louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03607279: Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels
Official title: Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels After Robot-assisted Laparoscopic Versus Retropubic Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatectomy
Keywords: NGAL
Prostatectomy
Acute kidney injury
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-07-31
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prostatectomy

Brief summary: The purpose of the study is to compare the effect of two surgical techniques (open vs robotic assisted) on plasma levels of NGAL (neutrophil gelatinase-associated lipocalin) after radical prostatectomy.

Detailed description: Patients undergoing radical prostatectomy are at increased risk of acute kidney injury (AKI) because of intraoperative bleeding, obstructive uropathy and older age. In particular robot-assisted laparoscopic radical prostatectomy (RALP) which is in increasing demand as an alternative surgical option for retropubic radical prostatectomy (RRP) is associated with postoperative renal dysfunction because pneumoperitoneum during RALP can decrease cardiac output and renal perfusion. NGAL may become important for diagnosis of postoperative AKI after urogenital oncosurgery.

Eligibility criteria: Inclusion Criteria:

* patients who undergo prostatectomy
* American Society of Anesthesiology (ASA) I-III

Exclusion Criteria:

* preexisting renal disease
* emergency surgery
* heart failure
* peripheral vascular disease

Primary outcomes:
measure: Plasma NGAL
timeFrame: 0 hours, 6 hours and 12 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Netherlands: Ministry of Health, Welfare and Sports
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orsolya M, Attila-Zoltan M, Gherman V, Zaharie F, Bolboaca S, Chira C, Bodolea C, Tomuleasa C, Irimie A, Coman I, Ionescu D. The effect of anaesthetic management on neutrophil gelatinase associated lipocalin (NGAL) levels after robotic surgical oncology. J BUON. 2015 Jan-Feb;20(1):317-24.
citation: Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.
Clinical trial NCT00289679: Cytokine Profile and Metal Ion Concentrations at Patients Undergoing a Revision THR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Revision
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2006-02-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the concentration of cytokines and metal ions in blod samples and biopsies from patients undergoing a hip revision.


Eligibility criteria: Inclusion Criteria:

* THR revision

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg University Hospital
Study officials:
affiliation: Frederiksberg University Hospital
name: arne borgwardt, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03241979: THRIVE in Pediatric Laryngeal Microsurgery
Official title: The Effects of Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) on the Oxygenation in Pediatric Patients Under Tubeless Airway Surgery - a Physiologic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngoscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients

Brief summary: Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios, however its use in spontaneously breathing pediatric patients undergoing tubeless airway surgery has not been described. This is a physiologic study that evaluates the feasibility of THRIVE during pediatric airway surgery under self-respiration.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation

Exclusion Criteria:

* Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation

Primary outcomes:
measure: number of low saturation events
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
citation: Kim EH, Ji SH, Lee JH, Kim JT, Jang YE, Kwon SK, Kim HS. Use of high-flow nasal oxygen in spontaneously breathing pediatric patients undergoing tubeless airway surgery: A prospective observational study. Medicine (Baltimore). 2022 Jul 8;101(27):e29520. doi: 10.1097/MD.0000000000029520.
Clinical trial NCT06666179: Safety and Immunogenicity Study of SCB-1019T in Children
Official title: A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Reactogenicity and Immunogenicity of a Bivalent Recombinant RSV Vaccine (SCB-1019T) in Children 2 to <6 Years of Age
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: RSV Infection
Keywords: RSV vaccine
Lead sponsor: Clover Biopharmaceuticals, Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-\<6 years of age.

Detailed description: This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of SCB-1019T vaccine in children 2-\<6 years of age. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.

Eligibility criteria: Inclusion Criteria:

• Male and female participants 2 to \<6 years of age at Visit 1. • Parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. • Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator.

For full inclusion criteria, please refer to full protocol.

Exclusion Criteria:

* Acute disease or fever (≥38°C) at time of vaccination. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled.
* Evidence of chronic diseases including hepatitis, bleeding disorders, metabolic diseases, autoimmune diseases, neurological conditions that impair respiratory functions, genetic disorders that increase the risk of severe respiratory diseases, major congenital malformations, cardiac and lung diseases or reactive airway diseases.

For full Exclusion criteria, please refer to full protocol

Primary outcomes:
measure: Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
timeFrame: Within 7 days after vaccination
measure: Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine
timeFrame: Within 28 days after vaccination
measure: Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine
timeFrame: Throughout the study period, from enrollment to 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: The Kids Research Institute
state: Western Australia
Study officials:
References:
Clinical trial NCT00102479: Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
Official title: A Phase II Study to Test PK Tolerability in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Mania
Keywords: Pharmacokinetics,
Aripiprazole
acute mania in pediatric populations
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2005-01-31
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder

Exclusion Criteria:

* History of mental retardation
* Any neurological disorder with the exception of Pervasive Developmental Disorder (PDD), Attention Deficit Hyperactivity Disorder (ADHD), and Tourette's Syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Findling RL, Kauffman RE, Sallee FR, Carson WH, Nyilas M, Mallikaarjun S, Shoaf SE, Forbes RA, Boulton DW, Pikalov A. Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study. J Clin Psychopharmacol. 2008 Aug;28(4):441-6. doi: 10.1097/JCP.0b013e31817dd520.
Clinical trial NCT03512379: Clinical Trial for the Application of Robotic System in Spinal Surgery
Official title: Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Robotic Surgical Procedures
Spinal Surgery
Safety
Keywords: robot-assisted surgery
pedicle screw
spine
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group
Primary purpose: TREATMENT

Brief summary: This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.

Detailed description: Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.

Eligibility criteria: Inclusion Criteria:

* Spinal disease required for screw fixation；signed the inform consent

Exclusion Criteria:

* Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.

Primary outcomes:
measure: Screw guide wire adjustment times
timeFrame: During surgery
measure: Screw adjustment times
timeFrame: During surgery
measure: Deviation of screw
timeFrame: Up to 12 weeks
measure: Perforation rate of screw
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Operation time
timeFrame: During surgery
measure: Blood loss
timeFrame: During surgery
measure: Complications
timeFrame: Up to 4 weeks
measure: Hospital stay after surgery
timeFrame: Up to 4 weeks
measure: Hospitalization costs
timeFrame: Up to 4 weeks
measure: Visual Analogue Scale
timeFrame: 3 days before surgery
measure: Visual Analogue Scale
timeFrame: 3 days after surgery
measure: Neck Disability Index
timeFrame: 3 days before surgery
measure: Neck Disability Index
timeFrame: 3 days after surgery
measure: Oswestry Disability Index
timeFrame: 3 days before surgery
measure: Oswestry Disability Index
timeFrame: 3 days after surgery
measure: modified Japanese orthopaedic association score
timeFrame: 3 days before surgery
measure: modified Japanese orthopaedic association score
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Wei Tian, MD,PHD
role: STUDY_CHAIR
References:
Clinical trial NCT01278979: Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
Official title: Diagnosing Perineal Tears. Consistency in Midwifes Clinical Judgement When Assessing Perineal Tears Using Two Different Assessment Methods.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Perineal Rupture
Keywords: obstetric
perineal tear
perineal injury
diagnosis
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2011-01-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare different midwife practitioners assessments of perineal tears.

Detailed description: Perineal injuries are one of the traumas most frequently suffered by women during delivery.Countries report wide variations in trauma rates, and within countries further variations exists among institutions and also among professional groups of caregivers.Visual and digital examination of the wound has been and is the most common way to assess and classify a perineal tear. However resent studies indicate that many tears diagnosed with this method are misclassified.The suggested reasons for this, apart from the fact that bleeding and tissue oedema make the diagnose difficult, is that many healthcare providers have too little training in perineal assessment and basic anatomy.

In this prospective randomised trial consenting women will be randomised in to the common visual and digital assessment of the perineal tear by to different midwives, blinded to each others assessment or visual and digital assessment and measuring of the tear with a small soft ruler, Peri-Rule also by two different midwives.

Eligibility criteria: Inclusion Criteria:

* Spontaneous vaginal birth
* Women over 18 years of age
* Healthy Child
* Written consent signed by participant
* Spontaneous tear in perineum that involves the perineal skin

Exclusion Criteria:

* Bleeding from tears that demand suturing immediately.
* Bleeding that affected the general condition negatively
* Complex tears that branched out in two or more different directions
* Women delivered instrumentally forceps or ventouse
* Women delivered with Cesarian section
* Women who sustain episiotomy

Primary outcomes:
measure: To investigate how different assessment methods affected the midwives´ clinical judgement between different midwife practitioners when they classify and evaluate perineal tears.
timeFrame: One and a half years
Secondary outcomes:
measure: Consistency between different midwife practitioners when the classify and evaluate perineal tears.
timeFrame: One and a half years
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Ostfold Hospital Trust
state: Ostfold
Study officials:
affiliation: Ostfold HT
name: Ann IC Morris, Reg. Midwife
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771979: Relative Bioavailability of Phase II and Phase III Formulations of AZD0530
Official title: A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Relative Bioavailability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Female subjects must be of Non- child-bearing potential
* Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg

Exclusion Criteria:

* Presence of any clinically significant illness
* Abnormal vital signs
* History of any conditions that may put the subject at risk by participating in the study
* Participation in another clinical study.

Primary outcomes:
measure: To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation.
timeFrame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.
Secondary outcomes:
measure: To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.
timeFrame: From time of consent to last visit.
measure: An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530
timeFrame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.
Other outcomes:
Locations:
city: Alderley Park
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca, Clinical Pharmacology Unit, Alderley Park
name: Raj Chetty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca,Parklands, Alderley Park
name: Mary Stuart, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04172779: Erlotinib for Hepatocellular Carcinoma Chemoprevention
Official title: Phase IIa Single-arm Clinical Trial of Hepatocellular Carcinoma Chemoprevention With Low-dose Erlotinib in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cirrhosis, Liver
Keywords: hepatocellular carcinoma
chemoprevention
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase IIa trial studies long-term low-dose erlotinib hydrochloride treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Adults (≥ 18 years-old)
* Clinically and/or histologically diagnosed cirrhosis
* No active hepatic decompensation
* No prior history of HCC
* Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70
* Both sexes and all racial/ethnic groups will be considered

Exclusion Criteria:

* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
* Uncontrolled intercurrent, use of CYP3A4 modulators
* Failed biopsy
* Erlotinib treatment \<4 weeks or \<80% of planned regimen at the end of week 4
* HCC development during the study

Primary outcomes:
measure: Modulation of gene expression signatures associated with hepatocellular carcinoma (HCC) risk
timeFrame: Baseline to week 48
Secondary outcomes:
measure: Overall adverse event profile for erlotinib hydrochloride
timeFrame: Baseline to week 48
measure: Change in quality of life (QOL)
timeFrame: Baseline to week 48
Other outcomes:
measure: Changes in phospho-ERK levels in the liver
timeFrame: Baseline to week 48
measure: Changes in PCNA levels in the liver
timeFrame: Baseline to week 48
measure: Changes in EGF levels in the liver
timeFrame: Baseline to week 48
measure: Changes in alphaSMA levels in the liver
timeFrame: Baseline to week 48
measure: Changes in GSTp levels in the liver
timeFrame: Baseline to week 48
Locations:
Study officials:
References:
Clinical trial NCT01037179: An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Official title: An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-12-22
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Subjects must provide written consent.
* Subjects must have a diagnosis of allergic conjunctivitis.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Itching and/or hyperemia associated with diseases other than allergic conjunctivitis.
* Retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye.
* Known history of ocular infection.
* Contact lens wear during study.
* Pregnant, nursing.
* Participation in another clinical study within 30 days of Informed Consent.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Itching Score by Visit
timeFrame: Up to Week 10
measure: Mean Total Hyperemia Score by Visit
timeFrame: Up to Week 10
Secondary outcomes:
measure: Mean Subjective Symptoms by Visit
timeFrame: Up to Week 10
Other outcomes:
Locations:
city: Osaka-shi
country: Japan
facility: Investigational Center
state: Osaka
Study officials:
References: