louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03847051: EPIMix Versus CT Brain Pediatric Study
Official title: EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Diseases
Keywords: MRI (magnetic resonance imaging)
Neuroradiology
EPIMix (Echo planar imaging mix)
Multicontrast EPI (echo planar imaging)
Clinical validation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2019-02-20
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Child with indication for elective brain CT.

Brief summary: This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population.

Detailed description: The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population. Imaging quality is analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC for diagnostic performance of minute MRI compared to computed tomography.

Included patients are children age 4-18 with suspicion of cerebral pathology with referral to elective computed tomography of the brain.

Study participants are in addition to computed tomography investigated during same day at 3T MR.

Eligibility criteria: Inclusion Criteria:

* Age 4-18 years.
* Patient with suspicion of cerebral pathology.
* Referral to elective brain CT study.

Exclusion Criteria:

* CT planned with sedation
* known previous cerebral pathology (follow up study)
* Emergency CT
* Aborted MR exam

Primary outcomes:
measure: Tolerance of a new fast MR method in children
timeFrame: At 0 hours
measure: Diagnostic potential
timeFrame: At 0 hours
Secondary outcomes:
measure: Lesion classification
timeFrame: At 0 hours
measure: Lesion location determination
timeFrame: At 0 hours
measure: Diagnostic imaging quality
timeFrame: At 0 hours
measure: Lesion description
timeFrame: At 0 hours
measure: Diagnostic confidence
timeFrame: At 0 hours
measure: Clinical diagnostic summary report
timeFrame: At 0 hours
measure: Ability to rule out diseases
timeFrame: At 0 hours
measure: Artefacts
timeFrame: At 0 hours
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT03161951: Differential Diagnostics of Etiology of Acute Infections
Official title: Differential Diagnostics of Etiology of Acute Infections Based on the Analysis of Expression of Activation Markers on the Surface of Peripheral Blood Monocytes and Neutrophils.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Infectious Diseases
Neuroinfections
Keywords: acute Infections, flow cytometry, cell activation
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the infectious departments of city hospitals.

Brief summary: Method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.

Detailed description: During the study, method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.This method will allow to make a diagnosis within an hour after blood sampling.

The expression of the following markers of activation will be studied using flow cytometry: CD11b, CD11c, CD13, CD16, CD32, CD35, CD38, CD62L, CD64, CD66b, CD88, CD284, HLA-ABC and HLA-DR.

Eligibility criteria: Inclusion Criteria:

* neuroinfections or acute intestinal infections;
* the possibility of blood sampling within a period of up to 24 hours from the moment of admission to hospital;
* less than 72 hours passed after the onset of the disease and until blood was collected;

Exclusion Criteria:

* refuse of patient to participate in the trial;
* more than 24 hours passed after the patient entered the hospital;
* the disease began more than 72 hours ago;
* concomitant severe acute and chronic diseases;
* malignant neoplasms, treatment at a time of less than 1 year, autoimmune diseases in the phase of exacerbation;
* pregnancy/lactation;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction.

Primary outcomes:
measure: Sensitivity of the diagnosis of bacterial vs viral acute infection
timeFrame: 1 month
measure: Specificity of the diagnosis of bacterial vs viral acute infection
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
name: Andrei Y Hancharou, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05878951: Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Official title: A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Urinary Incontinence
Overactive Bladder Syndrome
Overactive Bladder
Urologic Diseases
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Ohio State University
name: University of Alberta
First posted: 2023-05-30
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Detailed description: Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.

Eligibility criteria: Inclusion Criteria:

* Males 18 -89 undergoing HoLEP
* Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires.

Exclusion Criteria:

* Allergy or hypersensitivity to OnabotulinumtoxinA injections
* Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
* Anticipated need for perineal urethrostomy at the time of HoLEP
* Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
* Patients who lack decisional capacity
* Active urinary tract infection

Primary outcomes:
measure: Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
timeFrame: 12 months
Secondary outcomes:
measure: Difference in safety/ adverse effects
timeFrame: 90 days
measure: Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)
timeFrame: 6 months
measure: Difference in efficacy endpoints (3-month clinic/telephone follow-up)
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Krambeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320251: Tissue Growth Characterization for Cochlear Implant Users
Official title: Tissue Growth Characterization for Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cochlear Implant
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is known from post-mortem histological studies that a significant portion of individuals who undergo cochlear implantation (CI) have scar tissue form around the implanted electrode array over time. This scar tissue affects the electrical performance of the cochlear implant, affecting how the implant stimulates the auditory nerve. It is possible that if this scar tissue was detected, the implant programming could be adjusted to account for the changing tissue properties. As part of another study, a computational modeling approach for patient-customized simulation of cochlear implant stimulation is being developed. The simulation approach uses as input CT images and electrophysiological measurements from the cochlear implant device to simulate stimulation by the cochlear implant. These computational simulation models also provide a way to estimate tissue growth around the array. Tissue growth estimates are optimized in the computational model so that electrophysiological metrics simulated by the model match measurements acquired from the patient's implant. In this study, the aim is to collect data necessary to validate these model predictions.

