the patient. The pharmacist will review the Kroger consent form and administer the pneumococcal vaccine, using sterile injection technique, if there are no contraindications. After the patient receives the vaccine or declines the vaccine recommendation, the pharmacist will then ask the patient to complete a brief survey. After completion or refusal of the survey, the pharmacist will document the date the survey was completed or denied and if the pneumococcal vaccine was given. After the patient encounter has ended, the pharmacist will edit the pop-up note in the patient profile to document the date the patient was educated, and no further intervention is needed." NCT06184815,Effectiveness of a Multidisciplinary Treatment and Structured Education Programme,"Inclusion Criteria: * Type 1 diabetes * Diabetes duration \>1 year * BMI 18.5-40kg/m2 * A1c 6.5-13% Exclusion Criteria: * Pregnancy * Dementia or severe cognitive impairment * Uncontrolled psychiatric disorder * Absence of \>20% of the educational sessions","Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic." NCT04016415,Decreasing Stress in Diabetes,"Inclusion Criteria: 1. Men and Women 2. Age 18 years or older 3. Diagnosed with diabetes for at least one year 4. Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session) 5. High Subjective stress defined as Perceived Stress Scale-10 score ≥ 12 6. Available for the intervention sessions with reasonable certainty 7. Have a device equipped with internet connection, camera and microphone and willingness to interact with study staff and class instructors virtually/remotely via this platform 8. Must have a Primary Care Provider (PCP) 9. Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence Exclusion Criteria: 1. Current suicidality 2. History of, or meets Mini International Neuropsychiatric Interview (MINI) structured interview criteria for, bipolar disorder, psychosis, or other significant psychopathology; Those with depression or anxiety will be allowed to participate since they are under the care of a PCP. 3. Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 weeks 4. Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months) 5. Inability to read, write or speak English 6. Current enrollment in a stress reduction program, or in any other investigative study 7. Previous participation in a mindfulness-based stress reduction (MBSR) course 8. Pregnant women 9. Have a household member who is currently, or was previously, assigned to study treatment","Specific Aims are: 1) To conduct a randomized controlled trial to determine the effects of an online 6-month Mindfulness-Based Stress Reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose levels in at least 290 adults with uncontrolled type 1 or type 2 diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. The primary outcome will be hemoglobin A1c (HbA1c), a measure of the average glucose level over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to 6-months. We will also look at the 2-month HbA1c, however it may be too brief a time period to fully capture the impact of MBSR. An absolute reduction in HbA1c of 0.5% would be expected to reduce the risk of any diabetes-related complication by at least 10%. Additionally, we will assess fasting glucose as a secondary outcome as it is linked with adverse health outcomes, and can be lowered with MBSR based on our pilot study; 2) To determine the effects of online MBSR compared to SME control on psychosocial, behavioral and physiological mechanisms potentially mediating the effects of MBSR and/or SME on glucose levels in adults with uncontrolled diabetes. Secondary outcomes include: diabetes-related distress, subjective stress, craving, the impact of Coronavirus Disease 2019 (COVID-19) on subjects' lives, subject expectancy, dietary intake, physical activity, and serum hsCRP as a marker of chronic inflammation. Adverse Childhood Experiences (ACEs) will be assessed at baseline. It is hypothesized that these measures may mediate the effects of MBSR and/or SME on glucose. The proposed study has the potential to transform current standards of care for diabetes by using a novel long-term MBSR intervention as a powerful adjunct intervention for diabetes. MBSR could impact the clinical picture of diabetes by empowering patients with skills for strengthening their own internal resources to promote self regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life." NCT00309608,Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes,"Inclusion criteria: Inclusion\_Criteria: * Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug * HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug * HbA1c 7.5 10.0% at screening for patients treated with metformin alone * HbA1c 7.5 10.0% at beginning of the placebo run-in phase * Age \> 21 and \< 75 years * MI \> 25 and \< 40 kg/m2 (Body Mass Index) Exclusion criteria: Exclusion\_Criteria: * Clinically relevant cardiovascular disease * Impaired hepatic function * Renal insufficiency or impaired renal function * Treatment with rosiglitazone or pioglitazone within 6 months prior to screening * Treatment with insulin within 3 months prior to screening",N/A NCT01427998,Effect of Olive Leaves as Hypoglycemic Agents in Diabetic Subjects,"Inclusion Criteria: * adults * type 2 diabetes Exclusion Criteria: * type 1 diabetes","The present study is a randomized, double blind, placebo controlled, clinical trial with a 14 week duration. Patients were randomized to treatment with a tablet of olive leaves or matching placebo in 1:1 ratio. Patients were instructed to consume a diet consistent with ADA recommendations and an exercise training program was prescribed. Weight, height, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in all subjects at the beginning and at the end of the study. Venous blood samples were drawn after an overnight fast of not less than 12 hours. Laboratory tests included fasting blood glucose (FBG), HbA1c, insulin, lipid panel and liver and renal function. A total of 79 subjects (51 men, 28 women) aged 18-79 years with type 2 diabetes mellitus, were recruited from and followed up at an outpatient clinic. The subjects were selected from a series of 93 consecutive diabetic patients. Eligible patients had been diagnosed with T2DM for at least 1 year. Subjects were randomized to treatment with olive leaf extract pills (1 500 mg pill daily taken orally) or matching placebo. The intervention was prepared as follows: olive leaves were picked from the Barnea cultivar in the Jezreel Valley region of Israel and immediately freeze-dried on dry ice. After the leaves were thoroughly rinsed with sterile distilled water to remove dust, insecticides, and contaminating material, the leaves were ground and successively Soxhlet extracted with hexane for 3 h and 80% aqueous ethanol for 6 h. The alcoholic extract was concentrated under reduced pressure at 25 °C, and reconstituted with 30% ethanol in water. Olive leaves or placebo tablet was taken once daily orally throughout the study. All subjects continue their stable treatment to diabetes. Data were analyzed using SPSS v10.0 (SPSS Inc., Chicago, USA). Continuous data were described a mean ± standard deviation and compared by treatment assignment using the t-test for independent samples. Associations between continuous variables were described by calculating the Pearson's correlation coefficients. Nominal variables such as sex and treatment assignment are described using frequency counts and compared by treatment assignment using the chi square test (exact as appropriate). All tests are two-sided and considered significant at p\<0.05." NCT03809793,Can the Health Benefits of a Walking-based Exercise Programme be Enhanced by Co-ingestion of a Lipid-lowering Drug?,"Inclusion Criteria: * BMI \>28 kg.m-2 * Pre-diabetic * Not currently using any anti-diabetes medication * Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year) * Not pregnant or currently breast feeding * Pre-menopausal * Not currently involved in a weight loss programme or using weight loss medication Exclusion Criteria: * Involved in regular exercise (engaged in more than 2 sessions of structured exercise of \>30 min per week) * Currently using anti-diabetes medication (e.g. insulin, metformin) * Currently using niacin/vitamin B3 supplements * Pregnant or breast feeding * Currently engaged in active weight loss programme or using weight loss medication * Diagnosed with chronic kidney disease","Study 3 investigates the hypothesis that an exercise programme of steady walking will have larger effects on insulin sensitivity and glycaemic control when combined with Acipimox intake prior to each exercise session in people with prediabetes. Thirty-four sedentary, overweight/obese people (aged 25-50 years, BMI \>28 kg.m-2) with prediabetes will be recruited using the same strategy as study 2 and split into two groups (detailed below). Pre-intervention assessments: Visit 1: Participants will undergo an assessment of body composition (DXA) and undertake a graded treadmill walking test to estimate maximal aerobic fitness (VO2max). Visit 2: Participants will be able to opt to undergo an MRI scan, taking place before breakfast. The MRI scan is used to measure fat stored in the liver and muscles. A continuous glucose monitoring (CGM) sensor will be inserted to measure insulin sensitivity. Visit 3: Participants will arrive at the laboratory after an overnight fast (\>10 h) to undergo a Hyperinsulinaemic euglycaemic clamp to assess whole-body insulin sensitivity. Plasma glucose will be measured at regular intervals and muscle biopsies will be obtained from the vastus lateralis muscle of one leg before and after 2 hours of the clamp. Exercise intervention: Pairs of participants from each group (matched for gender, age and VO2max) will be randomized to undertake 12 weeks of steady walking combined with ingestion of either Acipimox or placebo in a counter-balanced, double-blind design. Supervised treadmill walking sessions will be undertaken at LJMU three times per week, with exercise performed at a speed equivalent to 45% VO2max. Participants will initially exercise for 30 mins per session (weeks 1 and 2), and each session will increase in duration by 5 mins every 2 weeks thereafter, up to 50 minutes of exercise. 1 hour before each walking session, participants will ingest either 250 mg Acipimox or nothing. Post-intervention assessments: The post-intervention assessments will be identical in all respects to the pre-intervention assessments and will be commenced ≥72 hours after the final training session." NCT00271193,A Primary Care Intervention for Weight Management,"Inclusion Criteria: Body mass index (BMI) of 27 to 50 kg/m2 Capacity to provide informed consent Ability to find transportation to and from counseling sessions Willingness to be randomized to either program Commitment to attend all sessions and to complete study-related assessments, including blood tests and questionnaires Exclusion Criteria: Type I diabetes Myocardial infarction or stroke within the previous 6 months Clinically significant renal or hepatic disease (as judged by a study physician) History of cancer in the past 5 years Congestive heart failure requiring diuretics Previous weight loss surgery Endocrine conditions that may cause weight gain, including unstable thyroid disease or hypercortisolism Initiation of therapy with or dose change to any of the following medications within 6 weeks of starting the study: insulin; metformin; sulfonylurea; thiazolidinedione; HMG-CoA reductase inhibitor (""statin""); or SSRI for depression Long-term use of any of the following medications: oral or high-dose inhaled steroid; atypical antipsychotic; tricyclic antidepressant; antiepileptic; any prescription or over-the-counter drug for weight loss Systolic blood pressure \> 160 or diastolic blood pressure \> 100 Hemoglobin A1c ≥ 10 Pregnancy or lactation Clinically significant psychiatric disease, including major depression, eating disorders, or substance abuse",N/A NCT00804921,"Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab","Inclusion Criteria: * macular edema Exclusion Criteria: * pulmonary chronic problems * chronic renal failure * intraocular inflammation * drug or alcohol addiction",N/A NCT06983821,Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW),"* New diagnosis of, or relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill consensus definitions * Positive ELISA test for anti-meyloperoxidase (MPO) or anti-proteinase 3 (PR3) * Severe kidney involvement from active AAV, characterised by both of the following: * eGFR \< 40ml/min/1.73m2 (Patients known to have a stable eGFR \<40 ml/min/1.73m2 for \>3 months prior to enrollment are NOT eligible) * Biopsy proven at least focal necrotizing/crescentic glomerulonephritis OR active urinary sediment by microscopy (greater than or equal to 10 red blood cells \[RBC\]/high power field with erythrocyte casts or greater than or equal to 20% dysmorphic RBCs or greater than or equal to 5% acanthocytes without an alternative cause. Exclusion Criteria (any of the following) * A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic vasculitis, rheumatoid vasculitis) * Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition * A diagnosis of systemic lupus erythematosus or Sjögren's syndrome * Receipt of dialysis for \>21 days immediately prior to randomization or prior renal transplant * Age \<18 * Pregnant at time of screening * Treatment with \>1 IV dose of CYC and/or \>14 days PO CYC and/or \>14 days of prednisone/prednisone (less than or equal to 30mg/day) and/or \>1 dose of RTX within the 28 days immediately prior to randomization * Chronic viral infection: HIV. HBV or HCV * Untreated latent mycobacterium tuberculosis infection * Active infection at time of presentation * A comorbidity or condition that, in the opinion of the investigator, precludes the use of GC, CYC or RTX","ANCA-associated vasculitis (AAV) is an auto-immune disease which often involves the kidneys. It is a serious condition as it can lead to severe kidney impairment, often kidney failure, and may even be life-threatening. Current treatments, typically cyclophosphamide (CYC) or rituximab (RTX) with a tapering course of glucocorticoids (GC), allow most patients to achieve control of their disease (remission). Glucocorticoids are most often used initially at high doses, and then gradually decreased to low doses over at least 6 months. This leads to major treatment toxicities, notably infections and GC-related adverse events, major contributors to patient morbidity and mortality. Recent research has focused on finding ways to reduce treatment-related toxicities without compromising efficacy for controlling disease manifestations. This includes a reduced-dose GC taper for severe AAV from the Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis (PEXIVAS) trial, an even more reduced-dose GC taper in patients with moderate severity AAV from the Effect of Reduced-Dose vs High-Dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-Associated Vasculitis (LOVAS) trial, and a novel GC-sparing agent examined in the Avacopan for the Treatment of ANCA-Associated Vasculitis (ADVOCATE) trial. Despite these advances, patients still experience high rates of infections, one of the major causes of death in the first year after diagnosis, particularly in patients with most severe forms of disease. Also, novel GC-sparing drugs are costly and have limited availability throughout the world; patients who cannot access this get exposed to significant amounts of GC and must suffer their dreaded side effects. This study addresses the unresolved issues of unacceptably high infection risk and of providing a widely available means of reducing GC exposure to minimise treatment side effects. The investigators will examine an induction treatment regimen for severe AAV consisting of 2 doses of IV CYC in combination with 4 weeks of GC and standard RTX. The control arm will be the current standard of care treatment for severe AAV. Non-controlled studies suggest the use of short duration CYC with RTX allows for minimisation of up-front GC use, as little as 1-2 weeks, but this needs to be tested in a prospective, controlled manner. The investigators hypothesize that the combination of CYC with standard RTX will allow less GC to be used for AAV. This study will begin as a pilot to examine the feasibility of the conducting the study, adherence to the intervention regimen, and of recruiting patients. If feasibility is demonstrated, the study will be extended to a full-scale trial." NCT04678752,PATHWEIGH: Pragmatic Weight Management in Primary Care,"Clinician Inclusion Criteria: * Affiliated with a participating primary care practice * Provide care for adult patients (\>=18 years old) Patient Inclusion Criteria: * All adult patients (age \>18 years) * BMI \>25 kg/m2 * Appointment at a primary care clinic participating in the study Patient Exclusion Criteria: * Unable to participate in weight loss treatment due to factors such as cognitive deficits, non-home residence, or limited life expectancy.","This study will investigate how PATHWEIGH, a weight management tool built into the EPIC electronic health record, in combination with clinician and staff training on the use of PATHWEIGH as a tool, education on effective weight management practices, and practice facilitation to support implementation can facilitate weight loss and maintenance for primary care patients. The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews. This study is being conducted because despite obesity being the leading cause of preventable death in the U.S. and a major risk factor for disease, people with any degree of overweight or obesity are rarely offered anything other than lifestyle advice, rather than more rigorous and evidence-based weight management strategies. Poor reimbursement for weight-related visits, competing priorities, lack of appropriate tools, and limited time in visits also prevent more widespread use of weight management interventions. PATHWEIGH helps primary care clinicians and teams prioritize weight management with their patients when appropriate and ensures that they have the tools and knowledge handy to do so effectively. As part of the assessment of the PATHWEIGH intervention, the study will identify predictors of patient weight loss and weight loss maintenance using mediator and moderator analysis. Relevant factors (patient demographics, health metrics (e.g. vital signs, anthropometrics, comorbidities), behaviors and goals, provider age, sex, years and % time practicing, and clinic information (e.g. size, location, culture scale)) will be evaluated by including interaction terms between the treatment variable and possible moderating variables in outcome regression models ." NCT04372849,Effects of Age and Obesity on Brain Insulin Sensitivity,"Inclusion Criteria: * Body-Mass Index (BMI) between 19-35 kg/m2 * HbA1c ≤6.0% * normal glucose tolerance during 75g oral glucose tolerance test (OGTT) Exclusion Criteria: * Not removable metal parts in or on the body * manifest cardiovascular disease * claustrophobia * recent surgery (less than 3 months) * Simultaneous participation in other studies * Acute disease or infection within the last 4 weeks * neurological and psychiatric disorders * treatment with centrally acting drugs * hemoglobin Hb \<13g / dl * Hypersensitivity to any of the substances used",N/A NCT07353749,Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms,"Inclusion Criteria: * （1）Aged ≥ 18 years; （2）Diagnosed with intracranial aneurysm (IA) via CTA, MRA, or DSA; （3）IA size ranging from 3 to 25 mm; （4）The patient and/or their authorized representative can understand the study purpose, voluntarily participate, and sign the informed consent form; （5）Patients scheduled to receive flow diverter treatment; （6）Patients willing to complete follow-up evaluations in accordance with the clinical study protocol. Exclusion Criteria: * （1）Patients with two or more multiple aneurysms who require secondary treatment within one month; （2）Female patients who are planning to become pregnant, are pregnant, or are breastfeeding; （3）Pre-onset modified Rankin Scale (mRS) score ≥ 2; （4）Patients complicated with systemic infectious diseases (latent or active stage), ulcerative colitis, diverticulitis, liver cirrhosis, myasthenia gravis, or ocular herpes simplex; patients with contraindications to glucocorticoids, such as active peptic ulcer and severe fungal infection; （5）Ruptured aneurysms, recurrent aneurysms, infectious aneurysms, dissecting aneurysms; complicated with arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, etc.; （6）Patients with symptomatic cerebrovascular stenosis ≥ 70%; （7）Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 30 days; （8）Patients scheduled to undergo other surgical/interventional procedures within 30 days; （9）Patients with severe comorbidities unsuitable for anesthesia or surgical treatment, such as major diseases of the heart, lungs, liver, spleen, and kidneys, atrial fibrillation, brain tumors, severe active infections, disseminated intravascular coagulation, and severe psychiatric history; （10）Patients who cannot receive antiplatelet aggregation or anticoagulant therapy; （11）Hypersensitivity to methylprednisolone sodium succinate; （12）Patients receiving long-term hormone therapy (≥ 1 week) due to other comorbidities before surgery; （13）Patients taking hepatic enzyme-inducing drugs, such as barbiturates, rifampicin, rifabutin, carbamazepine, phenytoin, primidone, and aminoglutethimide; or patients taking hepatic enzyme-inhibiting drugs, such as erythromycin and ketoconazole; （14）Patients undergoing chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 μmol/L (2.5 mg/dl)); （15）Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg that is uncontrollable with oral antihypertensive drugs; （16）Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L; （17）Patients who have received a vaccine injection within the past month or have a plan for vaccination; （18）Patients who cannot understand or are unwilling to complete follow-up evaluations in accordance with the clinical study protocol; （19）Patients with advanced diseases with an expected life expectancy of \< 6 months; （20）Patients currently participating in other clinical trials.","Title: A Study on the Efficacy and Safety of Methylprednisolone in Preventing Cerebrovascular Adverse Events after Flow-Diverting Device Implantation in Patients with Unruptured Intracranial Aneurysms-A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Sponsor: Zhujiang Hospital, Southern Medical University Leading Institution: Zhujiang Hospital, Southern Medical University Research Objectives: Primary Objective: To evaluate the efficacy of methylprednisolone treatment on the composite outcome of any new cerebrovascular adverse event and neurologic death within 30 days after flow-diverting device implantation in patients with unruptured intracranial aneurysms (IAs). Secondary Objectives: 1. Incidence of any cerebrovascular adverse event (ischemic or hemorrhagic brain events) within 72 hours, 5 days, and 30 days post-operation. 2. Incidence of any ischemic brain event (ischemic stroke, in-stent thrombosis, urgent revascularization) within 72 hours, 5 days, and 30 days post-operation. 3. Incidence of any hemorrhagic brain event (intraparenchymal hemorrhage, subarachnoid hemorrhage, or subdural hematoma) within 72 hours, 5 days, and 30 days post-operation. 4. All-cause mortality within 30 days post-operation. 5. Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 30 days post-operation. 6. Proportion of patients with an mRS score of 3-5 at 30 days post-operation. 7. Incidence of transient ischemic attack (TIA) within 72 hours post-operation. 8. EQ-5D score at 30 days post-operation. 9. Safety endpoint: Incidence of no new moderate or severe adverse events within 72 hours, 5 days, and 30 days post-operation. 10. Secondary safety endpoints: * Incidence of any intracranial hemorrhage within 72 hours post-medication. * Incidence of systemic bleeding complications (including gastrointestinal bleeding, systemic subcutaneous hemorrhage). * Incidence of non-hemorrhagic serious adverse events. * Incidence of gastrointestinal bleeding within 7 days post-operation. * Incidence of pulmonary infection during hospitalization. Research Hypothesis: Methylprednisolone treatment can effectively reduce the incidence of cerebrovascular adverse events and neurologic death within 30 days after flow-diverting device implantation in patients with unruptured intracranial aneurysms. Study Design: Multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Sample Size: The study is designed as randomized, double-blind, parallel, placebo-controlled. The primary outcome is the composite cerebrovascular event within 30 days post-implantation, defined as any new target vessel-related event: (1) ischemic stroke, (2) hemorrhagic stroke, (3) neurologic death. Based on prior observational studies, the estimated primary outcome rate is 4.7% in the methylprednisolone group and 12.4% in the control group. With a two-sided significance level α=0.05 and power 1-β=0.80, the calculated sample size is approximately 203 per group. Accounting for a 5% dropout rate, 214 participants per group (428 total) are needed. Adopting a more conservative estimate (methylprednisolone group: 6.0%, placebo group: 11.5%), the calculated sample size is approximately 410 per group. With a 5% dropout rate, 432 participants per group (864 total) are needed. Study Population: Diagnostic Criteria: Patients with unruptured intracranial aneurysms confirmed by CTA, MRA, or DSA. Inclusion Criteria: 1. Age ≥ 18 years. 2. IA diagnosed by CTA, MRA, or DSA. 3. IA size between 3-25 mm. 4. Patient and/or legal representative understands the study purpose, volunteers to participate, and provides written informed consent. 5. Patients scheduled for flow-diverting device treatment. 6. Willing to undergo follow-up evaluations as per the study protocol. Exclusion Criteria: 1. Patients with two or more multiple aneurysms requiring treatment within one month. 2. Women who are planning pregnancy, pregnant, or breastfeeding. 3. Pre-morbid mRS score ≥ 2. 4. Patients with systemic infectious diseases (latent/active), ulcerative colitis, diverticulitis, liver cirrhosis, myasthenia gravis, ocular herpes simplex; contraindications to corticosteroids such as active peptic ulcer, severe fungal infection. 5. Ruptured, recurrent, infectious, or dissecting aneurysms; patients with arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, etc. 6. Symptomatic cerebral vascular stenosis ≥ 70%. 7. History of stroke (intracerebral hemorrhage, cerebral infarction) within the past 30 days. 8. Planned for other surgical/interventional procedures within 30 days. 9. Severe comorbidities unsuitable for anesthesia or surgery (e.g., major cardiac, pulmonary, hepatic, splenic, renal diseases, atrial fibrillation, brain tumor, severe active infection, DIC, severe psychiatric history). 10. Inability to receive antiplatelet or anticoagulant therapy. 11. Allergy to methylprednisolone sodium succinate. 12. Long-term preoperative hormone therapy (≥1 week) for other conditions. 13. Concomitant use of hepatic enzyme-inducing drugs (e.g., barbiturates, rifampin, carbamazepine, phenytoin) or inhibitors (e.g., erythromycin, ketoconazole). 14. Chronic hemodialysis or severe renal insufficiency (GFR \<30 ml/min or creatinine \>220 μmol/L). 15. Uncontrolled hypertension (SBP \>180 mmHg or DBP \>110 mmHg despite medication). 16. Blood glucose \<2.8 mmol/L or \>22.2 mmol/L. 17. Vaccination within the past month or planned vaccination. 18. Unwilling or unable to comply with follow-up requirements. 19. Life expectancy \<6 months due to any end-stage disease. 20. Participation in another clinical trial. Main Interventions: Experimental Group: Methylprednisolone treatment. Control Group: Placebo treatment. Follow-up: Within 24 hours post-surgery, within 72 hours post-surgery, at postoperative day 5/early discharge, and at 30±7 days. Evaluation Indicators: Primary Outcome: Incidence of the composite outcome of any new cerebrovascular adverse event and neurologic death within 30 days post-implantation. Secondary Outcomes: Incidence rates as specified in objectives (2) through (17) above at the defined time points. Statistical Methods: For the primary outcome, a Log-binomial regression model will be the primary method to calculate the Risk Ratio (RR) and 95% CI. A multivariate model adjusting for baseline variables (gender, age, aneurysm location, blood pressure grade) will be used. If convergence fails, robust Poisson regression or logistic regression will be employed as alternatives. A two-sided p-value \<0.05 will be considered statistically significant." NCT03855449,A Task Analysis Study of DECIDE For African American Patients With Type 2 Diabetes,"Inclusion Criteria: * African American * English speaking * Access to the Internet daily * Reading level of at least 5th grade * Diagnosis of Type 2 Diabetes per one of the following 1. Fasting blood glucose ≥ to 126 mg/dL 2. 2 hr plasma glucose ≥ 200 mg/dL 3. Glycosylated hemoglobin HbA1c ≥ to 6.5% 4. Random plasma glucose ≥ 200 mg/dL Exclusion Criteria: * Glycosylated hemoglobin HbA1c ≤ 7.0 * Pregnancy * Severe visual or hearing impairment or any existing condition that would limit or hinder one's ability to use the Internet * Dementia * Use of supplemental oxygen * Chest pain or angina * Prior lower extremity amputation * A diagnosis of a life threatening malignancy within the past year","The Task Analysis study of the DECIDE program is phase I (part 1) of a three-part study. Part 2 is usability testing and Part 3 is the pilot clinical trial. For part 1, a single group will receive the DECIDE intervention program as investigators conduct a task analysis of DECIDE in preparation for building the web-based version (eDECIDE). This web-based version will be used for part 3 of the study, which will be the pilot clinical trial (eDECIDE). Self-management is important for persons with type 2 diabetes for glycemic control. When diabetes is uncontrolled, it is important to get back in control in order to decrease further health complications. New ways of delivering self-management that improve access to treatment are needed. This study will help provide background information on any potential problems and or benefit of using web-based and mobile phone applications (mHealth) for diabetes self-management. In addition, this study will help researchers at University of Kansas School of Medicine create a web-based version of the in-person DECIDE program, known as eDECIDE. Data gathered from the in-person DECIDE group sessions will be used to create a series of events for designing a web-based copy based on several task (current study). Therefore, this study is known as a task analysis. Task Analysis: This entails documenting observations of an existing system, sequence of tasks, and information flows. High-level tasks are divided into subtasks and operations. Informational sources required in each subtask are also recorded. This technique is a critical step in any software development process to ensure a basic understanding of user needs and requirements necessary for optimal learning. It also provides a perspective on individual differences across patients. Understanding this workflow is critical and will serve as the basis for developing eDECIDE. For the task analysis up to 8 individuals will be recruited to take part in the in-person DECIDE problem-solving curriculum (task analysis), the information learned in the task analysis will help build and test (usability testing) the eDECIDE website, which are both integral to the pilot clinical trial (part 3) which will take place last. PROCEDURES The current study will administer the DECIDE curriculum to a single group, examine responses, build the website, and then prepare for implementing the pilot clinical trial. The information gathered from this study will provide information about barriers to problem solving for diabetes self-management and perceptions of using a web-based diabetes problem-solving format. Participants who meet eligibility criteria will take part in 9-weekly sessions on diabetes self-management and problem-solving techniques. The sessions will be recorded by audio and video tape. All audio and video taped recordings will be used to help create the web-based version of DECIDE, known as eDECIDE. All and any personal information that is recorded by audio tape will be removed when transcribing the audio recordings. All personal information such as name and face will be removed and blurred if video recording clips are used in an academic or conference meeting setting. Other personal identifiable information such as date of birth, address, or telephone number will be removed when transcribing and you will be identified by participant id number. The researcher will ask participants questions about their diabetes self-management behaviors; go over problem-solving techniques, and self-management skills. The recordings of the focus group sessions will be destroyed 12 months after publication of the research results. Task Analysis and usability testing Procedures: Using information gathered from the task analysis, the research team will develop a wire frame prototype of eDECIDE. A benefit of the prototype is to have a layout of the interface without the distraction of color or visual elements that would normally be a part of the actual webpages. Once the prototype of the website design is complete, investigators will conduct usability testing (part 2) to assess the efficiency, ease-of-use, and user satisfaction based on participant feedback. Participant feedback is collected via web camera and online questionnaires. Objective data are collected via logging software designed for usability testing. Usability testing is a step-by-step process conducted several times throughout the design and development process. Results from each test are used to make design recommendations for the eDECIDE website. Once usability testing is complete, the pilot clinical trial (part 3) of eDECIDE will begin. Our long-term goal is to understand how problem-solving skills training (PSST), delivered using web-based and mobile phone technology, can improve diabetes self-management in community populations. Currently Recruiting: Clinical Trial Phase of eDECIDE: Plot 2-Arm Study: Intervention arm: eDECIDE Online Curriculum Comparison arm: DECIDE Traditional Curriculum delivered one/on/one (Self-Study). Will recruit at total of 40-70 participants Primary outcome A1c Secondary outcomes: goal setting, problem-solving, feasibility of use for eDECIDE online, satisfaction with eDECIDE online." NCT02625649,Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients,"Inclusion Criteria: * Capable * type 2 diabetes mellitus * speaks and understands Danish * presents written concent * cases must be Roux-en-Y operated between 2006-2011. Exclusion Criteria: * Converted Roux-en-Y * chronic inflammatory bowel disease * ischemic heart disease * liver disease * cholecystectomy. Controls can not be bariatric operated.","One hundred Danish type 2 diabetes mellitus (T2DM) patients who underwent Roux-en-Y gastric bypass surgery (RYGB) between 2006-2011 will be evaluated clinically together with 50 T2DM patients, matched on gender, age, presurgical body mass index, and diabetes duration. The clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density) a peripheral quantitative compute tomography (HR-pQCT), stool samples (microbiota), ophthalmological examination including retina photo, and a questionaire. More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19 and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part of the patients." NCT03669458,Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.,"Inclusion Criteria: * Patient is willing and able to provide informed consent and able to comply with the study protocol. * Peripheral arterial disease that can be treated using PTA. * Life expectancy \>1 year in the investigator's opinion * Male or non-pregnant female \> 18 years of age * Patent inflow artery * Target vessel(s) reconstitutes(s) at or above the ankle, excluding the dorsalis pedis and the calcaneal branch of the posterior tibial artery * Target lesion starts at or below 3 cm below the tibial plateau as measured by angiography * Target vessel for Spur device is ≥ 3.5 mm (4mm); ≥ 2.5 mm (3mm) in diameter by visual estimate. * Lesion(s) must be able to be treated with a minimum of one Spur or PTA or DCB product. * Infrapopliteal lesion(s) that are located in either the left or right leg Infrapopliteal artery(s) may be treated with only one modality per artery: DCB, Spur or Spur/DCB. * Arterial length/diameter and quantity must be able to be treated with DCB or Spur or Spur/DCB * The treated segment is defined as the total length of artery treated with PTA. * The cumulative treated segment of infrapopliteal artery(s) must be ≤34.0 cm. * Lesions in the treated segment may be continuous or may have gaps present between stenosis or occlusions * Patient has Rutherford Classification of 3-5. * Successful pre-dilatation of the target lesion. * Iliac, SFA and popliteal inflow lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first, prior to consideration of treatment of infrapopliteal lesions. * The patient can be enrolled if the inflow lesions have acceptable angiographic results (must have \<30% residual stenosis and no evidence of embolization or flow limiting dissection) Exclusion Criteria: * Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study * Prior stent(s) or bypass surgery within the target vessel(s) * Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. * Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure. * Previous PTA of the target vessel within 30 day prior to index procedure * Angiographic evidence of thrombus within target limb. * Subject has an active infection of the foot, including pus or wet gangrene that is not controlled at the time of the procedure. * Planned major (above the ankle) amputation of the target limb * Recent MI or stroke \< 30 days prior to the index procedure. * Heart failure with Ejection Fraction \< 30% * Impaired renal function (GFR \<30 mL/min) and patients on dialysis * Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica. * Patient receiving systemic corticosteroid therapy. * Inability to tolerate concomitant antiplatelet and oral anticoagulation therapy. * Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure. * The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.","The objective of this study is to perform a prospective, multi-center (min 2 sites), non-randomized study to evaluate the safety and efficacy of the Spur system and compare treatments arms (if applicable) in treating subjects with infrapopliteal disease who are at risk for amputation. The study protocol will ensure consistency in performing the procedure, patient management and results of the procedure. Safety and efficacy will be evaluated during index procedure through one (1) year follow up" NCT05518448,The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes,"Inclusion Criteria: * Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications. * Non-smoking * Blood pressure \<160/100 mm/Hg Exclusion Criteria: * Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment. * Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements. * Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease. * Smoker * Blood pressure \>160/100 mm/Hg * Lactose intolerant","Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver. Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal. Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver. Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D." NCT04248335,Effect of Obesity on Proton Pump Inhibitors,"Inclusion Criteria: * 6-21 years of age * Obese and non-obese individuals * BMI ≥10th percentile for age (6-20 years of age) * BMI ≥18.5 (\>20 years of age) * Otherwise healthy; or otherwise healthy with diagnosis of GERD, NAFLD, chronic abdominal pain or obesity, according to report of medical history and/or review of the medical record * Receiving or not receiving pantoprazole or lansoprazole for routine medical care * MRI Hoop Test Clearance Exclusion Criteria: * Unable or unwilling to give written permission/assent/consent * For PO Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, including Bariatric surgery, Nissen fundoplication or equivalent surgery. * For IV Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, except Bariatric surgery, Nissen fundoplication or equivalent surgery. * For subjects undergoing weight management, treatment in the last 7 days with proton pump inhibitors omeprazole, esomeprazole, dexlansoprazole, or grapefruit juice. * For subjects not undergoing weight management, treatment in the last 7 days with medications known to clinically significantly inhibit (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, trazodone, valproic acid, topiramate) or induce (e.g., phenobarbital, carbamazepine, phenytoin) CYP2C19; and those known at therapeutic doses to significantly inhibit (e.g., erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, ketoconazole) or induce (e.g., oxcarbazepine, carbamazepine, phenytoin, phenobarbital, St. John's Wort, rifampin, rifapentine) or CYP3A4 activity in the last 7 days. * Unable to have blood drawn for the screening lab tests * Unable or unwilling to fast overnight prior to the study session * Unable to have blood drawn for the screening lab tests * If taking lansoprazole or pantoprazole for clinical purposes, unable or unwilling to abstain from that PPI for 3 days prior to PK visit when the PPI is not the same as the study drug for that PK visit * Metal in the body or any foreign bodies that precludes MRI sequencing * Claustrophobia * Exceeds 500lbs or 227 kg in Body Weight * Demonstrated adverse reaction to previous pantoprazole or PPI exposure * Impaired hepatic activity as determined by routine liver function testing and defined as values ≥ 5 times the age-specific upper limit of normal (ULN) for AST, ALT, total bilirubin \>2.0mg/dl, alkaline phosphatase ≥ 5 times the age-specific ULN * Impaired renal function defined as creatinine ≥ 3 times the age-specific ULN * Females of child-bearing age who are pregnant or breast-feeding * Any known infection with hepatitis B, C, or human immunodeficiency virus (HIV)","The purpose of this research study is to see how the body breaks down certain medicines. Many medicines are broken down in the liver. The liver is an organ in the belly. A person's age, size, genetics (DNA), and the health of their liver decide how quickly the body breaks down medicines and how much medication a person needs to take. Everybody's liver has some fat in it, but the amount of fat is different from person to person. The purpose of this study is to see if the amount of fat in the liver affects how quickly acid suppression medications start and stop working and get removed from the body." NCT04967235,Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population,"Inclusion Criteria: * Hemodynamically stable * Previously attending exercise-based cardiac rehabilitation and dance classes for at least 3 months * Do not present orthopedics or neurologic impairments that could preclude the execution of dance movements * To be previously diagnosed with at least one of the following cardiac risk factors: 1. Age ≥ 55 years 2. Family history: Known myocardial infarction, coronary revascularization, or sudden death in the first-degree relatives before 55 years in male or 65 years in female relatives 3. Hypertension: values of systolic blood pressure (SBP) equal to or higher than 140 mmHg and/or values of diastolic blood pressure (DBP) equal to or higher than 90 mmHg, or daily use of antihypertensive drugs 4. Dyslipidemia: values of low-density lipoprotein (LDL) ≥ 130 mg.dL-1, or values of high-density lipoprotein (HDL) \< 40 mg.dL-1, or daily use of lipid-lowering drugs 5. Obesity: body mass index ≥ 30 Kg.m-2 6. Cigarette smoking: former smokers for more than six months 7. Diabetes Mellitus: fasting blood glucose level ≥ 100 mg.dL-1 8. Physically inactivity: the volunteer will be considered physically inactivity when classified as ""sedentary"" or ""irregularly active A or B"" by the International Physical Activity Questionnaire (IPAQ) 9. Stress: the presence of stress will be evaluated by the Lipp's Stress Symptoms Inventory (LSSI), and the classifications ""alert"", ""resistance"", and ""exhaustion"" will be considered Exclusion Criteria: * Volunteers who present errors superior to 5% in the RR intervals time series * Volunteers who do not attend all study phases",N/A NCT04680208,Study of Direct Admission of Postoperative Patients to ICU,"Inclusion Criteria: * Adult patients over the age of 18 who underwent surgery and got admitted directly to ICU postoperatively Exclusion Criteria: * Patients who were admitted to specialized ICU ( cardiothoracic and neurosurgery ) or to the ward and then ICU * Pediatric patients","There are 2 Levels of care available for patients who require high level of organ support and monitoring. First of them is the high dependency unit (HDU) where higher level organ support and monitoring is given (exception for mechanical ventilation) such as invasive blood pressure monitoring. Second one is the intensive care unit (ICU), which provides support for patients with multiple organ dysfunction that needs higher level of care which cannot be provided in the ward or the high dependency unit (HDU) and without this care the patient may not survive. ICU admission post-operatively can be either in a planned or unplanned way. The complex interaction between associated comorbidities, anticipated complications intra-operatively and high American Society of Anesthesiologists (ASA) Physical Status are major factors in planning for ICU admission post-operatively. ASA physical status indicates patient's health status and has been accepted as a determinant of comorbidity and mortality. Unplanned ICU admissions can be due to unpredicted surgical or anesthetic intra-operative complications or poor assessment of perioperative factors. After surgery, some patients are admitted to ICU for further management and monitoring based on their underlying low functional status and co-morbidities. Out of these some patients may actually need ICU interventions and others may not. If an ICU bed is booked for unworthy patient, this may lead to unnecessary increased expenditure, wastage of valuable resources as well as deny the ICU services to potentially survivable and worthy critically ill patient. This study aimed to assess perioperative factors associated with planned and unplanned admissions to find out the main reasons of admission to ICU at Sultan Qaboos University hospital (SQUH). This will help to lay guideline for guiding future admission to ICU for surgical patients in immediate postoperative period and help to reduce the unplanned admission. Methods This retrospective observational study traced all adult patients (above 18 years old) who underwent surgery and got admitted to ICU directly from operating theatre during the 3-year period: 2016-2018 at SQUH. These were segregated into planned and unplanned admissions. Required information was accessed using the hospital information system after receiving the ethical approval from Sultan Qaboos University Hospital Ethics and Research Committee (MREC#1937). Patients who were admitted to specialized ICU and those who underwent neurologic or cardiothoracic operations were excluded from this study since they are admitted postoperatively to ICU by default. Patient's data that were collected included age, gender, social status like smoking, ASA physical status (American Society of Anesthesiologists), associated comorbidities such as diabetes, hypertension, ischemic heart disease, valvular heart disease, pulmonary diseases, chronic kidney disease and cirrhosis. Associated factors and investigations were collected like dehydration, hypoxia, hypercarbia, pH changes, pulmonary complications, fluid/electrolyte imbalance, temperature changes, random blood sugar, sepsis, coagulopathy, elevated WBC, low hemoglobin, hemodynamic instability, septic shock, hypovolemic shock, infection, blood loss more than 20%, hypotension and cardiac arrhythmia. Type, nature and duration of surgery, type of anesthesia and airway issues were recorded. Patients mortality outcome and length of stay in ICU were included as well. Statistical methods: Statistical Package for the Social Sciences (SPSS) was used for patient's data analysis. Descriptive statistics were used to determine median, frequencies and percentages of the data and were presented in form of graphs and tables. For testing the significance between the way of ICU admission (planned/unplanned) and different variables, Chi-square and Fisher's exact test were used. To assess risk factors of mortality outcome and long ICU stay, odds ratio was used. P-value of 0.05 or less was considered to be significant." NCT01076608,DETECT-Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment,"Inclusion Criteria: * unselected primary care patients Exclusion Criteria: * none","What kind of information will DETECT provide? I. From the cross sectional part (descriptive epidemiological part on 16th/18th September 2003) * Frequency, characteristics and severity of cardiovascular diseases, selected associated metabolic syndromes and atherosclerotic diseases and syndromes * Identification and determination of the proportion of patients with high-risk constellations (e.g., post myocardial infarction, associated morbidities, laboratory measures) * Rates of General Practitioners recognition, diagnostic and therapeutic profiles * Assessment of quality of care (comparison with guidelines) * Indicators of undertreatment, overtreatment and inadequate treatment II. From the longitudinal part Changes of laboratory parameters and diagnoses after one and five years, in relation to: * Initial diagnostic and therapeutic status * Selected intervention criteria * Composition of risk indicators, and comparison with existing indices (PROCAM, Framingham, Score etc.) * Measurement of frequency and point of critical outcomes e.g., myocardial infarction, associated morbidity, hospitalisation, critical medical interventions * Significance of established and ""new"" cardiovascular risk factors * Prognostic value of biomarkers for risk stratification" NCT01830608,Risk Factors for Drusen Progression,"Inclusion Criteria: * Men and postmenopausal women aged ≥ 50 years * AREDS categories 2 or 3 in at least one of the eyes * No ocular surgery within last 6 months Exclusion Criteria: * Late form of AMD in one or two eyes (AREDS category 4) * Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy * Clinically significant macular edema * Macular or peripheral retinal dystrophies * Ocular surgery other than uncomplicated cataract surgery * Opacity of the ocular media by cornea or lens or diseases, which could potentially influence scan quality",N/A NCT05365425,Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia,"Inclusion Criteria: * Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit * Male or female of 20 years or over * Mixed dyslipidemia: triglyceride 200\~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL * Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm * Creatinine ≤1.8 mg/dL Exclusion Criteria: * Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL * Uncontrolled hypertension * Severe renal dysfunction * GOT/GPT \>120/120 or chronic liver disease * Pregnant or childbearing woman who does not have enough contraception * Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months * Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)","In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound." NCT01806025,Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients,"Inclusion Criteria: Patients diagnosed with CF according to diagnostic criteria , between the ages of 0 and 50, who are themselves, or their parents or guardians, able to give informed consent. Two known severe (class I , II and III) mutations Exclusion Criteria: none","Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. The severity of the disease is determined by genetic factors (type of mutation), environmental factors (exposure to bacteria) and behavioral (adherence with therapy). Even among patients with the same severity of mutations there is a variation of the severity of CF. Haptoglobin is a protein responsible for collecting Iron from senescent Red Blood Cells. There are two genes of Haptoglobin, numbered 1 and 2, and combinations between the two genes create three forms of proteins: 1-1, 1-2, and 2-2. The 1-1 Phenotype was found to be associated with a predisposition to infection. In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications. To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype by gel- electrophoresis. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications. FEV1- Forced Expiratory Volume in 1 second." NCT00434525,Laparoscopic Sleeve Gastrectomy With and Without Omentectomy,"Inclusion Criteria: * Morbidly obese VETERANS ONLY (BMI\>35 with comorbidities or BMI\>40) * Age \> 18 Exclusion Criteria: * Pregnancy * Uncontrolled medical or psychiatric conditions * Previous bariatric procedure",This is a phase 3 prospective randomized trial. NCT04218734,A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM,"Inclusion Criteria: * Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard; * Age 18-75 years, men and women; * BMI 19-35 kg/m2; * HbA1c 7.0%-9.5%; * Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks. * Signed informed consent from the patient; * Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication. Exclusion Criteria: * FPG \> 13.9 mmol/L; * Insulin treatment required in the investigator's opinion; * Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening; * Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma); * Severe hypoglycemia; * Serious diabetic complications (such as diabetic foot, etc.); * History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.); * History of being allergic to DPP-4 inhibitors; * Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia; * Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study; * Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders; * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 3\*upper limit of normal (ULN), or total bilirubin \> 1.5ULN; * Abnormal renal function; * White blood cells (WBC) \< 3.0109/l, neutrophil count of peripheral blood \< 1.5109/l, hemoglobin \< 100g / L, triglyceride \> 5.7 mmol/l; * HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive; * Pregnant or lactating women; * History of alcohol or drug abuse; * Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening; * Significant unstable diseases; * Any condition that in the investigator's opinion might render the patient unable to participate the trial.",N/A NCT02041234,Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment,"Inclusion Criteria: 1. Established diagnosis of DM2 = or \< 10 years 2. Age 21-65 3. BMI 27-32. 4. HBA1c ≥ 8%, on maximum treatment from primary care physician 5. At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class I nephropathy, retinopathy. Exclusion Criteria: 1. Subjects who had previous Bariatric surgery or extensive upper abdominal surgery 2. Pregnant subjects. 3. Nephropathy requiring dialysis 4. Subjects who are not fit for general anaesthesia. 5. Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological. 6. Subjects who are unwilling or possibly unable to participate in the follow up process. 7. Subjects who are reluctant to be randomised into the two study groups. 8. Subjects who suffers from unstable psychiatric illness 9. Subjects who are active substance abusers 10. Glutamic acid decarboxylase antibody positive. 11. fasting C-peptide \< 300 pmol/L","40 subjects with DM2 will be recruited, randomised into two arms. The surgical arm will be subjected to RYGB. The medical arm will be treated maximally utilising the best means available and following internationally available protocol/guidelines. The study population will be subjected to a set of tests which is over and above the standard tests for similar groups of patients undergoing standard care (details below). Some test samples will be bio-banked. Treatment end points and follow up protocol will be the same for each treatment arm. The International Diabetic Federation (IDF) in 2011 recommended that bariatric surgery should be considered an alternative treatment option for those Asian DM2 subjects with BMI of 27 or above. Data for the effectiveness of Bariatric Surgery for those DM subjects with lower BMI is not as well established as those with higher BMI. There is scant good quality data, especially from Asian subjects. As their treatment is totally funded by the research project, subjects on the non surgical treatment arm will benefit from the more intense management of their disease with no restriction due to cost. The surgical arm will also be fully funded by the research project. They will be exposed to the standard risks associated with this type of surgery. Subjects in both arms will have to provide more blood and other samples than usual and has to follow visits protocol as close as possible. RYGB is a major surgical procedure, with significant potential complications; during the process of surgery and afterwards, both short and long term. Procedure related mortality is about 0.3%. Major complications that may require surgical intervention includes: anastomotic leakage about 3-4%, bleeding 3%, infection 3%, venous thrombo-embolism 1%. Some of these complications will require prolong hospitalisation. After surgery, loose stool, dumping syndrome, anastomotic ulcers can occur in less than 3%.Life long dietary supplement will be required. Longer term post surgical complications include intestinal obstruction due to adhesions or internal hernia, about 2%, further surgery may be needed. This risk is lifelong. Nutritional deficiencies, especially if not compliant with regular supplement intake, may occur. Drug allergies can occur; from simple rash to life threatening anaphylactic reaction. Blood taking can cause bruising, pain at the puncture site and sometimes fainting." NCT01401634,Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department,"Inclusion Criteria: * Any patient, above the age of 18 years old, presenting to Emergency Department triage with a fingerstick glucose between 250 and 500 mg/dL Exclusion Criteria: * Patients with evidence of DKA (hyperglycemia with ketonuria and abnormal pH or bicarbonate on venous blood gas), HHS, or other critical illnesses requiring immediate medical attention (as determined by ED triage nurses), * end-stage renal disease requiring dialysis through an arterio-venous shunt or fistula, * abnormal mental status (GCS \< 15), * unstable vital signs including pulse \> 100, SBP \< 100, respiratory rate\>20, (or any combination of vital signs not meeting these cutoffs but deemed worrisome by the triage nurse) or unable to tolerate oral intake/actively vomiting. * Patients who receive IV fluids prior to or during the study period. * Patients unable to communicate in English or Spanish. * Jail patients will also be excluded.",N/A NCT03109587,Pilot Study of Probiotics in Pre-diabetic Adolescents,"Inclusion Criteria: * Male or female, 13-19 y. of age at Visit 1. * BMI: 99th percentile or greater * Acanthosis nigricans * Pubertal Tanner stage ≥3 Exclusion Criteria: * Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies. * Known severe immunodeficiency, or immune compromised. * Current or previous history for insulin or metformin therapy (within last 3 months). * Antibiotic or probiotic therapy 3 months prior to enrollment. * Start of new dietary intervention within 1 month prior to enrollment. * Diagnosed food hypersensitivity or active gastrointestinal disease","Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children. The probiotic strains are known to improve glycemic control." NCT03083587,Frequent Activity Snacks Breaks,"Inclusion Criteria: * Sedentary lifestyle, * BMI 30-40 kg/m2 Exclusion Criteria: * Unable to read Swedish (for informed consent), * anticoagulant therapy, * unability to perform intervention",N/A NCT05629221,Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values,"Inclusion Criteria: * being diagnosed with T2DM; * aged ≥ 18 and ≤ 85 years old; * having an HbA1c level \>7% (53 mmol/mol) and \<12% (108 mmol/mol); * being able to walk without walking aids; * having provided written informed consent; * having a smartphone or a tablet and being able to download the App that will be used to insert the required data. Exclusion Criteria: * having a BMI \<18 Kg/m² and \>45 Kg/m²; * having a sBP \<100 or \>200 mmHg and/or dBP \<50 or \>120 mmHg; * being diagnosed with a stage 5 CKD\* * being diagnosed with a NYHA stage IV; * poor collaboration (ie unwilling to modify the actual plan of control and therapy, even if not ideal) for which adherence to the study is unlikely * having no possibility of using a smartphone or a tablet * having medical conditions affecting the study participation (i.e. life expectancy \< 1 year)","Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the 21st century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. Smartphone application - App) in the health field has progressively increased as it has been proved effective in helping some individuals manage their long-term diseases. Therefore, it has the potential to reduce health service utilization and its related costs. The objective of this study is to evaluate the impact of using a digital platform called ""TreC Diabete"" embedded into a novel organizational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy.This trial was designed as a multi-center, open-label, randomised, superiority study with two parallel-groups and a 1:1 allocation ratio. Individuals regularly attending outpatients diabetes clinics, providing informed consent are randomised to be prescribed TreC Diabete platform or not as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis.This trial is the first conducted in the PAT for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organizational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed." NCT04145804,Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections,"Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c \< 12.5% 3. Age18-65 years at the initiation of the 670G system 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period 5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software 6. Clinically planning to and be able to start the Medtronic 670G HCL system 7. History of 3 clinic visits in the last year 8. With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist. Exclusion Criteria: 1. Diabetic Ketoacidosis in the 6 months prior to screening visit 2. Type 2 diabetes 3. Hyperthyroidism at time of screening 4. Using Pramlintide, Dipeptidyl peptidase 4 (DPP-4) inhibitor, Glucagon-like peptide-1 (GLP-1) agonists, metformin, sodium-glucose transport protein 2 (SGLT2) inhibitors at time of screening. 5. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study.","Goal The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop systems in achieving glucose control of patients on MDI. Methods This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 40 subjects (age 18-65) will be enrolled in order to reach 34 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from Continuous Glucose Monitoring (CGM) will be performed at baseline and at the end of the 3-month study period. The following parameters will be analyzed"" % patients achieving glucose readings Time in Range (TIR) \> 67% in (70-180 mg/dl); % patients achieving \<3% Time below Range ( \<70 mg/dl) and % patients achieving both TIR \> 67% and \<3% Time below Range.Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server." NCT02474147,Processed Meat and Brain Regions Related to Reward and Addiction,"Inclusion Criteria: Inclusion criteria for T2D: 1. Type 2 diabetes mellitus for at least one year 2. Treatment of T2D: diet or oral antidiabetic agents (stable drug therapy at least 3 month before the trial 3. The presence of metabolic syndrome - any three of the following symptoms: * Abdominal obesity - waist circumf. in men\> 102 cm, in women \> 88 cm * Diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (FPG\>5,6 mmol/l) * Raised blood pressure (BP): systolic BP \> 130 mm Hg or diastolic BP \>85 mm Hg, or treatment of previously diagnosed hypertension * Reduced HDL cholesterol in men \< 1 mmol/l, in women \< 1,3 mmol/l (or treatment) * Raised triglycerides \> 1,7 mmol/l (or treatment) 4. HbA1c (according to IFCC) ≥4.2 a ≤10.5% 5. Men and women aged 30-70 years 6. Body Mass Index (kg/m2) in the range of 25- 45 7. The signed informed consent Exclusion Criteria: Exclusion criteria for T2D: 1. Type 1 diabetes mellitus 2. Unstable drug therapy at least 3 month before the trial 3. Treatment with Byetta or Victosa 4. Pregnancy (positive β-HCG test), breast feeding or trying to become pregnant 5. Presence of pacemaker or other metal implant in the body (MR) 6. Alcoholism or drug use 7. Significant weight loss (more than 5% of body weight) in previous 3 months before the screening 8. Presence of other medical condition, which occurs during physical examination, laboratory tests, ECG, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data 9. Metal in the body (fMRI)","The mesolimbic dopaminergic system of the brain, which converges on the nucleus accumbens (part of the striatum), plays a central role in reward and craving, and this system appears to mediate hedonic food responses. In rodent studies, extracellular concentrations of dopamine and its metabolites in the nucleus accumbens increased more after the consumption of highly palatable food than standard rodent feed pellets. Furthermore, microinjections of opiate into the nucleus accumbens increased food intake and the reward value of food. Clinical studies that used functional brain imaging have reported greater activation in the nucleus accumbens or other regions of the striatum in obese than lean individuals after they viewed or consumed palatable, high-calorie food. Of particular interest, striatal dopamine D2 receptor availability was significantly lower in obese individuals than in nonobese matched controls, which raised the possibility that overeating may compensate for low dopaminergic activity. The recurrent activation of the striatum may down-regulate dopamine availability and further heighten the drive to overeat. However, the information on the exact effect of different foods and nutrients on the mesolimbic dopaminergic system is missing. Preliminary findings that lead to the project A positive association between high consumption of total and red meat, especially processed meat, and incidence of T2D has been demonstrated. Previous studies support the concept that increased oxidative stress may play an important role in T2D manifestation. Dietary fat quality has been proposed to be a critical factor. Several studies have suggested that a high intake of saturated fatty acids naturally present in meat contributes to the risk of glucose intolerance. In an intervention study, humans suffering from metabolic syndrome who were consuming a diet rich in saturated fats displayed higher oxidative stress markers postprandially. It is not clear if saturated fatty acids per se or via increased oxidative stress markers may activate the mesolimbic dopaminergic system. In contrast, some intervention trials (including ours) demonstrated a greater improvement in insulin sensitivity, glycemic control and a reduction in oxidative stress markers in T2D patients consuming a vegetarian diet compared to a conventional diabetic diet. The effect of a vegetarian diet on the mesolimbic dopaminergic system has not been studied yet. Aims and priorities of the project The purpose of this study is to 1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls. 2. Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers) Hypothesis 1. Obese and T2D subjects relative to lean healthy controls will show greater activation in the gustatory cortex and in somatosensory regions in response to the intake of processed meat hamburger (vs. a vegetarian sandwich). However, they will also show decreased activation in the caudate nucleus in response to consumption of processed meat hamburger (vs. a vegetarian sandwich). 2. Changes in serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones and oxidative stress markers will be involved in gut-brain axis signaling. The investigators hypothesise to find an association between postprandial changes in serum concentrations of FFA and postprandial changes in activation in the gustatory cortex and in somatosensory regions of the brain. The actual need for this study The pandemic of obesity and diabetes especially in western countries calls for high-quality research and relevant action. A better understanding of the pathophysiological mechanisms of the stimulation of brain regions involved in reward and craving in response to processed meat, one of the most significant present risk factors for obesity and type 2 diabetes, is needed in order to develop more effective preventive and therapeutic strategies." NCT06907147,SPYRAL GEMINI Pilot Study,"Inclusion Criteria: All Subjects (both cohorts): 1. ≥18 and ≤80 years of age. 2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg. 3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline. Exclusion Criteria: 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy. 2. Prior renal or hepatic denervation. 3. Prior stroke or transient ischemic attack (TIA). 4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months. 5. Secondary cause of hypertension. 6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement. 7. Estimated glomerular filtration rate (eGFR) of \<40 8. Pregnant, nursing or planning to become pregnant during the study. 9. Primary pulmonary arterial hypertension. 10. History or evidence of active / suspected chronic liver or biliary disease. 11. Current or chronic pancreatitis.","This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts: * Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and, * Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s)." NCT03432858,Preoperative Antibiotics for Carpal Tunnel Release Surgery,"Inclusion Criteria: * High probability (\>12 points) on the Carpal Tunnel-6 diagnostic aide * Recommendation for carpal tunnel release * Capable of providing informed consent/LAR to act on subject's behalf Exclusion Criteria: * Patients allergic to both penicillin/cephalosporins and vancomycin * Patient immobilized with splint or cast * Unwilling unable to provide informed consent * Children under the age of 18",Study participants will be randomized to a prophylactic IV antibiotic treatment arm (Vancomycin or Cefazolin) or a placebo IV saline solution. Subjects will be monitored following surgery for surgical site infections. NCT01234155,Exercise Training and Type 2 Diabetes,"Inclusion Criteria: * age 18 to 80 * normal glucose tolerance, impaired glucose tolerance, or type 2 diabetes (as evidenced by use of oral hypoglycemic medication or 2-hour OGTT glucose \> 11.1 mmol/l) Exclusion Criteria: * Insulin treatment or type 1 diabetes * BMI \<19 or \>40 * Physically active * Undergoing weight-loss/gain * Pregnancy * Contraindication to exercise (ECG/CPX) * Significant cardiovascular disease * History of renal/hepatic/gastrointestinal/pulmonary disease * Clotting or bleeding disorders",N/A NCT06754878,Assessment of Serum Magnesium Level with Diabetic Foot Ulceration in Type II Diabetes Associated with Diabetic Nephropathy Patients,"Inclusion Criteria: * age\>18 years\<60 years Diabetic type 2 Patients with Diabetic foot ulceration Diabetic nephropathy CKD patients not on dialysis Exclusion Criteria: * • Patients with recent infectious disease, immunological disorders, taking diuretics and magnesium containing antacids * malabsorption syndrome, chronic diarrhea * CKD Stage V on dialysis, pancreatitis, alcoholism, liver diseases * tuberculosis, thyrotoxicosis, any malignancy.","Magnesium (Mg), is the fourth most common cation in the body, with an essential role in fundamental biological reactions, whose deficiency provokes biochemical and symptomatic alterations in the human organism. This ion is now established as a central electrolyte in a large number of cellular metabolic reactions, including DNA and protein synthesis, neurotransmission, and hormone receptor binding. It is a component of GTPase and a cofactor for Na+/ K +-ATPase, adenylate cyclase, and phosphofructokinase. Magnesium is a cofactor in more than 300 cellular enzymatic systems and has a key role in cellular metabolism; the recognition that Mg deficiency or excess may be associated with significant clinical consequences has resulted in an increased interest in the utility of serum Mg measurement. Diabetes mellitus (DM), characterized by metabolic disorders related to high levels of serum glucose, is probably the most associated disease to Mg depletion in intra and extra cellular compartments. In several studies reduced magnesium concentrations have been observed in diabetic adults. Hypomagnesemia has been related as a cause of insulin resistance, also being a consequence of hyperglycemia, and when it is chronic leads to the installation of macro and microvascular complications of diabetes, worsening the deficiency of Mg. The association between diabetes mellitus and hypomagnesaemia is compelling for its wide ranging impact on diabetic control and complications. Hypomagnesaemia has been linked to poor glycemic control, coronary artery diseases, hypertension, foot ulceration and diabetic neuropathy . Nerve Conduction Test (NCS)is the gold standard test that should be performed to confirm the presence of neuropathy to determine it's severity and to differentiate other causes of neuropathy from diabetic neuropathy." NCT00820378,The Epidemiology of Aortic Diameter in China,"Inclusion Criteria: * Patients aged 40 to 100 were referred to the hospital with a recent diagnosis of clinically evident arterial disease or a cardiovascular risk factor. Exclusion Criteria: * Those with connective tissue disease, congenital heart disease, cardiomyopathy, congestive heart failure,rheumatic arthritis, secondary causes of hypertension, or active cancer.","The purpose of this study was to analyze the size of the entire aorta at different anatomic levels in a large group of Chinese population with clinically evident arterial disease or cardiovascular risk factors to further explored the risk factors and potential alternative pathomechanisms for the development of aortic dilatation. Comprehensive transthoracic M-mode, 2-dimensional, and Doppler echocardiographic studies will be performed using commercially available equipment. The aortic dimensions were assessed at end-diastole at the different levels: (1) the annulus, (2) the mid-point of the sinuses of Valsalva, (3) the sinotubular junction, (4) the ascending aorta at the level of its largest diameter, (5) the transverse arch, (6) the descending aorta posterior to the left atrium, and (7) the abdominal aorta just distal to the origin of the renal arteries. The extension of dilation is defined as the number of dilated aortic segments. The relations among aortic dimensions and clinical characteristics will be assessed by multiple regression analysis. The current study was to determine the association of risk factors of CVD and atherosclerosis diseases with aortic dimension in Chinese patients with clinical event atherosclerotic disease or risk factors of atherosclerotic disease." NCT03046498,Addressing Diabetes Together,"Inclusion Criteria: * Adults 18 years or older * Diagnosis of diabetes * enrolled in the DSMP or DPP Exclusion Criteria: * unable to provide consent",N/A NCT07370987,Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial,"Inclusion Criteria: * Aged ≥ 45 years old * Candidate for pancreaticoduodenectomy by laparotomy * Body mass index (BMI) ≥ 25kg/m2 * Diameter of main pancreatic duct (MPD) \< 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area) * Affiliation to a social security system (AME excepted) * Signed informed consent Exclusion Criteria: * Surgery indication : Chronic pancreatitis * Surgery indication : Pancreatic ductal adenocarcinoma * History of syndromic or hereditary pancreatic tumor * Contraindication to pancreaticoduodenectomy * Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy * Planned external drainage of the main pancreatic duct at the end of the surgery * Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy * History of chronic hepatitis (F3) or cirrhosis (F4) * Contraindication to radiotherapy * Previous history of abdominal radiotherapy * Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus) * History of complicated peptic ulcer * Patient treated for less than 4 weeks for an ulcer * History of pancreatic surgery * Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control * Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator * Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study * Treatment with systemic corticosteroids (excluding inhaled corticosteroids) * Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study * Protected persons under legal guardianship or conservatorship",N/A NCT05694793,Trial for Reliability of Urodynamics SysTem,"Inclusion Criteria: 1. Female patient must be ≥ 18 years of age 2. Patient is a candidate for urodynamics per standard of care 3. Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: 1. Pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period 2. Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria). 3. Patient has history of recurrent UTIs (≥ 3 episodes in previous 12 months). 4. Patient has used antibiotics within the past 7 days from the baseline/screening visit. 5. Patient diagnosed with neurogenic LUTS (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine). 6. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS). 7. Patient with a urostomy. 8. Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall). 9. Patient who has from one or more major strictures in the urethra. 10. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen). 11. Patient with a colostomy. 12. Patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis. 13. Patient has a known inability to void or is in complete retention. 14. Subjects who, at the principal investigator's determination, would not be appropriate for this study",N/A NCT03524404,BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT,"Inclusion Criteria: * Men and women age ≥ 60 years * Diabetes Risk Score \>=5 Exclusion Criteria: * Decisional incapacity to consent",N/A NCT04979806,Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP),"Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Provide a signed written informed consent prior to any study-specific procedures 3. Meet the clinical criteria for either cUTI or AP 4. Requires hospitalization to manage the cUTI or AP 5. Agrees to use effective methods of contraception Exclusion Criteria: 1. Known or suspected disease that may confound the assessment of efficacy. 2. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy. 3. Rapidly progressive illness such that the subject is unlikely to survive the study period. 4. Pregnant or breastfeeding women 5. History of a seizure disorder requiring current treatment 6. Creatinine clearance \< 15 mL/min or on renal dialysis 7. Neutropenia or elevated liver enzymes 8. Hypersensitivity to beta-lactam antibiotics 9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject",N/A NCT06444906,"A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix","Inclusion Criteria: 1. Participant 18 years old or older 2. Type I or Type II diabetes mellitus 3. Participant has well controlled glucose levels, with HbA1c \< 12% within 3 months of Dermacyte Matrix application 4. Participant has adequate lower extremity perfusion, with Ankle-Brachial Index \> 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) \> 30 mmHg. The presence of tibial and plantar pulses is preferred. 5. Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes 6. DFU is full thickness (Wagner Grade I or II) 7. Adults with a chronic non-healing DFU (at least 30 days but no longer than 52 weeks old) will be eligible for enrollment 8. Participant's ulcer size \>0.5cm2 and \< 20cm2 area post-debridement 9. Participant has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care 10. Participant should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis) 11. Participant should have no evidence of underlying co-morbid conditions that would adversely affect wound healing such as: Cancer, Raynaud's syndrome, severe venous insufficiency or uncorrected arterial insufficiency, etc. 12. Participant should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc Exclusion Criteria: 1. Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis 2. Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including: 1. Adriamycin (doxorubicin), bleomycin, sirolimus (Rapamune, rapamycin) and anti-TNF cytotoxic/immunosuppressive agents; 2. Radiation therapy at the ulcer site; 3. Other immunosuppressive agents. 3. Subjects presenting with: 1. Charcot foot with a bony deformity 2. Chopart's amputation 3. Calcaneus ulcers 4. Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment 5. Subjects with evidence of skin cancer within or adjacent to the ulcer site. 6. History of bone cancer of the affected limb 7. Subjects who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index \< 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) \< 30 mmHg; absence of tibial or plantar pulses. 8. Subjects who have documented clinically significant medical conditions, which would impair wound healing. This includes: 1. Renal impairment (creatinine \>2.5 mg/dL); 2. Hepatic impairment (2XULN); 3. Hematological disorders (abnormities of formed elements); 4. Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator; 5. Excessive lymphedema that could interfere with wound healing 6. Subjects with signs and symptoms of cellulitis; 7. Subjects with ulcers with sinus tracts associated with an ongoing infection; 8. Subjects with active deep vein thrombosis; 9. Subjects with uncontrolled diabetes, as demonstrated by increased HbA1C (\> 12%); 10. Immunocompromised subjects (e.g., lymphoma, AIDS, myelodysplastic disorders) 9. HBOT within 3 days of treatment visit","This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or standard of care (SOC). Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12. In Part 2 of the study approximately 65 participants will be randomized 1:1 to receive Dermacyte Matrix or SOC for 12 weeks. The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study. For the purposes of this study, SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated." NCT03641352,The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes,"Inclusion Criteria: * between 19 years and 80 years old(male or female) * Type 2 diabetes mellitus * The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test * BMI between 21kg/m2 and 40kg/m2 * C-peptide ≥ 1.0 ng/ml * Agreement with written informed consent * HbA1c 7 to 10% after Run-in period Exclusion Criteria: * Type 1 diabetes mellitus or secondary diabetes mellitus * Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening * Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide * Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening * Treatment with anti-obesity drugs within 3 months",The aim of this phase 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759 NCT06055452,Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension,"Inclusion Criteria: • Meeting all the following criteria: 1. Aged 18 years and above. 2. Hypertensive patients currently taking at least one antihypertensive medication as recommended by guidelines, and blood pressure is within the target range (\<140/90 mmHg). 3. Within 3 months prior to screening，result meet any of the following criteria: 1. Left atrial volume index \> 34 mL/m² measured by echocardiography; 2. Average E/e' \> 9 measured by echocardiography; 3. NT-proBNP \> 125 ng/ml. 4. Signing an informed consent form. Exclusion Criteria: * • Exclusion criteria include any of the following conditions: 1. History of diabetes. 2. History of heart failure. 3. History of myocardial infarction, acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months 4. Left ventricular systolic dysfunction, defined as LVEF \< 50%. 5. Systolic blood pressure \< 100 mmHg. 6. A history of arrhythmias such as atrial fibrillation, atrial flutter, frequent atrial premature contractions, and frequent ventricular premature contractions may impact the structural and functional aspects of the heart. 7. Moderate and above valvular heart disease. 8. Severe obstructive disease of the left ventricular outflow tract, including aortic valve stenosis. 9. Confirmed diagnosis of cardiomyopathy and infiltrative myocardial diseases. 10. Visited within the past 1 month due to Genitourinary tract infection. 11. Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73m². 12. Alanine aminotransferase or aspartate aminotransferase levels \> 3 times the upper limit of normal. 13. Contraindications to taking SGLT2 inhibitors. 14. Currently taking SGLT2 inhibitors, SGLT-1/2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.). 15. Pregnancy or planning pregnant, or currently breastfeeding. 16. Malignant tumors or other severe illnesses with a life expectancy of less than 3 years. 17. History of alcohol abuse or substance abuse within the past year. 18. Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study. 19. Participation in or currently participating in other clinical trials within the last 3 months. 20. Known poor compliance with study follow-up or study drug. 21. Any condition or contraindication that makes a person intolerant to magnetic resonance imaging (MRI) or contraindicates MRI examination, such as the presence of implanted intracranial aneurysm clips, cardiac pacemakers or defibrillators, insulin pumps, etc.","Hypertension is the leading risk factor of heart failure with preserved heart failure. The overall control rate is about 16% in China. Given the large amounts of hypertensive patients at pre-heart failure (stage B), it's critical to explore the effect of additional cardioprotective medication in addition to well-controlled blood pressure. Sodium-glucose cotransporter-2 inhibitors (engagliflozin) have been shown to improve cardiac function or prognosis in patients with diabetes or heart failure. However, whether it has a cardioprotective effect on hypertensive patients with pre-heart failure and without diabetes remains unknown. We will conduct a multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes. We will enroll 120 eligible patients randomized to receive a placebo or engagliflozin (10mg/d) for follow them for 6 months. The primary endpoint is the left atrial volume index, which reflects left ventricular diastolic function. The secondary endpoints include echocardiography or magnetic resonance imaging to measure structural and functional parameters, blood pressure, glucose, and blood biomarkers of inflammation and fibrosis. We sought to comprehensively evaluate the effect of empagliflozin on the structure and function and explore the underlying mechanisms to provide insights and evidence for the prevention of heart failure in hypertensive patients." NCT01881347,Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus,"Inclusion Criteria: * Male and female subjects * Age over 21 years old * Body mass index less than 38 kg/m2 * Clinical stable type 2 diabetes mellitus Exclusion Criteria: * Women who are lactating or pregnant * Treatment with an investigations product within 30 days of screening * Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate * Liver transaminase levels greater than 3 times the upper limit of normal * History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study * Vitamin supplements exceeding two times the recommended daily allowance * Resveratrol or other dietary supplements except for a daily multivitamin",N/A NCT04217447,Assessment of Quitting Versus Using Aspirin Therapy In Patients Treated With Oral Anticoagulation for Atrial Fibrillation or Other Indication With Stabilized Coronary Artery Disease,"Inclusion Criteria: * Patients \>18 year-old * All patients that need anticoagulation with direct oral anticoagulant (DOAC) or vitamin K antagonist (VKA) for AF (paroxysmal, persistent or permanent) or other indication and have a stabilized CAD (free from MI, or coronary revascularization in the past year) but remain at high residual risk of recurrent coronary and vascular events. The use of DOAC will be promoted as recommended by guidelines. * Two different categories of patients could be included in the study, i) patients treated at the time of inclusion with the association of OAC and single antiplatelet therapy, it will be tested for them aspirin vs. interruption of antiplatelet therapy ii) patients treated with OAC alone at the time of inclusion, it will be tested for them administration of aspirin vs. no additional treatment with aspirin. * High-risk of coronary and vascular event is defined as follow : 1. History of PCI during an ACS involving placement of ≥1 stent(s) since \>6 months. 2. History of PCI (\>6 months) outside the context of ACS but with high-risk features of ischemic event recurrences defined as: diabetes, or diffuse multivessel disease (defined by the involvement of the 3 coronary vessels), or chronic kidney disease (creatinine clearance \< 50ml/min), or prior stent thrombosis, or complex PCI (defined by: stenting of the last remaining patent coronary artery, left main, at least 3 stents implanted and/or 3 lesions treated, bifurcation with two stents, length of stent \>60mm and chronic total coronary occlusion) or the presence of peripheral artery disease (previous limb revascularization bypass or percutaneous angioplasty, previous limb or foot amputation for arterial vascular disease, history of intermittent claudication of peripheral artery stenosis (≥50%) ,previous carotid revascularization or carotid stenosis ≥50%). * Women of childbearing potential with effective contraception defined as * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation : * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation : * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system ( IUS) * bilateral tubal occlusion * vasectomised partner * sexual abstinence Exclusion Criteria: * Any coronary event within 6 months prior to randomization * High risk of bleeding defined as recent (≤6 months) ISTH major bleeding event * Constitutional or acquired haemorrhagic disease including gastrointestinal bleeding and thrombocytopenia * Planned PCI within the next 6 months after randomization or subject requiring P2Y12 receptor antagonist therapy * Stroke within 1 month or any history of hemorrhagic stroke * Any contraindication to aspirin (ASA) or any of these excipients or other NSAIDs (hypersensitivity, allergy, active bleeding) * Any contraindication to anticoagulant * History (s) of asthma induced by the administration of salicylates or substances of close activity (especially NSAIDs) * Evolutionary gastroduodenal ulcer * Any other gastroduodenal history * Severe renal insufficiency * Severe hepatic insufficiency * Severe, uncontrolled heart failure * Lactose intolerance * Pregnancy * Breastfeeding patients * Unable (protected adults : tutorship, curatorship) orunwilling to consent","* Long-term aspirin (ASA) is the standard recommended antithrombotic therapy in patients with stable coronary artery disease (CAD), especially following stenting (Class I, Level A). * Long-term oral anticoagulation (OAC) is the standard antithrombotic therapy in patients with atrial fibrillation (AF) associated with one or more risk factor for stroke (Class I, Level A). * During the first year following acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), several studies evaluating the combination of OAC treatment and antiplatelet therapy are either already published or ongoing. * At distance of the index ACS and/or PCI, patients with stable CAD and concomitant AF remain at particular high-risk of ischemic (3 to 4 times higher as compared to patients with stable CAD without AF) and bleeding events. Antithrombotic management of these patients is subsequently highly challenging in clinical practice. The European task force suggests that the use of a full-dose anticoagulant monotherapy without any antiplatelet therapy should be the default strategy in such patients with both, AF and stable CAD. * However, evidences are sparse and weak to support such a strategy (only observational studies with many biases) and no randomized trial has assessed this question. These patients, especially those at high-risk of recurrent ischemic events (post- ACS, diabetes, multivessel CAD…) may benefit from the combination of OAC and aspirin at long-term. Indeed the crude event rate of ischemic events is much higher than the crude event rate of bleeding in this specific population. Ischemic events are 2 to 3 times more frequent than bleeding in daily practice. * The benefit/risk ratio of these two different strategies (ASA in combination with OAC vs. OAC alone) in patients at high-risk of recurrent coronary and vascular events remains unknown. Dual therapy with full-dose anticoagulation and ASA may lead to higher risk of major bleeding, while stopping ASA in stabilized high-risk patients after PCI may lead to poorer outcome regarding ischemic events. AQUATIC is a prospective, randomized, double-blind, placebo controlled, parallel-group, multi-center study. Randomization into 2 treatment groups and stratified on study center, type of OAC (VKA vs. DOAC), antithrombotic treatment received at the time of inclusion (dual therapy combining single antiplatelet therapy + OAC vs. OAC alone). Experimental group : Patients intaking full-dose OAC + ASA 100mg od. Control group : Patients intaking full-dose OAC + Placebo of ASA 100mg od. Note: * For Apixaban: in case of \> 1 of the followings: \> 80 years old, weight \< 60kg, creatinine level \> 133μmol/l; Or a creatinine clearance between 30 and 50 ml/min (Cockroft Formula), the dose of Apixaban will be reduced to 2.5 mg bid. * For Rivaroxaban: in case of moderate creatinine clearance (Cockroft Formula) (between 30 and 50 ml/min) or severe renal insufficiency (between 15 and 29 ml/min) the dose of Rivaroxaban will be reduced to 15 mg od. * For Dabigatran: in case of moderate creatinine clearance (Cockroft Formula) (between 30 and 50 ml/min) with age between 75 and 80 years: the dose of Dabigatran will be 150 mg bid or 110 mg bid, according to the ischemic and hemorrhagic risk of the patient. In case of age \> 80 years and/or concomitant administration of Verapamil, the dose of Dabigatran will be reduced to 110 mg bid. * For VKA: target INR (International Normalised Ratio) between 2 and 3. The primary efficacy objective is to demonstrate, in high-risk stabilized patients after PCI requiring also anticoagulation for AF, the superiority of the dual therapy ASA 100mg od + full-dose of OAC for 24-48 months versus full-dose of OAC alone (+ placebo) on a composite endpoint associating: cardio-vascular (CV) mortality, myocardial infarction, stroke, coronary revascularization, systemic embolism, and acute limb ischemia. The primary safety objective is major bleeding (ISTH : International Society of Thrombosis and Haemostasis). The secondary efficacy objectives are evaluation of efficacy of dual therapy SA 100mg od + OAC full ose versus OAC alone (+placebo) for: * The composite of CV mortality, MI (Myocardial Infarction ), stroke * CV mortality * All cause death * Myocardial infarction (MI) * Stent thrombosis (definite or probable) * Stroke (ischemic, hemorrhagic, or stroke of uncertain cause, transient ischemic attack \[TIA\]) * Coronary revascularization * Systemic embolism * Acute limb ischemia Net clinical benefit: * All cause mortality * Major bleeding \[define according to the International Society of Thrombosis and Haemostasis (ISTH): an acute, linically overt bleeding accompanied by one or more of the following findings: 2g/dl decline in Hemoglobin level r = 2 red blood cell transfusions over a 24-hour period, leeding of a major organ (intracranial, intramedullary, intraocular, pericardial, interarticular, intramuscular and / or retro peritoneal) or fatal bleeding\] * Thrombotic cardiovascular events: * Myocardial infarction * Stent thrombosis * Stroke (ischemic, hemorrhagic, or stroke of uncertain cause, TIA) * Any coronary revascularization * Systemic embolism * Acute limb ischemia The secondary safety objectives are : * Major and clinically relevant non major bleeding (ISTH) * Major bleeding (TIMI : Thrombolysis In Myocardial Infarction) * Major bleeding (BARC ≥3 : Bleeding Academic Research Consortium) All the included patients will be randomized at visit 1 and followed every 6 months until death or the end of the study (i.e. achievement of 2-year follow-up of the last included patient, maximum of 48 month followup for the first included patient).The first patient may require up to 9 visits . 2000 patients are expected to be included. Inclusion period : 72 months. Duration of patient's participation: 24 to 48 months depending of time of inclusion. Total study duration: 48 months. All included patients will remain in the study until death or the end of the trial (i.e. achievement of 2-year follow-up of the last included patient)." NCT05295849,Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss Intervention,"Inclusion Criteria: 1. 18-65 years old 2. BMI 30-45 kg/m2 3. has wifi connectivity at home (for wifi scale) 4. logs into Facebook at least 5 days per week over the past 2 weeks, and has posted/replied at least once a week in the past 2 weeks 5. able to participate in the study in English. Exclusion Criteria: 1. Pregnant/lactating or plans to become pregnant during study period 2. bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression 3. had bariatric surgery or plans to have surgery during the study 4. currently taking medication affecting weight 5. has lost ≥10% of weight in past year 6. is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving 7. chronic pain that interferes with the ability to exercise 8. Type 1 or 2 Diabetes 9. unable to make dietary changes or increase physical activity 10. unable to walk ¼ mile unaided without stopping 11. currently smokes or vapes nicotine 12. does not live in the United States 13. had major surgery in past 6 months 14. hospitalized for psychiatric reasons in past 12 months 15. has concerns about being audiotaped during the focus groups 16. does not have or not willing to create Fitbit account for study 17. unable to access smartphone at home and at work 18. does not have FB 19. has done a study with this PI before 20. has concerns about being in FB group with faculty/students of same university in which they work/attend 21. does not have smartphone 22. smartphone type/version not meeting app requirements 23. prisoner 24. unable to provide consent 25. does not complete onboarding steps for the study","The purpose of this single-arm pilot is to evaluate the feasibility of the intervention in 20 adults with obesity. We define feasibility as use of the mobile app features (dietary self-monitoring, slip tracker, and problem sharing/solving), retention, engagement (overall, problem solving), acceptability, and burden. This study will give us information that we can use to modify the intervention and our procedures before the larger pilot study. We will enroll 20 adults with obesity to participate in the 6-week pilot. Eligible participants will receive a link to complete surveys, mailed a wifi scale, and asked to provide staff with login information for the scale so weight can be recorded during assessments. They will then have a 60-minute call with a counselor to 1) download and receive training on program technology (MyFitnessPal, Habit app, and Fitbit scale) and 2) be entered into the Facebook group. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app. Every Monday in the group, participants will be given one diet and one exercise goal for the week and every Sunday they will be asked to share their progress on those goals. Every Friday they will participate in a ""weigh in"" thread in the group. In addition to the group, for the first two weeks, participants will be asked to use MyFitnessPal; for the second two weeks, they will be asked to use the Temptation/Slip Tracker and Exercise Planner; and for the final two weeks they will be asked to use the Problem Solver. We will ask each participant to share at least one diet or exercise problem with the group over the 6 weeks and to participate in each other's problem solving posts. Participants may attend optional weekly breakout sessions where weight loss related problems will be discussed. On the final day of the intervention, a post will go up in the group asking for a volunteer who used the app enough to brainstorm how to improve it to participate in a team meeting to discuss how to improve the program. If more than one participant volunteers, one will be randomly selected to participate. After the 6-week intervention, participants will complete the weight loss problem solving skills survey, provide a final weight, and complete individual phone interviews to discuss their experience. We will convene a team meeting with the investigators, interventionists, and a participant to discuss the results and any modifications that should be made to the program before progressing to the pilot study." NCT04784338,Virtual Weight Management Shared Medical Visit,"Inclusion Criteria: * English speaking * BMI =\> 30 * Must have documented measured blood pressure, weight, height in the 12 months prior to the intervention * Enrolled in Boston Medical Center's (BMC's) Food Pantry Program Exclusion Criteria: * Patients with advanced dementia or uncontrolled psychiatric disease * Uncontrolled medical illness including severe hypertension, recent acute coronary syndrome, active malignancy or other condition that would make the subject unable to complete the study procedures",N/A NCT02631148,Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.,"Inclusion Criteria: * Body Mass Index (BMI) ≥ 30 kg/m2 * Hemoglobin A1c (HbA1c) 6.7-6.4% * Self reported sleep \< 7 hours per night Exclusion Criteria: * Inability to extend sleep by one hour each night * Current or prior history of diabetes OR random serum glucose ≥200mg/dL * Pregnancy * Preexisting lung disease requiring oxygen * Preexisting cardiovascular disease * Active or uncontrolled psychotic disorder * Active or uncontrolled bipolar illness * Active malignancy with in the prior 5 years * Use of hypoglycemic medication * estimated glomerular filtration rate (eGFR) \<60ml/min/1.73m2 * Use of antihypertensive medications * Hepatic impairment * Job requiring rotating overnight shifts * Bariatric surgery within prior 12 months * Use of hypnotic medications * Hematocrit \<34% (women), \<36% (men)","The investigators will recruit individuals from the Boston area who meet the inclusion and exclusion criteria. The investigators will include both men and women and all races and ethnicities. The only exception will be women who are pregnant because certain medications used during the inpatient evaluations (e.g., nitroglycerine), and certain study medications (i.e., captopril) are contraindicated during pregnancy. Participant Enrollment Responders to advertisements will be pre-screened by telephone to obtain a body mass index (BMI) estimate and a medical history to gauge potential eligibility. For participants who may be eligible following this phone query, the basic study schema will be described to identify those who remain interested in participation after learning the duration, inpatient requirements, and potential medication use. These individuals will then be invited to attend an outpatient screening visit. The pilot study is a double-blind, placebo-controlled randomized trial, in which 16 subjects with obesity (body mass index \[BMI\] ≥30 kg/m2), pre-diabetes (hemoglobin A1C \[HbA1C\], 5.7-6.4%), and self-reported short sleep duration (\<7 hours/night) are randomly assigned 1:1 to receive either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour before bed for 6 weeks. All subjects will be asked to extend their sleep time by one hour during the 6 week period between inpatient visits. Endpoints will be measured at both the baseline and 6-week inpatient visits. Screening Visit: Screening visits will take place at the Brigham and Women's Outpatient Center for Clinical Investigation During the outpatient screen, Dr. McMullan will explain the study in detail, review the consent form, and answer questions. After obtaining written informed consent for participation, a history and physical examination will be performed in order to initially judge eligibility based upon the criteria set out in that section of this record. Participants deemed potentially eligible based upon the screening history and exam will undergo phlebotomy and analysis for HbA1c, serum chemistries and glucose, and complete blood count (CBC) to confirm eligibility using the criteria presented in the table. Study Procedures Pre-admission: All participants will wear a wrist activity monitor for a total of 8 weeks; 2 weeks prior to the baseline inpatient visit and for the 6 weeks between inpatient visits. Participants will complete a daily sleep log during the 2 weeks preceding each visit. Three days before admission, participants will be placed on a high salt diet by supplementing their usual diet with 150 millimoles (mmol) sodium/day for 3 days using dry bouillon added to food. Treatment assignments: Prior to admission for the baseline visit, participants will be randomized (1:1) to receive study medication (melatonin 2mg of controlled release formulation or placebo). All participants will be asked to extend their sleep time by one hour during the 6 week period between inpatient visits. Baseline and Follow-up inpatient visit: Baseline and 6-week inpatient visits will be virtually identical. Each inpatient visit will begin at 4:00PM on Day 0 and end at 4:00 PM on Day 1. Day 0 - All participants will begin 24 hour urine collection on admission to the Brigham and Women's Hospital Center for Clinical Investigation (CCI) on the evening of day 0. The 24-hour urine collection will be continued overnight (nurses will keep the daytime (8AM to 8PM) and nighttime (8PM to 8AM) urine separate to permit analysis of diurnal variation in urinary analytes). Subjects will fast after 9 pm to ensure a 12-hour fast by the next morning. Day 1 -At 8 am, central blood pressure and vascular compliance will be assessed, followed at approximately 9 am by measurement of renal specific RAAS activity via para-aminohippurate (PAH) renal plasma flow testing with captopril, and systemic renin-aldosterone-angiotensin system (RAAS) will be measured by plasma renin activity (PRA), plasma angiotensin II (Ang II) and urine aldosterone. Next the participant will receive a mixed meal (10kcal/kg, 45% carbohydrate, 15% protein, 40% fat, 1g/kg glucose) to be consumed in 15 minutes with blood draws at 0, 10, 20, 30, 60, 90 and 120 minutes from the time the meal had begun to be consumed. Plasma glucose, insulin and c-peptide will be measured in all 7 samples of blood. The 24-hour urine collection will conclude at 4 pm on day 1 and will be used to measure 24-hour excretion of sodium and aldosterone. Finally the participant will be fitted with a Spacelabs 90207 ambulatory blood pressure (BP) monitor prior to discharge to be worn for 24-hours. Follow-up - During the study, participants will be phoned weekly by a study coordinator to assess for compliance and potential side effects. Dr McMullan will call all subjects every 2 weeks to discuss difficulties encountered with their new sleep schedule, to recommend improvements and encourage compliance with the protocol. Parameters Measured: At the inpatient visits, the following measurements will be made: Renal Specific renin-aldosterone-angiotensin system (RAAS) - The activity of the local kidney RAAS can be measured by examining the change in effective renal plasma flow (RPF) after oral captopril while in high sodium balance. Effective RPF is measured as clearance of para-aminohippuric acid (PAH), because PAH is cleared solely and nearly entirely by the kidney. The protocol to measure PAH clearance is performed with the participant supine. Systemic renin-aldosterone-angiotensin system (RAAS) - plasma renin activity (PRA) and angiotensin II (Ang II) levels will be measured on the first morning blood draw. Central Blood Pressure - Will be measured using pulse wave analysis using the SphygmoCor system (AtCor Medical, West Ryde, New South Wales, Australia), which measures central blood pressure and arterial stiffness. Glucose metabolism - Will be evaluated by applying the Oral Minimal Model method to the results of a 2 hour 7- measurement, mixed meal tolerance test.2 Subject will be given breakfast in the form of a mixed meal (10kcal/kg, 45% carbohydrate, 15% protein, 40% fat, 1g/kg glucose) which must be consumed within 15 minutes with glucose, insulin and c-peptide measured from arterialized blood drawn at 0, 10, 20, 30, 60, 90 and 120 minutes from start of meal. From the glucose, insulin and c-peptide measurements calculation of insulin sensitivity (reciprocal of insulin resistance) and β-cell responsivity will be calculated. Data Collection: This study will collect demographic information (age, self-described race and ethnicity, sex), and physical data (height, weight, screening blood pressure). Blood and urine samples will be analyzed for various biomarkers to collect the data necessary to carry out the specific aims, as described in the section above. All of these data will be recorded in association with a study identification (ID) number, and kept as secure excel files by the statistician and programmer. The only individually identifiable private data that will be collected are names, addresses, and contact phone numbers so that participants can be screened with follow-up phone calls, and they will be admitted to the inpatient CCI under their name. This personal information, however, will not be associated with the results obtained from the various tests performed, as the latter will be associated with a study ID number. The file linking the study ID number and the personally identifiable information will be kept by the Principal Investigator in a secure location and will not be violated unless it becomes medically necessary to contact a participant on the basis of one of their lab screening tests (e.g., elevated liver function tests)." NCT03220685,Relationship Between Gut Microbiota And Anemia In Patients With Chronic Renal Failure,"Inclusion Criteria: 1 - Subjects participating in this study are CKD patients having eGFR less than 60 mL/min/1.73m2 for more than three months. 2\. Individuals may be taking laxative drugs but they must be discontinued 3or more weeks before admission. 3\. Age 18-70 years (in order to minimize the effect of aging on gut microbiota). Exclusion Criteria: * Subjects with a history or clinical manifestation of: 1. Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) and irritable bowel syndrome. 2. Lactose intolerance. 3. Eating disorders such as anorexia nervosa , bulimia and binge eating syndrome. 4. Taking weight loss drugs. 5. Use of any antibiotic or probiotic agents within 6 months prior to minimize the potential effects of these substances on the gut microbiota. 6. Use of antacids (Proton pump inhibitors, H2 antagonists or aluminum/magnesium hydroxide) 3 months prior to the study assessed by self-report because a modified gastric pH might affect the gut microbiota as well. 7. Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana). 8. Diabetic patients. 9. Patients on dialysis.","From the early stages of chronic kidney disease (CKD) there is a quantitative and qualitative alteration of intestinal microflora (dysbiosis); so the composition and metabolic activities of microflora are changed in CKD. These alterations include changes in intestinal transit, decreased protein absorption, decrease in dietary fibre intake, treatment with oral iron and frequent use of antibiotics. All of this contributes to systemic inflammation and the accumulation of uraemic toxins that are absorbed by intestine and eliminated by the kidney. This uraemic toxins have been associated with deleterious biological effects in different tissues and cell lines and with an increased risk of the progression of CKD, morbidity and mortality) * Progression of CKD: both indoxyl sulfate(IS) and p-cresyl sulfate (PCS) are associated to the development of fibrosis, deterioration of renal function and disease progression . In vitro studies have shown a deleterious effect of these molecules on renal tubular cells. - Cardiovascular complications: in CKD patients, IS is associated with endothelial damage, arterial stiffness and aortic calcification . * Anaemia: IS has been associated with anaemia of the renal patient; it interfere with the adequate production of erythropoietin and increased eryptosis (programmed cell death of red blood cells) .Polyamines are associated to anaemia in renal patients, through an intra-erythrocytic effect ,reduces erythropoiesis, and inhibit the activity of erythropoietin) * Alterations of bone-mineral metabolism: IS reduces bone formation by promoting oxidative stress in osteoblasts and inducing resistance to PTH, which favours the development a dynamic bone .There is a positive correlation between FGF-23 and IS serum levels, suggesting an association between this molecule and metabolic bone disease in uraemic patients . * Insulin resistance: In CKD patients the catabolism of insulin is reduced and often, they also have insulin resistance, which is associated with an increased risk of mortality; it seems that insulin resistance is related to some of the uremic toxins ." NCT01583335,The Healthy Start Project: Primary Prevention of Overweight in Preschool Children Susceptible to Future Overweight,"Inclusion Criteria: * Born between 2004-2007 * Born in 11 selected municipalities in the greater Copenhagen area * Classified as susceptible to overweight and obesity (At least one of the following risk factors present: A high birth weight (\> 4000 grams), maternal pre-pregnancy obesity (BMI \> 28 kg/m\^2), or maternal low education (\<= 10 years) * Normal weight at baseline examination Exclusion Criteria: * Moved to another municipality after birth, * Had requested protection from participation in statistical or scientific surveys based on data delivered from the Danish Central Person Registry * No permanent address * Lived in a children's home * Had died * Had emigrated * Registered in the Danish Central Person Registry as being disappeared or had unknown life status * Not speaking Danish * Overweight (including obesity) at baseline examination","In 2009, data on all births between 2004 and 2007 in 11 selected municipalities from the greater Copenhagen area was obtained from the Danish national birth register at the National Board of Health. This register contains information on all births, whether at hospital or home, on factors such as birth weight and length, height and pre-pregnant weight of the mother, parity, and Central Personal Registry number (CPR-number). Data on socioeconomic status was obtained from the administrative birth forms. This was done manually using the CPR-numbers obtained from the birth register. After selection of the children eligible for participation, the children were allocated to three groups, (intervention group, control group, shadow group) using computer based randomization. All siblings were allocated to the same group. After the random allocation, children from the intervention group and the control group were sent a letter with an invitation to participate in the project. Children from the shadow group were also identified, and their general practitioners were contacted and asked for information on each child's height and weight." NCT00276406,Use of Pyridostigmine for Constipation in Diabetics,"Inclusion Criteria: * Subjects with diabetes mellitus (Type I or type II), diagnosed by a physician. * On medical treatment for diabetes (oral medication or injected insulin) for at least one year * Symptomatic constipation at least 25% of the time in the past year (Rome II criteria for functional constipation) * 18-70 years of age * Colonoscopy negative for obstructive lesions, cancer, or inflammatory bowel disease (IBS) within the last 8 years if 50 years of age or older * Able to provide written informed consent before participating in trial * Able to communicate adequately with the Investigator and to comply with the requirements for the entire study Exclusion Criteria: * History of pelvic floor dysfunction (other functional GI disorders, eg IBS, non-ulcer dyspepsia are acceptable); Specifically, patients will be excluded if they have at least 2 of the following 3 criteria: * History of digital evacuation of the rectum or pressure on the posterior aspect of the vagina or perineum to facilitate defecation * Examination findings suggestive of puborectalis spasm or anismus, on assessment by an experienced gastroenterologist with expertise in this field; i.e. high anal sphincter tone at rest, failure of perineal descent by \>1cm on straining, and tenderness or paradoxical contraction of the puborectalis on digital examination * Requirement of \> 200g to expel a rectal balloon during voluntary straining * Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair * Suspected or known gastrointestinal or genitourinary obstruction * Uncontrolled hypertension (defined as \> 150/90 at rest) * Known cardiac arrhythmia or ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree atrioventricular (AV) block, prolonged corrected QT interval (QTc)(\> 460 msec) or bradycardia (\< 45 beats/minute)) * Renal insufficiency with serum creatinine greater than 2 mg/dl based on a reading from the previous 6 months * Asthma or chronic obstructive pulmonary disease requiring systemic steroids in the previous 3 years (inhaled steroids acceptable) * Current use of narcotics, gut prokinetic drugs (eg metoclopramide, domperidone, tegaserod, senekot), anticholinergic medication (eg. Hyoscyamine, belladonna), antidiarrheals (Imodium, Lomotil), or laxatives other than fiber supplements, docusate, or glycerin suppositories. Patients on any of these restricted medications must cease use at least 48 hours before starting and for the duration of both study phases. No rescue laxatives will be permitted within 7 days of transit testing * Patients who have taken any investigational medications within the past 30 days * Known intolerance or allergy to eggs * Pregnant or breast-feeding females","Chronic constipation in diabetes mellitus is associated with colonic motor dysfunction and is managed with laxatives. Cholinesterase inhibitors increase colonic motility. The study evaluated the effects of a cholinesterase inhibitor (pyridostigmine vs. placebo) on gastrointestinal and colonic transit and bowel function in diabetic patients with constipation. After a 9-day baseline period, patients with diabetes mellitus and chronic constipation without defecatory disorder will be randomized to oral placebo or pyridostigmine, starting with 60 mg three times a day, increasing by 60 mg every third day up to the maximum tolerated dose of 120 mg three times a day; this dose will be maintained for 7 days. Gastrointestinal and colonic transit (assessed by scintigraphy) and bowel function will be evaluated at baseline and the final 3 and 7 days of treatment, respectively." NCT02881684,Aspiration Therapy in Asian Patients,"Inclusion Criteria: 1. Measured body mass index (BMI) of 27.5-55.0 kg/m2 at time of screening. 2. 21- 65 years of age (inclusive) at time of screening. 3. Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs) 4. Stable weight (\<3% change in self-reported weight) over the previous 3 months at time of screening. 5. Women of childbearing potential who agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, intrauterine device (IUD), condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit 6. Willing and able to provide informed consent and comply with the protocol. Exclusion Criteria: 1. Evidence of an eating disorder or major depression 2. History of gastrointestinal disease or previous gastric surgery that would increase the risk of the AspireAssist® Tube (A-Tube) placement 3. Severe co-existing medical diseases or malignancies 4. Bleeding tendency (low platelet, coagulopathy including being on anti-coagulants) 5. Pregnant/lactating","Obesity is a major global health problem and Asians are equally affected. According to the latest Behavioural Risk Factor Survey in 2014, 20.8% of adults in Hong Kong have body mass index (BMI) belonging to the obese category. Obesity is associated with a multitude of medical and psychological comorbidities that could cumulate in increased healthcare costs and impaired quality of life. As such, an effective treatment strategy for obesity is imperative. Sustainable weight reduction by lifestyle measures alone is often difficult if not impossible. Pharmacotherapy can provide additional weight reduction when used as an adjunct to lifestyle intervention but the efficacy is modest. The most effective method for weight reduction to date is bariatric surgery but this is limited by its invasiveness and irreversibility. The limitations of current obesity treatment has led to an increased interest in endoscopic treatment, which may be more effective than pharmacotherapy and less invasive and more reversible than bariatric surgery. The AspireAssist® Aspiration Therapy System is a novel endoscopic therapy developed by Aspire Bariatrics Inc. (King of Prussia, United States) for treatment of obesity. The system takes advantage of percutaneous endoscopic gastrostomy (PEG) tube technology to induce weight reduction by aspirating a portion of ingested meals from the stomach. In a pilot study involving 18 Caucasian obese subjects randomly assigned in a 2:1 ratio to aspiration therapy group and lifestyle therapy only group, the weight reduction was 18.6% +/- 2.3% and 5.9% +/- 5.0% respectively. The present study aims to investigate the effectiveness and safety of this device in Asian subjects." NCT04841304,Cardiac Arrhythmia in Patients with End-Stage Renal Disease,"Inclusion Criteria: Patients with diabetes: * Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization * Treated with glucose-lowering drugs at inclusion * Receiving in-center maintenance hemodialysis for more than 3 months * Age ≥ 18 years Patients without diabetes: * No known diagnosis of diabetes * No previous treatment with glucose-lowering drugs * HbA1c \< 48 mmol/mol at screening * Receiving in-center maintenance hemodialysis for more than 3 months * Age ≥ 18 years Exclusion Criteria: For both groups: * Cardiac pacemaker or implantable cardioverter defibrillator (ICD) * Known permanent (chronic) atrial fibrillation * History of sustained (\> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion criterion) * Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome) * Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation) * Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction * Inability to give written informed consent",N/A NCT06700447,Protecting Against HIV Vaccine Misinformation With Adolescent Girls and Young Women in South Africa,"Inclusion Criteria: * Female * Age 18-29 years * Self-reported history of sexual activity in the past 12 months * Self-reported HIV-negative status or unknown HIV status at enrolment * Willing and able to provide written informed consent * Able to read and understand English Exclusion Criteria: * Unwilling or unable to provide consent for study participation.",N/A NCT04803838,"The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study","Inclusion Criteria: \- patients \>18 years with an symptomatic og asymptomatic atherosclerotic carotid stenosis ≥ 50% (NASCET criteria) Exclusion Criteria: * active infection * current antibiotic treatment * autoimmune or autoinflammatory disease * malignancies","The Project will include four studies: Study 1: (Comparative cross-sectional study) The main objective in this study is to assess if patients with carotid atherosclerosis have increased serum levels gut microbiota dependent metabolites compared to healthy controls. This study will be done on prospectively collected information already available in our existing database. Approximately 215 patients will be included in this study where collected samples will be analyzed and levels of metabolites quantified. These metabolite levels will be compared to a control group of 70 healthy controls without carotid atherosclerosis (verified by ultrasound), cardiovascular outcome defined as stroke/TIA or vascular death, as well as traditional risk factors for ischemic stroke (diabetes, hypertension, smoking and coronary artery disease). Study 2: (Comparative cross-sectional study) The aim of this study is to asses if microbiota and microbiota metabolite Levels are Associated With certain types of diet, in particular Rich in red meat and egg yalk. In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls. Dietary intake and food habits will be recorded using the SmartDiet questionnaire developed by 'Lipidklinikken Rikshospitalet'. Feces, saliva and blood will be collected analyzed for microbiota and metabolites. Antroprometrics, blood pressure and pulse will be recorded. In patients undergoing carotid endarterectomy and immunohistochemical analysis will be done. Study 3: (Comparative cross-sectional study) The aim of this study is to evaluate correlation between the microbiota and microbiota metabolite Levels With other inflammatory markers in blood, as well as known risk factors for stroke and inflammation on imaging modalities (ultrasound, 3-T MRI and PET/CT) . In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls. Patients will undergo investigations with carotid ultrasound, carotid and cerebral MR imaging, blood tests including inflammatory biomarkers. A sub-group of patients will in addition undergo PET/CT imaging of carotid arteries. Study 4: (Follow up study) The aim of this study is to evaluate the ability of microbiota and microbiota metabolites to predict ischemic stroke in patient With carotid stenosis. Patients in study 2 and 3 will be followed up after 2 years with repetition of investigations. Findings with serum levels of microbiota metabolites, traditional risk factors and imaging will be correlated to clinical and radiological ischemic events and plaque progression."