louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05316077: Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
Official title: Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with confirmed diagnosis of hepatocellular carcinoma (HCC) and eligible for cTACE procedures

Brief summary: This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at collecting clinical data, to confirm the General Safety and Performance Requirements of Vectorio® which is a Lipiodol Resistant Mixing \& Injection System for cTACE.


Eligibility criteria: Inclusion Criteria:

1. Female or male adult patient older than 18 years
2. Patient with confirmed diagnosis of HCC and eligible for cTACE procedure
3. Patient affiliated to national health insurance according to local regulatory requirements
4. Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form

Exclusion Criteria:

1. Patient with contraindications to cTACE procedure
2. Patient with known contra-indication(s) to the use or with known sensitivity to Lipiodol or chemotherapeutic agent
3. Pregnant or breast-feeding female patient.
4. Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study

Primary outcomes:
measure: Rate of leakage/breakage
timeFrame: During cTACE procedure
Secondary outcomes:
measure: Time necessary to obtain a water in oil emulsion defined as time between the filling of 20 mL-syringe with Lipiodol (T0) and the obtention of water in oil emulsion ready for injection (Te).
timeFrame: During cTACE procedure
measure: Ease of emulsion preparation through a rating scale
timeFrame: During cTACE procedure
measure: Need to perform remixing during cTACE procedure
timeFrame: During cTACE procedure
measure: Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT
timeFrame: During cTACE procedure
measure: Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)
timeFrame: Study period
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Univ.-Klinik für Radiologie
city: Dijon
country: France
facility: CHU-Hôpital François Mitterrand
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
References:
Clinical trial NCT05343377: A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Official title: Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Extranodal Natural Killer/T-cell Lymphoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Zhenjiang First People's Hospital
name: Changzhou First People's Hospital
name: Changzhou Second People's Hospital
name: Wuxi People's Hospital
name: Second Affiliated Hospital of Soochow University
name: The First Affiliated Hospital of Nantong University
name: Huaian first people's hospital
name: Yancheng First People's Hospital
First posted: 2022-04-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E


Eligibility criteria: Inclusion Criteria:

* newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria
* Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol

Exclusion Criteria:

* The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study

Primary outcomes:
measure: Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL
timeFrame: 2 years
Secondary outcomes:
measure: To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
References:
Clinical trial NCT00638677: Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Official title: Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Infectious Diseases
Keywords: Oral microbiology
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Chr Hansen
name: Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier)
name: Plastone Oy, Konnevesi, Finland (provides the pacifiers)
First posted: 2008-03-19
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aims:

1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier.
2. Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.

Main hypothesis:

The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.

Detailed description: Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier.

Recruiting of subjects to the study is completed.

Eligibility criteria: Inclusion Criteria:

* The infant is healthy
* The family agrees to use the novel slow-release pacifier
* The infant starts to use the pacifier before the age of 3 months

Exclusion Criteria:

* The child is not healthy

Primary outcomes:
measure: MS colonization
timeFrame: 2 years
Secondary outcomes:
measure: Acute infectious diseases
timeFrame: 2 years
measure: Caries occurrence
timeFrame: 4 years
Other outcomes:
Locations:
city: Muurame and Korpilahti
country: Finland
facility: Health Care Centre
Study officials:
affiliation: Assoc. Prof., University of Turku
name: Eva M Söderling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taipale T, Pienihakkinen K, Alanen P, Jokela J, Soderling E. Administration of Bifidobacterium animalis subsp. lactis BB-12 in early childhood: a post-trial effect on caries occurrence at four years of age. Caries Res. 2013;47(5):364-72. doi: 10.1159/000348424. Epub 2013 Apr 5.
Clinical trial NCT01110577: Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)
Official title: Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords: MRI
Hepatic Steatosis Study
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited for the study

Brief summary: This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.


Eligibility criteria: Inclusion Criteria:

* Patient is able to travel to MRI centers
* All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit
* Patient is male or female and at least 18 years of age
* At least 5 patients have type 2 diabetes mellitus or pre-diabetes

Exclusion Criteria:

* Female patient is pregnant or has a positive pregnancy test at screening;
* Patient has known liver disease other than fatty liver
* Patient has a history of neoplastic disease
* Patient is HIV positive
* Patient has known claustrophobia or other contraindication to MRI

Primary outcomes:
measure: Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method
timeFrame: 28 +/- 7 days from Imaging Visit 1
Secondary outcomes:
measure: ICC for repeated HFF measurements from the 3-point Dixon method
timeFrame: 28 +/- 7 days from Imaging Visit 1
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Mashhood A, Railkar R, Yokoo T, Levin Y, Clark L, Fox-Bosetti S, Middleton MS, Riek J, Kauh E, Dardzinski BJ, Williams D, Sirlin C, Shire NJ. Reproducibility of hepatic fat fraction measurement by magnetic resonance imaging. J Magn Reson Imaging. 2013 Jun;37(6):1359-70. doi: 10.1002/jmri.23928. Epub 2012 Nov 21.
Clinical trial NCT01824277: DCI: A Community Based Pre-cardiac Surgery Diabetes Care Project
Official title: Diabetes Cardiac Surgery Initiative (DCI): A Community Based Pre-cardiac Surgery Diabetes Care Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C\>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada.

The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.

Detailed description: This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).

Eligibility criteria: Inclusion Criteria:

* Able to speak and understand English
* Age \> 18
* Able to provide informed consent
* A1C\>7%
* Placed on the waiting list for elective cardiac surgery in Manitoba

Exclusion Criteria:

* Progressive cognitive deficit or disease.
* Age \< 18
* Unable to provide informed consent
* A1C\<7%
* Undergoing emergent cardiac surgery

Primary outcomes:
measure: Change in A1C over the study period.
timeFrame: Baseline to the patients' 3-months post-operative appointment
Secondary outcomes:
measure: Changes to the responses on the validated patient surveys
timeFrame: Baseline to the patients' 3-months post-operative appointment
measure: Changes in the patient perioperative outcomes
timeFrame: Baseline to the patients' 3-months post-operative appointment
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Youville Diabetes Center
state: Manitoba
city: Winnipeg
country: Canada
facility: I.H. AsperInstitute, St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Rakesh C Arora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Sora Ludwig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018577: The Association of Neurotoxin Exposure With Parkinson's Disease and Parkinsonism in World War II Veterans and Other Men
Official title: The Association of Neurotoxin Exposure With Parkinson's Disease and Parkinsonism in World War II Veterans and Other Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: MALE
Minimum age (years): 81
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This program aims to investigate factors associated with development of parkinsonism or idiopathic Parkinson's Disease in an ongoing cohort of patients established in 1965 who are currently undergoing their sixth examination.


Eligibility criteria: This is a cohort study. Population consist of 8,006 Japanese-American men.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Honolulu Dept of Veterans Affairs
state: Hawaii
Study officials:
name: Jordan Popper, M.D.
name: Caroline Tanner, M.D., Ph.D.
name: Helen Petrovitch, M.D.
name: Lon White, M.D.
References:
Clinical trial NCT02378077: Understanding the Relationship Between Inflammation and Insulin Resistance in the Adipose Tissue
Official title: Immunomodulatory Role of Eosinophils in Determining Inflammation and Insulin Sensitivity in Human Adipose Tissue- Aims 1&2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
Insulin Resistance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being done to better understand the relationship between inflammation and insulin resistance in your Adipose (fat) Tissue .

Detailed description: This study is being done to determine whether eosinophils (a type of white blood cell) play an important role in human fat metabolism and inflammation.

This study is being done to determine if fish oil supplement could play a role in reducing inflammation and improving insulin sensitivity in your fat tissue.

Eligibility criteria: Lean, healthy person with a body mass index (BMI) of 25 or less, or you are obese, BMI between 30 and 50, and non-diabetic.

Lean healthy controls will not be on any medication and will be undergoing elective abdominal surgery excluding those involving acute inflammation (i.e. acute cholecystitis, bowel perforation, or diverticulitis).

Obese, non-diabetic subjects will have a BMI between 30 and 50 and be taking no medications affecting glucose metabolism or lipid metabolism. These subjects will be identified from a pool of patients undergoing an elective abdominal surgical procedure such as inguinal hernia repair, laparoscopic Nissen fundoplication, planned cholecystectomy, but also bariatric surgery.

Volunteers will not be taking corticosteroid therapy or have a history of asthma, COPD or atopic syndrome. All subjects will undergo a medical history intake and a physical examination followed by an OGTT to confirm normal glucose.

Primary outcomes:
measure: Eosinophil content in adipose tissue
timeFrame: baseline
Secondary outcomes:
measure: Relationship between eosinophils content and body mass index (BMI)
timeFrame: baseline
Other outcomes:
measure: Change in insulin sensitivity
timeFrame: Baseline, post fish oil supplementation (approximately 3 months)
measure: Change in plasma inflammatory cytokines
timeFrame: Baseline, post fish oil supplementation (approximately 3 months)
measure: Change in plasma inflammatory adipokines
timeFrame: Baseline, post fish oil supplementation (approximately 3 months)
measure: Change in adipose tissue inflammatory markers
timeFrame: Baseline, post fish oil supplementation (approximately 3 months)
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Elena Anna De Filippis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00690053: Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)
Official title: Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Toxicity
PET
HX-4
cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
First posted: 2008-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.

Detailed description: To determine the toxicity of the hypoxia PET-tracer \[18F\]-HX4 in cancer patients in two dose-steps:

* Step 1 (3-6 patients): a single dose of maximum 6 mCi (222 MBq) dose of \[18F\]HX4 (which contains a maximum of 15 μg HX-4) via a bolus IV injection.
* Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of \[18F\]HX4 (which contains a maximum of 27 μg HX-4) via a bolus IV injection.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.
* Normal white blood cell count and neutrophils
* Normal platelet count
* No anaemia requiring blood transfusion or erythropoietin
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
* Calculated Creatinin clearance at least 60 ml/min
* No administration of Fluor-18 in the previous 24 hours
* Capable of complying with study procedures

Primary outcomes:
measure: Toxicity (CTCAE 3.0)
timeFrame: 9 months
Secondary outcomes:
measure: Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)
timeFrame: 9 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology (MAASTRO clinic)
Study officials:
References:
Clinical trial NCT03104153: Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection
Official title: Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Draining Wound
Breast Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare early drain removal versus output-based drain removal, assessing the following end-points:

Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain output versus volume of seroma.

Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance and implications on daily activities.

Cost-effectiveness


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for breast cancer surgery with placement of suction drainage
* Female or male
* Age \> 18 years
* All stages of disease (inclusion is independent of TNM-classification)

Exclusion Criteria:

* Patients scheduled for breast cancer surgery without placement of suction drains
* No informed consent: Patient refuses participation OR is not able to give a written informed consent

Primary outcomes:
measure: Quality of Life
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: