There are about 4814 clinical studies being (or have been) conducted in India. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
Environmental hazards of human activity are a topic of present day world, global warming being one of the leading concerns. Gases that contribute to this are greenhouse gases. Nitrous oxide (N2O) is a greenhouse gas that is commonly used in medical practice, mostly confined to provision of anaesthesia during surgical procedures in the operation theatre. N2O is not a potent anesthetic, and is used as a carrier for volatile anesthetic during general anaesthesia. This is to reduce the use of volatile anesthetics and other analgesic drugs while maintaining adequate depth of anaesthesia and analgesia. The N2O gas that is used during general anaesthesia is scavenged and released into the atmosphere without any processing. In the atmosphere it stays and produces deleterious greenhouse effect primarily owing to its long lifetime of 114 years. In addition, it also causes depletion of ozone layer. The green house effect of gases is evaluated and compared with the use of carbon-di-oxide equivalents (CDE). When the effects are considered for 20 years it is termed CDE20.The efforts to reduce these harmful effects can be directed towards reduction/cessation of N2O use, or its post anesthetic processing. The long history of its use in clinical practice and benefits such as analgesia for various procedures; makes it difficult to be completely taken out of usage in the present day anaesthesia practice. Though processing of N2O after use during GA is possible, it's impractical because of cost efficiency. We therefore, have directed our focus on further reducing its consumption while being used for GA. Low- flow anaesthesia has been in practice for the same reason (i.e. to reduce the wastage of gases). This study is aimed to reduce the N2O consumption even further by employing a novel 'streamed-in' technique of N2O administration during low-flow GA. Conventionally, N2O use is initiated during the initial high fresh gas flows (FGF) before shifting to low-flow ventilation. 'Streamed-in' N2O administration strategy employs initiation of N2O into FGF after the institution of low-flow anaesthesia. Hence, the participants are not exposed to an unconventional drug or a new route of its administration, but an alternate strategy to its conventional use. We aim to evaluate the novel technique of 'streamed-in' N2O during sevoflurane GA for its global warming effects (in terms of CDE20) and its clinical effects ( intraoperative general anaesthesia state, hemodynamic profile) and post operative effects( postoperative nausea vomiting -PONV, postoperative pain profile- numerical rating scale-NRS)
Medical thoracoscopy is the preferred procedure for performing pleural biopsy in patients with pleural effusions that remain undiagnosed after pleural fluid analysis. Surgical site infections (SSI) and empyema are among the important complications of the procedure. At author's center, povidone-iodine is used for surgical site preparation during MT. The investigators hypothesized that chlorhexidine-alcohol would be superior to povidone-iodine in reducing the rate of infectious complications following thoracoscopy. In this study, the authors propose to investigate the efficacy of chlorhexidine-alcohol scrub in preventing post procedural infectious complications in subjects undergoing medical thoracoscopy
Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough. The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications. In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates. The authors hypothesized that both the techniques would improve FEV1 similarly.
Bronchoalveolar lavage (BAL) via flexible bronchoscopy is a method used to sample the cellular and microbiological components of the alveolar space. It is a procedure in which 2-3 measured aliquots of sterile normal saline are instilled after wedging the scope to the suitable segmental bronchus. BAL is performed from the segments/ lobes showing ground-glass opacities (GGO), tree-in-bud lesions or focal consolidations guided by HRCT. In diffuse lung involvement, BAL is performed either from RML or the lingula.[3] It is recovered through the bronchoscope via different suction methods so as to get a sample of epithelial lining fluid of small airways and alveoli. Either manual suction or wall suction can be used for aspiration of fluid during BAL. The fluid recovered is then sent for cytology and microbiology examination studies including AFB, MGIT, GeneXpert, Galactomannan, fungal cultures to diagnose various conditions like PAP, eosinophilic pneumonia, bacterial or fungal infections, specific forms of ILD. Three techniques have been described to perform BAL. To the best of our knowledge no previous study has compared the three methods of obtaining the BAL in the same cohort of subjects.The authors believe that the procedural yield of BAL will be best by manual suction using rubber tubing compared to manual suction without rubber tubing or wall suction. Herein, the investigators compare the three methods of obtaining BAL in subjects undergoing BAL for various respiratory diseases
Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam. During the EBUS procedure, oxygen supplementation can either be provided using low flow or high flow through a nasal cannula. The investigators hypothesize that the use of high flow nasal cannula (HFNC) for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors plan to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.
There is very little data related to the natural history of disease from covert HE (MHE and grade 1 HE) to overt HE (grades II, III and IV) in ACLF, with implications on long-term neurological recovery after an episode of overt HE. The evolution and pathogenesis of HE is well described in ALF and cirrhosis, but the dynamic changes in HE in ACLF in response to therapy such as ammonia reduction measures, antibiotics to target sepsis and inflammation, measures to alter dysbiosis such as probiotics or fecal microbiota transplant, and measures to target immune dysfunction such as steroids in alcohol-associated hepatitis. The central role of ammonia in the pathogenesis of HE in ACLF has been challenged by recent data. The approach to HE in ACLF has now refocused on systemic and neuro-inflammation, gut dysbiosis, immune dysregulation, and multi-omics approach. Most importantly, the modulation of the metabolome in response to therapy and interventions, and the use of sedatives, paralytic agents, antibiotics etc. in ACLF with HE in a real-world setting has not been reported.
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis. An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.
Introduction: Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programs aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programs on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care. Methods and analysis: We will pilot a pragmatic three-armed parallel, cluster randomised, controlled trial in India, where neither of these programs are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC, and two to standard care. The primary outcome will be all cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider, and process measures. All outcomes except time to event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care, and PTC versus standard care using absolute and relative differences along with associated confidence intervals. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury, and elderly. In parallel to the pilot study we will conduct community consultations to inform the planning of the full-scale trial.
An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)], six-sequence, crossover, balanced, single dose oral bioequivalence study.