Hemodiafiltration

Tungs' Taichung Metroharbour Hospital

Comparison of Post- and Pre-dilutional Hemodiafiltration in Hemodialysis Patients

Effects of Post- and Pre-dilutional Hemodiafiltration on Patients With End-stage Renal Disease

The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules

intradialytic tolerance including symptomatic hypotension, cramps, headache, nutrition, and inflammatory status.

Tungs’ Taichung Metroharbour Hospital

Patients with acute coronary syndrome with ST elevation and fibrinogen receiving a dose of 400 mg every 24 hours of Bezafibrate in addition to conventional anti-ischemic treatment

Patients with acute coronary syndrome with ST elevation and hyperfibrinogenemia who received only conventional anti-ischemic treatment

Acute Myocardial Infarction

Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day or just conventional therapy

Bezafibrate

Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction

Early Effect Of Bezafibrate On Fibrinogen Levels, Inflammatory Response And Clinical Impact, In Patients With ST Elevation Acute Myocardial Infarction

PT-Fibrinogen HS Plus kit (Beckman Coulter, Brea, CA) to determine prothrombin time and fibrinogen and to evaluate extrinsic pathway of coagulation in citrated human plasma using an auto-analyzer ACL-800 (Cobas, Roche Diagnostics, Indianapolis, IN) where fibrinogen levels are determined through turbidimetry.

Concentration of cytokines (IL-8, IL-1β, IL-6, IL-10, TNF e IL-12) measured by ELISA system (Biosource)

angina, reinfarction, heart failure, death, and combined endpoints

Any side effect that comes with the intake of bezafibrate

Maria Alejandra Madrid Miller

Head of the Division of Health Research, UMAE Hospital de Cardiologia, Centro Médico Nacional Siglo XXI, IMSS, México, D.F.

Instituto Mexicano del Seguro Social

Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

Multiple System Atrophy

EGCG as putative neuroprotective agent

Placebo

Fox trial finder of the Michael J Fox foundation

Neurology Department, Ludwig-Maximilians University

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus für Bewegungsstörungen

Charité - Universitätsmedizin Berlin

Technische Universität Dresden

Heinrich-Heine-Universität, Neurologische Klinik

Paracelsus-Elena-Klinik Kassel

Universität Leipzig

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Philipps Universität Marburg

Eberhard Karls Universität Tübingen

Universitätsklinikum Ulm

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Double-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)

To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in clinical global impression

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral atrophy (3D MP-RAGE MRI volumetry, 3D FLAIR)

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral iron deposition in pons and striatum (T2* MRI)

Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time)

To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6 to V7) to explore possible symptomatic effects.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in Albumine, total protein, ferritin, iron, transferrin

Dr. Johannes Levin

Sponsor delegated person

German Center for Neurodegenerative Diseases (DZNE)

Deutsche Parkinson Vereinigung

German Foundation for Neurology

ParkinsonFonds Deutschland gGmbH

Study drug (TNFa inhibitor-infliximab or adalimumab) treated group.

Subjects with IBD without TNFa inhibitor treatment

This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn's disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.
Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment.

Treatment Group

CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.

Observation Group

Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn's disease (CD). The rate of infections in the CGD patients without IBD are monitored.

Control Volunteer

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Number of Infections from Baseline to 1 year

Treatment

Observation

Control Volunteers

Safety of Study Drug

Measured participant Crohn's disease Activity Index (CDAI) values. The CDAI is a tool comprised of clinical and laboratory factors such as stool frequency, consistency, abdominal pain, general well being, weight and blood profile as an objective measure of disease activity. A higher score corresponds to greater severity of inflammatory bowel disease; severe disease conventionally defined as >450, a remission as <150, and a response to treatment as a fall of CDAI of >70 points. Infections and IBD are not expected in healthy control subjects. The greater the score, the more severe the disease, and a score of less than 5 represents clinical remission.

Efficacy of Treatment With Study Drug

Gut Immune cell types and their cytokine profile

Gut Immune Cell Types and Their Cytokine Profile

Overall Study

De Ravin, SukSee

Chronic Granulomatous Disease

Crohn'S-like IBD

Inflammatory Bowel Disease (IBD)

Infliximab

National Institutes of Health Clinical Center, 9000 Rockville Pike

Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease

Tumor Necrosis Factor Alpha Inhibitor (Lnfliximab, Adalimumab) Treatment for Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease: A Phase I/II Study Assessing Clinical and Immune Responses to Treatment and Genetic Influences

muscle cramp/nekróza

Comparison of Post- and Pre-dilutional Hemodiafiltration in Hemodialysis Patients

Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease

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