louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05802082: Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
Official title: The Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Anxiety
Postoperative Delirium
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 64

Brief summary: The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery.

Detailed description: It is known that the frequency of postoperative delirium increases in children with preoperative anxiety.

The Modified Yale Preoperative Anxiety Inventory (m-YPAS) was developed as a tool to assess children's preoperative anxiety, and m-YPAS≥30 was considered 'anxious'.

Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes.

There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.

Eligibility criteria: Inclusion Criteria:

* 2-10 years old,
* ASA I-II risk group
* Those who will be operated under general anesthesia under elective conditions.
* Will undergo surgery for adenoidectomy and/or tonsillectomy
* Patients whose informed consent form was read to their parents and their consent was obtained

Exclusion Criteria:

* Those whose families do not want to participate in the study,
* ASA III -IV-V patients
* Having a history of drug allergy and drug interaction,
* Having a history of systemic disease such as heart, kidney, liver failure,
* Having a history of bleeding diathesis,
* Difficult intubation expected,
* Obese,
* Emergency patients,
* Mental-motor retarded,
* Having psychiatric and neurological diseases,
* Those with chronic drug use

Primary outcomes:
measure: Preoperative Anxiety on Postoperative Delirium in Adenotonsillectomy Surgery
timeFrame: During the first 2 hours postoperatively
measure: Preemptive analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
timeFrame: During the first 2 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT02242682: Video Education: Capitalizing on Caregiver Time Spent in the Pediatric Emergency Department Waiting Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Passenger Seat Safety
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if video education is an effective means of caregiver education in the waiting room of a pediatric emergency department (ED). This will be tested with the showing of a child passenger safety video.


Eligibility criteria: Inclusion Criteria:

* caregivers of patients presenting to Children's Hospital of Wisconsin for treatment
* family use of automobile for transportation

Exclusion Criteria:

* non-English speaking caregivers
* triage level 1 or 2 or requiring immediate medical attention

Primary outcomes:
measure: Efficacy: Difference in caregiver knowledge on a questionnaire
timeFrame: day 0 in the ED
Secondary outcomes:
measure: Retention
timeFrame: up to 4 weeks after enrollment
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Wheeler JG, Fair M, Simpson PM, Rowlands LA, Aitken ME, Jacobs RF. Impact of a waiting room videotape message on parent attitudes toward pediatric antibiotic use. Pediatrics. 2001 Sep;108(3):591-6. doi: 10.1542/peds.108.3.591.
citation: Dunn RA, Shenouda PE, Martin DR, Schultz AJ. Videotape increases parent knowledge about poliovirus vaccines and choices of polio vaccination schedules. Pediatrics. 1998 Aug;102(2):e26. doi: 10.1542/peds.102.2.e26.
citation: Macy ML, Davis MM, Clark SJ, Stanley RM. Parental health literacy and asthma education delivery during a visit to a community-based pediatric emergency department: a pilot study. Pediatr Emerg Care. 2011 Jun;27(6):469-74. doi: 10.1097/PEC.0b013e31821c98a8.
citation: Shenoi R, Saz EU, Jones JL, Ma L, Yusuf S. An emergency department intervention to improve knowledge of child passenger safety. Pediatr Emerg Care. 2010 Dec;26(12):881-7. doi: 10.1097/PEC.0b013e3181fe909f.
citation: Schnellinger M, Finkelstein M, Thygeson MV, Vander Velden H, Karpas A, Madhok M. Animated video vs pamphlet: comparing the success of educating parents about proper antibiotic use. Pediatrics. 2010 May;125(5):990-6. doi: 10.1542/peds.2009-2916. Epub 2010 Apr 12.
citation: Uherick L, Gorelick MH, Biechler R, Brixey SN, Melzer-Lange M. Validation of two child passenger safety questionnaires. Inj Prev. 2010 Oct;16(5):343-7. doi: 10.1136/ip.2009.022681. Epub 2010 Aug 30.
citation: Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.
Clinical trial NCT03751982: Closed Loop TES for Enhancing Slow Wave Sleep
Official title: Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Insomnia
Keywords: transcranial electrical stimulation
Lead sponsor: Brain Electrophysiology Laboratory Company
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.
Primary purpose: BASIC_SCIENCE

Brief summary: Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.

