Rohtak

Researchers are studying how bite force and bone turnover markers change during the retention phase after orthodontic treatment in patients with different vertical facial growth patterns. The study compares patients with vertical hyperdivergent and horizontal hypodivergent craniofacial growth to understand relapse and bone remodeling processes over a 12-month retention period. This prospective clinical trial aims to provide insights into maintaining teeth alignment using retention appliances after fixed orthodontic treatment. The trial includes two groups of patients who have completed fixed orthodontic treatment and are ready for retainer delivery. Group 1 consists of patients with vertical growth patterns FMA 26 or more, while Group 2 includes those with horizontal growth patterns FMA 24 or less. Both groups will receive a Beggs retainer formed conventionally and delivered within 24 hours of debonding. Changes in bite force will be measured using a bite force device, and bone turnover markers CTX bone resorption and BALP bone formation will be assessed using ELISA at baseline and at 1, 3, 6, and 12 months after retainer delivery. Participants will undergo bite force measurements and biomarker testing at five timepoints during the 12 months retention phase at retainer delivery, then after 1, 3, 6, and 12 months. Data on bone turnover markers and bite force changes will be collected and compared between the two groups. The study includes monitoring of functional occlusion, oral hygiene, and retainer compliance. The total participation time spans 12 months, during which researchers will assess both clinical and biochemical indicators of bone remodeling and bite function after orthodontic treatment.

Researchers are evaluating the safety, immune response, and consistency between different vaccine lots of BBV87, an inactivated Chikungunya virus vaccine, in healthy individuals aged 12 to 65 years. This Phase IIIII clinical trial is randomized, observer-blind, and placebo-controlled, aiming to understand how well the vaccine works and its safety profile across multiple study centers. Participants will be randomly assigned to receive one of three lots of the BBV87 vaccine or a placebo. Each subject will receive two doses of 40 micrograms administered as injections into the deltoid muscle of the arm, with the second dose given about 28 days after the first. Safety data will be reviewed by an independent board during the study to ensure participant protection. During the study, participants will attend visits for vaccination and follow-up assessments, including blood tests to measure antibody levels against the virus 28 days after each dose. Researchers will monitor for any adverse events for up to 11 months post-vaccination. The main outcomes measured include immune response levels and the percentage of participants who develop antibodies, along with the safety and tolerability of the vaccine.

Researchers are conducting a Phase I open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adults with relapsed advanced malignancies. The study focuses on patients with selected advanced solid tumors, such as non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer, who have no curative or life-prolonging treatment options left. This first-in-human trial aims to find the best dose of AUR107 using a traditional dose-escalation design. Participants will receive oral AUR107 once daily at escalating doses ranging from 5 mg to 200 mg. The trial follows a 33 dose escalation design to evaluate safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The study is multicenter and includes dose expansion following dose escalation. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over 28-day cycles. Researchers will measure pharmacokinetic parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and elimination half-life at various time points under fasting and fed conditions. Safety assessments and clinical evaluations will be conducted throughout the study, which is expected to continue until June 2027.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of an oral drug called AUR108 in adult patients with relapsed advanced lymphomas, including Non-Hodgkin and Hodgkin lymphoma. This Phase 1, open-label, first-in-human study focuses on patients who have no available curative or life-prolonging treatments left and have exhausted all effective local therapies. The study uses a traditional dose-escalation design to determine the best dose of AUR108 based on safety and biological data. Participants will receive AUR108 orally with doses planned at 50, 90, 150, 220, and 300 mg in a cycle of 3 days of dosing followed by 4 days off each week. The study follows a 33 dose-escalation method to evaluate safety and drug behavior in the body and to select the optimal biological dose. This is a multicenter trial with dose expansion planned after the initial dose-escalation phase. During the study, participants will be closely monitored for dose-limiting toxicities during the first 28-day cycle and treatment-related adverse events throughout the trial, which may last about a year. Researchers will collect blood samples to measure drug levels and effects at multiple time points, including days 1, 8, and 17. Participants will undergo safety assessments, organ function tests, and evaluations of their lymphoma status to track treatment impact and side effects over time.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are conducting a Phase 1 study to evaluate the safety and tolerability of SBO-154 in adults with advanced solid tumors who have either not responded to or cannot tolerate standard treatments. The study aims to find the highest dose of SBO-154 that patients can safely tolerate and then further assess its safety in specific advanced cancers. The study is divided into two parts. In Part 1, participants receive escalating doses of SBO-154 administered intravenously every three weeks to determine the maximum tolerated dose. In Part 2, the safety of the selected doses from Part 1 is further evaluated in patients with particular types of advanced solid tumors. Treatment continues with dosing every three weeks during the study period. Participants will be closely monitored through scheduled visits involving laboratory tests and assessments to track any dose-limiting toxicities and treatment-related adverse events up to 30 days after the last dose. Researchers will also evaluate tumor response using imaging every six weeks for up to 12 months and monitor the presence of anti-drug antibodies for up to one year. The overall study duration extends through 2030, with ongoing safety and response evaluations.

Researchers are investigating how facial growth patterns affect the relapse of teeth alignment after orthodontic treatment during the retention phase. The study focuses on differences between horizontal and vertical growers, hypothesizing that horizontal growers show more vertical tooth movement, especially in overbite, while long-faced individuals may experience more relapse in lower front teeth alignment and crowding. Understanding these factors helps predict and prevent relapse, aiming to improve long-term orthodontic treatment stability. Participants are grouped based on facial growth type vertical growers with a fixed mandibular plane angle FMA of 26 degrees or more, and horizontal growers with an FMA of 24 degrees or less. All participants have completed fixed orthodontic treatment and will receive a Beggs retainer formed by conventional methods within 24 hours of debonding. The study compares 3-dimensional dentitional changes in the teeth over a 12-month retention period using advanced 3D superimposition techniques. During the study, participants will be monitored for tooth movement in three planes of space antero-posterior, vertical, and transverse. Researchers will assess these changes using measurements like the Littles irregularity index and PAR score to evaluate occlusion and alignment. Regular follow-ups will track retention compliance, oral hygiene, and periodontal health. The main outcome is the comparison of 3D dentitional changes over 12 months to understand how facial growth patterns influence orthodontic relapse and stability.

The research investigates the clinical and radiographic results of direct pulp capping in mature permanent mandibular molars with reversible pulpitis, focusing on comparing outcomes between deep and extremely deep carious lesions. The study aims to assess the success of this treatment in teeth with different depths of caries and to evaluate pain after the procedure, involving adults aged 18 to 40 years. There is a need to clarify how caries depth affects treatment success, as current data are limited and show varying success rates. Participants will receive direct pulp capping treatment after a clinical diagnosis of reversible pulpitis is confirmed. The procedure includes cleaning and controlling bleeding at the pulp exposure site with 3% sodium hypochlorite, applying a layer of ProRoot MTA over the lesion followed by resin-modified glass ionomer cement, and final restoration with composite resin. Two groups are studied one with deep carious lesions and one with extremely deep lesions. Follow-up includes clinical and radiographic assessments at 7 days, 6 months, and 12 months to evaluate treatment success. During the study, participants will be monitored for pain levels at baseline and daily for one week after treatment. Radiographic images will be taken at 6 and 12 months to assess the tooths condition. Success rates will be measured at 12 months, with researchers tracking bleeding control time during treatment and ensuring healthy periodontal status. The total participation period may last up to one year, with regular evaluations to monitor healing and any complications.

Researchers are comparing two dental treatmentsindirect and direct pulp cappingin adult patients with deeply decayed mature mandibular molars showing signs of moderate pulp inflammation called moderate pulpitis. This trial aims to evaluate which method better preserves tooth vitality and reduces pain. The study focuses on teeth with clinical and radiographic signs that suggest moderate pulpitis, a condition where the pulp shows prolonged sensitivity and dull pain but may still recover if treated properly. The trial involves two treatment approaches. One group will receive partial removal of the decayed tissue followed by indirect pulp capping, where a protective material called MTA is applied over the remaining dentin, then sealed with a resin and composite restoration. The other group will undergo complete caries removal, which may expose the pulp, followed by direct pulp capping where the exposed pulp is treated with MTA, sealed with resin, and restored with composite. Both treatments are performed under sterile conditions to promote healing. Participants will be monitored over 12 months to assess clinical and X-ray success of the treatments. Pain levels will be recorded daily for one week after treatment to evaluate reduction in discomfort. Follow-up visits will include pulp sensibility tests and radiographs to check tooth health and healing. This trial lasts for one year, with regular check-ups to track outcomes and treatment success in these dental procedures.