There are about 5618 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.
The present study D5272C00001 (Legacy # 3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.
This is a single center phase 2a, randomised double-blind, placebo-controlled factorial design, proof of concept trial. Patients with Crohn's disease who are on an adequate dose of azathioprine and still continue to active disease (CDAI > 150 and c-reactive protein > 6) will be enrolled. Forty patients will be randomised in a 1:1:1:1 ratio into 4 groups in a 2x2 factorial design to receive artesunate 200 mg PO daily for 2 weeks and / or Curcumin 2 gm PO daily for 3 months or placebo. Treatment Curcumin x 13 weeks Placebo C x 13 weeks Artesunate x 2 weeks Group 1 Group 2 Placebo A x 2 weeks Group 3 Group 4 During the treatment period and follow up period patients will be continued on their regular dose of azathioprine and 5-aminosalicylic acid with no change allowed during the study period. Patients will maintain a daily diary of symptoms and adverse events. Scheduled hospital visits with blood and stool tests will be at baseline, week 1, month 1, month 3 and month 6. Primary endpoint will be remission (defined as CDAI < 150) at 3 months
This is a sub-study nested into the existing NICHD Global Network for Women's & Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. This study will assess the prevalence of iron deficiency anemia (IDA) and non-iron deficiency anemia (NIDA) in Eastern Maharashtra and will assess the association between both conditions and neo-natal and infant health outcomes (birth weight, gestational age at birth, weight-for-gestational-age z-score and infant hemoglobin concentration at 6 weeks). The investigators will also assess the relative strength of the association between anemia in the 1st trimester and 3rd trimester (after iron needs have increased but mothers may have been taking iron folic acid (IFA) supplements for several months) and infant health outcomes.
Postoperative delirium (POD) is the most common adverse neurologic complication that can occur in patients of any age. Its incidence varies across age groups and is substantially influenced by patient-related risk factors. POD occurs in 17%-61% of major surgical procedures. Several risk factors which contribute to the development of POD include age more than 60 years, pre-existing cognitive dysfunction, presence of comorbidities, sensorial deficits, malnutrition, polypharmacy, impaired physical mobility and frailty. Postoperative delirium has several wide ranging and adverse outcomes that are consistently associated with delirium such as mortality, increased length of hospital stay, and increased hospital costs. A recently devised tool for rapid assessment of delirium is the 4 A's test. It has now been validated for identifying delirium in the surgical population. The proposed prospective observational study will be conducted on 150 patients belonging to ASA Physical Status I-III of either sex, scheduled to undergo non-cardiac surgery under general anaesthesia (GA), requiring at least 24 hours of postoperative inpatient care. This prospective, observational study aims to evaluate the incidence, risk factors and outcomes of postoperative delirium in elderly patients more than 65 years of age undergoing non-cardiac surgery.
TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes: 1. Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT); 2. Mindfulness videos; 3. Game-based Cognitive Bias Modification paradigms; 4. An empathetic chatbot. This study's primary aim is to test the differential effectiveness of this full-featured version of TreadWill compared to a text-based CBT program.
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge
In intensive care units (ICU), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (RRT). These include peripheral intravenous catheters (PIVC), specialized venous ports like central venous catheters (CVCs), and hemodialysis ports. The investigators plan to do this pre- and post-intervention study to know the effect of intensive training and education of HCW (doctors and nurses) on the condition of venous access devices in critically ill patients.
Gingival marginal tissue recession is the displacement of the soft tissue margin apical to the cementoenamel junction (CEJ) with exposure of the root surface. It is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots leading to esthetic concerns and dentinal hypersensitivity are the most frequent reasons for patients to seek treatment for the same. Gingival recession therapy is still challenging for clinicians. The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an esthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths. Various treatment modalities have been put forth for the correction of gingival recession. These include free gingival autograft, subepithelial connective tissue graft (SCTG), coronally advanced flap (CAF) and various combinations. Coronally advanced flap (CAF) in conjunction with the connective tissue graft (CTG) is considered the gold standard of treatment of gingival recession due to its high predictability of the treatment results. Several authors have explored the use of biological agents or like enamel matrix derivative (EMD), platelet-derived growth factor-BB (PDGF), fibroblast growth factor-2 (FGF-2), which are a group of proteins capable of inducing gene or cell activation for cell recruitment, matrix biosynthesis, and cellular differentiation, in an attempt to regenerate the lost periodontium to enhance its long term stability Hyaluronic acid (HA) is one such biologic agent that demonstrates future for periodontal regeneration. It is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to allow the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues. HA suppresses tissue breakdown activating metalloproteinase inhibitors. It represents one of the most hygroscopic molecules known in nature. As a physical background material, it functions as space filler, lubricant and a protein excluder as well. In vitro studies and animal studies have demonstrated that HA significantly increases the tensile strength of granulation tissue, stimulates clot formation, induces angiogenesis, increases osteogenesis, and does not interfere in the calcification nodules during bone formation. Furthermore, HA facilitates cell migration and differentiation during tissue formation and repair of both soft and hard tissues. It improves ligament cell viability and early osteogenic differentiation. Considering the fact that HA has positive effects on wound healing, we hypothesized that it may also improve the results of root coverage by CAF+CTG. Therefore, the aim of this randomized controlled clinical trial (RCT) will be to evaluate the potential benefit of the adjunctive use of HA in combination with CAF+CTG and to compare the outcomes with CAF+CTG alone, when treating single Miller class I and class II/RT1gingival recessions.
This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).