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Database Profile

General information

URL: http://www.clinicaltrials.gov
Full name: U.S. National Library of Medicine
Description: The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
Year founded: 2015
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Country/Region: United States

Contact information

University/Institution: National Institute of Health
Address: Department of Hepatobiliary Surgery, Humanitas Research Hospital, University of Milan School of Medicine, Rozzano, Italy
City:
Province/State:
Country/Region: United States
Contact name (PI/Team): Matteo Donadon
Contact email (PI/Helpdesk): guido.torzilli@humanitas.it

Publications

37178160
Breast carcinoma detection in ex vivo fresh human breast surgical specimens using a fast slide-free confocal microscopy scanner: HIBISCUSS project. [PMID: 37178160]
Angelica Conversano, Muriel Abbaci, Paul van Diest, Aurélie Roulot, Giuseppe Falco, Malek Ferchiou, Saverio Coiro, Milan Richir, Pierre-Michel Genolet, Carine Clement, Odile Casiraghi, Aicha Ben Lahkdar, Nizard Labaied, Moira Ragazzi, Marie-Christine Mathieu

BACKGROUND: New generation ultra-fast fluorescence confocal microscopy allows the ex vivo intraoperative analysis of fresh tissue. The High resolution Imaging for Breast carcInoma detection in ex vivo Specimens after breast Conserving sUrgery by hiStolog Scanner (HIBISCUSS) project aimed to develop an online learning program to recognize the main breast tissue features on ultra-fast fluorescence confocal microscopy images and to evaluate the performance of surgeons and pathologists in diagnosing cancerous and non-cancerous breast tissue in ultra-fast fluorescence confocal microscopy images.
METHODS: Patients who underwent conservative surgery or mastectomy for breast carcinoma (invasive or in situ lesions) were included. The fresh specimens were stained with a fluorescent dye and imaged using a large field-of-view (20 cm2) ultra-fast fluorescence confocal microscope.
RESULTS: One hundred and eighty-one patients were included. The images from 55 patients were annotated to generate learning sheets and images from 126 patients were blindly interpreted by seven surgeons and two pathologists. The time for tissue processing and ultra-fast fluorescence confocal microscopy imaging was between 8 and 10 min. The training program was composed of 110 images divided into nine learning sessions. The final database for blind performance assessment comprised 300 images. The mean duration for one training session and one performance round was 17 and 27 min respectively. The performance of pathologists was almost perfect with 99.6 per cent (standard deviation (s.d.) 5.4 per cent) accuracy. Surgeons' accuracy significantly increased (P = 0.001) from 83 per cent (s.d. 8.4 per cent) in round 1 to 98 per cent (s.d. 4.1 per cent) in round 7 as well as the sensitivity (P = 0.004). Specificity increased without significance from 84 per cent (s.d. 16.7 per cent) in round 1 to 87 per cent (s.d. 16.4 per cent) in round 7 (P = 0.060).
CONCLUSION: Pathologists and surgeons showed a short learning curve in differentiating breast cancer from non-cancerous tissue in ultra-fast fluorescence confocal microscopy images. Performance assessment for both specialties supports ultra-fast fluorescence confocal microscopy evaluation for intraoperative management.
REGISTRATION NUMBER: NCT04976556 (http://www.clinicaltrials.gov).

BJS Open. 2023:7(3) | 1 Citations (from Europe PMC, 2024-04-06)
31439071
An update on the efficacy of anti-inflammatory agents for patients with schizophrenia: a meta-analysis. [PMID: 31439071]
Çakici N, van Beveren NJM, Judge-Hundal G, Koola MM, Sommer IEC.

BACKGROUND: Accumulating evidence shows that a propensity towards a pro-inflammatory status in the brain plays an important role in schizophrenia. Anti-inflammatory drugs might compensate this propensity. This study provides an update regarding the efficacy of agents with some anti-inflammatory actions for schizophrenia symptoms tested in randomized controlled trials (RCTs).
METHODS: PubMed, Embase, the National Institutes of Health website (http://www.clinicaltrials.gov), and the Cochrane Database of Systematic Reviews were systematically searched for RCTs that investigated clinical outcomes.
RESULTS: Our search yielded 56 studies that provided information on the efficacy of the following components on symptom severity: aspirin, bexarotene, celecoxib, davunetide, dextromethorphan, estrogens, fatty acids, melatonin, minocycline, N-acetylcysteine (NAC), pioglitazone, piracetam, pregnenolone, statins, varenicline, and withania somnifera extract. The results of aspirin [mean weighted effect size (ES): 0.30; n = 270; 95% CI (CI) 0.06-0.54], estrogens (ES: 0.78; n = 723; CI 0.36-1.19), minocycline (ES: 0.40; n = 946; CI 0.11-0.68), and NAC (ES: 1.00; n = 442; CI 0.60-1.41) were significant in meta-analysis of at least two studies. Subgroup analysis yielded larger positive effects for first-episode psychosis (FEP) or early-phase schizophrenia studies. Bexarotene, celecoxib, davunetide, dextromethorphan, fatty acids, pregnenolone, statins, and varenicline showed no significant effect.
CONCLUSIONS: Some, but not all agents with anti-inflammatory properties showed efficacy. Effective agents were aspirin, estrogens, minocycline, and NAC. We observed greater beneficial results on symptom severity in FEP or early-phase schizophrenia.

Psychol Med. 2019:49(14) | 71 Citations (from Europe PMC, 2024-04-06)
29722838
Vitamin A and D intake in pregnancy, infant supplementation, and asthma development: the Norwegian Mother and Child Cohort. [PMID: 29722838]
Parr CL, Magnus MC, Karlstad Ø, Holvik K, Lund-Blix NA, Haugen M, Page CM, Nafstad P, Ueland PM, London SJ, Håberg SE, Nystad W.

Background: Western diets may provide excess vitamin A, which is potentially toxic and could adversely affect respiratory health and counteract benefits from vitamin D.
Objective: The aim of this study was to examine child asthma at age 7 y in relation to maternal intake of vitamins A and D during pregnancy, infant supplementation with these vitamins, and their potential interaction.
Design: We studied 61,676 school-age children (born during 2002-2007) from the Norwegian Mother and Child Cohort with data on maternal total (food and supplement) nutrient intake in pregnancy (food-frequency questionnaire validated against biomarkers) and infant supplement use at age 6 mo (n = 54,142 children). Linkage with the Norwegian Prescription Database enabled near-complete follow-up (end of second quarter in 2015) for dispensed medications to classify asthma. We used log-binomial regression to calculate adjusted RRs (aRRs) for asthma with 95% CIs.
Results: Asthma increased according to maternal intake of total vitamin A [retinol activity equivalents (RAEs)] in the highest (≥2031 RAEs/d) compared with the lowest (≤779 RAEs/d) quintile (aRR: 1.21; 95% CI: 1.05, 1.40) and decreased for total vitamin D in the highest (≥13.6 µg/d) compared with the lowest (≤3.5 µg/d) quintile (aRR: 0.81; 95% CI: 0.67, 0.97) during pregnancy. No association was observed for maternal intake in the highest quintiles of both nutrients (aRR: 0.99; 95% CI: 0.83, 1.18) and infant supplementation with vitamin D or cod liver oil.
Conclusions: Excess vitamin A (≥2.5 times the recommended intake) during pregnancy was associated with increased risk, whereas vitamin D intake close to recommendations was associated with a reduced risk of asthma in school-age children. No association for high intakes of both nutrients suggests antagonistic effects of vitamins A and D. This trial was registered at http://www.clinicaltrials.gov as NCT03197233.

Am J Clin Nutr. 2018:107(5) | 18 Citations (from Europe PMC, 2024-04-06)
26458460
[Basics and clinical application of human mesenchymal stromal/stem cells]. [PMID: 26458460]
Miura Y.

Human mesenchymal stromal/stem cells (MSCs) show a variety of biological characteristics. The clinical trials database provided by the National Institutes of Health, USA, contains about 400 clinical trials of MSCs for a wide range of therapeutic applications internationally (http://www.clinicaltrials.gov, key words "mesenchymal stem cells", as of April, 2015). Encouraging results from these clinical trials include evidence of efficacy against graft versus host disease (GVHD) in hematopoietic stem cell transplantation. Treatment for and/or prevention of engraftment failure and insufficient hematopoietic recovery have also been explored. Herein, we will address the basic principles of MSCs and the current status of clinical studies using MSCs. Future prospects for MSC-based therapy will also be discussed.

Rinsho Ketsueki. 2015:56(10) | 1 Citations (from Europe PMC, 2024-04-06)
25217112
Safe hepatectomy selection criteria for hepatocellular carcinoma patients: a validation of 336 consecutive hepatectomies. The BILCHE score. [PMID: 25217112]
Donadon M, Costa G, Cimino M, Procopio F, Fabbro DD, Palmisano A, Torzilli G.

BACKGROUND: Selection criteria for hepatectomy for hepatocellular carcinoma (HCC) are object of debate. We presented our criteria for safe hepatectomy for HCC, and we compared the results with those obtainable using the most common scores for HCC.
METHODS: All patients submitted to hepatectomy for HCC based on the same criteria were reviewed from our prospectively maintained database. Such criteria included bilirubin (BIL), cholinesterases (CHE), ascites, esophageal varices, and residual liver volume.
RESULTS: A total of 336 patients were analyzed. One hundred fifteen patients (33 %) had thoracoabdominal approach, but only 39 (12 %) had major or extended resections. The median tumor number was 1 (range 1-33), while the median tumor size was 3.6 cm (range 1.1-28). Of those, 94 (29 %) had postoperative complications, of which 6 % were graded as major (Dindo III-IV). The 90-days mortality was 2 %. The MELD, APRI, and CPT scores were not found to be statistically significant for complications, while combining BIL and CHE we defined four classes of risk. The association of BIL >1 mg/dl (>17.1 µmol/l) and CHE ? 5,900 U/l was the best to detect complications (OR = 4.45; P = 0.007).
CONCLUSIONS: This study shows that our selection criteria that count mainly on two commonly available, and inexpensive parameters, BIL and CHE, lead to identify patients potentially at risk of postoperative complications after hepatic resection for HCC.
REGISTRATION NUMBER: NCT02056041 ( http://www.clinicaltrials.gov).

World J Surg. 2015:39(1) | 27 Citations (from Europe PMC, 2024-04-06)

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All databases:
786/6000 (86.917%)
Health and medicine:
178/1394 (87.303%)
786
Total Rank
117
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13
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Record metadata

Created on: 2018-01-29
Curated by:
Xinyu Zhou [2023-08-27]
Amjad Ali [2019-10-26]
Ghulam Abbas [2019-10-18]
raza muhammad [2018-04-04]