Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Infections

Rare Diseases

Prostatic Neoplasms

Carcinoma, Renal Cell

Congenital Abnormalities

Nephritis

Kidney Calculi

Nephrolithiasis

Tuberculosis

Hydronephrosis

Kidney Neoplasms

Tuberculosis, Renal

Calculi

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Urolithiasis

Urinary Calculi

Pathological Conditions, Anatomical

Tuberculosis, Extrapulmonary

Renal Cell Carcinoma

Jörg Simon, PD Dr. med.

Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

The objective of this observational study is to collect systematically and proactively data regarding the Aesculap® DS Titanium Ligation Clip under daily clinical practice when used in urology in different indications.

The hypothesis of this study is that this event, slippage / movement of the clip, is extremely rare through the design if used in accordance with the Instructions for Use (IfU). The observed rate through the total number of clips might be a valuable parameter and could influence future research.

Furthermore, this study is one of the PMCF measures which enable the manufacturer to monitor the safety and performance of the Aesculap® DS Titanium Ligation Clips. The products bear the CE-marking and are routinely used within this institution for the above-mentioned procedures.

DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Estimated operative time from first cut to last stitch

Length of patient's stay in hospital after surgery

The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects

Slippage / movement of the Aesculap® DS Titanium Ligation Clip is an observable slippage, movement, or rotation after the clip was successfully applied and the application forceps was removed. The number of observed slippage / movement of the clip will be documented on the CRF, the clip size, step of the procedure and further measures were necessary, i.e. removal of the clip or application of another clip, will be documented.

In the end the rate will be brought in relationship to the overall number of applied clips. Thus, the number of applied clips is documented, for each clip size.

* Postoperative bleedings
* Infections
* Urine extravasation in partial nephrectomy
* Prolonged urinary catheter drainage in radical prostatectomies
* Ileus
* Venous thrombo-embolic events
* Sepsis
* Other

Aesculap AG

Immune System Diseases

Autoimmune Diseases

Necrosis

Proteinuria

Glomerulonephritis, IGA

Glomerulonephritis

Urination Disorders

Urological Manifestations

IgA Nephropathy

Anti-Infective Agents

Antirheumatic Agents

All Drugs and Chemicals

Antihypertensive Agents

Antineoplastic Agents

Vasoconstrictor Agents

Hydroxychloroquine

Valsartan

Interferons

Enzyme Inhibitors

Interferon-alpha

Antiparasitic Agents

Antimalarials

Immunoglobulin A

Antiprotozoal Agents

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

valsartan (160mg/d) and Hydroxychloroquine Sulfate ( 400mg/d, twice daily)

Hydroxychloroquine Sulfate

RUITONG GAO, MD

Ruitong Gao, MD

Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world.There is to date no curative therapy for patients with IgAN.It is considered that dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine in IgAN patients.

Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world. Its estimated frequency is at least 2.5 cases per year per 100,000 adults. The glomerulopathy usually progressed slowly leading to end stage renal disease (ESRD). ESRD developed in 20%-40% of patients after 20 years. Given its complex and as yet incompletely understood pathogenetic mechanisms, there is to date no curative therapy for patients with IgAN.

Although pathogenesis of IgAN is still obscure, underglycosylated IgA-containing immune-complex including IgG or IgA antibodies against the hinge region of IgA1 are key factors for IgA nephropathy. Aberrant mucosal immune response might lead to increased production of underglycosylated IgA1. It is considered that dendritic cells, Toll-like receptor (TLR)9, and cytokines interleukin-6 (IL-6), , interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response.

Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis.

Therefore, hydroxychloroquine, targeting dendritic cells, TLR, IL-6, IFN-α and TNF-α，may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine added to valsartan in IgAN patients.

Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy

Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study

CR: proteinuria \<0.3 g/24 hr with no worsening of renal function (\<15% estimated glomerular filtration rate(eGFR) reduction from Baseline).PR: proteinuria \<3.5g/24 hrs but ≥0.3g/24 hrs and a decrease of \>50% from Baseline based on 24 hours pooled urine, with no worsening of renal function(\<15% eGFR reduction from Baseline). eGFR at Baseline will be defined as the Day 0 values.

Proteinuria is being assessed at Weeks 0, 4, 12, 24 follow-up visits. Proteinuria is based on 24 hours pooled urine. Baseline is defined as the Day 0 values. The ratio is defined as the post-Baseline value divided by the Baseline value.

Serum creatinine is being assessed at Weeks 0, 4, 12, 24 follow-up visits. Baseline is defined as the Day 0 values. The ratio is defined as the post-Baseline value divided by the Baseline value.

eGFR is being assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. eGFR is calculated at Weeks 0, 4, 12, 24 follow-up visits. Baseline is defined as the Day 0 values. The ratio is defined as the post-Baseline value divided by the Baseline value.

IgA levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits. Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Interleukin-6 levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits by means of enzyme linked immunosorbent assay (ELISA). Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Interferon alfa levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits by means of enzyme linked immunosorbent assay (ELISA). Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Tumor necrosis factor alpha levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits by means of enzyme linked immunosorbent assay (ELISA). Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Peking Union Medical College Hospital

Digestive System Diseases

Nervous System Diseases

Intestinal Diseases

Endometriosis

Gastrointestinal Diseases

Neurodegenerative Diseases

Genital Diseases, Female

Genital Diseases

Re-consent will not be required. This protocol allows distribution of the specimens following the terms agreed to by the subject in the original consent.

Specimens obtained from surgical, phlebotomy or other non-invasive procedure

This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data.

Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples.

This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.

Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

The number of specimens and subjects distributed per disease will be measured and reported.

iSpecimen Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)	NCT04869462	Prostate Cancer Kidney Cancer Congenital Abno... Nephrolithiasis Kidney Tubercul... Nephritis Kidney Injury Hydronephrosis		18 Years -	Aesculap AG
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy	NCT02765594	Primary IgA Nep...	Hydroxychloroqu... Valsartan	18 Years - 60 Years	Peking Union Medical College Hospital
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use	NCT03884400	Cancer Pregnancy Relat... Gastro-Intestin... Cardio-Respirat... Women's Health:... Autoimmune Dise... Nephritis Healthy Neuro-Degenerat...	Specimens obtai...	-	iSpecimen Inc

Spots Global Cancer Trial Database for nephritis

Every month we try and update this database with for nephritis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nephritis

Every month we try and update this database with for nephritis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nephritis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.