Jodhpur

Olfaction, the sense of smell, is important for quality of life and has played a key role in human survival and social interaction. Endoscopic endonasal surgeries are commonly used to remove brain tumors involving the pituitary gland and skull base because they are minimally invasive and allow faster recovery. However, these surgeries can risk damaging the olfactory epithelium, the tissue responsible for smell, due to its location and the surgical techniques used. This study aims to compare how using a scalpel versus cautery during these surgeries affects patients' olfactory function. Participants will undergo endoscopic endonasal skull base surgery requiring the elevation of a nasoseptal flap. During surgery, one group will have the flap raised using a scalpel, while the other group will have it raised using cautery. The study will assess which method better preserves the patient's sense of smell after surgery. Throughout the study, researchers will measure participants' olfactory function using the Combined Olfactory Score and assess discomfort or pain with a Visual Analogue Scale before surgery, immediately after, and 3 to 6 months postoperatively. This will help determine the impact of each surgical technique on smell recovery and patient experience over time.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are conducting a high-quality, prospective, multicenter, randomized clinical trial to evaluate seizure prevention after traumatic brain injury (TBI). This study compares the use of two anti-epileptic drugs, phenytoin and levetiracetam, against a placebo to determine their effectiveness in preventing early post-traumatic seizures (PTS). Additionally, the study explores how genetic differences (drug polymorphisms) may influence seizure occurrence and treatment outcomes. This trial addresses gaps in current knowledge and represents the first global effort to assess these factors in TBI patients. Participants are randomly assigned to one of three groups: phenytoin, levetiracetam, or placebo. The phenytoin group receives an initial intravenous loading dose followed by maintenance doses administered intravenously every 8 hours, switching to an oral extended-release tablet once able to tolerate oral intake. The levetiracetam group is given intravenous doses twice daily, then two oral extended-release tablets daily when oral intake is possible. The placebo group receives matching intravenous saline and placebo tablets during the treatment period. All treatments are given for one week following the traumatic brain injury. During the study, participants are monitored for seizures within seven days after injury, with genetic testing performed to analyze drug polymorphisms. Researchers assess clinical and functional outcomes, safety, and cost-effectiveness for each treatment group. The trial aims to provide strong evidence on the role of preventive anti-epileptic drugs after TBI and the impact of genetic factors, enhancing understanding of seizure management in this population.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the safety and effectiveness of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) compared to a placebo in adults recently diagnosed with SARS-CoV-2 infection who do not need hospitalization. This Phase 3, double-blind, randomized trial aims to assess participants' clinical status seven days after treatment using a five-category scale ranging from no symptoms to critical illness or death. The study also examines outcomes in two groups: those receiving other approved antiviral treatments and those who are not. Participants receive either a single 3.5-gram infusion of hIVIG or a 35-milliliter infusion of saline placebo, with equal chance of assignment to each group. The randomization is stratified by study site and whether participants are receiving standard antiviral care. The infusion occurs once, and participants are monitored thereafter to compare the effects of hIVIG plus standard care versus placebo plus standard care. During the study, participants provide written consent and agree to follow study procedures through 28 days. Researchers assess clinical status seven days after infusion and track safety and disease progression. The study excludes those with prior immune therapies or certain medical conditions and requires participants to avoid other COVID-19 treatment trials through Day 7 unless hospitalized or experiencing significant disease worsening. Clinical assessments and monitoring continue to ensure participant safety and capture outcomes related to COVID-19 illness severity.

Researchers are evaluating the effects of pre-operative chlorhexidine mouthwash and perioperative oxygen levels on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This Phase 3, multi-center, randomized controlled trial is conducted across hospitals in low and middle-income countries, focusing on adults and children aged 10 years or older having elective or emergency midline laparotomy. The study aims to reduce serious postoperative complications that significantly contribute to mortality and healthcare burden, especially in these resource-limited settings. Participants will be randomly assigned to one of four groups combining the use or non-use of chlorhexidine mouthwash before surgery and different oxygen concentrations during surgery: (a) mouthwash with high oxygen (80-100% FiO2), (b) no mouthwash with high oxygen, (c) mouthwash with low oxygen (21-30% FiO2), or (d) no mouthwash with low oxygen. The trial includes a 6-month internal pilot phase to assess recruitment and compliance, followed by a main phase enrolling approximately 12,924 participants. During the study, researchers will monitor participants for pneumonia and surgical site infections within 30 days after surgery using CDC definitions. Data on treatment adherence and participant outcomes will be collected and assessed by blinded outcome assessors. The study will track complications and follow patients through their recovery to evaluate how these interventions might reduce postoperative infections and improve surgical outcomes.

Researchers are investigating oral squamous cell carcinoma, particularly cases with advanced nodal disease (N2-N3), to determine the benefit of adding induction chemotherapy before surgery. This phase 3, multicenter, randomized controlled trial focuses on patients with operable oral cancer presenting at an advanced stage, aiming to improve disease-free survival and overall outcomes by better selecting patients likely to respond to treatment. The study addresses limitations of earlier trials that included heterogeneous patient groups and stages, which may have affected results. Participants are randomly assigned to one of two treatment groups: the standard arm receives surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, while the experimental arm receives two cycles of TPF or TPX induction chemotherapy before surgery, then the same adjuvant treatment. The chemotherapy regimens include docetaxel, cisplatin, and 5-fluorouracil or capecitabine, administered in specific dosing schedules over a three-week cycle. Patients showing disease progression but still resectable may proceed to surgery, while others may receive alternative treatments. During the study, participants will be monitored for disease-free survival over two years, with further follow-up extending to five years. Researchers will also evaluate overall survival, treatment response rates, toxicity, compliance, postoperative complications, and quality of life. Tissue samples from oral cancer will be collected for future research. The study aims to enroll 346 patients aged 18 to 75 with adequate organ function and performance status, assessing the impact of induction chemotherapy on long-term outcomes.