louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03984591: A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
Official title: Cluster and Registry Trials Of the Working Group of Heart Failure in Denmark: Are SPironolactone and Eplerenone Comparable Treatments?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Systolic Heart Failure
Keywords: aldosterone antagonists
spironolactone
eplerenone
mortality
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2019-06-13
Enrollment: 7200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction.

Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.


Eligibility criteria: Inclusion Criteria:

* all patients registered in the Danish Heart Failure Registry who has a baseline left ventricular ejection fraction \<40% and who has filled in a prescription for an aldosterone antagonist

Exclusion Criteria:

* patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Mortality or hospitalization for heart failure
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
name: Jens Jakob Thune, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00657891: The Effect of Xolair (Omalizumab) on Allergy Blood Cells
Official title: The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Allergic Asthma
Anti IgE
Xolair
Basophil
IL-13
IL-4
Histamine
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-04-14
Enrollment: 49
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Detailed description: Must be allergic-asthma with IgE between 30 and 700 IU/ml.

Eligibility criteria: Inclusion Criteria:

* 2 year history of ragweed allergic rhinitis
* positive skin prick tests to ragweed \>5 mm wheal diameter
* serum IgE \<700 iU/m

Exclusion Criteria:

* Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 1 week
* History of immunotherapy in the past 2 years
* Exposure to Omalizumab in the past 2 years
* Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
* Asthma other than mild intermittent
* Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
* Known sensitivity to study drug Xolair
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Patients with a previous history of cancer
* Use of any other investigational agent in the last 30 days

Primary outcomes:
measure: To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.
timeFrame: 1 year
Secondary outcomes:
measure: To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin).
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Robert G Townley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03946891: Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
Official title: Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Premature Birth
Premature Infant
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective,randomized, cross over study comparing the efficacy and safety of nebulizedfurosemide with Intra Venous (IV)furosemide in preterm infants who areventilator-and oxygen dependent. Reviewing the patient census on Neo data by the Sub Investigator will identify the potential subjects. Subject will be randomized to either A arm or B arm. Subjects in the A arm will receive 1 mg/kg of inhaled furosemideQ 24 hours for 3 days. This will be followed by a washout period of a day followed by 1mg/kg of intravenous furosemide Q 24 hours for 3 days. Subjects in the B arm will receive 1 mg/kg of intravenous furosemide Q 24 hours for 3 days followed by a washout period, which is then followed by 1 mg/kg of inhaled furosemide Q 24 hours for 3 days.


Eligibility criteria: Inclusion Criteria:

* Subjects who are born prematurely at\<34 weeks of gestation
* Subjects who are at least 14days old, on Oxygen and mechanical ventilation.
* Radiologic evidence of pulmonary parenchymal disease
* The NICU medical team to start furosemide administration as a part of the routine clinical management

Exclusion Criteria:

* Subjects who have received any diuretics;IV or PO for 48 hoursbefore the study initiation
* Subjects with congenital heart disease withR-L shunts.
* Subjects with acute sepsis.
* Subjects with kidney diseasedefined by creatinine \> 1mg/dl or oliguria, defined as urine output \< 0.6 ml/kg/hour
* Subjects with necrotizing enterocolitis (NEC)or suspected NEC
* Subjects with congenital malformations.Subjects who are receiving steroids, or have received steroids in the last 7 days(patients need to be off steroids for at least 7 days).

Primary outcomes:
measure: Daily percent change from pre-treatment FiO2 requirement measurement.
timeFrame: days 1, 2, 3, 5, 6, and 7
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Melodi Pirzada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664391: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.


Eligibility criteria: Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Adverse events and their intensity and their association with the treatment.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05536791: A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Official title: Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Collection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 0
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paediatric patients from birth to \< 2 years of age considered by investigator after screening as eligible for Dabigatran Etexilate (DE) treatment of acute Venous thromboembolism (VTE) or secondary prevention of recurrent VTE will be enrolled in the Post-Authorization Safety Study (PASS).

Brief summary: The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.

The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.


Eligibility criteria: Inclusion criteria:

* Written informed consent from parents/care givers
* Children from birth to less than 2 years of age
* Initiation of Dabigatran Etexilate (DE) administration:

  * for treatment of Venous thromboembolism (VTE) or/and
  * prevention of recurrent VTE due to presence of unresolved clinical VTE risk factor(s).

Exclusion criteria:

* Participation in any Randomised Clinical Trial or use of any investigational product
* Any contraindications to DE according to the EU Summary of Product Characteristics (SmPC)

Primary outcomes:
measure: Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE)
timeFrame: up to 6 months
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: up to 6 months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
city: Madrid
country: Spain
facility: Hospital Materno Infantil Gregorio Marañón
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
Study officials:
References:
Clinical trial NCT06602791: The Effect of Watching Short Videos on Preoperative Anxiety
Official title: The Effect of Watching Short Videos on Preoperative Anxiety in Pediatric Endoscopy Patients: A Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Anxiety
Keywords: anesthesia
anxiety
short videos
pediatric endoscopy
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II will be enrolled.

Brief summary: Preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. The aim of this study is to evaluate whether watching short videos on platforms such as YouTube Shorts, Instagram Reels, or TikTok has an impact on preoperative anxiety levels in pediatric endoscopy patients.

Detailed description: The study was designed as a prospective randomized trial. Patients aged 6-12 years undergoing endoscopy and/or colonoscopy in the pediatric endoscopy unit will be divided into the video and the control groups. Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone/tablet for 20 minutes under the supervision of their parents. The control group will receive standard preoperative preparation. Anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at six different time points: upon entry to the pre-procedural preparation room (T1), upon exiting the pre-procedural preparation room (T2), in the procedure room (T3), upon entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and upon exiting the recovery unit (T6). Additionally, the indication for the procedure (e.g., celiac disease, Crohn's disease, ulcerative colitis), history of prior endoscopy/colonoscopy, oxygen saturation (SPO2%), heart rate (HR), mean arterial pressure (MAP) during the procedure, and the duration of monitoring in the recovery unit will also be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II

Exclusion Criteria:

* Patients under 5, over 12, or with ASA score \>2
* Epilepsy

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale (mYPAS) scores
timeFrame: 1 hour
Secondary outcomes:
measure: Recovery Time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: Caner Genc, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02497391: A Study of Different Particle Sizes of Evacetrapib in Healthy Participants
Official title: A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 95
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy participants of non-child bearing potential
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)
* Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

* Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
timeFrame: Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose
measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
timeFrame: Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06943391: Clinical Study of Biostimulation With Low-Power Diode Laser After Dental Extractions
Official title: CLINICAL STUDY OF BIOSTIMULATION WITH LOW-POWER DIODE LASER AFTER DENTAL EXTRACTIONS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Therapy, Low-Level
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I (Experimental): patients subjected to a tooth extraction and immediately given an intraoral PBM session with an EPIC X Biolase diode laser (BIOLASE, Inc. USA), with a voltage of 100-240 V, 1.5 A, a power of 0.5 W, and an application of an energy of 15J per cm², for 10-30 seconds at 1 mm of the tissue with an sterile surgical tip, based on the opti-mum biostimulation parameters by Cronshaw et al. . It was applied at three points in the area: buccal, palatal/lingual, and occlusal to stimulate the tissue. Group II (Sham): pa-tients undergoing tooth extraction and the application of inactive/simulated PBM imme-diately after using the same procedure
Primary purpose: PREVENTION

Brief summary: the objective of the present work is to assess the efficacy of photobiomodulation (PBM) with respect to pain, inflammation, and healing after tooth extractions as compared with a sham treatment


Eligibility criteria: Inclusion criteria: adult patients who needed tooth extractions for any reason and who signed an informed consent form

Exclusion Criteria:patients who according to the ASA preoperative evaluation, did not meet the medical con-ditions for a surgical intervention. Immunocompromised patients. Patients with decom-pensated systemic diseases; undergoing chemotherapy treatment or taking immunosup-pressants. Pregnant women. Patients with severe mental disorders. Patients who had re-ceived head and neck radiotherapy

-

Primary outcomes:
measure: Pain Intensity (Self-Reported Visual Analog Scale - VAS, 0-10)
timeFrame: Self-reported Pain Scores Using 0m Visual Analog Scale 10 Pain Score.Total pain improvement over day 0 to day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Mur
country: Spain
facility: Lopez-Jornet Pia
Study officials:
References:
citation: Ahrari F, Eshghpour M, Zare R, Ebrahimi S, Fallahrastegar A, Khaki H. Effectiveness of Low-Level Laser Irradiation in Reducing Pain and Accelerating Socket Healing After Undisturbed Tooth Extraction. J Lasers Med Sci. 2020 Summer;11(3):274-279. doi: 10.34172/jlms.2020.46. Epub 2020 Jun 21.
citation: Camolesi GCV, Silva FFVE, Aulestia-Viera PV, Marichalar-Mendia X, Gandara-Vila P, Perez-Sayans M. IS THE PHOTOBIOMODULATION THERAPY EFFECTIVE IN CONTROLLING POST-SURGICAL SIDE EFFECTS AFTER THE EXTRACTION OF MANDIBULAR THIRD MOLARS? A SYSTEMATIC REVIEW AND META-ANALYSIS. J Evid Based Dent Pract. 2024 Jun;24(2):101983. doi: 10.1016/j.jebdp.2024.101983. Epub 2024 Feb 28.
Clinical trial NCT01873391: Pain in Diagnostic Hysteroscopy
Official title: Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain in Diagnostic Hysteroscopy
Keywords: Diagnostic hysteroscopy
Pain
VAS
Multivariate analysis
Normal saline
Carbon dioxide
Lead sponsor: Azienda Ospedaliera S. Maria della Misericordia
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 603
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* female gender
* diagnostic hysteroscopy indication
* italian-speaking patients

Exclusion Criteria:

* patients who had previously undergone a diagnostic hysteroscopy
* patients who had been previously undergone to cervical surgery
* ongoing pregnancy
* cervical carcinoma
* pelvic inflammatory disease
* excessive uterine bleeding
* performance of an endometrial biopsy during the procedure

Primary outcomes:
measure: Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.
timeFrame: 5 minutes after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Arbor Vitae Endoscopic Centre
Study officials:
affiliation: University Of Perugia
name: Sandro Gerli, MD
role: STUDY_DIRECTOR
References:
citation: Mazzon I, Favilli A, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Pain in diagnostic hysteroscopy: a multivariate analysis after a randomized, controlled trial. Fertil Steril. 2014 Nov;102(5):1398-403. doi: 10.1016/j.fertnstert.2014.07.1249. Epub 2014 Sep 18.