louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03943836: Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy
Official title: Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety, Dental
Keywords: Dental Anxiety
Pediatric dentistry
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II)
* Patient needs restorative procedure (with or without local anesthesia or nitrous oxide)
* Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons)

Exclusion Criteria:

* Patients with hearing impairments
* Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)

Primary outcomes:
measure: Anxiety as assessed by the Pediatric 7 question survey
timeFrame: baseline
measure: Anxiety as assessed by the Pediatric 7 question survey
timeFrame: immediately after the dental procedure (within 5 minutes after procedure)
measure: Parent's prediction of child's anxiety in the dental office as assessed by survey
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nancy Ly, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136536: Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery
Official title: Kärlkirurgi Vid Komplicerade kroppspulsåderbråck - Utfall, Riskfaktorer Och sökande Efter biomarkörer för Organskada
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Spinal Ischaemia
Gastrointestinal Ischaemia
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing endovascular advanced thoracoabdominal aortic surgical procedures at Örebro University Hospital, Örebro, Sweden.

Brief summary: The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.


Eligibility criteria: Inclusion Criteria:

* Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
* Adult

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Mortality
timeFrame: 1 year postoperative
Secondary outcomes:
measure: Organ dysfunction and failure
timeFrame: Postoperative: 7 days, 30 days, 1 year follow-up
Other outcomes:
measure: Proteomics
timeFrame: Postoperative: 7 days
Locations:
city: Örebro
country: Sweden
facility: Department of Cardio-thoracic and Vascular Surgery, Örebro University Hospital
Study officials:
affiliation: Department of Cardio-thoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
name: Kristofer F Nilsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06049836: Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections
Official title: Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatobiliary Neoplasm
Keywords: Liver surgery
Preoperative planning
3D rendering
Augmented reality
Holograms
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)
First posted: 2023-09-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this trial is to compare the evaluation of 3D liver models visualised as holograms with HoloLens 2 and on digital PDF files in HPB surgical trainees.

The main questions it aims to answer are:

* Do the holographic models allow a superior accuracy in terms of anatomical evaluation and surgical planning?
* Is there any difference in terms of time consumed and Task Load Index? Participants will analyse cases through both modalities and answer a questionnaire.


Eligibility criteria: Inclusion Criteria:

* General Surgery Trainees with at least 6 months experience in HPB surgery

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Diagnostic and planning accuracy
timeFrame: Immediately after completing the evaluation
Secondary outcomes:
measure: Time consumed
timeFrame: Immediately after completing the evaluation
measure: NASA Task Load Index
timeFrame: Immediately after completing the evaluation
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
affiliation: Federico II University
name: Roberto I Troisi, MD PhD FEBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01137136: Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea
Official title: Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Polymorphism
CYP19
Aromatase Inhibitor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 300
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausa women who underwent surgery for breast cancer

Brief summary: Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor. However, the incidence of variation of CYP19 in Korea has not known. Therefore, the investigators want to know the incidence of variation of CYP19 and to assess the effect of these variations of CYP19 to aromatase inhibitor users.


Eligibility criteria: Inclusion Criteria:

* hormone receptor positiveBreast cancer patient
* postmenopausal women
* first user of aromatase inhibitor

Exclusion Criteria:

* premenopausal
* The patient who take the other antihormonal therapy
* osteoporosis patients

Primary outcomes:
measure: The prevalence of CYP19 polymorphism
timeFrame: 12. 31. 2011
Secondary outcomes:
measure: The effect of CYP19 polymorphism to the prognosis of AI user
timeFrame: 12. 31. 2016
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery
name: Seok Jin Nam, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01388036: Genetic Determinants of Hemodynamic Response to Esmolol
Official title: A Study in Healthy Subjects to Evaluate Genetic Determinants of the Variability in Hemodynamic Response to Esmolol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decrease in Heart Rate Below Baseline Value
Keywords: heart rate
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD and hypertension. However, there is large interindividual variability in the response to beta blockers.

The hypothesis underlying this study is that genetic differences between individuals will determine the individual response to esmolol, a betablocker that is administered intravenously. Esmolol will be administered intravenously to healthy volunteers, and the effects on heart rate and blood pressure will be monitored. In addition, we will measure plasma renin activity and plasma levels of norepinephrine.


Eligibility criteria: Inclusion Criteria:

* healthy male and female
* able to understand and sign informed consent

Exclusion Criteria:

* consumption of any medication
* bradycardia \<50 BPM
* hypersensitivity to beta blockers

Primary outcomes:
measure: Change in heart rate during exercise
timeFrame: 3 hours
Secondary outcomes:
measure: change in systolic blood pressure during exercise
timeFrame: 3 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References:
citation: Muszkat M, Hoofien A, Orlanski-Meyer E, Makhoul H, Porat E, Davidson EM, Blotnick S, Caraco Y. The common Arg389gly ADRB1 polymorphism affects heart rate response to the ultra-short-acting beta(1) adrenergic receptor antagonist esmolol in healthy individuals. Pharmacogenet Genomics. 2013 Jan;23(1):25-8. doi: 10.1097/FPC.0b013e32835afde6.
Clinical trial NCT01737736: Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Neurokeeper Technologies
Sponsor class: INDUSTRY
First posted: 2012-11-29
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 undergoing Carotid Endarterectomy

Brief summary: The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.

The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective, open label, single arm, self control, single center study.

This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.

Exclusion Criteria:

* General anesthesia
* Selective carotid artery shunting.
* Previous major hemispheric stroke.
* Any known major hemispheric lesion.
* Significant movement disorder.
* Local skull or skin affliction which prevents electrodes application.
* Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Primary outcomes:
measure: Neurological detrioration detection
Secondary outcomes:
measure: Time from deterioration to detection
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Moshe' Herskovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05974436: Green Dialysis: Dialysis With Reduced Dialysate Flow
Official title: Green Dialysis: Hemodialysis With Reduced Dialysate Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uremic Syndrome
Keywords: dialysis efficiency
lowered dialysis fluid
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hemodialysis patients consume per year 18.720-26.208L of dialysis fluid (i.e. water). From an ecological point of view, the present study investigated whether reducing this water amount has an impact on the extraction and total solute removal of different uremic toxins. The efficiency of hemodiafiltration with a standard high-flux dialyzer is compared to hemodialysis with a medium cut-off dialyzer with a dialysate flow of either 700mL/min or 300mL/min.

Detailed description: Hemodialysis is currently performed with dialysate flows in the range 500 and 700mL/min respectively in hemodialysis and hemodiafiltration mode. With a standard daytime dialysis scheme of three times four hours a week, each patient consumes up to 360-504L dialysate per week or 18.720-26.208L per year.

From an ecological point of view, one can wonder whether patients can be dialyzed adequately enough using hemodialysis mode with a lower dialysate flow, and as such consuming less water.

Changing the mode from hemodiafiltration to hemodialysis mainly has an impact on the removal of larger toxins which benefit of the convective transport. Lowering dialysate flow in hemodialysis mode mainly has an impact on the removal of small water soluble toxins which are mainly removed by diffusion. For this transport, different parameters are important: blood and dialysate flow, dimensions of the membrane (surface area and thickness), fiber diameter, and extra-luminal space, and membrane porosity (Sieving coefficient). This also implies that, for the same blood and dialysate flow, the choice of the dialyzer will determine toxin transport. The use of a medium cut-off membrane with smaller and more open fibers might thus be more adequate in hemodialysis mode than a standard high-flux dialyzer with wider fibers.

The aim of this study is to quantify instant extraction and overall total solute removal of representative uremic toxins in hemodiafiltration with a standard high-flux hemodialyzer versus hemodialysis with a medium cut-off membrane, either with a standard or reduced dialysate flow.

Eligibility criteria: Inclusion Criteria:

* stable chronic hemodialysis patient
* well functioning vascular access

Exclusion Criteria:

* active infection
* malignancies

Primary outcomes:
measure: Dialysis efficiency
timeFrame: three midweek dialysis sessions (3 arms)
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Van Biesen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05176236: Pictographic Education Handout on Tracheostomy Care
Official title: Develop a Pictographic Educational Handouts and Validate Its Preliminary Efficacy on Tracheostomy Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Keywords: tracheostomy care
participatory action research
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International Honor Society of Nursing
name: University Hospitals Seidman Cancer Center
First posted: 2022-01-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of the study is to address the clinical problem of poor education outcome from the current practice of teaching tracheostomy care by providing them with a pictographic education handout to assist their learning. The study seeks to establish face validity and preliminary efficacy of a pictographic education handout with patients and identify factors associated with lower self-efficacy level on tracheostomy care.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Had a tracheostomy as part of head and neck cancer treatment, and who is not on mechanical ventilation
* His or her date of the related tracheostomy surgery was within the past 6 months
* Have received the discharge tracheostomy care education from the clinical nurse

Exclusion Criteria:

* Documented major physical or cognitive disabilities that would limit the ability to give informed consent or answer survey questions

Primary outcomes:
measure: Author-developed self-efficacy on tracheostomy care scale
timeFrame: immediately after consenting and post intervention (up to 2 weeks) on study survey
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University Frances Payne Bolton School of Nursing
state: Ohio
Study officials:
References:
Clinical trial NCT00241436: Open Label Arimidex in Gynecomastia
Official title: An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gynecomastia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 35
Sex: MALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent/assent (as per local requirements), males aged 11-18 yrs. (after his 10th and prior to 19th birthday), gynecomastia, one breast measuring ≥ 2 cm in diameter (by ultrasound or caliper measurement) that has not decreased during the prior 3 month period by medical history and has been present for 12 months or less (date of onset based on best estimate of treating physician after discussion with patient and or patient's parent/guardian), normal renal liver and thyroid function, no evidence of hormone producing tumor, no evidence of hypogonadism or androgen resistance.

Exclusion Criteria:

* Patients who have been given medications known to cause gynecomastia within the previous 6 months, involvement in the planning and conduct of the study (includes AZ staff and investigative site staff), previous enrollment in the present study, investigators opinion patient would be unable to comply with study protocol.

Primary outcomes:
measure: Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration
Secondary outcomes:
measure: Determine efficacy by the response rate following 6 months of treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Arimidex Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: Mauras N, Bishop K, Merinbaum D, Emeribe U, Agbo F, Lowe E. Pharmacokinetics and pharmacodynamics of anastrozole in pubertal boys with recent-onset gynecomastia. J Clin Endocrinol Metab. 2009 Aug;94(8):2975-8. doi: 10.1210/jc.2008-2527. Epub 2009 May 26.
Clinical trial NCT03488836: Evaluation the Post Operative Pain of Endodontic Treated Molar Tooth With Race and Reciprocal Systems Among Bandarabbas Patients in 2017
Official title: Evaluation the Post Operative Pain of Endodontic Treated Molar Tooth With Race and Reciprocal Systems Among Bandarabbas Patients in 2017: A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Endodontically Treated Teeth
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Although debris extrusion is an inevitable finding even when instrumentation is limited to the confines of the canal, different armamentarium seem to be associated with different amounts of debris extrusion. Studies on the effect of various rotary files on post-endodontic pain are very few and have yielded conflicting results with some favoring full-sequence and others leaning towards reciprocal rotary systems. This study aims at assessing the intensity of post-endodontic pain following two different rotary systems, Reciproc and race.

Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150 otherwise healthy patients aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region were analyzed. A clinician performed the endodontic treatment in two groups, a group instrumented using race and a third group with instrumentation performed using Reciproc rotary systems.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: the otherwise healthy patients were aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region.

Exclusion Criteria:

* Exclusion criteria: previous endodontic treatment; a history of drug intake including corticosteroids; opioids and NSAIDs in the previous 12 hours; pregnancy; complicated anatomy (curves greater than 25 degrees); calcifications; internal \& external resorption; open apices; periodontal disease; swelling \& abscess; presence of periapical lesions; sensitivity to percussion and lack of occlusal contact.

Primary outcomes:
measure: change of the Visual analogue scale
timeFrame: 6-12-18-24-48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Dental clinic of BandarAbbas faculty of dentistry
state: Hormozgan
Study officials:
References: