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About This Study

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.

Design

Interventions / Regimen

• Drug: sigvotatug vedotin — Administered into the vein (IV; intravenously)
• Drug: pembrolizumab — 200mg every 3 weeks or 400mg every 6 weeks, given by IV
• Drug: cisplatin — 75 mg/m2 every 3 weeks, given by IV
• Drug: carboplatin — AUC 5 mg/mL per min every 3 weeks, given by IV

Primary Outcomes

• Number of participants with adverse events (AEs) (Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years)
• Number of patients with laboratory abnormalities (Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)
• Number of participants with dose-limiting toxicities (DLTs) (Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years)

About This Study

To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.

Design

Primary Outcomes

• Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs) (For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months.)

About This Study

To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.

Design

Interventions / Regimen

• Device: Hemotag — Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days

Primary Outcomes

• To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration. (12 months)

About This Study

Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.

Design

Interventions / Regimen

• Behavioral: Home Based Testing — Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.
• Behavioral: Clinic Based Screening — Community Health Workers (CHWs) will offer referral to clinic based OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.
• Dietary Supplement: Food order nutritional intervention before meals — Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement before meals (protein-fiber first) or consume it after meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.
• Dietary Supplement: Food order nutritional intervention after meals — Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement after meals (protein-fiber first) or consume it before meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.

Primary Outcomes

• Number of participants who completed OGTT during the first year postpartum (Up to 1 year and 3 months)

About This Study

This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.

Design

Interventions / Regimen

• Drug: Insulin icodec — Insulin icodec will be administered as subcutaneous injection.
• Drug: Basal insulin analogues — Basal insulin analogues will be administered as subcutaneous injection.

Primary Outcomes

• Change in glycated haemoglobin (HbA1c) (From baseline week 0 to week 52)

About This Study

This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes.

Design

Interventions / Regimen

• Other: 75g glucose beverage (Glucola, Trutol, or similar brand) — Subjects will present fasting to the study day and ingest the glucose beverage during the oral glucose tolerance test.
• Other: DXA, whole body — Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.

Primary Outcomes

• Glucose response to an oral glucose load (samples will be collected over four hours and these results will be used to calculate area under the curve)

About This Study

The main goal of this two-phase clinical trial is to learn whether local heat therapy, using heat pads applied to the legs, can enhance skeletal muscle health, physical function, and blood sugar control in a manner comparable to exercise, specifically High-Intensity Interval Training (HIIT), in older individuals with prediabetes. The study aims to answer the following questions: 1. Does local heat therapy improve muscle architecture (e.g., muscle cross-sectional area, capillary density, mitochondrial content), glucose tolerance, and frailty indicators similarly to HIIT in older individuals with prediabetes? 2. Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?

Design

Interventions / Regimen

• Behavioral: Heat therapy — Heat pads will be set to a pre-determined, optimized temperature and applied to both legs for 90 min, 6d/wk (5 at-home and 1 in-lab).
• Behavioral: High-intensity interval training — High-intensity interval training will be performed 3 days per week for 12 weeks.

Primary Outcomes

• Glycemic control (Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group))
• Skeletal muscle architecture 1 (Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group))
• Skeletal muscle architecture 2 (Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group))
• Frailty status (Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group))
• Exercise capacity (Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group))

About This Study

Methodology Patient with diabetes 2 with informed consent -convenience sampling over a one year period.The tooth isolated with a rubber dam and the correct disinfection procedures will be used. researcher will do the Access preparation Working length -electronic apex locator (Dentsply Propex II) as well as a radiographic approach. After the canals will be obturated using ZOE sealer and gutta percha and post endodontic restoration is done using composite restoration. Patient is kept on follow up for 7days, 15 days, 30 days ,45 days and 60 days Clinical outcome is measure using periapical radiograph (RVG) Pain is measured using visual analog scale to mark the pain intensity. Data will be analysed statistically To enlarge the root canals (ISO size 20 file) A sterile paper point inside the root canal for one minute until the apex of the root canal is reached Using T.E Buffer, samples will be delivered to the School Of Basic Life Sciences, Sharda University. The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal. Grouping Following instrumentation, 5% NaOCl and 17% EDTA irrigation will be done. Control group (n=15) The final irrigant will be saline Group 1 (n=15) Irrigation using 5% apple cider vinegar done The final irrigant will be saline Group 2 (n=15) Diode laser is used for disinfection in the presence of saline Group 3 (n=15) Gymnema Sylvestre Mother Tincture Q 1000 CH solution is used for disinfection in the presence of saline Group 4 (n=15) Diode laser is used for disinfection in the presence of 5% apple cider vinegar. The final irrigant will be saline Group 5 (n=15) Diode laser is used for disinfection in the presence of Gymnema Sylvestre Mother Tincture Q 1000 CH solution. The final irrigant will be saline After cleaning and shaping, samples will be collected and sent through T.E. Buffer to the School Of Basic Life Sciences, Sharda University. The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal.