While the existence of tissue growth around the implanted array is not typically known for most patients, a subset of cochlear implant recipients need to undergo revision surgery when a device failure or poor placement is suspected. For these individuals, the existence of tissue growth around the array in the base of the cochlea can be visualized in the operating room by the surgeon. Individuals will be recruited who are undergoing CI revision surgery at Vanderbilt University Medical Center to participate in this study. In surgery, the presence of scar tissue growth will be evaluated by visual confirmation by the surgeon.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age and above undergoing revision cochlear implant surgery.

Exclusion Criteria:

* Age \< 18 years or not undergoing revision cochlear implant surgery.

Primary outcomes:
measure: Tissue growth
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Jack Noble, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Robert Labadie, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06437951: to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection
Official title: A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Erosive Gastroesophageal Reflux Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants


Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc

Exclusion Criteria:

1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4. A person who has been tested positive for Helicobacter pylori
5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc

Primary outcomes:
measure: PK of Fexuprazan
timeFrame: 0 and 72hour
measure: PK of metabolite
timeFrame: 0 and 72hour
measure: PD of Fexuprazan
timeFrame: up to 15days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Injin zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03514251: Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Official title: Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Hypoparathyroidism
Marker; Structural
Complication of Surgical Procedure
Parathyroid Function Low Adverse Event
Keywords: Thyroid Cancer
Hypoparathyroidism
parathyroid marker
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery

Detailed description: This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .

Eligibility criteria: Inclusion Criteria:

* Patients with thyroid cancer who need central compartment dissection
* Routine neck incision surgery
* Patients undergoing primary neck surgery

Exclusion Criteria:

* Benign thyroid tumor patients
* Selecting patients with endoscopes, small incisions, or robotic surgery
* Patients with hyperparathyroidism

Primary outcomes:
measure: The stitch marking operation time
timeFrame: During surgery
measure: Specimen inspection time
timeFrame: During surgery
measure: The number of transplanted parathyroid glands
timeFrame: When the surgery is completed
measure: Parathyroid hormone level testing
timeFrame: 0 days, 1 day, 2 weeks after surgery
measure: Calcium levels
timeFrame: 0 days, 1 day, 2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: FuZhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT02240251: Excimer Laser Assisted IVC Filter Retrieval
Official title: A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVC Filters
Keywords: Inferior Vena Cava Filter
IVC Filter
IVC filter removal
Excimer Laser
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone ages 18-100 years old that will undergo laser assisted IVC filter removal at Northwestern Memorial Hospital in Chicago IL USA

Brief summary: This is a prospective chart review to follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.

Detailed description: At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed \>95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques.

Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will be consented to participate in the chart review study and become a part of a registry kept at Northwestern Memorial Hospital. The procedure itself is not being used as part of the study. Chart reviews will be completed and data collected on the procedure to remove the filter. Follow up after the procedure by phone call and chart review will be completed at least once, 1 week after the filter removal.

Eligibility criteria: Inclusion Criteria:

* Patients will be male and female aged 18 years to 100 years old who were treated with either permanent or retrievable IVC filter placement and were referred to the Interventional Radiology or Vascular Surgery departments for IVC filter retrieval starting December 1, 2011.
* Patients have failed all other traditional methods/attempts at removal of their IVC filter.

Exclusion Criteria:

* Patients who refuse the use of the excimer laser device to attempt to remove their IVC filter.

Primary outcomes:
measure: Evaluate any adverse events related to laser assisted IVC filter removal
timeFrame: up to 1 year after Laser Assited IVC filter removal
measure: Effectiveness of Laser Assisted IVC filter removal
timeFrame: At time of IVC filter removal
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert Lewandowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006151: Combining a Smoke Ending Aid With Behavioral Treatment - 1
Official title: Combining a Smoke Ending Aid With Behavioral Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: nicotine fading
Accu Drop
cigarette tapering
smoking cessation
motivational interviewing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2000-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to combine a smoke ending aid with behavioral treatment.

Detailed description: The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (\*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD\&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.

Eligibility criteria: Inclusion Criteria:

* 21 years of age or older, and no greater than 65 years of age
* Medically stable
* Smoke at least 15 filtered cigarettes daily
* Motivated to quit smoking

Exclusion Criteria:

* Medically unstable
* Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
* Pregnant

Primary outcomes:
measure: Abstinence Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Peter W Gariti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gariti P, Alterman AI, Lynch KG, Kampman K, Whittingham T. Adding a nicotine blocking agent to cigarette tapering. J Subst Abuse Treat. 2004 Jul;27(1):17-25. doi: 10.1016/j.jsat.2004.03.005.