Chuo-ku Niigata-shi, Japan

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

Phase III, randomized, open label, multi-centre study. Randomization on a 1:1 ratio, stratification performed according to: - Prior adjuvant chemotherapy (yes or no) - Prior pelvic radiotherapy (yes or no) - Disease status: newly diagnosed advanced / metastatic disease versus relapse

Screening Study for Participants With Malignant Tumors

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to placebo and standard of care in patients with native C3G. CLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants treated with iptacopan compared to placebo, as well as the proportion of participants who achieve a composite renal endpoint consisting of eGFR and UPCR elements. These effects of iptacopan in conjunction with increases in serum C3 levels will provide support for an iptacopan profile that includes stabilization of eGFR, clinically meaningful reductions in proteinuria and inhibition of the complement AP. Kidney biopsies will be performed in adult participants to evaluate histopathological improvements in immunofluorescence and light microscopy that support these functional benefits of iptacopan.

A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.

An Follow-Up Study of Liver Cirrhosis

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

The investigators will perform a global, Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone. The investigators will include participants with a volume of ICH ≥ 2 and < 60 cc, no more than a small volume of intraventricular hemorrhage (IVH) (IVH score ≤ 7), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use emergency research informed consent procedures (including exception from informed consent (EFIC) in the United States) and mobile stroke units (MSUs), with a goal of ½ of participants treated within 90 minutes, as accomplished in the NINDS t-PA trials. The FASTEST Trial will include approximately 100 hospital sites and at least 15 MSUs in the NINDS-funded StrokeNet and key global institutions with large volumes of ICH patients and the ability to treat them within 120 minutes of stroke onset. Recruitment of 860 participants over 3½ years is planned. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, and the United Kingdom. Involving other countries may be possible in the future depending upon recruitment needs. Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg. The primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 180 days, but participants will be followed by remote assessment at 30 days and 90 days. To measure growth of ICH, all participants will have a standard of care baseline non-contrast CT of the head and a repeat scan at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be performed for both time points. Novo Nordisk A/S will manufacture and supply rFVIIa as a research medication for use in the FASTEST Trial. Novo Nordisk A/S will also manufacture and supply matching placebo that is identical to rFVIIa in appearance and administration.

Distribution of Lymph Node Metastases in Esophageal Carcinoma

Primary Objective: Aim of the TIGER study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least 2-field lymphadenectomy. Secondary Objective(s): - Accuracy of preoperative diagnostics (especially EUS and PET-CT) and added value of EBUS (endobronchial ultrasonography) to existing staging with EUS (endoscopic ultrasonography)/PET-CT - Prognostic value of different lymph node stations - Three- and 5-year overall and disease free survival - Distribution pattern of recurrence or metastases - Number of harvested lymph nodes in patients who are treated with and without neo-adjuvant chemoradiotherapy - Frequency of skip nodal metastases - Ratio of nodal metastases inside and outside the radiation field o Lymph node metastases will be defined as inside or outside the radiation field nodes. Study design: TIGER is a multinational observational cohort study. The duration of the study will approximately be 7 years (2 years inclusion, 5 years follow-up). The participating centers are distributed over 18 countries. Sample size calculation: In 2012, the incidence of esophageal cancer was 456,000 new cases worldwide. Only a small percentage of patients with esophageal cancer present with curable disease at time of diagnosis. We aim to include all patients with resectable disease in participating centers in a 2 year time period. We aim to include 5000 patients. This number suffices for (i) descriptive purposes and (ii) clustering of metastases diffusion profiles into meaningful subgroups within predefined strata (patients with adenocarcinoma or squamous cell carcinoma, with and without neoadjuvant therapy, different tumor heights and invasion depths, and following a 2- or 3-field lymphadenectomy). Study procedures: Patients will not undergo any additional procedures for the study. This is an observational study only. Patients will be treated according to national guidelines. Follow-up: Patients will be followed up for 5 years after the operation according to national guidelines. Follow-up will be scheduled every three months the first year, every six months the second until the fourth year and once yearly until the fifth year. Investigations are performed according to national guidelines. In the Netherlands, these are performed on indication of patients' complaints. Statistical analysis: Primary study parameter(s): Numbers and percentages of resected lymph nodes and lymph node metastases will be given per lymph node station. Tumor location and invasion depth will be categorized. Patients with adenocarcinoma and squamous cell carcinoma and patients with and without neoadjuvant therapy will be analyzed separately. Also patients following a 2- or 3-field lymphadenectomy will be analyzed separately. Secondary study parameter(s) : The sensitivity, specificity, and positive and negative predictive values of EUS and PET-CT will be reported. Perioperative morbidity and mortality will be summarized descriptively. For each patient group mentioned in 5.4, explorative cluster analyses will be done to identify subgroups of patients with different patterns of lymph nodes metastases, tumor locations and invasion depths. Potentially relevant other characteristics at the time of surgery like age, gender, tumor differentiation, vaso-invasive growth will be included in the analysis. No restrictions will be applied to the number of clusters in each analysis, but the ratio of the largest cluster size to the smallest cluster size should preferably not exceed the value of 3 and/or the smallest cluster size should be minimally 30 patients. Characteristics introducing patient outliers will be excluded and one should further be able to attribute meaning to the resulting cluster profiles. Clusters that show the phenomenon of skip metastases will be noted. The resulting clusters will be evaluated for the diffusion pattern of future metastases during follow-up (descriptive analysis), the number of future metastases during follow-up (Poisson regression or generalized estimation equation, whichever appropriate), for 3- and 5-year overall and disease free survival (Kaplan-Meier survival analysis). Multivariate analysis will be performed using the Cox hazard regression method. The univariate analysis, including all baseline parameters, will serve as the basis for the multivariate Cox hazard regression model. Variables showing association (p < 0.10) with survival in univariate analysis will be included in the multivariate analysis. Age and sex will be included in all multivariate analyses. Results are presented as hazard ratio with exact 95% confidence interval (95% CI). After 5-years of follow-up the efficacy index will be determined (incidence of metastases to an area (%) x 5-year overall survival rate (%)). A log-rank test, Mann-Whitney U test, or χ2-test will be used as indicated to compare groups. A value of p < 0.05 will be considered statistically significant. Statistical analysis will be performed with SPSS 21.0 software (SPSS, Inc., Chicago, IL, USA). No formal power analysis or sample size calculation will be performed, but the 5,000 inclusions will suffice for an exploratory study. Other study parameters: Baseline characteristics will be presented in a baseline table. Clinical and pathology data will be presented in separate tables. Study population: Central data management is organized via the secured TIGER database that can be found on TIGERstudy.net. Patient inclusion and data registration of these patients will be done by the participating local PI, surgeon or fellow for the center they are representing on the TIGER website. The local PI is responsible for the inclusion and data registration of all eligible patients in his or her center. All patients with resectable esophageal carcinoma undergoing transthoracic esophageal resection are eligible for inclusion. Patients will be treated according to national guidelines and may be neo-adjuvantly treated with chemotherapy or chemoradiation. An esophagectomy with a 2- or 3-stage lymphadenectomy will be performed followed by a gastric tube or colonic interposition for reconstruction. All lymph node stations will be excised and separately sent for pathological examination. Initial microscopic evaluation will be performed by standard H&E staining. In case of suspicion of micro-metastasis or isolated tumor cells in the lymph node, or in case of suspicion of residual tumor cells in patients with extensive response to neoadjuvant therapy, additional keratin stains will be performed. For the TIGER-study a new lymph node classification is designed, and lymph nodes will be recorded according to that classification system. Patients will be followed-up for 5 years after the operation.

Study To Assess Frequency Of Serious Infections In Clinical Practice In Japan For Adult Participants With Rheumatoid Arthritis Receiving Oral RINVOQ Tablets