louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01675362: Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?
Official title: A Randomized Controlled Trial for Evaluating Protective Effects of Antioxidants (Selenium and Vitamins A, C and E), Calcium Channel Blocker (Verapamil) and Angiotensin Receptor Blocker (Losartan) Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Calculi
Keywords: Extracorporeal shockwave lithotripsy (ESWL)
Kidney calculi
Renal protection
Antioxidants
Calcium channel blockers
Angiotensin receptor blockers
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.

Detailed description: The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI.

Eligibility criteria: Inclusion Criteria:

1. Well functioning kidney (serum creatinine \<1.2 mg/dl).
2. Solitary renal stone.
3. Size: 25 mm or less in the largest diameter.

Exclusion Criteria:

1. Contraindications to ESWL
2. Previous surgical treatment of renal stones.
3. Congenital renal anomalies.
4. Pediatric patients (age \<18 years).
5. Patients with Diabetes or hypertension

Primary outcomes:
measure: Renal damage
timeFrame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)
Secondary outcomes:
measure: The mechanisms of renal protection
timeFrame: Before ESWL, 2 hours and 1 week after ESWL
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
Study officials:
affiliation: Mansoura University
name: Ahmed R. EL-Nahas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01275391: cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
Official title: cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Tobacco Abuse
Alcohol Abuse
Drug Abuse
Keywords: Tobacco use
Alcohol abuse
Drug abuse
Substance use
Prevention
Brief intervention
Screening
Adolescents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Pearl Network
First posted: 2011-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.

Detailed description: The goal of this project is to prepare for a large multi-site comparative effectiveness trial of a behavioral intervention, computer-facilitated Screening, Brief Intervention, and Referral to Treatment (cSBIRT) system that targets tobacco, alcohol, and drug use among adolescent dental patients. This enhanced computerized screening system includes: (1) screening, feedback, and provider talking points for tobacco and non-medical use of prescription drugs, (2) an interactive 2-part Motivational Enhancement Therapy module for adolescents at highest risk to complete from home, and (3) technological extenders (TEs), which are computer-generated messages that the provider sends to adolescents during the months following the clinic visit to reinforce the effect of the intervention over time.

Eligibility criteria: Inclusion Criteria:

* 12-21 years of age
* arriving for routine care to dental office

Exclusion Criteria:

* dentally, medically, or psychologically unstable at the time of the visit
* cannot read or understand English at a 6th grade level
* unavailable for 1-month post-visit assessment

Primary outcomes:
measure: Percent days abstinent of tobacco, alcohol and drugs
timeFrame: Past 90 days
Secondary outcomes:
measure: Prevalence of tobacco, alcohol and drug use
timeFrame: Past 90 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R. Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Clinical trial NCT03129191: Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
Official title: Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Conductive
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss.

An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Adults (age ≥ 18 years on the test date)
* Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
* German native speakers
* Willingness and ability to perform all tests required for the study

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Allergy against silicon (ear mold casting mass)

Primary outcomes:
measure: Speech reception threshold in noise (S0NDIFF)
timeFrame: Day 1
Secondary outcomes:
measure: Speech reception threshold in noise (S90NDIFF)
timeFrame: Day 1
measure: Speech reception threshold in noise (S270NDIFF)
timeFrame: Day 1
measure: Sound localization
timeFrame: Day 1
measure: Subjective evaluation of the sound quality
timeFrame: Day 1
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Hearing Research Laboratory, University Hospital Bern
Study officials:
affiliation: University Hospital Bern, Inselsptial
name: Martin Kompis, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381691: Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
Official title: Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonates Analgesy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 60
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.

Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.

In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.


Eligibility criteria: Inclusion Criteria:

* neonates fed with their mother breast milk,
* gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days,
* postnatal age ≤ 10 days
* birth weight greater than the 5th percentile according to Olsen curves et al.
* clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease
* the two legal representatives must have signed an informed consent.

Exclusion Criteria:

* neonates for whom no video was recorded during the venipuncture

Primary outcomes:
measure: clinical score assessment PIPP (Premature Infant Pain Profile)
timeFrame: 20 minutes
Secondary outcomes:
measure: DAN score (Acute Pain of Newborn)
timeFrame: 20 minutes
measure: salivary cortisol level
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique des Hopitaux de Marseille
Study officials:
affiliation: APHM
name: Desalbres Urielle
role: STUDY_DIRECTOR
References:
Clinical trial NCT03144791: Lighting and Human Response in Motor Time, Autonomic Nervous System, and Emotion
Official title: Lnfluence of Light Conditions on Brain Activity, Response Time, Autonomic Nervous Response, and Emotion in the Elderly and Young Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physical Activity
Emotions
Autonomic Nervous System Imbalance
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
First posted: 2017-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Light influences on human movement, autonomic nervous system, and emotion. It is inconclusive whether illuminance (Ev) and colour temperature (Tc) is appropriate to human movement, autonomic nervous systme, and emotion. Effect of Ev and Tc on responses of movement, autonomic nervous system, and emotion in human is investigated.

Detailed description: The adult and elderly sign informed consent form. They sit in a room where Ev and Tc is adjusted. During sitting they are measured response of movement, autonomic nervous system, and emotion.

Eligibility criteria: Inclusion Criteria:

* age between 18 - 79 years old
* Normal visual acuity with or without own glasses or contact lens
* Normal visual field
* Normal visual color perception
* Able to following commands
* Able to read, write, and understand in Thai language
* Able to sit independently with or without support
* Able to move dominant upper limb
* No pain in dominant Shoulder, Elbow, Wrist, and Hand during movement

Exclusion Criteria:

* Aggravated pain at trunk and lower limb during movement of dominant upper limb
* Having Neurological disorders
* Having uncontrolled diseases
* Having psychological problems

Primary outcomes:
measure: motor response time
timeFrame: 1 minute
Secondary outcomes:
measure: Brain activity
timeFrame: 5 minutes
measure: Heart rate variability
timeFrame: 2 minutes
measure: emotion
timeFrame: 2 minutes
measure: skin conductance level
timeFrame: 2 minute
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Vimonwan Hiengkaew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuijsters A, Redi J, de Ruyter B, Heynderickx I. Lighting to Make You Feel Better: Improving the Mood of Elderly People with Affective Ambiences. PLoS One. 2015 Jul 20;10(7):e0132732. doi: 10.1371/journal.pone.0132732. eCollection 2015.
citation: Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645.
citation: Garin N, Olaya B, Miret M, Ayuso-Mateos JL, Power M, Bucciarelli P, Haro JM. Built environment and elderly population health: a comprehensive literature review. Clin Pract Epidemiol Ment Health. 2014 Oct 21;10:103-15. doi: 10.2174/1745017901410010103. eCollection 2014.
Clinical trial NCT01658891: Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Official title: A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 NEXThaler® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE) AND THE FREE COMBINATION OF LICENSED BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ASTHMATIC CHILDREN ALREADY TREATED WITH INHALED CORTICOSTEROIDS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Asthma in Children
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids


Eligibility criteria: Inclusion Criteria:

* Prepuberal male and female outpatients, ≥ 5 and \< 12 years old in Tanner stadium I according to Investigator's assessment;
* Clinical diagnosis of mild asthma during at least two months prior to screening visit;
* Forced Expiratory Volume during the first second (FEV1) \> 80% of predicted normal values at screening visit;

Exclusion Criteria:

* Endocrinological diseases including growth impairment or other chronic diseases;
* Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;

Primary outcomes:
measure: Lower Leg Growth rate measured by Knemometry
timeFrame: after 2 weeks of treatment
Secondary outcomes:
measure: 24-hour urinary free cortisol/creatinine levels
timeFrame: after 2 weeks of treatment
measure: Changes in pre-dose morning and evening PEF (L/min)
timeFrame: after 2 weeks of treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: BørneAstmaKlinikken
Study officials:
References:
Clinical trial NCT06684691: The Effect of an Escape Room Simulation on Post-mortem Care Training
Official title: The Effect of an Escape Room Simulation on Post-mortem Care Training for Nursing Students: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation Training
Game-Based Learning
Nursing Care
Keywords: Escape room
Simulation
Nursing student
Education
Post-mortem care
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled parallel group trial
Primary purpose: OTHER

Brief summary: Simulated escape room games create an active learning environment to increase students' motivation and participation and encourage learning while developing skills. Therefore, this study examines the effectiveness of simulated escape room games in nursing students' post-mortem care education.

Detailed description: To meet the emotional and physical needs of the individual living in the last days of life, the nurse must have the necessary knowledge, skills, and understanding. For this reason, post-mortem care has an important place in the nursing education curriculum. To increase student motivation and include them in the learning process in clinical skills laboratory environments, game strategies have been frequently used in education in recent years. The "escape room" game has emerged as a new pedagogical method to provide interactive teaching. The use of interactive teaching and games in health education has a positive effect on the learning process.

Eligibility criteria: Inclusion Criteria:

* Being 4th grade nursing student

Exclusion Criteria:

* Not willing to participate the study

Primary outcomes:
measure: Knowledge
timeFrame: 5 week
measure: Self-Efficacy
timeFrame: 5 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey, Gulhane Faculty of Nursing
state: Please Select One
Study officials:
References:
Clinical trial NCT02412891: Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
Official title: Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infectious
Keywords: introduction of urinary catheter
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.

The use of urinary catheters is a common medical practice in the perioperative setting.

As such, it exposes the patient to certain comorbidities, including urinary tract infections.

The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.

Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.


Eligibility criteria: Inclusion Criteria:

* Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.

Exclusion Criteria:

1. Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.
2. patients with a urinary tract infection in the past year.
3. Patients with a urinary tract infection when inserting a catheter.
4. pregnant women.
5. Patients under the age of 18.
6. without judgment.

Primary outcomes:
measure: side effects and complications of urinary catheter usage
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00854191: Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period
Official title: A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing ERCP Examination
Keywords: mechanical simulator
ERCP
training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.

Detailed description: Background: The impact of mechanical simulator practice on clinical ERCP performance has not been reported.

Hypothesis: Practice with mechanical simulator improves clinical ERCP performance of novice trainees.

Design: A prospective randomized controlled trial.

Method: 8 trainees without prior ERCP experience from 2 hospitals attended didactic lectures on ERCP. They were randomized in pairs (per hospital) to receive simulator practice and usual training (S) versus usual training only as control (C). Simulator practice included selective bile and pancreatic duct cannulation using a catheter and/or guide wire with different artificial papillae (flat, standard, dual channels) and settings (standard, rotated papilla or duodenum), and exchange of guide wire/accessories and biliary stenting. Local trainers tracked trainees' subsequent clinical ERCP performance for 3 months. Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation. Trainer blinded to the randomization provided assessment (1=poor, 5=excellent) of each trainee performed ERCP.

Statistics: Fisher exact test and Mann-Whitney U test.

Eligibility criteria: Inclusion Criteria:

* GI trainees who met the minimum endoscopy training experience

Exclusion Criteria:

* GI trainees with no endoscopy experience

Primary outcomes:
measure: Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation
timeFrame: 3 months
Secondary outcomes:
measure: Trainer blinded to the randomization provided assessment of each trainee performed ERCP
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Gastroenterology, National Taiwan University Hospital
Study officials:
References:
citation: Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29.