Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Rare Diseases

Myasthenia Gravis

Asthenia

Muscle Weakness

Paresis

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

All Drugs and Chemicals

Tacrolimus

Glucocorticoids

Immunosuppressive Agents

Immunologic Factors

Calcineurin Inhibitors

Enzyme Inhibitors

Tacrolimus capsule

Placebo

Use Central Contact

To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy

Astellas Pharma China, Inc.

Astellas Pharma Inc

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Imidacloprid

take advantage of RFA to destroy hepatocellular carcinoma by high temperature

radiofrequency ablation

Zhe Tang, Dr.

The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.

The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.

RFA Plus Carrizumab vs Carrizumab Alone for HCC

Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study

Time from patients received treatment fist time to disease progress or death

The ratio of patients with regressive disease ,including complete response and partial response

The ratio of patients with regressive or stable disease, including complete response, partial response and stable disease.

Time from the random assignment to death (the last follow-up time for patients lost to follow-up, the end of study for patients still alive

Time from the first time of complete regression or partial regression to progressive disease or death

Second Affiliated Hospital, School of Medicine, Zhejiang University

Blood and Lymph Conditions

Lymphopenia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Immunologic Deficiency Syndromes

Hematinics

Liver Extracts

A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry.

A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed including overall survival, recurrence-free survival, association between clinical parameter with mortality, patient characteristics by pre-lymphopenia and post-lymphopenia levels and lymphocyte status of HCC patients with usage of different immunosuppressants. In prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry to identify the major immune cell subsets and the characteristics of patients in the prospective cohort between pre-LT lymphopenia and non-lymphopenia groups.

Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma

Persistent Lymphopenia as a Prognostic Indicator in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma Recipients

The clinical records of 145 patients with HCC from seven days pre-LT to one-year post-LT illustrated that the longitudinal values of lymphocytes were persistently low in patients with peritransplant high neutrophil lymphocyte ratio, indicating a significant decrease in survival rate when compared to other patients.

A significant decrease in cell counts and percentage of overall T cells in the peritransplant lymphopenia group. In particular, the counts of T cell subsets, T helper cells, and cluster of differentiation 8 (CD8+) cytotoxic/activated T cells significantly decreased in the peritransplant lymphopenia group with all of their naïve, effector, and memory forms.

In the subset of 116 of 145 HCC recipients (80%) who did not experience or recover from lymphopenia, no significant associations were observed with immunosuppressant use. Surprisingly, HCC recipients with long-term peritransplant lymphopenia exhibited a significant association with increased sirolimus use (p = 0.024) and decreased tacrolimus use (p = 0.001), whereas those with post-LT lymphopenia showed no association with the use of different immunosuppressants.

Chang Gung Memorial Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.

Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Central Contact

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months.

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.

Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.

Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.

Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.

Sr Manager Clinical Trial Registries

Serious Adverse Events possibly related to study drug were collected.

The only other Adverse Events collected were those associated with study drug dose changes.

Subjects who experienced an Adverse Event with the same preferred term multiple times were only counted once.

Total

Age Continuous

Sex: Female, Male

American Indian or Alaskan Native

Black or African American

White

Race/Ethnicity, Customized

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Senior Medical Director, Medical Affairs

A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with complete IIEF questionnaire data at 18 months are included in the calculation.

Erectile Function Domain Score Between Treated and Untreated Groups

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who achieved normal erectile function are included in the calculation.

Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who used any impotence medications were included in the calculation.

Percentage of Patients Considered Successful Responders to Impotence Medications

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who had a successful response to impotence medications were included in the calculations.

Time to Achieve Response to Impotence Medications

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis	NCT01325571	Myasthenia Grav...	Tacrolimus caps... Placebo	18 Years - 70 Years	Astellas Pharma Inc
RFA Plus Carrizumab vs Carrizumab Alone for HCC	NCT04150744	Tumor Immunity Immunosuppressi... Radiofrequency ...	radiofrequency ...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma	NCT06368349	Lymphopenia		20 Years - 80 Years	Chang Gung Memorial Hospital
RFA Plus Carrizumab vs Carrizumab Alone for HCC	NCT04150744	Tumor Immunity Immunosuppressi... Radiofrequency ...	radiofrequency ...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy	NCT00106392	Erectile Dysfun... Prostate Cancer	Tacrolimus Placebo	- 65 Years	Astellas Pharma Inc
Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma	NCT06368349	Lymphopenia		20 Years - 80 Years	Chang Gung Memorial Hospital
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis	NCT01325571	Myasthenia Grav...	Tacrolimus caps... Placebo	18 Years - 70 Years	Astellas Pharma Inc
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy	NCT00106392	Erectile Dysfun... Prostate Cancer	Tacrolimus Placebo	- 65 Years	Astellas Pharma Inc

Spots Global Cancer Trial Database for immunosuppressant