The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.

No prophylactic antibiotics will be administered.

Cholangitis

Intravenous Ceftriaxone will be given during the procedure.

Ceftriaxone

Oral Levofloxacin will be given for 3 days after the procedure.

Levofloxacin

Los Angeles County Hospital

Antibiotics to Decrease Post ERCP Cholangitis

Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis

The primary outcome will be the proportion of patients who develop develop post-ERCP cholangitis as defined by the Revised Tokyo criterion within 1 week of ERCP.

The number of days of hospitalization following ERCP will be compared among the two groups.

The proportion of patients in the two groups who develop allergic reactions, C. difficile colitis, and other adverse symptoms attributable to antibiotic use will be compared.

James Buxbaum

Chief Endoscopist/Associate Professor of Clinical Medicine

University of Southern California

subjects to be randomized into two arms: antibiotic arm and no antibiotic arm

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

Post ERCP Pancreatitis

Diclofenac 90mg, 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

Diclofenac

normal saline 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

normal saline

Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine

Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

Acute pancreatitis was defined as serum amylase at least three times the upper limit of normal range 24hours after the procedure associated with new or increased upper abdomen or epigastric pain, back pain, and epigastric tenderness and hospitalization or prolongation of existing hospitalization for at least 2 nights.

cholestasis/pykinimas

Antibiotics to Decrease Post ERCP Cholangitis

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

Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

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