louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04803240: Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
Official title: Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
Collaborators: name: Iris Pharma
First posted: 2021-03-17
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc...)

Brief summary: Multi-centre, international, non-interventional, prospective survey

Detailed description: To assess after 84 days, on a large scale patient population, the evaluation of ocular surface diseases and the satisfaction of dry eye disease (DED) treatment naïve patients or those who had to switch for tolerance, dissatisfaction or efficacy reasons to Thealoz® Duo.

Eligibility criteria: Inclusion Criteria:

* All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc...)
* Outpatients of either sex, aged at least 18 years
* Patients informed of the objectives of the survey and agreeing to participate.

Exclusion Criteria:

* Use of cyclosporine, lifitegrast, tacrolimus, sirolimus within last 3 months and during the survey
* Use of topical ophthalmological treatments (glaucoma, etc...)
* Use of lacrimal plugs
* Ocular surgery in the last 12 months
* Concomitant use of corticosteroids
* Concomitant use of autologous serum or any blood derivatives
* Severe blepharitis
* Severe dry eye associated to

  * Eyelid malposition
  * Corneal dystrophy
  * Ocular neoplasia
  * Sjogren syndrome
  * Any systemic pathologies
* Pregnancy/lactation

Primary outcomes:
measure: OSDI
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University of Plymouth
Study officials:
affiliation: Hospital Miguel Servet
name: Antonio MATEO, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Plymouth
name: Philip BUCKHURST, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340740: The Effect of Cetirizine on Bronchoconstriction
Official title: The Effect of Cetirizine on Bronchoconstriction in Patients With Allergic Rhinitis and Wheezing in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Asthma
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of cetirizine, an oral antihistamine, on wheezing in patients with allergic rhinitis. Patients presenting to the pediatric emergency department who have a history of allergic rhinitis and who are wheezing will be asked to participate. Half of patients will receive a dose of cetirizine and the other half will receive placebo and their response will be monitored over the course of their emergency department visit with vital signs, physical examinations, and measurement of bronchoconstriction with spirometry.

Detailed description: This is a prospective randomized, placebo-controlled trial to look at the effect of cetirizine on bronchoconstriction in patients with allergic rhinitis who present to the Pediatric Emergency Department with wheezing. Oral second generation antihistamines such as cetirizine are already the standard of care for allergic rhinitis. Wheezing pediatric patients with allergic rhinitis who are not already on this therapy will be randomized to receive either age-appropriate-dosed cetirizine or placebo in addition to standard asthma therapy at the discretion of the treating clinician, and will be monitored every 30 minutes with asthma scores and FEV1 measurements. At the conclusion of 3 hours, each patient who received placebo will receive a dose of cetirizine, and each patient who received cetirizine will receive a placebo medication dose, such that initiating therapy for allergic rhinitis is delayed by no more than 3 hours.

Eligibility criteria: Inclusion Criteria:

* History of allergic rhinitis
* Wheezing

Exclusion Criteria:

* Use of antihistamine within the past 72 hours
* Chronic Pulmonary Condition other than asthma
* Other contraindication to cetirizine
* Severe asthma exacerbation requiring resuscitation

Primary outcomes:
measure: Change in Pulmonary Index Score between baseline and 3 hours
timeFrame: At baseline and at 3 hours
Secondary outcomes:
measure: Change in FEV1 between baseline and 3 hours
timeFrame: At baseline and at 3 hours
Other outcomes:
measure: Number of patients admitted to the hospital for inpatient management of wheezing
timeFrame: At 3 hours
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Jacobi Medical Center
name: Stephen Blumberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028040: AZD Single Ascending Dose Study In Healthy Japanese Subjects
Official title: Phase I, Single Centre, Open Label Study to Access The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After A) a Single Ascending Bolus Dose and B) a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Japanese Volunteers (Age Range 20-45 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
AZD3043
Japanese healthy volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 with suitable veins for cannulation or repeated venepuncture.
* Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator

Primary outcomes:
measure: To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B).
timeFrame: From screening period to follow-up visit 42 days (Maximum)
Secondary outcomes:
measure: To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK
timeFrame: Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)
measure: To evaluate the onset, level and recovery of/from sedation/anaesthesia.
timeFrame: Assessed on Day 1
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Richmond Pharmacology Limited
name: Dr. Ulrike Lorch, MFPM FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04231240: Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)
Official title: Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Event
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with cardiac surgery with or without cardiopulmonary bypass supported in the Department of Anesthesia - Resuscitation of the Louis Pradel Hospital (Lyon, France).

Brief summary: Cardiac surgery needs the use of cardiopulmonary bypass. During this time, it is necessary to prevent thrombosis with high level of heparin and to control the good efficiency with a point of care test. Investigators want to test if two different devices, Hemochron and Istat, are giving similar results.

Detailed description: The management of the extracorporeal circulation (ECC) for cardiac surgery requires massive anticoagulation of the circuit by heparinization at 300 IU / kg of unfractionated heparin (HNF). To ensure an adequate level of safety, it is necessary to monitor the effectiveness of this dose of NHF. Several point of care monitors measuring activated coagulation time (ACT) are available on the market. Among these are the Hemochron (currently used routinely in the institution) and the IStat. These two monitors have been compared in adult cardiac surgery without deep hypothermia, but there is no comparative study in pediatric cardiac surgery.

The result of the ACT being dependent, in addition to heparinization, the platelet count, the fibrinogen level and the body temperature, it is therefore necessary to test the approval and the interchangeability between the monitors in different clinical situations .

The objective of this study is to reproduce the results published in adults and to compare these two monitors in pediatrics.

Eligibility criteria: Inclusion Criteria:

* adults or children
* Supported in the Department of Anesthesia - Resuscitation of the Louis Pradel Hospital (Lyon, France) for cardiac surgery with or without cardiopulmonary bypass
* Patient or Parents / Holders of parental authority informed and not opposed to participate in the study

Exclusion Criteria:

* patient with heparin-induced thrombocytopenia
* patient receiving antiplatelet therapy targeting GpIIbIIIa receptors

Primary outcomes:
measure: Agreement of ACT measurement with Istat and Hemochron
timeFrame: Maximum 6 hours (time of surgery)
measure: Interchangeability of ACT measurement with Istat and Hemochron
timeFrame: Maximum 6 hours (time of surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL
Study officials:
References:
Clinical trial NCT06571240: Validity and Reliability of the Turkish Version of the Tegner Activity Score
Official title: The Turkish Version of the Tegner Activity Score: Cultural Adaptation, Validity, and Reliability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Injuries
Keywords: Tegner activity score
Anterior cruciate ligament injury
Validity
Reliability
Patient reported outcome
Lead sponsor: Kırklareli University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-08-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted with people undergoing anterior cruciate ligament reconstruction at Gazi University Hospital.

Brief summary: The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* Is the Turkish version of the Tegner Activity Score a valid scale?
* Is the Turkish version of the Tegner Activity Score a reliable scale?
* What is the minimal clinically important difference value of the Turkish version of the Tegner Activity Score?
* What is the substantial clinical benefit value of the Turkish version of the Tegner Activity Score?


Eligibility criteria: Inclusion Criteria:

* to be over 18 years old
* to undergo surgery for a ruptured anterior cruciate ligament

Exclusion Criteria:

* to have metabolic or autoimmune diseases
* to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair
* to have cognitive issues that will hinder the completion of the study forms
* to lack sufficient proficiency in Turkish

Primary outcomes:
measure: Functional level
timeFrame: before the surgery, after 1 week from the surgery and after 3 months from the surgery
Secondary outcomes:
measure: Functional level
timeFrame: before the surgery
measure: Functional level
timeFrame: before the surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi Üniversitesi Hastanesi
Study officials:
affiliation: Kırklareli University
name: Ozan Gür, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04869501: Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer
Official title: Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancer
Lead sponsor: I-Mab Biopharma US Limited
Sponsor class: INDUSTRY
First posted: 2021-05-03
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.


Eligibility criteria: Inclusion Criteria:

1. Participation in the Tracon sponsored 4309ST101 or I-Mab sponsored TJ004309STM103 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from dosing of TJ004309 in combination with atezolizumab.
2. Willing or able to comply with study treatment and standard of care testing and procedures.

Exclusion Criteria:

1. Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ004309 inappropriate.
2. Current treatment in another clinical study or treatment with other standard of care therapy.
3. Currently pregnant.
4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, P.C.
state: Arizona
Study officials:
References:
Clinical trial NCT01086501: ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients
Official title: Efficacy and Safety of an ER-formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients Under Consideration of Quality of Life Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: open, non-interventional
Lead sponsor: Desitin Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 225
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newly diagnosed epileptic patients or patients who will be switched from other antiepileptic drugs to oxcarbazepine ER

Brief summary: The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.


Eligibility criteria: Inclusion Criteria:

* patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures
* mono- or combination therapy
* male and female from the age of 6

Exclusion Criteria:

* hypersensitivity to oxcarbazepine MR or one of its excipients

Primary outcomes:
measure: tolerability and safety
timeFrame: 12 months per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dr. Stephan Arnold
state: Bavaria
Study officials:
affiliation: Private Practice
name: Stephan Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller AD, Krauss GL, Hamzeh FM. Improved CNS tolerability following conversion from immediate- to extended-release carbamazepine. Acta Neurol Scand. 2004 Jun;109(6):374-7. doi: 10.1111/j.1600-0404.2004.00291.x.
Clinical trial NCT05988801: Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars
Official title: Clinical and Radiographic Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pits and Fissures Sealant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars

Detailed description: GIC has a hydrophilic nature which makes it compatible with clinical situations when isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture. Glass ionomers release fluoride, which promotes enamel remineralization and has an antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which is critical in the case of young patients and patients with disabilities.

Eligibility criteria: Inclusion Criteria:

* • Children aged between 6 to 9 years

  * Children with deeply stained fissures of the first permanent molars.
  * First permanent molars are completely erupted
  * The patient's willingness to receive treatment

Exclusion Criteria:

* • Special child, a child with compromised systemic health.

  * First permanent molars covered by operculum.
  * Children with high salivary flow when isolation will be impossible

Primary outcomes:
measure: Marginal discoloration
timeFrame: 6 months
Secondary outcomes:
measure: sealant retention
timeFrame: 6 months
measure: Dental Caries
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03631901: Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
Official title: Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Febrile Seizures
Keywords: Melatonin
Diazepam
recurrence
prophylaxis
Febrile convulsions
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

Detailed description: To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 months to 5 yrs .
* Simple febrile seizures

Exclusion Criteria:

* Complex febrile seizures
* Child with history of neonatal seizure.
* Afebrile seizures.
* History of anticonvulsive therapy.
* Children suffering from epilepsy.
* Children with abnormal EEG.
* Children with abnormal neurological examination.
* Positive family history of epilepsy.

Primary outcomes:
measure: recurrence of febrile seizures during febrile illness
timeFrame: 6 months
Secondary outcomes:
measure: side effect of medications reported in children
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Faculty of Medicine
Study officials:
affiliation: Tanta University Hospital
name: Amira Darwish
role: PRINCIPAL_INVESTIGATOR
References: