louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05257070: The Clinical Validation of a Dried Blood Spot Method for Vancomycin and Creatinine
Official title: The Clinical Validation of a Dried Blood Spot Method for Vancomycin and Creatinine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vancomycin
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized adults receiving intravenous vancomycin

Brief summary: A widely used antibiotic is vancomycin. To ensure adequate exposure to vancomycin, drug doses are adjusted based on whole-blood concentration measurements, a practice known as therapeutic drug monitoring (TDM). The need for TDM of vancomycin is well established, as described in several national and international guidelines, for dose-optimization in order to achieve successful treatment and to prevent toxicity and reduce microbial resistance. A sampling method for TDM that has become more popular over the recent years is dried blood spotting (DBS). DBS is a design of blood sampling consisting of positioning a drop of capillary blood, preferably taken from the finger, on filter paper. Unlike venous blood sampling (the current gold standard for TDM of vancomycin), DBS seems to have advantages for the patient. The finger prick is less invasive than venipuncture. DBS also enables patients to perform one or multiple finger prick(s) themselves, with the possibility to sample at multiple time points. Due to the fact that vancomycin is nephrotoxic, it would be very efficient and convenient to measure creatinine in the same dried blood spot as the vancomycin. This study is a clinical validation study to validate the DBS assay for vancomycin.


Eligibility criteria: Inclusion Criteria:

* Clinical patients
* Aged 18 and over
* Able to understand written information and able to give informed consent
* Treated with vancomycin
* Able and willing to undergo a finger prick for dried blood spot sampling
* Able and willing to fill in a questionnaire

Exclusion Criteria:

* Unable to draw blood samples for study purposes

Primary outcomes:
measure: To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis
timeFrame: 5 months
Secondary outcomes:
measure: Analyzing the differences in the measured concentrations in the dried blood spot made with blood obtained from venous sampling and capillary sampling.
timeFrame: 5 months
measure: Evaluating the need of a correction factor and optimizing the correction factor when measuring the hematocrit in the DBS samples
timeFrame: 5 months
measure: To investigate the patients' experience with the DBS method in comparison to venipuncture
timeFrame: 5 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Brenda de Winter, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03417570: Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study
Official title: Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age.
* Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE.
* Must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Prior endoscopic treatment for BE.
* Unable to tolerate sedation due to medical comorbidities.

Primary outcomes:
measure: Number of Participants Who Had a Diagnostic Yield Obtained
timeFrame: At the time of procedure (day 1)
Secondary outcomes:
measure: Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
timeFrame: At the time of procedure (day 1)
measure: Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
timeFrame: At the time of procedure (day 1)
measure: Total Procedure Duration in Seconds
timeFrame: At the time of procedure (day 1)
measure: Safety as Measured by Number of Participants With Procedure-related Adverse Events
timeFrame: Through 48 hours after EGD
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Vladimir M Kushnir, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623370: The Effect of Methylprednisolone on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group
Official title: The Effect of Methylprednisolone Administration on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sugammadex Reversal Time
Muscle Weakness
Keywords: sugammadex
methylprednisolone
reversal time
rocuronium
pediatric patients
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to thoroughly investigate the interaction between methylprednisolone and sugammadex in the pediatric patient population. Our hypothesis is that methylprednisolone will interact with sugammadex, leading to a prolonged reversal time of rocuronium by sugammadex and, at the same time, a reduction in the effect profile of methylprednisolone.

Approximately 80 volunteers will be included in the study. Patients will not have any additional responsibilities related to this study. There are no risks or benefits to patients associated with this research. The study will begin immediately before the patient's surgery and will end two hours after the operation. Volunteers participating in the study will be randomly assigned to one of two groups: one group will receive methylprednisolone during surgery, and the other group will not. Methylprednisolone is a medication used to prevent postoperative pain, swelling, nausea, and vomiting. If these complaints are detected in patients from either group after surgery, appropriate treatments will be administered to alleviate them.


Eligibility criteria: Inclusion Criteria:

* Patients who are able to provide informed consent and reliably report symptoms to the research team,
* Classified as Physical Status 1 and 2 according to the American Society of Anesthesiologists (ASA).

Exclusion Criteria:

* Patients for whom parental or personal consent could not be obtained
* ASA Physical Status 3 or higher
* Known history of allergic reactions to the drugs specified in the protocol
* Patients requiring emergency surgery
* Expected difficult airway
* Preoperative corticosteroid use
* Presence of respiratory system diseases
* Presence of neuromuscular diseases
* Presence of enzymatic or endocrine disorders
* Presence of liver or kidney failure
* Presence of cardiovascular diseases
* Patients with abnormal cognitive or physical development
* History of treatment with drugs that have a high potential for interaction with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid).

Primary outcomes:
measure: reversal time
timeFrame: The study will conclude after the patient has been postoperatively monitored for 2 hours in the recovery unit
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References:
Clinical trial NCT02443870: Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction
Official title: Retrospective Analysis of Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Lower Urinary Tract Dysfunction
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2015-05-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals with neurogenic lower urinary tract dysfunction

Brief summary: The long-term changes of bladder function in individuals with lower urinary tract dysfunction will be investigated. Patients presenting for regular urodynamic examination of bladder function will be included. Bladder diary details and urodynamic data will be collected in order to investigate bladder function.


Eligibility criteria: Inclusion Criteria:

* neurogenic lower urinary tract dysfunction
* urodynamic data

Exclusion Criteria:

* duration of neurogenic lower urinary tract dysfunction \< 10 years
* \< 5 urodynamic follow-ups

Primary outcomes:
measure: maximal detrusor storage pressure
timeFrame: 12 month after previous investigation
Secondary outcomes:
measure: bladder capacity
timeFrame: 12 month after previous investigation
measure: bladder compliance
timeFrame: 12 month after previous investigation
measure: maximal detrusor voiding pressure
timeFrame: 12 month after previous investigation
measure: reflexive bladder volume
timeFrame: 12 month after previous investigation
Other outcomes:
measure: gender
timeFrame: time of injury
measure: age
timeFrame: time of injury
measure: lesion level
timeFrame: time of injury
measure: lesion severity
timeFrame: time of injury
measure: bladder evacuation method
timeFrame: 12 month after previous investigation
measure: presence of incontinence
timeFrame: 12 month after previous investigation
measure: complications
timeFrame: 12 month after previous investigation
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT06462170: Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study
Official title: The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity (PIPC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.

In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.

With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.

Detailed description: This study will measure the ability of the pancreas to produce insulin after the participant drinks a Boost Original meal replacement shake. The Boost Original meal replacement shake contains nutrients similar to a typical meal, and allows to standardize this "meal" for all participants. This is a cross-sectional study for 90 participants with type 2 diabetes mellitus who undergo a single study visit that lasts 2 hours with blood drawn at five time points. The area under the curve will be a quantitative measure of each participant's pancreatic insulin production capacity.

Eligibility criteria: Inclusion Criteria:

1. Consent provided
2. Age \>= 18 years.
3. Diagnosed as type 2 diabetes mellitus.
4. Not on insulin therapy.

Exclusion Criteria:

1. Diagnosed as another form of diabetes mellitus.
2. Allergic to one or more ingredients in Boost meal replacement shake.
3. Unable to fast since midnight and attend in person for the morning protocol.

Primary outcomes:
measure: Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.
timeFrame: 12 months
Secondary outcomes:
measure: The impact of participant's self-reported weight gain in the past year (12 months prior to the single study visit) on participant's PIPC.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Cathy Sun, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00829270: Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques
Official title: Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitochondrial Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2009-01-27
Enrollment: 550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting clinical features of mitchondrial diseases

Brief summary: Mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000) and are clinically heterogeneous making diagnosis particularly challenging for clinicians.

Molecular analysis of mitochondrial DNA (mtDNA) is a critical step in diagnosis and genetic counselling of respiratory chain defects. DNA sequencing remains the gold standard but it is time-consuming and fails to detect mutations that may be present at a low heteroplasmic level (20% or below); therefore the diagnosis is yet based on the detection of a few number of pathogenic mutations.

The present study aims to evaluate the benefit and the cost of a diagnosis strategy based on the combined use of 2 techniques named "Surveyor Nuclease" and "Mitochip". Surveyor nuclease is a mismatch-specific DNA endonuclease that will be used for screening the entire mtDNA in order to identify heteroplasmic mutations. In absence of any identified mutation, another technique based on the use an oligonucleotide sequencing microarray (MitoChip) will be performed for the identification of homoplasmic mutations. Mitochip is an array-based sequencing platform for rapid and high-throughput analysis of mitochondrial DNA.

The economical study will compare the cost of these techniques to the standard diagnosis method in term of direct and indirect costs


Eligibility criteria: Inclusion Criteria:

* patients without deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation
* patient with health insurance

Exclusion Criteria:

* patients with deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation
* absence of patient consent

Primary outcomes:
measure: Evaluation of the benefit and the cost of a mitochondrial disease diagnosis strategy based on the combined use of 2 techniques named "Surveyor Nuclease" and "Mitochip"
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of the benefit of the studiad strategy in comparison with standard diagnosis method in term of indirect costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Medical genetics laboratory
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Véronique PAQUIS-FLUCKINGER, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04581070: The COVID-IYON Study - Study Examining Data Pertaining to Clinical Outcomes and Organisational Responses to the 2020 SARS-CoV-2 Pandemic"
Official title: COVID-IYON Study. Prospective, Multisite, Descriptive, Observational Clinical/Epidemiological Study Examining Data Pertaining to Clinical Outcomes and Organizational Responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) Pandemic
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
COVID-19
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2020-10-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under the care of medical oncology \& malignant haematology services, admitted at participating sites, who test positive for SARS-CoV-2 infection.

Brief summary: This is a prospective, multisite, descriptive, observational clinical/epidemiological study examining both quantitative and qualitative data pertaining to clinical outcomes and organizational responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) pandemic.

Detailed description: This study collects real-time observational data regarding the impact of SARS-CoV-2 infection on patients with cancer, and on the functioning and organisation of cancer and malignant haematology services in the Republic of Ireland in response to the 2020 SARS-CoV-2 pandemic.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Informed consent has been obtained.
3. Cytotoxic chemotherapy, targeted anticancer therapy, immunomodulatory anticancer therapy, hormonotherapy, radiotherapy, oncologic surgery, or other anticancer treatment within the last 12 months (ongoing and completed).
4. Tested positive for SARS-CoV-2.

Exclusion Criteria:

There are no exclusion criteria

Primary outcomes:
measure: A qualitative description
timeFrame: Up til 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
References:
Clinical trial NCT06323070: Effects of Watermelon or Low-fat Cookie Consumption on Wellness
Official title: Effects of Watermelon or Low-fat Cookie Consumption on Wellness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults.


Eligibility criteria: Inclusion Criteria:

* Generally healthy subjects
* BMI 20-40 kg/m2

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required antibiotics use
* Required dietary supplement use
* Required medication of metabolic disorders, mental health and sexual health
* Allergy to watermelon or wheat

Primary outcomes:
measure: Change of sexual health questionnaire scores
timeFrame: Baseline and week 4
measure: Change of skin hydration scores
timeFrame: Baseline, 1 min post application and week 4 consumption
measure: Change of microbiome diversity
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change of depression questionnaire scores
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: San Diego
country: United States
facility: School of Exercise and Nutritional Sciences
state: California
Study officials:
affiliation: San Diego State University
name: Mee Young Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01882270: Third Molar Clinical Trials: Pericoronitis Studies
Official title: Pericoronitis; Oral and Systemic Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pericoronitis
Keywords: pericoronitis
periodontal
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with adjacent 2nd molar with recommended treatment being removal of 3rd molars.

Brief summary: The purpose of this research study is to find out if the infection around 3rd molars and the resulting inflammation around the gum also produces a general systemic inflammation.

Detailed description: Relate signs and symptoms of mild pericoronitis, an oral clinical condition characterized by intense inflammation and pain around a lower 3rd molar, to indicators of oral and systemic inflammation in patients seeking treatment for the condition.

Eligibility criteria: Inclusion Criteria:

* Mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with adjacent 2nd molar (spontaneous pain with localized swelling, purulence/drainage) with recommended treatment being removal of 3rd molars,
* Age 18 - 35 years,
* ASA I, II health status,
* AAP 1-3 periodontal status,
* Willingness to participate in the study,
* Geographic proximity to UNC.

Exclusion Criteria:

* Major signs/symptoms of pericoronitis (Temperature \>101 , dysphagia, limited mouth opening \<20mm incisor, facial swelling/cellulitis, severe uncontrolled discomfort),
* ASA III, IV health status,
* Medical contraindication to full mouth periodontal probing,
* AAP 4 periodontal status,
* Antibiotic treatment within the past 2 months,
* Current tobacco use,
* BMI \> 29,
* Pregnancy,
* Non English speaking.

Primary outcomes:
measure: Quality of Life
timeFrame: one year
Secondary outcomes:
measure: inflammatory mediators
timeFrame: one year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Dentistry
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ray White, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golden BA, Baldwin C, Sherwood C, Abdelbaky O, Phillips C, Offenbacher S, White RP Jr. Monitoring for periodontal inflammatory disease in the third molar region. J Oral Maxillofac Surg. 2015 Apr;73(4):595-9. doi: 10.1016/j.joms.2014.10.010. Epub 2014 Oct 22.
citation: Magraw CB, Golden B, Phillips C, Tang DT, Munson J, Nelson BP, White RP Jr. Pain with pericoronitis affects quality of life. J Oral Maxillofac Surg. 2015 Jan;73(1):7-12. doi: 10.1016/j.joms.2014.06.458. Epub 2014 Jul 7.