Rohtak

Researchers are studying the changes that happen after orthodontic treatment, focusing on unwanted shifts called relapse. They are examining how bite force and bone health markers vary in patients with different jaw growth patterns—those with vertical growth (hyperdivergent) and those with horizontal growth (hypodivergent). This prospective, single-blind clinical trial aims to assess these changes over a 12-month retention period using Begg's retainer. Participants are divided into two groups based on their jaw growth pattern: one group with vertical growth and a fixed orthodontic treatment history with a certain mandibular plane angle, and another group with horizontal growth and a different mandibular plane angle. Bite force is measured with a special device, and bone turnover markers CTX (bone resorption) and BALP (bone formation) are analyzed using ELISA tests at multiple time points: at retainer delivery, and after 1, 3, 6, and 12 months. During the study, participants will undergo bite force tests and have samples taken to measure bone biomarkers at these scheduled visits. Researchers will track changes in bite force and bone remodeling markers throughout the retention period to understand the functional status of the masticatory system and bone remodeling after orthodontic treatment. The total study duration for each participant is 12 months with regular assessments.

Researchers are evaluating the safety and immune response of BBV87, an inactivated Chikungunya virus vaccine, in healthy individuals aged 12 to 65 years. This seamless Phase II/III clinical trial aims to study the vaccine's immunogenicity, safety, and consistency across different production lots. The study involves approximately 1000 participants randomized regardless of their prior exposure to Chikungunya virus. Participants will be randomly assigned in a 3:3:3:1 ratio to receive one of three lots of the BBV87 vaccine or a placebo. Each participant will receive two doses of the vaccine or placebo, with each vaccine dose containing 40 micrograms of the inactivated virus. The study is observer-blind, and safety data will be reviewed by an independent board after Day 56 to ensure participant protection. During the study, participants will undergo assessments to measure antibody levels 28 days after the second vaccine dose. Researchers will monitor immune responses, including the percentage of participants who develop antibodies and the consistency of antibody levels across vaccine lots. Safety evaluations will be ongoing throughout the trial to assess any adverse effects or concerns related to the vaccine. The total participation period includes vaccination and follow-up visits up to Day 56.

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adult patients with relapsed advanced solid tumors. These tumors include non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer. Participants must have no available curative or life-prolonging treatments and have exhausted all effective local therapies. Participants will receive oral AUR107 once daily. The study uses a traditional 3+3 dose escalation design to assess safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The treatment period focuses on finding the best dose and assessing how the drug behaves in the body. During the study, participants will be monitored for dose limiting toxicities and treatment-related adverse events over 28 days. Researchers will evaluate pharmacokinetics parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and half-life at specified days. Safety assessments, disease measurements, and tolerability will be closely followed to understand the effects of AUR107.

Researchers are conducting a Phase 1, open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR108 in adult patients with relapsed advanced lymphomas. This study focuses on patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who have exhausted effective local treatments and have no curative or life-prolonging options available. The trial uses a traditional 3+3 dose escalation design to evaluate AUR108 as a single oral agent. Participants will receive oral AUR108 with a schedule of dosing for 3 days followed by 4 days without dosing each week. The study includes dose escalation to determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The research will monitor treatment-related adverse events and measure drug levels and effects over time. During the study, participants will undergo safety assessments including monitoring for dose-limiting toxicities and treatment-related adverse events, pharmacokinetic evaluations at specified time points, and clinical evaluations for disease response. The study duration averages about one year with ongoing safety follow-up. Researchers will collect data on adverse events, drug concentration, and patient health to evaluate the treatment's safety and dosing parameters.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are comparing two treatments, direct pulp capping and complete pulpotomy, for mature permanent mandibular molars showing clinical signs of moderate pulpitis. Moderate pulpitis is characterized by prolonged sensitivity to cold lasting minutes, possible sensitivity to percussion, and spontaneous dull pain, which may indicate irreversible pulpitis. The study is based on the idea that removing the source of infection and sealing the pulp in a sterile environment may allow healing even when the pulp is inflamed beyond recovery. The trial aims to find out if the less invasive direct pulp capping is as effective as complete pulpotomy for these cases. Participants will receive either direct pulp capping or complete pulpotomy. In direct pulp capping, after removing decay, bleeding is controlled with sterile cotton soaked in 3% sodium hypochlorite; if bleeding stops within 6 minutes, mineral trioxide aggregate (MTA) is applied over the pulp exposure, followed by a resin-modified glass ionomer cement (RMGIC) and composite resin restoration. For complete pulpotomy, the exposed pulp is removed down to the canal orifices, the site is irrigated and hemostasis achieved with 3% sodium hypochlorite; MTA is then placed similarly, covered with RMGIC and composite resin. If bleeding does not stop within 6 minutes, root canal therapy is performed instead. Both procedures follow a standard restoration technique. During the 12-month follow-up, participants will be evaluated for clinical and radiographic success, including pain incidence and severity during the first week after treatment. Assessments include pulp sensitivity tests, radiographs, and monitoring of tooth and periodontal health. Outcomes measured will focus on healing, absence of symptoms, and tooth functionality. The study will track treatment success and safety throughout this period to compare both approaches.

This research aims to compare the outcomes of two dental procedures called indirect and direct pulp capping after either partial or complete removal of deep decay in mature lower jaw molars showing signs of moderate pulp inflammation (pulpitis). The study focuses on teeth with deep caries and aims to assess which method leads to better clinical and X-ray results, as well as to evaluate pain levels after treatment. It is based on the idea that inflamed pulp tissue can heal if infection is removed and the tooth is properly sealed with biocompatible materials. Participants will receive either indirect pulp capping, which involves removing most but not all decay to avoid exposing the pulp, disinfecting the cavity, and placing a layer of mineral trioxide aggregate (MTA) and resin before final restoration, or direct pulp capping, where complete decay removal exposes the pulp, bleeding is controlled, and MTA and resin are applied directly to the pulp before final filling. These procedures are performed on deeply carious mature mandibular molars diagnosed with moderate pulpitis. The study follows a randomized clinical trial design. During the study, participants will be monitored for clinical and radiographic success over a 12-month period. Pain will be assessed every 24 hours for one week after treatment to observe incidence and reduction. Researchers will evaluate pulp health using clinical tests, X-rays, and pain reports. This comprehensive follow-up aims to determine the long-term effectiveness and safety of both pulp capping methods in managing deep caries with moderate pulp inflammation.

Researchers are investigating how well complete pulpotomy compares to root canal treatment in patients with type 2 diabetes mellitus who have irreversible pulpitis in mature permanent mandibular posterior teeth. This study addresses the lack of clinical trials evaluating the effect of diabetes on dental pulp healing and treatment success, as existing research shows diabetes may impair pulp wound repair and regeneration. The study involves two treatment groups: one receiving complete pulpotomy, where the exposed pulp tissue is removed and treated with a material to encourage healing, and the other receiving root canal treatment performed in a single visit using standard techniques for cleaning and filling the canals. Success will be evaluated through clinical and radiographic assessments at 3, 6, and 12 months, with additional quality of life assessments at 1 week, 6 months, and 12 months after treatment. Participants will undergo regular examinations including pulp sensibility tests, clinical evaluations, and radiographic imaging to monitor healing and treatment outcomes. Researchers will track both clinical and radiographic success at 12 months as primary outcomes. The total study duration for each participant is one year, allowing comprehensive monitoring of treatment effects and patient wellbeing over time.