Nutritional and Metabolic Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Metabolic Diseases

Anemia

Anemia, Aplastic

Flushing

Hematologic Diseases

Bone Marrow Failure Disorders

Pancytopenia

Bone Marrow Diseases

Skin Manifestations

Aplastic Anemia

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Heparin

Calcium heparin

5ml 10 units/ml IV heparin 3 times per week

Normal saline

Martin A Campbell, MBBS FRACP

The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs) with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per week, in preventing CVC occlusions.

Tunneled central venous catheters (CVCs) are now used routinely in pediatric hematology and oncology patients. Flushing with heparin solution is routinely recommended to prevent occlusion of long term CVCs, although the concentration of heparin used, and frequency of its use varies between centres. Once weekly Normal saline is also used successfully in some pediatric enters. There is little evidence to support one method over the other.

The investigators have designed a randomised crossover trial to directly compare once weekly Normal saline flushing with 3 times per week 10U/ml heparin flushing, to determine whether Normal saline is not inferior to heparin.

Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients

A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada

Stollery Children's Hospital

Alberta Children's Hospital

Paediatric Oncologist

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diabetes Mellitus

Kidney Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Male and female volunteers aged 10+ years in good general health as evidenced by medical history

Male and female patients aged 10+ years diagnosed with diseases thought to alter metabolism or body composition and/or taking medication thought to alter metabolism or body composition

Margaret S McGehee, C.R.N.P.

Kong Y Chen, Ph.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Scientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.

Objective:

This natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.

Eligibility:

Healthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.

Design:

Participants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.

Participants will undergo many tests:

They will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.

They will lie on a padded table for about 15 minutes while their body is scanned.

They will stand on a platform while a 3D scanner measures their body.

They will have a test to measure how fast an electric signal moves through their body.

They will grip an instrument to measure the strength of their hands.

They will drink salty water and provide blood and urine samples.

Participants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.

Study Description:

This study will examine the relationships between comprehensively measured resting energy expenditure (REE), body composition, and body surface area (BSA) in a wide range of healthy and diseased individuals.

Objectives:

Primary Objectives:

* To compare estimated and measured BSA.
* To determine if measured BSA is associated with REE independent of body composition measures

Endpoints:

Primary Endpoints:

* Mean difference and limits of agreement at baseline between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight.
* Increase in R\^2 when measured BSA is added to equations predicting REE.

A Natural History Study of Metabolic Sizing in Health and Disease

Increase in R2 when measured BSA is added to equations predicting REE

Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Neoplasms

Inflammation

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

clinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM)

A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms

Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D

A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms

Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters

Iwona Gawron, PhD, MD

Robert Jach, Prof.

Kazimierz Pitynski, Prof.

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).

Activity of Chronic Inflammation in PCOS

Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes

Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes

Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes

Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes

Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes

Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes

Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes

Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between the HOMA-IR and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between HOMA-IR value and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between the concentration of HOMA-IR and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between the BMI value and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between the BMI value and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between the BMI and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between BMI value and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between BMI value and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between the BMI value and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)

Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: leukocyte count (n/µL)

Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: CRP (mg/l)

Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-1 (pg/ml)

Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-6 (pg/ml)

Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-10 (pg/ml)

Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)

Jagiellonian University

Principal Investigator

Diseases and Abnormalities at or Before Birth

Immune System Diseases

Nervous System Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Anemia, Sickle Cell

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Thalassemia

Hematologic Neoplasms

Immunologic Deficiency Syndromes

Metabolism, Inborn Errors

Adrenoleukodystrophy

Genetic Diseases, Inborn

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Sickle Cell Anemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

X-linked Adrenoleukodystrophy

Adrenomyeloneuropathy

The CliniMACS CD34 Reagent System is a medical device that is used in vitro to select and enrich CD34+ cells from heterogeneous hematologic cell populations for transplantation in cases where this is clinically indicated.

CliniMACS CD34 Reagent System

Erin Arbuckle

Joanne Kurtzberg, MD

The objective of this study is to make T-cell depleted stem cells from a family member who is a half match (haplo-identical) available on an expanded access basis to patients receiving one or two unrelated cord blood transplants who are at a higher risk of not engrafting in a safe amount of time. The purpose of the related stem cells is the give the bone marrow a "jump start" towards recovery. Ultimately, the cord blood cells will grow and permanently rescue the bone marrow.

The primary purpose of the study is to provide expanded access of T-cell depleted haplo-identical stem cells for patients receiving allogeneic transplantation from a related haplo-identical donor and an unrelated, umbilical cord blood (UUCB) unit(s) for the treatment of high risk malignancies and non-malignant disorders. The T-cell depleted haplo-identical stems cells are intended to facilitate early, short-term myeloid engraftment with the primary goal of minimizing early infections and other non-relapse mortality while the UUCB cells engraft as the durable and permanent graft. Patients with high risk or refractory malignancies, or non-malignant disorders amenable to stem cell transplantation therapy but lacking conventional related or unrelated donors will be eligible for this protocol.

Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants

A Compassionate Release Protocol: Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Allogeneic Transplantation Using a Related Haplo-Identical Donor and Unrelated, Umbilical Cord Blood Donor(s) for the Treatment of High Risk Malignancies or Non-Malignant Disorders Requiring Allogeneic Transplantation

Duke University

Miltenyi Biotec, Inc.

Digestive System Diseases

Liver Neoplasms

Hepatic Insufficiency

Liver Failure

Liver Failure, Acute

Biliary Atresia

Liver Diseases

Gastrointestinal Diseases

Bile Duct Diseases

Biliary Tract Diseases

Congenital Abnormalities

Digestive System Abnormalities

Gastrointestinal Neoplasms

Digestive System Neoplasms

Hematinics

Liver Extracts

Zhifeng Xi, MD

Qiang Xia, MD, PhD

Background: In mainland China, the development of pediatric liver transplantation (LT) has lagged behind that of adult LT during the past two decades, but it has been progressing immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric transplant center in mainland China.

Aim and method: This study is performed for establishment of key techniques for pediatric LT in mainland China, including the indications and timing for pediatric LT, the criteria for donor selections, living donor LT planning, prevention and treatment for posttransplant complications, long-term follow-up management et al.

Outcome measures:

* Annual caseloads of pediatric liver transplantation
* Patient survival: 1-, 3- and 5-year patient survival after liver transplantation
* Graft survival: 1-, 3- and 5-year graft survival after liver transplantation
* Posttransplant complications, such as biliary complications, vascular complications, acute rejections, infections et al.
* Perioperative data, such as duration of operations, postoperative hospital stay et al.
* Clinical data for living donors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients	NCT01343680	Childhood Cance... Aplastic Anemia Metabolic Disor...	Heparin Normal saline	- 17 Years	Alberta Children's Hospital
A Natural History Study of Metabolic Sizing in Health and Disease	NCT05398783	Metabolic Disor... Cancer Chronic Kidney ... Diabetes Normal Physiolo...		2 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Activity of Chronic Inflammation in PCOS	NCT06300593	Polycystic Ovar...	Measurement and... Evaluation of t...	18 Years - 45 Years	Jagiellonian University
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients	NCT01343680	Childhood Cance... Aplastic Anemia Metabolic Disor...	Heparin Normal saline	- 17 Years	Alberta Children's Hospital
Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants	NCT01881334	Hematologic Mal... Inborn Errors o... Immune Deficien...	CliniMACS CD34 ...	- 65 Years	Duke University
Clinical and Basic Study for Pediatric Liver Transplantation	NCT02503384	Biliary Atresia Metabolic Disor... Fulminant Liver... Hepatic Tumors		1 Month - 17 Years	RenJi Hospital

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