Osaka-sayama-city, Japan

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies

This study is a multicenter, randomized, factorial-design, double-blind, controlled trial investigating the effects of fecal microbiota transplantation (FMT) and dietary interventions in patients with mild to moderate, treatment-naïve, active inflammatory bowel disease. The trial is being conducted across multiple clinical centers, with a central microbiome analysis facility. Randomization and Blinding: Randomization: Centralized, computerized randomization is employed to ensure balanced treatment allocation. The permuted block method, along with stratification based on disease characteristics, ensures equal distribution across intervention arms Blinding: Patients, investigators collecting clinical data, and endoscopic video assessors are blinded to treatment allocation. The dietitian and endoscopist performing FMT (or sham FMT) are unblinded Intervention Arms: Participants are assigned to one of four treatment arms: FMT + Anti-inflammatory Diet (AID) +Advanced therapy FMT + Sham Diet+ Advanced therapy Sham FMT + AID+ Advanced therapy Sham FMT + Sham Diet+ Advanced therapy FMT is administered via colonoscopy at 0, 2, and 6 weeks, with responders receiving maintenance doses every 8 weeks until week 48 Participant Timeline and Assessments: Baseline Assessments: Clinical, laboratory, and endoscopic evaluations, including serological tests, inflammatory markers, and microbiome profiling. Follow-up Schedule: Visits occur at Week 0, Week 6, Week 10, and then every 8 weeks until Week 48. Endoscopic Monitoring: Colonoscopy is performed at baseline, Week 10, and Week 48. Centralized endoscopic video scoring ensures consistency Data Collection and Management: Paper CRF's and Electronic Data: The paper based CRF's will be filled first and then data will be entered into a REDCap software. Dietary Monitoring: Participants will use the IBD NutriCare mobile application for diet tracking. Microbiome Analysis: Fecal samples are processed and analyzed at a designated microbiome research center. Safety Monitoring and Compliance: Adverse Event Reporting: All safety events, including potential serious adverse events (SAEs), are logged and monitored by the Data and Safety Monitoring Board (DSMB). Protocol Deviations: Documented and assessed for impact on trial integrity. Training and Quality Control: Regular site training ensures adherence to the protocol, and periodic audits maintain data quality

A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant

Methodology: - Study population: All patients undergoing adult living donor liver transplant recipients - Study design: Open label Randomized control Study - Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025 - Sample size: n=100 - Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 - Monitoring and assessment: Not valid - Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea - Stopping rule Not valid (b) Expected outcome of the project: Perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) Ethical issues in the study and plans to address these issues: None expected

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

A Research Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis

Study design: A patient and outcome assessor blinded, multiple- arm, randomized, placebo controlled clinical trial Setting: All India Institute of Medical sciences New Delhi Selection of patients: Consecutive patients diagnosed with Oral Submucous Fibrosis based on WHO clinical criteria (Warnakulsurya et al 2007, 2021) and classified as Moderate Oral Submucous Fibrosis based on functional staging of More et al 2011 (Functional staging M2 and M3: maximal interincisal distance 15-35 mm) will be prospectively recruited after ethical clearance and informed written consent. Clinicopathologic characteristics: The clinical demographics, Tobacco and Areca nut habit history ( Type, quantity, frequency, duration), association with other habits like smoking/ smokeless tobacco with/ without slaked lime, alcohol and addictive drugs will be recorded. The clinical characteristics and staging/grading of OSMF would be recorded as per prepared proforma and protocol. The clinical grading of moderate OSMF will be done according to WHO clinical criteria and More et al 2011 classification. Biopsy of any suspicious oral lesions if found will be done to rule out malignancy and referred to the cancer center for further management and excluded from study. Enrolment of subjects fulfilling the inclusion and none of the exclusion criteria will be done after information and written informed consent before any further investigation. Routine blood investigations to rule out common systemic conditions ( CBC, Blood glucose, LFT, KFT) Participants will be randomized into three arms (1:1:1) Group A: Photobiomodulation therapy (parameters defined below) given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management. Group B: Photobiomodulation therapy (parameters defined below) given intraorally (bilateral buccal mucosa) and extraorally (bilateral masseter muscle) with conventional non-invasive management. Group C: Sham (Use of laser handpiece with only red guide light and without using the foot pedal which activates the laser)Photobiomodulation therapy(Placebo) (Intraoral and Extraoral) with conventional non-invasive management. Randomization: Block randomization with varying block size will be done using computer generated random numbers using the Nquery software. Allocation concealment: Participants will be randomized using sequentially numbered, opaque sealed envelopes (SNOSE). 315 white envelopes will be prepared with aluminum foil sheet and carbon sheet in each. Assigned treatment protocol will be mentioned clearly on a paper and put in each envelope. For each treatment protocol 105 envelopes will be prepared and sealed. Each envelope will have an identifier of trial on its front. Envelopes will be opened sequentially by an operator blinded to the study protocol after which patients will be allotted a study arm as per the treatment mentioned in the envelope. Before opening the envelope we will write the patient's study identifier number, date and operator's signature in front of the envelope, which will be transferred on white paper through carbon paper. Used envelopes will be stored separately until the completion of trial. Blinding: The subjects will be blinded to the group assignment as they will receive PBM ( Active or Sham as per group assignment ) both intraorally and extraorally The outcome assessor will be blinded to the group assignment of the subjects as they will be identified by unique randomization code only Conventional non-invasive management (Usual care): All subjects in the three groups will receive the same standard conventional non- invasive management advised for moderate OSMF as per current scientific evidence. Brief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up. Oral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy(Mouth opening and cheek ballooning exercises) Control of systemic conditions (Anemia, Diabetes, hypertension, thyroid disorders) by specialist referral Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy /sour/ hot foods and drinks) Regular surveillance for malignant transformation Photobiomodulation Therapy (PBM therapy): PBM will be given with 940nm long infrared wavelength diode laser with following specifications Biolase Epic X Diode LASER (USFDA and CE approved) LASER Classification- IV Medium- InGaAsP Semi-Conductor Diode Wavelength- 940+10nm Maximum Output Power= 10W Pulse repetition rate= upto 20kHz Pulse duration Rate= 0.01ms- 20ms Power modes- Continuous/ Pulsed Protocol for PhotoBioModulation( PBM) therapy Protocol for PBM therapy has been made as per guidelines of the consensus statement ( Zelcha et al 2016) regarding the applications, protocols, safety, dosimetric considerations of PBM in management of side effects of chemoradiation therapy in Head and neck cancers like mucositis and fibrosis. Protective laser wavelength specific eyewear will be used for patient, operator. The device will be used according to the manufacturer's instructions and calibration before each therapy in the trial. The surgical handpiece (diameter 0.6cm) will be used without the fibre optic tips in defocused mode and head sanitized before therapy. Peak Power : 0.3Watts Power density: 1 Watt/cm2 Fluence: 4J/cm2 per cycle Spot size : 0.28cm2 Distance : 2mm from surface Mode: Continuous, Non- contact mode, circular motion, overlapping, in clockwise concentric manner with laser handpiece perpendicular to surface Duration of cycle : 20 seconds with interval of 30 seconds alternating with other side Cycles per sitting: Three for each side Four Sittings: Day 0,3, 7, and 15 Intraoral: Bilateral buccal mucosa will be divided arbitrarily into three zones superior, middle and inferior for equal distribution of laser energy during each cycle Extraoral :Bilateral masseter muscle will be divided into three zones superior, middle and inferior for equal distribution of laser energy during each cycle Therapeutic monitoring: Site of application of LASER will be evaluated continuously for any discomfort, signs of inflammation like redness of skin/ mucosa during therapy and during follow up. The following options will be considered during therapy Move the Handpiece relative to the affected anatomy. Defocus the energy by moving the Handpiece further away from the skin. Decrease the power setting.(considering the Fitzpatrick Skin type scale) Stop/ Defer the treatment. Patient will be interviewed to know any adverse effects they might be feeling after initiation of treatment with Laser. Training of operators: All the operators giving intraoral and extraoral PBM therapy will be trained in the protocol as per study before subject recruitment. Withdrawal criteria: If any patient withdraws consent after treatment is initiated or develops any of the conditions mentioned in exclusion criteria, the patient will be withdrawn from the study. Protocol Deviation : When/If subjects develop changes suspicious of malignancy (erosion, ulceration, induration, exophytic growth) during follow up after Usual care/PBM, they will undergo incisional biopsy to rule out malignant changes and managed as per institutional protocol for oral malignant lesions by referral to cancer center at IRCH. Statistical Analysis: Data will be entered in an electronic data form and managed using Research Electronic Data Capture (REDcap) software. Comparison of baseline continuous variables will be compared between the two groups( A and C, B and C) using Unpaired T-test and categorical variables will be compared using Chi Squared Test or Fisher's Exact Test. The primary outcome measure- Interincisal Distance at maximum mouth opening will be compared between the two groups using Unpaired T-test and analyzed using Intention to Treat and Per Protocol Analysis. Secondary continuous outcome variables will be compared between the two groups using Unpaired T-test or Wilcoxon Rank Test as appropriate. Secondary categorical outcome variables will be compared between the two groups for two proportions/Z-test. Comparison between primary and secondary outcome variables between groups A and B will also be done using the same scheme although the sample size is not estimated for the same. Results will be presented as Difference in Means/Proportions with 95% confidence interval and p<0.05 will be considered statistically significant.

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis