Jodhpur

Olfaction plays a vital role in a persons quality of life by helping to identify safe food, detect threats, and support social interactions. This research investigates how different surgical techniques during endoscopic endonasal skull base surgeries affect olfactory ability, focusing on whether the use of a scalpel or cautery to elevate the nasoseptal flap better preserves smell function. The study is a prospective randomized controlled trial sponsored by the All India Institute of Medical Sciences, Jodhpur. Participants will be randomly assigned to one of two groups during their endoscopic endonasal skull base surgery one group will have the nasoseptal flap elevated using a scalpel, while the other group will have it elevated using cautery. These surgeries are minimally invasive and aim to remove tumors involving the pituitary and skull base with better visualization and faster recovery. The study compares the effects of these two surgical tools on the olfactory epithelium, which is at risk during such procedures. Participants will undergo assessments of their sense of smell using the Combined Olfactory Score I-smell test and Visual Analogue Scale before surgery, immediately after, and 3 to 6 months post-surgery. They will also complete the 22-item Sino Nasal Outcome Test questionnaire at these same time points. The study will monitor the changes in olfactory function over time to determine which method better preserves smell after surgery. Total participation includes preoperative and postoperative follow-ups lasting up to six months.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the prevention of early post-traumatic seizures PTS in patients with traumatic brain injury TBI. This multicentric, prospective, randomized, placebo-controlled, double-blinded study aims to compare the seizure incidence and effectiveness of two anti-epileptic drugs, phenytoin and levetiracetam, against a placebo. The study also investigates how genetic differences affect seizure occurrence and the safety and cost-effectiveness of these treatments. Participants will be randomly assigned to one of three groups the phenytoin group, the levetiracetam group, or the placebo group. The phenytoin group receives an intravenous loading dose followed by maintenance doses, transitioning to oral medication within one week post-injury. The levetiracetam group receives intravenous doses twice daily, then switches to oral extended-release tablets for one week. The placebo group receives matching saline infusions and placebo tablets over the same period. Genetic testing will be performed to analyze drug polymorphisms. During the study, participants will be monitored for clinical seizures within seven days after injury, with follow-ups at hospital discharge, six months, and one year. Assessments include Glasgow Coma Scale and Glasgow Outcome Scale scores, genetic polymorphism analysis, and a cost-effectiveness evaluation of the drugs. The total study duration involves monitoring seizure occurrence early after injury and longer-term clinical and functional outcomes.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups pre-operative chlorhexidine mouthwash combined with high oxygen levels 80-100% FiO2, no mouthwash with high oxygen levels, mouthwash with low oxygen levels 21-30% FiO2, or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.

Researchers are studying oral squamous cell carcinoma, focusing on patients with advanced nodal disease N2-N3 who are operable and present biologically aggressive tumors. The study aims to evaluate whether adding induction chemotherapy before surgery improves 2-year disease-free survival compared to upfront surgery alone. This phase 3, open-label, multi-center randomized controlled trial addresses previous trial limitations by selecting a more homogenous patient group likely to benefit from chemotherapy. Secondary goals include assessing overall survival, treatment response, compliance, toxicity, postoperative complications, quality of life, and tumor biobanking for future research. The study compares two treatment approaches. The standard arm involves surgery wide local excision with comprehensive neck dissection followed by adjuvant radiotherapy with or without concurrent chemotherapy. The experimental arm adds two cycles of induction chemotherapy using TPF or TPX regimens before surgery and similar adjuvant treatment. Patients will receive standard care according to current guidelines, with surgery timed after assessing chemotherapy response. Participants aged 18 to 75 with confirmed operable oral squamous cell carcinoma and advanced nodal involvement will be followed for up to five years. Researchers will monitor disease-free survival at two years as the primary outcome, alongside overall survival, treatment completion, toxicity, quality of life assessments over multiple timepoints, and surgical morbidity. Tumor and blood samples will be collected for biobanking. Safety and quality of life will be tracked regularly, including early and late radiotherapy-related toxicities and financial impact questionnaires.