Detailed description: Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required.

Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.

Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* persons with epilepsy

Primary outcomes:
measure: Slow wave amplitude
timeFrame: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.
measure: Slow wave duration
timeFrame: Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Brain Electrophysiology Laboratory Company
state: Oregon
Study officials:
References:
Clinical trial NCT01231282: Technique Optimization With Whole-body Diffusion-weighted MRI
Official title: Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native diffusion-weighted images and low ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced necrosis, the EES will be enlarged due to the lower density of cells, or in case of necrosis, the complete absence of cellular organization. This will facilitate water diffusion, leading to absent SI on native diffusion-weighted images and high ADC.

The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the whole body diffusion-weighted images which can be used as a reference in further studies with patients scanned with the same whole body diffusion-weighted imaging scan protocol.

A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan on a 3 Tesla T-MRI system.

A total scan session will take about 30 minutes. Contrast administration is not required and patients will not be exposed to radiation.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* no severe illness in the past
* no current infection/inflammation

Primary outcomes:
measure: normal aspect of human anatomy on WB-DWI images/ technique optimization
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: vincent.vandecaveye@uzleuven.be
name: Vincent Vandecaveye
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Paepe KN, Van Keerberghen CA, Agazzi GM, De Keyzer F, Gheysens O, Bechter O, Wolter P, Dierickx D, Janssens A, Verhoef G, Oyen R, Koole M, Vandecaveye V. Quantitative Whole-Body Diffusion-weighted MRI after One Treatment Cycle for Aggressive Non-Hodgkin Lymphoma Is an Independent Prognostic Factor of Outcome. Radiol Imaging Cancer. 2021 Mar 26;3(2):e200061. doi: 10.1148/rycan.2021200061. eCollection 2021 Mar.
Clinical trial NCT02423382: Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade
Official title: Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: silicone oil
retinal saturation
retinal blood flow
retinal detachment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.

Detailed description: Silicone oil is the first choice treatment for long-term vitreous replacement in complicated cases of retinal detachment. However, it will cause various problems for permanent tamponade, such as keratopathy, glaucoma, cataracts, and silicone oil emulsification3. In addition, silicone oil has the potential to cause retinal toxicity. Moreover, the gravity and mechanical pressure of the silicone oil on the retina may influence retinal blood flow and, and the presence of silicone oil in the vitreous cavity may block the oxygen exchange between the retinal surface and the vitreous humor, resulting in the metabolic disturbance of the retina. In this study, the investigators utilized a noninvasive measurement (Oxymap, Reykjavik, Iceland) to evaluate the effect of silicone oil tamponade on oxygen saturation and diameter in retinal vessels in complicated retinal detachment cases.

Eligibility criteria: Inclusion Criteria:

* initial silicone oil tamponade duration of more than 3 months
* transparent reflecting media
* intraocular pressure (IOP) between 11 and 21mmHg
* complete retinal re-attachment
* healthy contralateral eye.

Exclusion Criteria:

* severe refractive media opacity (serious keratoleukoma and cataracts)
* silicone oil emulsification
* ocular hypertension
* retinal detachment
* retinal scar within the main vascular arch
* any ocular disease and any history of surgery in the contralateral eye
* any type of systemic disease
* pregnancy

Primary outcomes:
measure: The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months
timeFrame: 1 day before silicone oil removal and 2 months after silicone oil removal.
Secondary outcomes:
measure: The changes from baseline in the retinal vessel width by Oxymap at 2 months
timeFrame: 1 day before silicone oil removal and 2 months after silicone oil removal.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center at Sun Yat-sen University
name: Xiaofeng Lin, MD, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT03202082: Impact of Neuropsychological Evaluation on Epilepsy Treatment
Official title: Impact of Neuropsychological Evaluation on Epilepsy Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study aims to expand the evidence base of neuropsychological services in the context of medical management of epilepsy, examining whether treatment outcome and patient satisfaction with medical care are significantly improved when neuropsychological evaluation is included as an additional component of medical care within a comprehensive epilepsy center. All participants will complete an initial survey and a follow-up survey regarding views towards their epilepsy treatment. Participants will be randomized into one of two groups. One group will be given a neuropsychological battery in addition to the survey. The primary study hypothesis is that the addition of neuropsychological services to treatment-as-usual will result in significant improvements in (a) satisfaction with medical care, (b) patient perceived treatment outcome, and (c) physician-rated medical compliance. The secondary hypothesis is that participants who undergo neuropsychological evaluation will be generally satisfied with their experience with neuropsychological services.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* experiencing some degree of epilepsy-related symptoms, but not of such severity as to preclude them from being able to provide consent or undergo neuropsychological assessment (requiring extended inpatient treatment, severely aphasic, or MMSE score \< 25)

Exclusion Criteria:

* Previously undergone neuropsychological testing
* Currently pursuing surgical treatment for epilepsy

Primary outcomes:
measure: Epilepsy Outcome Study Survey
timeFrame: 2-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References:
Clinical trial NCT01837082: Iron in Congestive Heart Failure
Official title: Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Iron Deficiency
Anemia
Keywords: Heart Failure
Iron Deficiency
Anemia
Ferric Carboxymaltose
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2013-04-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Congestive heart failure
* At least 18 years of age
* Iron deficiency
* Dyspnea class II or III according to New York Heart Association
* Left-ventricular ejection fraction ≤ 45%

Exclusion Criteria:

* Known sensitivity to any of the products to be administered during dosing
* Immediate need of transfusion
* Patients presenting with an active infection
* Thalassaemia
* Other forms of microcytic anemia not caused by iron deficiency
* History of acquired iron overload
* Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
* Women who are pregnant or of childbearing age and not using medically acceptable effective contraception

Primary outcomes:
measure: The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University of Aachen
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University of Ulm
name: Mahir Karakas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06862882: Impact of a Community-Based Primary Health Care Project on the Inappropriate Use of Emergency Medical System in Bergamo
Official title: Impact of a Community-Based Primary Health Care Project on the Inappropriate Use of Emergency Medical System in Bergamo
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Health Care
Lead sponsor: Fondazione San Giuliano Onlus
Sponsor class: OTHER
Collaborators: name: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS (FondazioneROM)
First posted: 2025-03-06
Enrollment: 10000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Citizen who call Emergency Medical System

Brief summary: The goal of this study is to reduce the inappropriate use of the Emergency Medical System in Bergamo. The main question it aims to answer is: can a Community-Based Primary Health Care Project impact on the use of the Emergency Medical System in Bergamo? Monthly changes in urgent calls to the Emergency Medical System will be analysed.


Eligibility criteria: Inclusion Criteria:

* Urgent Emergency Medical System call

Exclusion Criteria:

* Non-urgent Emergency Medical System call

Primary outcomes:
measure: Number of inappropriate access to Medical Emergency System
timeFrame: during the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ciserano
country: Italy
facility: Fondazione San Giuliano Onlus
Study officials:
affiliation: Fondazione San Giuliano Onlus
name: Mirco Nacoti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504082: Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy
Official title: Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ectopic Pregnancy
Keywords: methotrexate
letrozole
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG \<5000 mIU/mL, ectopic mass \<3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ectopic pregnancy according to the diagnostic criteria
* Patients with β-hCG levels \<5000 mIU/ml,
* Patients without serious or persistent abdominal pain
* Patients without fetal cardiac activity observed
* Ectopic mass size smaller than 3-4 cm
* Patients without contraindications for methotrexate and letrozole

Exclusion Criteria:

* Ruptured ectopic pregnancies
* Hemodynamically unstable patients
* Patients with acute abdomen or intra-abdominal bleeding
* Patients with fetal cardiac activity
* β-hCG levels below 500 mIU/mL or above 5000 mIU/mL
* Patients non-compliant with treatment
* Ectopic pregnancy size over 40 mm

Primary outcomes:
measure: Decrease in β-hCG levels
timeFrame: On day 1, 4 and 7
Secondary outcomes:
measure: Need of surgical interventions
timeFrame: On the days of admission.
measure: Hospitalization Days
timeFrame: Through study completion, an average of 3 weeks
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
state: Tuşba
Study officials:
References: