Clinical trials

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

The goal of this study is to assess the effectiveness of the Indian Asthma Care Bundle (I-ACB) in improving post-discharge asthma management among patients with asthma in India, specifically targeting adults and children experiencing severe asthma exacerbations. The main questions it aims to answer are: 1. Does the I-ACB reduce the rate of hospital readmissions within 30, 60, and 90 days post-discharge? 2. How does the I-ACB impact treatment adherence, lung function, symptom control, and overall quality of life, compared to usual care? Researchers will compare outcomes among participants receiving the I-ACB with those receiving standard asthma care (usual care) to determine whether the I-ACB improves health outcomes and reduces the need for emergency department visits. Participants will be asked to: * Engage in a structured asthma management program that includes education on inhaler techniques and adherence to treatment plans. * Report their symptoms and treatment adherence regularly. * Participate in follow-up assessments that monitor lung function and quality of life over a specified period. The importance of this study lies in its potential to address significant gaps in asthma management in India, which currently lead to high hospitalisation rates and substantial healthcare costs. By developing a tailored care strategy, the I-ACB aims to improve health outcomes for millions of asthma patients, reducing the burden on families and healthcare systems alike, and ultimately transforming the approach to asthma care in the region.

This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care. The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.

The aim of the study is to test the feasibility \& loco-regional control rate by combining high precision SBRT with chemotherapy in stage III NSCLC in tumor/lymph nodes if tumors/lymph node size with ≤ 6cms in size.

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India. The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India. Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

The aim of SWOAR TRIAL is to test sparing of Dysphagia/ Aspiration risk structures (DARS) and contra lateral submandibular gland by IMRT. HNSCC of the oropharynx, larynx and the hypopharynx treated with radical concurrent chemoradiotherapy or radiotherapy will be included in the trial. Patients will be randomized to SWOAR IMRT or standard IMRT. Swallowing function will be evaluated the MD Anderson Dysphagia Inventory (MDADI) scoring. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. Secondary Objectives include longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Swallowing function, will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months. Assessment of acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, and 24 months post treatment as per RTOG and LENT SOMA score, respectively. Treatment outcomes will be assessed in terms of loco-regional tumor recurrence and overall survival, assessed at follow-up visits 3, 6, 12, and 24 months post treatment and then annually until 5 years post treatment.

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centres in India and Bangladesh. The study compares patient outcomes using standard wound care with a High Purity Type-I Collagen-Based Skin Substitute against standard wound care with an Acellular Intact Fish Skin Matrix.

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \[(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)\]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

To evaluate and compare the effect of orthograde and retrograde MTA root end filling on clinical, 2D and 3D radiographic success and quality of life after periapical surgery in posteriors- A Randomised Control Trial

This study aims to compare the bioavailability of Dimotec 1000 mg film-coated tablet (Test; Keri Pharma Hungary Kft.) with Detralex 1000 mg film-coated tablets (Reference; Les Laboratoires Servier Industrie, France) in healthy adult human participants under fed conditions. The study will also evaluate the safety and tolerability of a single dose of the investigational products.

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).