Design

Interventions / Regimen

• Other: 940 nm diode laser — laser for irrigation
• Other: apple cider vinegar — 5% apple cider vinegar
• Other: Gymnema Sylvestre — antidiabetic agent
• Other: Saline (NaCl) — saline is used as ideal irrigant
• Other: Diode laser and Gymnema Sylvestre — This is the combination disinfection
• Other: Diode laser and apple cider vinegar — combination therapy used will enhance the disinfection

Primary Outcomes

• Visual Analog Scale (VAS) (6 months)
• Detection of peptostreptococcus species after the use of intervention (one year)

About This Study

EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up

Design

Interventions / Regimen

• Drug: Exenatide — All patients initiating exenatide during the study period will be identified by ATC codes and be included in the exenatide group in a hierarchical manner, regardless of previous use of non-GLP-1 RA based glucose lowering drugs.
• Drug: Non-GLP-1 RA based glucose lowering drugs — Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period.

Primary Outcomes

• Incidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population (Follow-up starts from the index date to the study completion, an average of 1.5 years or less)
• Hazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed population (Follow-up starts from thr index date to the study completion, an average of 1.5 years or less)

About This Study

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.

Design

Interventions / Regimen

• Drug: Lenbelintide — IMP injected subcutaneously, once a week.
• Drug: Placebo — Placebo matching IMP dose injected subcutaneously, once a week.

Primary Outcomes

• Percent change in body weight from baseline at 68 weeks of treatment (68 weeks)

About This Study

Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.

Design

Interventions / Regimen

• Drug: Allisartan Isoproxil — Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.
• Drug: Amlodipine 5mg — Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).
• Other: Standard treatment by current guideline — No BP-lowering medications are used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.

Primary Outcomes

• Composite of Major Adverse Cardiovascular and Cerebrovascular Events (From date of randomization until the date of first documented incidence of the major adverse cardiovascular events prespecified, whichever comes first, assessed up to 60 months)

About This Study

The goal of this clinical trial is to determine whether a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) is more effective than standard care in achieving diabetes remission in adults with overweight and type 2 diabetes mellitus. The study will also evaluate the effects of the intervention on metabolic and clinical outcomes associated with diabetes remission. The main questions it aims to answer are: * Does a low-calorie diet combined with intensive lifestyle intervention using iPDM increase the proportion of participants who achieve diabetes remission compared with standard care? * Does the intervention improve metabolic and patient-centered outcomes, including glycemic control, body weight, body composition, Time in Range (TIR) measured by continuous glucose monitoring (CGM), quality of life, and cost-effectiveness? Researchers will compare participants receiving a low-calorie diet combined with intensive lifestyle intervention using iPDM with participants receiving standard diabetes care to determine whether the intervention is more effective in achieving diabetes remission and improving metabolic health. Participants will: * Be randomly assigned to either the intervention group or the standard care group. * Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study. * If assigned to the intervention group, consume two low-calorie meal replacements per day and follow an individualized meal plan providing no more than 1,200 kcal per day during the first 3 months (intensive phase), together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks. During the following 3 months (maintenance phase), continue lifestyle modification with reinforcement sessions delivered via telemedicine every 4 weeks while following a meal plan providing no more than 1,500 kcal per day.

Design

Interventions / Regimen

• Behavioral: Low-calorie diet — Participants in the intervention group will receive a Thai food-based low-calorie diet consisting of two meal replacements per day, combined with individualized dietary counseling to achieve a total daily energy intake of ≤1,200 kcal/day during the 3-month intensive phase. During the subsequent 3-month maintenance phase, participants will transition to a Thai food-based energy-controlled diet with reinforcement of behavioral modification strategies and nutritional education delivered via telemedicine every 4 weeks, with a recommended total daily energy intake of ≤1,500 kcal/day.
• Device: Continous Glucose Monitor (CGM) — Real-Time Continuous Glucose Monitoring
• Other: Standard Care (in control arm) — Standard diabetes care with routine clinical visits every 3 months.
• Behavioral: Personalized exercise program — The exercise intervention is individualized according to the FITT (Frequency, Intensity, Time, and Type) principles for adults with type 2 diabetes mellitus. Baseline cardiorespiratory fitness is assessed using the YMCA 3-Minute Step Test. Heart rate recovery following the test is used to classify participants' fitness level and determine their initial exercise prescription. Exercise intensity is subsequently individualized and progressively adjusted using the Rating of Perceived Exertion (RPE) and/or heart rate monitoring to ensure safe and effective progression throughout the intervention.

Primary Outcomes

• Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months (3 months)