louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03720132: Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Official title: Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheter Related Blood Stream Infections
Keywords: Vancomycin
Therapeutic drug monitoring
Catheter related blood stream infections
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 10
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.

Detailed description: In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously.

Flushing will be done with sodium chloride 0.9 % solution.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with a port catheter
* Treated with systemic vancomycin and/or vancomycin "lock"

Exclusion Criteria:

* Age \> 18 years
* Active downgrading of care

Primary outcomes:
measure: Vancomycin trough levels via port catheter and peripheral vein
timeFrame: At steady state i.e. approximately 36 hours after initation of the treatment or a change in dose
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Isabel Spriet, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877.
citation: Wright DF, Al-Sallami HS, Jackson PM, Reith DM. Falsely elevated vancomycin plasma concentrations sampled from central venous implantable catheters (portacaths). Br J Clin Pharmacol. 2010 Nov;70(5):769-72. doi: 10.1111/j.1365-2125.2010.03749.x. No abstract available.
citation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
Clinical trial NCT01718132: Reduction of Postoperative Pain, Nausea and Vomiting
Official title: Reduction of Postoperative Pain, Nausea and Vomiting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Pain
Nausea and Vomiting
Keywords: Quality of the anaesthetic care in a PACU
reduction of postoperative pain
reduction of postoperative nausea and vomiting
quality markers
Lead sponsor: Triemli Hospital
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 16309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that have been transferred to the postanesthesia care unit postoperatively

Brief summary: Aim of this prospective study was to assess the quality of postoperative care in a postoperative anaesthesia care unit (PACU) using postoperative pain, nausea and vomiting as well as their reduction as quality markers. So far, only sparse data related to this topic are available and there are currently no established quality markers of a PACU service.


Eligibility criteria: Inclusion Criteria:

All patients that have been transferred to the postanesthesia care unit postoperatively

Primary outcomes:
measure: Pain
Secondary outcomes:
measure: Postoperative nausea and vomiting
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Triemli City Hospital
Study officials:
References:
Clinical trial NCT04134832: Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region
Official title: Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neuroendocrine Tumor
Keywords: Pancreatic neuroendocrine tumors
Neutrophil-to-lymphocyte ratio
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma, with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease and covered in one of the participating centres between 01/01/2008 and 01/01/2019

Brief summary: Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas.

pNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population


Eligibility criteria: Inclusion criteria:

1. Major topic ((≥18 years)
2. Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma
3. Subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease.
4. Subject covered in one of the participating centres between 01/01/2008 and 01/01/2019
5. Have a pre-therapeutic biological check-up
6. Subject who has not expressed opposition to the use of his or her data for research purposes

Exclusion criteria:

1. Subject who expressed opposition to participate in the study
2. Lack of histological data
3. Minor subject
4. Patient under the protection of justice
5. Subject under guardianship or trusteeship

Primary outcomes:
measure: The survival will be evaluated by Kaplan Meier Method. The prognostic factors will be evaluated with univariate and multivariate analysis by Cox regression model.
timeFrame: The participant will be followed-up for a maximum of 11 years, and 1 year at least.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Hematologie Et D'Oncologie
Study officials:
References:
Clinical trial NCT00013637: Lead Exposure, Genetics, and Osteoporosis Epidemiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Osteoporosis
Lead
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-28
Enrollment: 650
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This study's primary objective is to assess the effects of environmental lead exposures and genetic risk factors on the development of osteoporosis in middle-aged women.


Eligibility criteria: Healthy participants in the Nurses' Health Study who live in the greater Boston metropolitan area.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06121037: Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)
Official title: Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Greater Occipital Nerve
Pulsed Radiofrequency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis

Detailed description: Traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (GON) have gained attention.

Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. The proximal and distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to disrupt pain signals transmitted by the GON and provide relief of pain for these headache disorders

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with combined migraine and cervicogenic headache according to The International Classification of Headache Disorders (ICHD)
* Age between 18 and 65 years.
* Willingness to participate and provide informed consent

Exclusion Criteria:

* Previous neurosurgical procedures for headache management.
* Patients with contraindications for the RF technique
* Pregnancy or lactation
* History of psychiatric disorders or substance abuse

Primary outcomes:
measure: Numerical rating score
timeFrame: baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
citation: Batistaki C, Madi AI, Karakosta A, Kostopanagiotou G, Arvaniti C. Pulsed Radiofrequency of the Occipital Nerves: Results of a Standardized Protocol on Chronic Headache Management. Anesth Pain Med. 2021 Oct 6;11(5):e112235. doi: 10.5812/aapm.112235. eCollection 2021 Oct.
citation: Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.
Clinical trial NCT05970237: A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
Official title: A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 9000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.

Brief summary: The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension


Eligibility criteria: Inclusion Criteria:

* Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.
* Those who voluntarily signed a written personal information agreement to participate in this clinical study.
* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria:

* Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
* Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1)
* Those who are expected to need insulin prescription during the study period
* Pregnant women, breast-feeding women

Primary outcomes:
measure: Target blood pressure control rate
timeFrame: 12weeks after administration
measure: Target blood glucose achievement rate
timeFrame: 12weeks after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
Study officials:
References:
Clinical trial NCT03413137: Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
Official title: A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Biopsy
Keywords: Prostate cancer
transperineal mp-MRI-fusion/TRUS biopsies
mp-MRI fusion/TRUS transrectal biopsy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.
Primary purpose: DIAGNOSTIC

Brief summary: This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy

Detailed description: This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).

First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.

The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

Eligibility criteria: Inclusion Criteria:

1. Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.

   • Either primary biopsy or repeated biopsy
2. Age 18-90.
3. PI-RADS classification of 3-5

Exclusion Criteria:

1. Men who do not have an MRI of the prostate.
2. PI-RADS classification of 2 or lower
3. Men who were diagnosed with prostate cancer and have begun treatment

Primary outcomes:
measure: Detection rate for clinically significant prostate cancer
timeFrame: within 2 years
Secondary outcomes:
measure: Percentage of cores positive per region of interest (ROI)
timeFrame: within 2 years
measure: Amount of volume of cores positive per region of interest (ROI)
timeFrame: within 2 years
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson campus
Study officials:
affiliation: Rabn Medical Center, Beilinson Campus
name: David Margel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567137: MR Characterisation/Localisation of Breast Cancer
Official title: Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with confirmed breast cancer

Brief summary: Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision.

Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven invasive ductal carcinoma of the breast
* Unifocal disease
* Patient proceeding to mastectomy

Exclusion Criteria:

* Multifocal disease
* Previous surgery to ipsilateral breast
* Neoadjuvant chemotherapy
* Ferromagnetic implants
* Claustrophobia
* Cup size DD or greater

Primary outcomes:
measure: Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions
timeFrame: 4 years
Secondary outcomes:
measure: Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour.
timeFrame: 4 years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References:
Clinical trial NCT03752437: Comparison of Two Dosages of Heparin Before Extracorporeal Circulation
Official title: Comparison of Two Dosages of Heparin Before Extracorporeal Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Extracorporeal Circulation; Complications
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
Primary purpose: OTHER

Brief summary: In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.

Detailed description: In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.

Eligibility criteria: Inclusion Criteria:

* All patients admitted for cardiac open chest surgery

Exclusion Criteria:

* Patient's refusal
* Antithrombin III factor \< 75%
* Patient under treatment by heparin IV

Primary outcomes:
measure: ACT performance
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc of Bouge
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394037: Active Surveillance for Limited GGNs
Official title: Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Ground-glass Opacities
Active Surveillance
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients visiting the hospitals/medical centers.

Brief summary: This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.

Detailed description: The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

Eligibility criteria: Patients eligible for enrollment in the study are required to meet all the following criteria.

1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

   1. Presence of one or two GGNs (bilateral lesions are permitted).
   2. All lesions have remained stable without regression or enlargement for at least 3 months.
   3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter ≥0.6cm and ≤2cm.
   4. CTR ≤0.25 in lesions.
   5. No lymph node with a diameter \>1cm in the mediastinal view.
   6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
2. Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
3. Aged 18-75 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Written informed consent.

Patients will be excluded if they meet any of the following criteria.

1. History of any prior malignancies within the past 5 years.
2. History of lung surgery.
3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: 10-year overall survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: