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.
Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids. Hence, regional block, using local anesthetics, becomes a good option in this surgery. The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain. Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries
This study is mainly focusing on reducing the pain scores during IV cannulation in pediatric population in the preoperative period. Applying EMLA cream is a well-known fact world wide. we would like to study the effect of ultrasound waves in the penetration of the given drung into the skin so that we could achieve the effect of the drug quickly.
Study population: A total of 90 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences with SBP with septic shock will be included. Study design: Randomized controlled trial Study period: August 2019 to December 2021. Sample size: Assuming that the response rate is 90% with GM-CSF and 60% without GM-CSF after day 5. With alpha 5 and power 80,we need to enroll 76 cases (38 cases with each). Further assuming 20 % drop-out due to various reasons, it was decided to enroll 90 cases randomly allocated into two groups (i.e., 45 in each) by block randomization method by taking block size as 6. So for the present study, it was decided to enroll 90 cases in all. Group A will be given Imipenem and Tigecycline. Patients with recent hospitalisation will be given Colistin in addition. Group B will be given: To another group we will give Imipenem and Tigecycline and GMCSF.Patients with recent hospitalisation will be given Colistin in addition. The dose of antibiotic will be given at dosage Inj Imipenem 1gm i.v. TDS Inj Tigecycline 100mg stat f/b 50mg i.v. OD Inj GM-CSF 500mcg s.c. OD Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD Monitoring and assessment At the baseline, all patients will undergo investigational evaluation as described Daily monitoring of following parameters: - Haemoglobin, - Total peripheral leucocyte counts, - Platelet counts, - Renal function tests - Liver function tests and - Chest X rays will be undertaken - Ascitic fluid analysis will be done on day 0, day 2 and day 5 Stopping rule:If the patient develops a TLC of more than 50,000, the dose of the GM CSF will be reduced to half and the treatment continued. If, even after the reduction, the TLC rises to more than 50,000, then the treatment will be stopped and the patient excluded. Expected outcome of the project: Addition of GM-CSF to standard antibiotic regimen helps resolve SBP and improves outcome in decompensated liver cirrhotic patients.
International registry to collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. Data will be collected during follow-up visits according to standard of care at 3 to 8 weeks, 3, 6, 12 and 24 months
This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.
The rehabilitation of dentoalveolar defects and tooth loss has seen remarkable advancements over time. Extraction of tooth leads to reduction in physiologic dimension of bone and it is imperative to evaluate the site before implant placement. To overcome the loss of volume and to avoid complications, procedures to restore the resorbed alveolar bones prior to or during implant placement are usually performed. Lateral bone augmentation procedures with guided bone regeneration (GBR) are well documented in the literature with predictable results. It generally involves bone substitute xenograft and bioresorbable membrane combined with implant placement in single stage procedure or separately in two- stage procedure. As the search for better and improved materials continues, a porcine derived ribose cross-linked volumising collagen matrix (VCMX) based on GLYMATRIX® technology has been introduced which showed benefits over the conventional membranes in terms of simplified procedure, degradation, membrane exposure and healing. The collagen scaffold has been reportedly used as a core material for guided bone regeneration, when there is sufficient bone to place an implant but a horizontal defect is present in the crestal ridge. As part of augmentation VCMX is designed to expand and ossify during healing. The advantage of the material is that when placed in one or two layers, it may eliminate the use of bone substitute or connective tissue graft thus simplifying the augmentation procedure. In addition, adding a bone substitute is a valid option based on indication. In the quest of better material and simplified procedures, few authors have performed case studies based on application of VCMX for guided bone regeneration around dental implants and has shown promising results. However, there are no controlled clinical trials on application of VCMX for lateral ridge augmentation. Thus, the present study aims to assess the efficiency of VCMX compared to resorbable collagen membrane (RCM) and bone graft (BG) for lateral ridge augmentation around implants through a well designed, controlled clinical trial.
The prospective study is a interventional study to evaluate and compare the effectiveness of periosteal pedicle as grafting technique and egg shell derived nano hydroxyapatite as regenerative graft material for regeneration of intrabony defects.
Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.
Irritable bowel syndrome (IBS), a common gastrointestinal (GI) disorder in India and in the rest of the World, is enigmatic in its pathogenesis. IBS is associated with recurrent abdominal pain or discomfort, bloating, incomplete evacuation, altered bowel habits, and abnormal stool forms. The etiology of IBS remains unclear and different factors were thought to be involved like genetics and environmental factors, visceral hypersensitivity, altered gut microbiota or disorder of the microbiota-gut-brain axis and various psychological factors like anxiety, depression, and insomnia or sleep disturbance. Due to increasing work pressure in today's society, and the consequent shift duty and psychological stress, the frequency of sleep disorders is increasing; disturbed sleep may be associated with a vicious cycle in which altered sleep may result in gastrointestinal (GI) disturbances, which in turn, may jeopardize sleep further. The disorder of the gut microbiota, the largest organ of the human body, is being suggested to be responsible for several GI and extra-GI diseases. Qualitative change in gut microbiota is currently studied by next-generation sequencing. Gut and sleep patterns work in an axis - a two-way street of communication, some studies reported altered gut microbiota or dysbiosis modulates peripheral and central nervous system function, leading to alterations in brain signaling and behavior that possibly leads to sleep disturbances.
This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur. Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.