louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00899873: Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997
Official title: Proposed Study of CLL Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: chronic lymphocytic leukemia
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E2997

Brief summary: RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment.

PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic lymphocytic leukemia who were treated on clinical trial ECOG-2997.

Detailed description: OBJECTIVES:

* To analyze the expression of a variety of informative molecules using a unique high-resolution flow cytometric immunophenotyping technology in samples from patients with chronic lymphocytic leukemia enrolled in clinical trial ECOG-2997.

OUTLINE: Cell samples are analyzed for the following prognostic biomarkers: ZAP-70, phospho-Syk, phospho-GSK-3β, phospho-Akt, phospho-ZAP-70, cyclin D1, cyclin D2, p21cip1, phospho-ReIA, IkappaBα, Bax, Mcl-1, PTEN, phospho-Erk1/2, and phospho-MEK1/2. Biomarker signals are amplified using enzymatic amplification staining to obtain high resolution detection of cell-surface markers on leukemic cells. Biomarker expression levels are measured using fluorescence activated cell sorting analysis. Relationships between clinical outcomes, standard flow cytometric analysis, cytogenetic studies, and high resolution immunophenotyping will also be assessed.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Stored frozen viable cells from patients with chronic lymphocytic leukemia treated on clinical trial ECOG-2997

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of biomarker analysis and correlation with outcome response
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Seidman Cancer Center
name: David Kaplan, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02164773: Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.
Official title: Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Agitation
Pediatric Disorder
Keywords: sevoflurane
pediatric
lower abdominal surgery
caudal
magnesium sulfate
Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
Agitation States as Acute Reaction to Exceptional Stress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 70
Sex: MALE
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The aim of the study is to delineate the effect of caudal magnesium sulfate in children undergoing lower abdominal surgery to prevent postoperative emergence agitation.

Detailed description: Emergency agitation is considered one of the postoperative complication after sevoflurane anesthesia.In the enrollment of this study,children undergoing lower abdominal surgery will be enrolled in one of two groups.BM group, receive caudal magnesium sulfate 50 mg beside the conventional bupivacaine in the caudal space in ,B group, addition of 1 ml of normal saline0.9% to bupivacine .Monitoring of the postoperative emergence agitation by different emergence agitation scores with monitoring of sedation score.Detection of expected postoperative complications as nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

* children undergoing lower abdominal surgery for hernia repair/orchiopexy in Ain Shams University ASA physical status I under sevoflurane anesthesia.
* age from 1-6 years.

Exclusion Criteria:

* children with developmental delay
* neurological disorder.
* psychological disorder
* difficult airway
* hyperactive airway disease
* contraindication to caudal block(sacral abnormality,bleeding disorder).

Primary outcomes:
measure: measure of postoperative pediatric anesthesia emergence delirium PAED score
timeFrame: first 30 minutes postoperative
Secondary outcomes:
measure: measure of postoperative sedation score.
timeFrame: the first 30 minutes postoperatively
Other outcomes:
measure: postoperative rescue propofol intravenous 1mg/kg in cases if agitation
timeFrame: first 30 minutes postoperative
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Alaa Elkateb, MD
role: STUDY_DIRECTOR
References:
citation: Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.
Clinical trial NCT05906173: Augmented Reality (AR) Chile
Official title: Successful International Training of Non-Technical Medical Crisis Skills Using Remote, Augmented Reality Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an international, collaborative study evaluating the non-technical skills (NTS) of anesthesiology residents. The goal is to explore the capability of performing a remote, international AR simulation for the purpose of assessing NTS during a neonatal medical crisis. Simulation experts in the United States will facilitate the AR simulations with anesthesiology residents in Chile. The medical simulation itself is grounded in traditional best practices in accordance with the American Heart Association and Neonatal Resuscitation Program.


Eligibility criteria: Inclusion Criteria:

* age above 18

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea, a history of seizures
* wear corrective glasses (they are not compatible with the AR hardware).

Primary outcomes:
measure: Individual performance of non-technical skills assessed by Anaesthetist Non-Technical Skills (ANTS)
timeFrame: immediately after simulation
Secondary outcomes:
measure: Individual performance of non-technical skills assessed by Behaviorally Anchored Rating Scale (BARS)
timeFrame: immediately after simulation
measure: System Usability Scale (SUS) Score
timeFrame: immediately after simulation
measure: ISO Ergonomic scale
timeFrame: immediately after simulation
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Parkard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Thomas J Caruso, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00994331: Stereotaxis Computed Tomography (CT) Co-Registration Study
Official title: Randomized Feasibility Study Comparing the Clinical Utility of the Stereotaxis Navigant™ Computed Tomography Angiography Importation and Co- Registration Feature, the NaviView™ Assisted Navigation Feature, and Standard Angiography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Magnetic Navigation
Computed Tomography
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Stereotaxis Niobe® II Magnetic Navigation System (MNS) is designed to direct and digitally control catheter and guidewire based therapeutic and diagnostic devices along complex trajectories within the heart and coronary vasculature.

Navigation using vectors acquired from the CT Co-registration feature of Navigant™ provides clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of contrast used during complex PCI procedures.


Eligibility criteria: Inclusion Criteria:

* Patients must be between 18-80 years of age
* Willing and able to provide prior written informed consent
* Patients present with a single bifurcated lesion or single non-CTO complex lesion requiring PCI.
* Able to be safely exposed to magnetic fields, such as magnetic resonance imaging (MRI)
* CT angiography performed prior to cardiac catheterization (must be performed \>48 hours prior to procedure to limit peri-procedural contrast use, but \<12 months prior to the procedure)

Exclusion Criteria:

* Patients with a creatinine greater than 2.0 mg/dL
* Exclude patients whom in the Investigator's opinion, are hemodynamically unstable on the day of the procedure.
* Untreatable allergy to contrast media
* Patients who have undergone CT angiography within 48 hours of index PCI procedure
* Patients with chronic total occlusions (CTOs) requiring intervention.
* Patients requiring treatment for lesions other than the single bifurcated or single non-CTO complex lesion.

Primary outcomes:
measure: The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
timeFrame: 6 months
Secondary outcomes:
measure: The secondary endpoint is to compare and evaluate the following data points between Groups A, B and C: fluoroscopy time, procedure time, crossing time, procedural contrast use, adverse events (AEs): e.g. clinically significant perforations
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Columbia Medical Center
state: New York
Study officials:
affiliation: New York Presbyterian Hospital-Columbia Medical Center
name: Jeffrey Moses, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06849531: Foot Biomechanics and Lower Extremity Muscle Mechanics
Official title: Evaluation of the Relationship Between Foot Biomechanics and Lower Extremity Muscle Mechanics, Strength and Balance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Balance
Lower Extremity
Foot
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young adults

Brief summary: This study is designed to investigate the relationship between foot biomechanics, balance, lower extremity muscle mechanical properties, and vertical jump in young adults. The aim is to highlight the correlations between foot biomechanics and the other parameters, as well as potential outcomes (if any).

Detailed description: This study is designed to investigate the relationship between foot biomechanics, balance, lower extremity muscle mechanical properties, and vertical jump in young adults. The independent variables of the study include participants' age, height, weight, calcaneotibial angle, navicular drop test, foot lengths, smoking/alcohol habits, socioeconomic status, and exercise habits. The dependent variables are the results from the Korebalance balance test, Flamingo balance test, vertical jump test, and Myoton-Pro assessment. The study aims to highlight the correlations between foot biomechanics and the other parameters, as well as potential outcomes.

Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study
* Aged between 18 and 25 years
* No regular exercise habits

Exclusion Criteria:

* Having a physical disability that prevents participation in the study (e.g., use of a wheelchair, walker, and/or crutches, etc.)
* Having conditions that directly affect balance, such as vertigo or multiple sclerosis (MS)
* Having a neurological disorder

Primary outcomes:
measure: muscle mechanics
timeFrame: Single assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylul University
state: Bandırma
Study officials:
affiliation: Bandırma Onyedi Eylül University
name: Derya Azim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00337831: Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Official title: Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Gambro Corporate Research, Sweden
First posted: 2006-06-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).


Eligibility criteria: Inclusion Criteria:

* stable on hemodialysis \>= 6 months
* of which presently on high-flux HD \>= 1 month
* 18 years \< age \< 85 years
* blood flow rate \>= 300ml/min

Exclusion Criteria:

* expected survival \< 1 year
* expected transplant within \< 1 year
* infectious diseases
* pregnancy
* chronic inflammation condition
* treated with single needle dialysis
* presently treated with hemodiafiltration or low-flux hemodiafiltration
* expected intradialytic body weight gain \>= 4kg

Primary outcomes:
measure: To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
timeFrame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
measure: To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins?
timeFrame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04464031: Electronic Alert for Acute Kidney Injury in Geriatric Wards
Official title: Study on the Application Value of Electronic Alert for Acute Kidney Injury in Geriatric Wards
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Alert
Geriatric wards
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Operating acute kidney injury electronic alert in geriatric wards; Acute authenticity evaluation of acute kidney injury electronic alert; To explore the clinical value of electronic alert for acute kidney injury prevention and treatment in geriatric wards.


Eligibility criteria: Inclusion Criteria:

* Age over 65 years old
* Diagnose of acute kidney injury by e-alert

Exclusion Criteria:

* Baseline serum creatinine \> 4mg/dL
* Stage-5 chronic kidney disease or maintenance hemodialysis
* Kidney transplantation
* Amputation

Primary outcomes:
measure: Diagnosis rate of acute kidney injury (Rate of missed diagnosis);
timeFrame: 1 year
measure: Rate of dialysis
timeFrame: 1 year
measure: Rate of death
timeFrame: 1 year
Secondary outcomes:
measure: Rate of nephrology consultation
timeFrame: 1 year
measure: Rate of nephrology follow-up
timeFrame: 1 year
measure: Renal function after 90 days of acute kidney injury
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01754831: Fluoride Administered and Retained After Topical Fluoride Varnish
Official title: Fluoride Administered and Retained After Topical Fluoride Varnish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: children
fluoride varnish
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration that will allow an estimate of the margin of safety of the procedure.

Detailed description: Fluoride varnish painted on the teeth is the standard method dentists use to prevent tooth decay (cavities) in preschool children in the United States. Fluoride varnish is not FDA approved specifically for prevention of cavities, but dentists may legally use it for this purpose. We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety. The fluoride varnish is being used for research purposes for this study by permission of FDA (IND #110869).

Premier Dental Product Company's Enamel Pro Varnish will be used. Up to six children aged 12-15 months will be enrolled in this study. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth. Baseline levels were measured on a separate day.

Eligibility criteria: Inclusion Criteria:

* consent obtained from parent or legal guardian of participant
* children aged 12 - 15 months
* at least 1 erupted tooth
* in general good health

Exclusion Criteria:

* known allergy to any drug, latex, nuts, or resin components or components of toothpaste/dental prophylaxis product
* participant has stomatitis or other oral conditions that preclude applying fluoride varnish comfortably

Primary outcomes:
measure: Urinalysis for fluoride levels
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Center for Pediatric Dentistry
state: Washington
Study officials:
affiliation: University of Washington
name: Peter Milgrom, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milgrom P, Taves DM, Kim AS, Watson GE, Horst JA. Pharmacokinetics of fluoride in toddlers after application of 5% sodium fluoride dental varnish. Pediatrics. 2014 Sep;134(3):e870-4. doi: 10.1542/peds.2013-3501. Epub 2014 Aug 18.
Clinical trial NCT02493231: Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cholecystitis
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for postoperative pain control, and reduce the needs of opioid.


Eligibility criteria: Inclusion Criteria:

* patient who scheduled laparoscopic cholecystectomy under general anesthesia
* American Society of Anesthesiologist(ASA) class I or II
* adult patient (age 20 - 65)

Exclusion Criteria:

* patient who has liver disease
* patient who has kidney disease
* patient who has diabetes mellitus(DM) or heart disease
* patient who takes opioid or beta-blocker
* patient who has airway disease
* patient who has allergy with the drug

Primary outcomes:
measure: analgesic requirement
timeFrame: During 1 hour at PACU
measure: duration of analgesic free
timeFrame: During 1 hour at PACU
Secondary outcomes:
measure: analgesic requirement
timeFrame: During 8 hours after arriving at ward
measure: Pain on the VAS scale
timeFrame: During 1 hour at PACU
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospita
Study officials:
References: