louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06165679: Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients
Official title: Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hemodynamic Instability
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 112
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries


Eligibility criteria: Inclusion Criteria:

* Patients aged 65 years old and above.
* Both genders.
* Patients scheduled to undergo endoscopic urological surgeries.
* ASA I and II class.

Exclusion Criteria:

* Patient refusal.
* Known local anesthetic (LA) allergy.
* Bleeding disorders.
* Skin lesions or infections at site of needle insertion.
* Hypertensive patients.
* Patients candidate for transurethral resection of the prostate
* ASA III and VI class

Primary outcomes:
measure: Hypotension
timeFrame: Till 30 minutes after spinal anesthesia.
Secondary outcomes:
measure: Use of vasopressor drugs
timeFrame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Other outcomes:
measure: Mean and systolic arterial blood pressure values
timeFrame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
measure: Heart rate
timeFrame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini hospital
Study officials:
References:
Clinical trial NCT01107379: Optimization and Refinement of Technique in In-Office Sinus Dilation 2
Official title: Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2010-04-21
Enrollment: 203
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: Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.

Brief summary: A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.


Eligibility criteria: Inclusion Criteria:

* Male/Female, 18 year or older
* Diagnosis of Chronic Rhinosinusitis
* Planned Endoscopic Sinus surgery

Exclusion Criteria:

* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* History of facial trauma precluding access to sinus ostium
* Ciliary Disfunction
* Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
* Pregnant or lactating female
* Inability to tolerate an awake procedure
* Participation in another investigational clinical study involving treatment for chronic rhinosinusitis

Primary outcomes:
measure: Mean Intra-patient Change in SNOT-20 Score
timeFrame: Baseline and 24 weeks
measure: Mean Intra-patient Change in Lund-Mackay CT Scan Score
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Procedure Tolerability
timeFrame: Day 0 (Day of Procedure)
measure: Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
timeFrame: Day 0 (Day of Procedure)
measure: Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
timeFrame: Day 0 (Day of Procedure)
measure: Mean Number of Days to Return to Normal Activities
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Las Vegas
country: United States
state: Nevada
city: Dublin
country: United States
state: Ohio
Study officials:
affiliation: Alabama Alabama Nasal and Sinus Center
name: Michael Sillers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.
Clinical trial NCT05749679: Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice
Official title: Prevention of NEphronic PErt in People With Type 2 DIABETIC Disease Followed in General Practice
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Insufficiency and Diabetes Mellitus
Keywords: diabetes mellitus, type 2
kidney diseases
primary care
prevention
early diagnosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 360
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This work will make it possible to identify the nephron loss of type 2 diabetic patients in the western region and to better define in general practice the impact of the elements put in place to reduce this loss and to raise awareness of the importance of these measures through training in comparison with a control group.


Eligibility criteria: Inclusion Criteria:

* Patient consulting his or her investigating general practitioner
* 50 years old or more
* type 2 diabetic for more than 5 years, with a GFR lower than 90 ml/mn and higher than 45 ml/mn (stage 2 and 3a of renal failure) and a nephron loss calculated on the average of the two previous years, higher than 3 ml/mn/year
* a microalbuminuria \> 30 mg/gr of creatinuria.
* Having declared the investigator as the treating physician

Exclusion Criteria:

* Patient under 50 years of age Patients who do not agree to the use of their data (refusal of consent) or are unable to give consent (dementia, other) Patients with other types of diabetes Patients with renal failure other than diabetic or hypertensive glomerulopathy Patients unable to give consent Patients who do not understand the French language Patients with less than 3 months of planned follow-up Patients with a barrier to follow-up Patients undergoing dialysis, transplantation

Primary outcomes:
measure: Change in annual glomerular filtration rate (GFR) slope
timeFrame: Every 3 months during 2 years
Secondary outcomes:
measure: Audit of clinical practices
timeFrame: before randomization, at 6 months and 24 months in the 2 groups
measure: Cumulative incidence of unscheduled hospitalizations for all reasons at 2 years from the start of care in the intervention group compared to the control group
timeFrame: At 2 years (the end of the study)
measure: change of Albuminuria
timeFrame: at baseline and every 3 months during the 2-year follow-up.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06805279: Axillary Vein Cannulation: 'Hockey' Probe Versus Linear Probe
Official title: Comparing Axillary Vein Cannulation with 'Hockey' Probe Versus Linear Probe for Central Venous Access
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CVC
Ultrasound Guided Central Venous Cannulation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled for elective placement of the central venous catheter in the axillary vein.

Brief summary: Central venous catheterization, specifically through the axillary vein, is a procedure of critical importance in various clinical contexts. Site selection is dependent on clinical assessment, experience and the physician preference. This study aims to evaluate the potential advantages of using the "hockey stick" ultrasonography probe for axillary vein cannulation and determine whether this probe enhances axillary vein imaging, accelerates the central vein cannulation procedure and reduces the rate of complications compared to the linear probe. Methods: 100 participants were recruited and allocated into two groups: the linear probe group and the hockey stick probe group. All procedures were performed by two senior anesthesia and intensive care residents, each with experience of over 100 central vascular access procedures. Follow-up chest X-rays were taken two hours post-procedure to verify the correct position of the catheter and to rule out complications such as pneumothorax, hemothorax, cardiac tamponade, and incorrect line placement.


Eligibility criteria: Inclusion Criteria:

* age above 18 years old
* scheduled for elective central venous catheter in the axillary vein

Exclusion Criteria:

* medical contraindication for axillary vein cannulation (coagulation abnormalities, local skin infection or chest wall deformation)
* patient consent decline

Primary outcomes:
measure: Success on first attempt
timeFrame: 24 hours
measure: Number attempts
timeFrame: 24 hours
measure: Procedure Time
timeFrame: 24 hours
measure: Cumulative number of complications
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: II Klinika Anestezjologii i Intensywnej Terapii
Study officials:
References:
Clinical trial NCT00587379: Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction
Official title: The Effect of Chronic Statin Therapy on Peripheral Arterial Tone Response to Sildenafil Citrate (Viagra), and on Erectile Function in Men With Coronary Artery Endothelial Cell Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: testing for Endothelial Dysfunction and coronary angiography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if 6 weeks of daily treatment with Atorvastatin 40 mg alters the immediate effect of Sildenafil Citrate (Viagra, Pfizer Inc, New York, NY) on endothelial function (activity of the artery) as measured by noninvasive peripheral arterial tonography in men and women. Also, to determine if 6 weeks of daily treatment with Atorvastatin 40 mg affects erectile function in men


Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary angiography
* No previous statin use
* Age \> 18 years old
* No PDE5-1 use in the past 6 months

Exclusion Criteria:

* Patients with an Acute Coronary Syndrome
* Patients with Cardiogenic shock
* Patients \> 30% coronary stenosis
* Patients with unexplained muscle pain
* Patients with acute liver disease
* Patients receiving immunosuppressant therapy, azoles, macrolide antibiotics, niacin, L-arginine
* Patients with serum creatinine \> 2.0
* Patients with total cholesterol \> 200 mmol/l
* Patients on current statin therapy or clinically indicated to be on statin therapy

Primary outcomes:
measure: To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin.
timeFrame: 6 weeks
Secondary outcomes:
measure: To determine if treatment with Atovastatin affects erectile function in men
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06244979: iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine
Official title: iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Allergic Bronchopulmonary Aspergillosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single center open-label feasibility trial involving a single study visit for participants. The purpose of the study is to demonstrate the feasibility of \[68Ga\]Ga-DFO-B PET/CT (gallium-68-deferoxamine) for the visualization of pulmonary Aspergillus infection.

The incidence of fungal infections is on the rise and are associated with significant mortality. Diagnosis pulmonary aspergillosis can be can be challenging, often requiring invasive tests such as bronchoscopy and lung tissue biopsies. Molecular imaging, specifically using radiolabeled siderophores like \[68Ga\]Ga-DFO-B, offers a non-invasive and location-specific approach to visualize and evaluate infections. Siderophores, critical for pathogenic microbes like Aspergillus fumigatus, play a role in iron acquisition. Preclinical studies with radiolabeled deferoxamine (DFO-B) demonstrated distinct accumulation at infection sites. Additionally, \[68Ga\]Ga-DFO-B PET/CT may differentiate between Aspergillus infection and cancer, making it a promising non-invasive diagnostic tool for pulmonary aspergillosis.


Eligibility criteria: Inclusion Criteria:

1. The patient is at least 18 years old on the day of inclusion.
2. The patient has suspected chronic pulmonary aspergillosis or ABPA.
3. There is no significant interference with standard care and follow-up.

Exclusion Criteria:

1. The patient is pregnant or planning on becoming pregnant.
2. The patient has severe kidney dysfunction with eGFR \< 30 ml/min/kg and/or receives dialysis.
3. The patient has (chronic) iron overload.
4. The patient has been receiving antifungal treatment for more than 48 hours prior to the study day.
5. The patient is not able to lie still in the scanner.

Primary outcomes:
measure: Standardized uptake values (SUV) of [68Ga]Ga-DFO-B
timeFrame: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
measure: Target-to-background ratios of [68Ga]Ga-DFO-B
timeFrame: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
Study officials:
affiliation: Radboud University Medical Center
name: Roger Brüggemann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02571179: Intranasal Fentanyl in Treatment of Labour Pain
Official title: Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Keywords: Labor pain
Fentanyl
Transmucosal
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Admescope Ltd
First posted: 2015-10-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intranasal fentanyl
Primary purpose: TREATMENT

Brief summary: Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.


Eligibility criteria: Inclusion Criteria:

* healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate

Exclusion Criteria:

* a disease that might affect hepatic or renal function, contraindications to opioid analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography, meconium stained amniotic fluid or placental insufficiency. The subjects should not have received fentanyl during the previous 14 days.

Not agreed to participate

Primary outcomes:
measure: Fentanyl maximum concentration
timeFrame: From the first intranasal fentanyl dose to birth of the newborn up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital, Kuopio, Finland
name: Merja Kokki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184379: Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
Official title: Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Depressive Disorder
Schizophrenia
Keywords: Family
Coping Skills
Psychoeducation
Stress, Psychological
Health Education
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.

Detailed description: The main aim of the study is to compare the effects of group psychoeducation for relatives to patients with serious mental illness with a waiting list control group. The main hypothesis is whether psychoeducation in groups has effects on the stress experience and coping style in the relatives. The relatives will receive group education in 6 weekly sessions. We will measure stress experience, coping style and the relatives' health condition before the sessions, after the sessions and at one year follow-up.

Eligibility criteria: Inclusion Criteria:

* Relatives to patients having a psychotic or bipolar disorder
* Good Norwegian language skills
* Consent to participate
* The patients' consent for their relatives to participate

Primary outcomes:
measure: ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)
timeFrame: 0-6 months
measure: COOP/WONCA (Bowling, 1995)
timeFrame: 0-6 months
measure: Selection of questions from COPE (Carver et al. 1989)
timeFrame: 0-6 months
measure: Evaluation-questions
timeFrame: 0-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
Study officials:
affiliation: Norwegian University of Science and Technology
name: Olav M Linaker, MD Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moller T, Gudde CB, Folden GE, Linaker OM. The experience of caring in relatives to patients with serious mental illness: gender differences, health and functioning. Scand J Caring Sci. 2009 Mar;23(1):153-60. doi: 10.1111/j.1471-6712.2008.00605.x. Epub 2009 Jan 21.
Clinical trial NCT05619679: A Clinical Practice Snapshot on Pediatric Kidney Transplantation
Official title: A Clinical Practice Snapshot on Pediatric Kidney Transplantation Healthcare in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Failure
Keywords: Kidney transplantation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 410
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric kidney recipients that were transplanted in one of the participating centers and followed up for at least one month

Brief summary: The aim is to create an overview of the similarities and differences in daily practice among the different centers performing pediatric kidney transplantation in Europe.

For this purpose, a Clinical Practice Snapshot will be used to provide insight in the current approaches.

Detailed description: In order to create an overview of the current care for pediatric kidney transplant (PKT) recipients a clinical practice snapshot was developed.

All participating centers were asked to answer 6 clinical questions on their last 30 transplanted patients.

Patient characteristics, donor charactertistics, use of stents, immunosuppressive medication and renal function are compared between centers.

Eligibility criteria: Inclusion Criteria:

* Kidney received \<18 years
* at least one month of follow-up
* transplantation and follow-up in dedicated PKT center

Exclusion Criteria:

* combined transplantation

Primary outcomes:
measure: Graft survival
timeFrame: at end of follow-up at least one month
measure: Donor type
timeFrame: At transplantation
Secondary outcomes:
measure: Immunosuppressants prescribed at discharge
timeFrame: 2 weeks
measure: Number of infections
timeFrame: end of follow-up, at least one month
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
References: