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dbGaP phs001347 Prematurity, Respiratory Outcomes, Immune System, and Microbiome Study (PRISM) - Eligibility

- 2024-11-11 - 5 Formulär, 2 Item-grupper, 20 Dataelement, 1 Språk
Item-grupper: IG.0, IG.5
Principal Investigator: Gloria Pryhuber, University of Rochester Rochester, Rochester, NY, USA MeSH: Infant, Premature,Infant, Newborn,Premature Birth,Term Birth,Microbiota,Gastrointestinal Microbiome,T-Lymphocytes,Bronchopulmonary Dysplasia,Respiratory Tract Diseases https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001347 *Public health importance*: Babies born preterm, approximately 1 out of every 9 live births in the United States, have significant respiratory morbidity over the first two years of life, exacerbated by respiratory viral infections. Many (50%) return to pediatricians, emergency rooms and pulmonologists with symptoms of respiratory dysfunction (SRD): intermittent or chronic wheezing, poor growth and an excess of upper and lower respiratory tract infections (LRTI). SRD correlate inversely with gestational age and weight at birth and is more common in those with chronic lung disease of prematurity, yet its incidence and severity varies widely among both the prematurely born and those born at term. There is evidence from clinical studies and animal models that risks of LRTI and recurrent wheezing is influenced by gut and respiratory flora and by T cell responses to infection. Information gained from this study will be used to identify characteristics, risk factors and potential mechanisms for early and persistent lung disease in children born at term and born preterm. This Clinical Research Study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity in preterm and full term infants. We hypothesize that the timing and acquisition of specific viral infections and bacterial species are directly related to respiratory morbidity in the first year of life as defined by SRD and by measures of pulmonary function. We hypothesize that cellular and molecular immuno-maturity are altered due to factors presented by premature birth in such a way as to promote chronic inflammatory and cytotoxic damage to the lung, with subsequent enhanced, damaging responses to infectious agents and environmental irritants. Our preliminary studies demonstrate both feasibility and expertise in mutiparameter immunophenotyping of small volume peripheral blood samples obtained from premature infants including gene expression arrays of flow cytometry sorted cells. We will use new technologies for known viral identification, as well as high-throughput metagenome sequencing of RNA and DNA virus like particles (VLP) to be used for viral discovery in infant respiratory sample and use of high-throughput pyrosequencing (454T) of bacterial 16S rRNA to determine shifts in bacterial community structure, occurring in pre-term (PT) as compared to full term (FT) infants, over the first year of life. Finally, we present statistical approaches to stratify disease risk predictors using multivariate logistic regression modeling approaches. We propose to evaluate T cell phenotypic and functional profiles relative to viral and predominant bacterial exposures according to highly complementary, but independent, Specific Objectives. *Objective 1*: To determine if viral respiratory infections and patterns of respiratory and gut bacterial community structure (microbiome) in prematurely born babies predict the rate and degree of immunologic maturation, and pulmonary dysfunction, measured from birth to 36 weeks corrected gestational age (CGA). *Objective 2*: To determine the relationship between respiratory viral infections and disease severity up to one year CGA, and the lymphocyte (Lc) phenotypes documented at term gestation (birth for term infants and 36 wks/NICU discharge in preterm infants) and at one year CGA. Three secondary outcomes of this objective will be to a) relate the quantity, type and severity of viral infections with pulmonary function at one and three years of life, b) relate the viral community structure to severity of viral infections and c) to seek evidence of modulation of viral susceptibility by bacterial respiratory and gut community structure (microbiome). The relationship of colonization with known and non-identified bacterial species in both the respiratory tract and the gut will be evaluated. Flow cytometry data corresponding to this study can be found within Immport study SDY1302. Positive and negative controls for microbiome samples are uploaded under SRA bioproject PRJNA474485. Microbiome samples corresponding to PRISM2 are distinguished from PRISM1 via "_PRISM2" appended to the sample name. Within the positive and negative controls, PRISM1 controls are uploaded as bam files and PRISM2 controls are uploaded as paired fastq. Samples ending in -08 correspond to TLDA qPCR results for a given sample. There is a column for each pathogen tested and a column to indicate where that pathogen was bacteria or virus.

pht006796.v3.p2

1 Item-grupp 32 Dataelement

pht006794.v3.p2

1 Item-grupp 7 Dataelement

pht006795.v3.p2

1 Item-grupp 2 Dataelement

pht006797.v3.p2

1 Item-grupp 94 Dataelement

dbGaP phs000659 Mount Sinai Hospital (MSH, Toronto, CANADA) pelvic pouch microbiome study - pht003521.v1.p1

- 2023-01-24 - 5 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: pht003521
Principal Investigator: Mark Silverberg, MD., PhD, Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital, Toronto, ON, CANADA MeSH: Inflammatory Bowel Diseases,Crohn Disease,Colitis, Ulcerative,Pouchitis,Adenomatous Polyposis Coli https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000659 This study involved evaluation of the tissue associated microbiome of the ileal pouch following surgery for ulcerative colitis (UC) or familial adenomatous polyposis (FAP). Individuals were recruited, with biopsies taken from the ileal pouch and the pre-pouch ileum, microbial DNA was extracted and sequenced using 454 pyrosequencing. Total bacterial community structure and abundance were evaluated to determine which changes were characteristic of inflammatory phenotypes including pouchitis (inflammation of the ileal pouch) and a Crohn's disease-like phenotype.

Eligibility

1 Item-grupp 7 Dataelement

pht003522.v1.p1

1 Item-grupp 3 Dataelement

pht003523.v1.p1

1 Item-grupp 6 Dataelement

pht003524.v1.p1

1 Item-grupp 5 Dataelement

dbGaP phs000263 Metagenomic Study of the Human Skin Microbiome Associated with Acne - Eligibility

- 2025-01-29 - 6 Formulär, 1 Item-grupp, 12 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Huiying Li, PhD, David Geffen School of Medicine, University of California, Los Angeles, CA, USA MeSH: Acne Vulgaris https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000263 Acne vulgaris affects 17 million Americans, more than 80% of the people of age 12-24. The goal of this study is to investigate the relationship between acne pathogenesis and the skin microbiota residing in the microcomedones. This study will enroll approximately 100 healthy individuals and acne patients, both male and female with age 13 or older. Data obtained from this study will help better understand the disease pathogenesis and may lead to the development of new effective therapeutic strategies for treatment of acne.

pht001233.v1.p1

1 Item-grupp 4 Dataelement

pht001234.v1.p1

1 Item-grupp 13 Dataelement

pht001235.v1.p1

1 Item-grupp 3 Dataelement

pht001236.v1.p1

1 Item-grupp 2 Dataelement

pht001428.v1.p1

1 Item-grupp 3 Dataelement

dbGaP phs000735 The Placenta Harbors a Unique Microbiome - Eligibility

- 2022-12-20 - 5 Formulär, 1 Item-grupp, 3 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Aagaard, Kjersti, M.D., Ph.D, Baylor College of Medicine, Houston, TX, USA MeSH: Bacterial Infections https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000735 This study is to investigate placental microbiome through 16S rDNA-based and whole genome shotgun metagenomic sequencing. Identified taxa and their gene carriage patterns were compared to other human body sites niches. The placental microbiome profiles were most akin to the human oral microbiome.

pht003796.v1.p1

1 Item-grupp 3 Dataelement

pht003798.v1.p1

1 Item-grupp 7 Dataelement

pht003795.v1.p1

1 Item-grupp 2 Dataelement

pht003797.v1.p1

1 Item-grupp 3 Dataelement

dbGaP phs000896 Functional Dynamics of the Elderly Gut Microbiome During Probiotic Consumption - pht005123.v1.p1

- 2024-04-02 - 6 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: pht005123
Principal Investigator: Patricia L. Hibberd, Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, USA MeSH: Human Microbiome https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000896 A mechanistic understanding of the health benefits conferred by consumption of probiotic bacteria has been limited by our knowledge of the resident gut microbiota and its interaction with the host. We used fecal samples from a study of twelve healthy individuals aged 65-80 to characterize the structure and functional dynamics of the gut microbiota associated with consumption of the single-organism probiotic, Lactobacillus rhamnosus GG ATCC 53103 (LGG). Samples were collected prior to probiotic consumption (day 0), on day 28 immediately after consuming 10^10 CFU of LGG twice daily for 28 days and day 56, one month after stopping LGG consumption. Our integrative approach incorporated bacterial 16S rRNA gene sequencing, whole-community expression profiling using RNA-seq, and metagenomic sequencing. We highlight the value of combinatorial 'omics methods and concomitant high-resolution informatics to probe the role that probiotics may play on the structure and function of the resident microbiota.

pht005124.v1.p1

1 Item-grupp 5 Dataelement

pht005125.v1.p1

1 Item-grupp 5 Dataelement

pht005126.v1.p1

1 Item-grupp 5 Dataelement

pht005127.v1.p1

1 Item-grupp 3 Dataelement

Eligibility

1 Item-grupp 1 Dataelement

dbGaP phs000258 Human Gut Microbiome in Amish Obesity - pht001240.v2.p1

- 2022-10-12 - 3 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: pht001240
Principal Investigator: Claire Fraser-Liggett, University of Maryland School of Medicine, Baltimore, MD, USA MeSH: Obesity,Obesity, Morbid https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000258 Emerging evidence that the gut microbiota may contribute in important ways to human health and disease has led us and others to hypothesize that both symbiotic and pathological relationships between gut microbes and their host may be key contributors to obesity and the metabolic complications of obesity. Our "Thrifty Microbiome Hypothesis" poses that gut microbiota play a key role in human energy homeostasis. Specifically, constituents of the gut microbial community may introduce a survival advantage to its host in times of nutrient scarcity, promoting positive energy balance by increasing efficiency of nutrient absorption and improving metabolic efficiency and energy storage. However, in the presence of excess nutrients, fat accretion and obesity may result, and in genetically predisposed individuals, increased fat mass may result in preferential abdominal obesity, ectopic fat deposition (liver, muscle), and metabolic complications of obesity (insulin resistance, hypertension, hyperlipidemia). Furthermore, in the presence of excess nutrients, a pathological transition of the gut microbial community may occur, causing leakage of bacterial products into the intestinal lymphatics and portal circulation, thereby inducing an inflammatory state, further aggravating metabolic syndrome traits and accelerating atherosclerosis. This pathological transition and the extent to which antimicrobial leakage occurs and causes inflammatory and other maladaptive sequelae of obesity may also be influenced by host factors, including genetics. In the proposed study, we will directly test the Thrifty Microbiome Hypothesis by performing detailed genomic and functional assessment of gut microbial communities in intensively phenotyped and genotyped human subjects before and after intentional manipulation of the gut microbiome. To address these hypotheses, five specific aims are proposed: (1) enroll three age- and sex-matched groups from the Old Order Amish: (i) 50 obese subjects (BMI 30 kg/m2) with metabolic syndrome, (ii) 50 obese subjects (BMI 30 kg/m2) without metabolic syndrome, and (iii) 50 non-obese subjects (BMI 25 kg/m2) without metabolic syndrome and characterize the architecture of the gut microbiota from the subjects enrolled in this study by high-throughput sequencing of 16S rRNA genes; (2) characterize the gene content (metagenome) to assess the metabolic potential of the gut microbiota in 75 subjects to determine whether particular genes or pathways are correlated with disease phenotype; (3) characterize the transcriptome in 75 subjects to determine whether differences in gene expression in the gut microbiota are correlated with disease phenotype, (4) determine the effect of manipulation of the gut microbiota with antibiotics on energy homeostasis, inflammation markers, and metabolic syndrome traits in 50 obese subjects with metabolic syndrome and (5) study the relationship between gut microbiota and metabolic and cardiovascular disease traits, weight change, and host genomics in 1,000 Amish already characterized for these traits and in whom 500K Affymetrix SNP chips have already been completed. These studies will provide our deepest understanding to date of the role of gut microbes in terms of 'who's there?', 'what are they doing?', and 'how are they influencing host energy homeostasis, obesity and its metabolic complications? PUBLIC HEALTH RELEVANCE: This study aims to unravel the contribution of the bacteria that normally inhabit the human gastrointestinal tract to the development of obesity, and its more severe metabolic consequences including cardiovascular disease, insulin resistance and Type II diabetes. We will take a multidisciplinary approach to study changes in the structure and function of gut microbial communities in three sets of Old Order Amish patients from Lancaster, Pennsylvania: obese patients, obese patients with metabolic syndrome and non-obese individuals. The Old Order Amish are a genetically closed homogeneous Caucasian population of Central European ancestry ideal for genetic studies. These works have the potential to provide new mechanistic insights into the role of gut microflora in obesity and metabolic syndrome, a disease that is responsible for significant morbidity in the adult population, and may ultimately lead to novel approaches for prevention and treatment of this disorder.

pht001242.v2.p1

1 Item-grupp 12 Dataelement

pht001241.v2.p1

1 Item-grupp 4 Dataelement

End of Study Psoriasis MIPSO EudraCT 2014-003022-40 DRKS00007147 - End of Study Psoriasis MIPSO EudraCT 2014-003022-40

- 2016-07-25 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: End of Study
MIPSO Comparative study of bacterial microbiota in the skin and intestines of psoriasis patients before and after systemic treatment with adalimumab or ustekinumab or ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. H. C. Thomas A. Luger

Study SHIP-TREND_TREND1_PIA - t1.signinfect2

- 2024-10-26 - 26 Formulär, 1 Item-grupp, 6 Dataelement, 2 Språk
Item-grupp: t1.signinfect2
SHIP Study https://doi.org/10.1093/ije/dyac034

t1.pia_sf12

1 Item-grupp 12 Dataelement

t1.symptomresp1

1 Item-grupp 32 Dataelement

t1.allergyresp

1 Item-grupp 24 Dataelement

t1.pia_solidar

1 Item-grupp 7 Dataelement

t1.piacontact

1 Item-grupp 37 Dataelement

t1.pia_impact

1 Item-grupp 75 Dataelement

SacBo TI: Case Report Form End Of Study Study Discontinuation DRKS00000084 NCT01143272 - SacBo TI: Case Report Form End Of Study Study Discontinuation NCT01143272

- 2016-02-11 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: End of study / study discontinuation, If study discontinuation
Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Initial Visit Hyperthermia Treatment Study

- 2015-11-19 - 1 Formulär, 12 Item-grupper, 79 Dataelement, 1 Språk
Item-grupper: Patient Identification, Inclusion, Initial Therapy, Response, Progression Treatment, Response, Radiology, Patient History, Vaccinations, Virological Diagnostics, Microbiological Diagnostics, Confirmation
Hyper-PEI-protocol:a programme with regional deep hyperthermia(RHT)in combination with PEI-chemotherapy.The Hyper-PEI protocol is offered in place of the intensive standard chemotherapy for high-risk patie nts with malignant, extracranial tumors. Patients have a measurable relapsed tumor,or a primary tumor that did not respond sufficiently to treatment according to standard protocols. Responsible MD: PD Dr. med. R Wessalowski, Clinic for pediatric oncology,haematology and immunology UKD, Moorenstr. 5, 40225 Dusseldorf Form has to be completed by cooperating center or clinic after inclusion and sent to the Hyper-PEI director.

Baseline RICH study NCT02669589

- 2016-06-12 - 1 Formulär, 21 Item-grupper, 234 Dataelement, 1 Språk
Item-grupper: Patient Information, Patient Data, Kidney Disease: Improving Global Outcomes (KDIGO), Renal function, Neurologic dysfunction, Pulmonary dysfunction, Cardiovascular disorder, Gastrointestinal dysfunction, Other organ dysfunction, Main diagnosis for admission, Pre-existing illness, Premedication, Glasgow Coma Scale, Mechanical ventilation, Catecholamine and inotropic therapy, Vital signs, Concomitant medication, Laboratory Parameters and Blood Gas Analysis, Fluid balance, Transfusion, Microbiology
NCT02669589 EudraCT-Nr. 2014-004854 [Titel anhand dieser ISBN in Citavi-Projekt übernehmen] -33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

dbGaP phs000266 Skin Microbiome in Disease States: Atopic Dermatitis and Immunodeficiency - pht001264.v4.p1

- 2025-01-29 - 6 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: pht001264
Principal Investigator: Julia Segre, PhD, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA MeSH: Dermatitis, Atopic,Job's Syndrome,Wiskott-Aldrich Syndrome https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000266 The NIH Intramural Skin Microbiome Consortium (NISMC) is a collaboration of investigators with primary expertise in genomics, bioinformatics, large-scale DNA sequencing, dermatology, immunology, allergy, infectious disease, and clinical microbiology. Atopic dermatitis (AD, "eczema") is a chronic relapsing skin disorder that affects ~15% of U.S. children and is associated with $1 billion of medical costs annually. AD is characterized by dry, itchy skin, infiltrated with immune cells. Colonization by Staphylococcus aureus (S. aureus) is ten-fold more common in AD patients and is associated with disease flares. We hypothesize that, in addition to S. aureus, AD may also be associated with additional novel microbes and/or selective shifts of commensal microbes that are relevant to disease progression. The NISMC seeks to define the microbiota that resides in and on the skin and nares of three patient groups, all of whom have eczematous lesions and are currently seen at the NIH Clinical Center: (1) AD patients; (2) Wiskott-Aldrich syndrome (WAS) patients; and (3) Hyper IgE syndrome (HIES) syndrome patients. Examination of the microbiome of patients with WAS or HIES syndromes, both rare immunodeficiencies, will advance our understanding of how an individual's immune system shapes their cutaneous microbial community. We are performing a prospective longitudinal study that follows these groups of patient thorough the cycles of eczema flares, ascertaining clinical data and samples at each stage.

pht001265.v4.p1

1 Item-grupp 5 Dataelement

Eligibility

1 Item-grupp 27 Dataelement

pht001266.v4.p1

1 Item-grupp 10 Dataelement

pht001446.v4.p1

1 Item-grupp 2 Dataelement

pht002360.v3.p1

1 Item-grupp 7 Dataelement

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