louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06980571: Randomised Prospective Study of CUSA Versus Radiofrequency Ablation Technique in Liver Resections
Official title: Randomised Prospective Study of CUSA Versus Radiofrequency Ablation Technique in Liver Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Disease
Keywords: liver resection
blood loss
resection technique
CUSA
radiofrequency ablation
health economics
benign and malignant liver disease
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a particular method of operating on the liver is superior to the "gold" standard commonest technique. CUSA (ultrasonic agitation) will be compared to the newer heat coagulation technique (radiofrequency ablation) and comparisons of blood loss, transfusion requirements, complication rates, hospital stay, effect on liver function, health economics and death rate will be made. The groups will be assessed for comparability in terms of underlying disease, resection type, underlying concurrent illnesses, sex, age, background liver disease. Standardisations of the rest of the operation will be carried out including anaesthetic technique and fluid requirements will be assessed by oesophageal Doppler. 100 patients will be recruited.


Eligibility criteria: Inclusion Criteria:

* any adult patient listed for liver resection giving informed consent

Exclusion Criteria:

* children, non-consent and diminished responsibility

Primary outcomes:
measure: Blood loss per cm squared of liver parenchyma cut through
timeFrame: operation date until three months from discharge
Secondary outcomes:
measure: mortality
timeFrame: inpatient and thirty day mortality
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Royal London Hospital
name: Robert R Hutchins, MB BS MS FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922571: A Study of Cataract Surgery With the Femtosecond Laser
Official title: A Study of Cataract Surgery With the Assistance of the Femtosecond Laser
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Femtosecond laser
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.


Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with the treatment/follow-up schedule and requirements
* Able to understand and provide written Informed Consent
* 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
* Patient age between 50 and 80 years old
* Pupil dilates to at least 8 mm
* Patient able to fixate
* 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions)
* Axial length between 22 and 26 mm

Exclusion Criteria:

* Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
* Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
* Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
* History of prior ocular surgery
* History of ocular trauma
* Co-existing ocular disease affecting vision
* Astigmatism greater than five diopters (D.)

Primary outcomes:
measure: Capsulotomy Size
timeFrame: Day of Surgery
Secondary outcomes:
measure: Cumulated Dissipated Energy (CDE)
timeFrame: Day of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Laser Center, Santo Domingo, Dominican Republic
name: Juan F. Batlle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04416971: Clinical Values of Mature Fistulas in Hemodialysis
Official title: Clinical Values of Mature Fistulas in Hemodialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis Access Failure
Hemodialysis Complication
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * aged 18 years and older
* underwent initial upper-extremity AVF creation for incident HD at our hospital
* divided into mature/immature AVF groups according to the AVF status on HD initiation

Brief summary: The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.


Eligibility criteria: Inclusion Criteria:

* underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital, Fudan University

Exclusion Criteria:

* with malignancies
* not followed-up at Zhongshan Hospital, Fudan University

Primary outcomes:
measure: AVF patency
timeFrame: June 2020 to June 2021
Secondary outcomes:
measure: Abandonment without use, infection, and other complications of AVF creation.
timeFrame: June 2020 to June 2021
Other outcomes:
Locations:
city: Shanghai
country: China
facility: No.180, Fenglin Road, Xuhui District
state: Shanghai
Study officials:
affiliation: Fudan University
name: bo shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01148771: Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion
Official title: Comparative Pharmacokinetics, Safety, and Pharmacodynamics of Ertapenem 1 Gram Daily Administered as an IV Bolus Versus Standard 30 Minute Infusion to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Pharmacokinetics
Safety
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.


Eligibility criteria: Inclusion Criteria:

* Healthy adults (18 years of age or older)

Exclusion Criteria:

* Ertapenem or other beta-lactam allergy
* Pregnant or breast feeding females
* Body Mass Index (BMI) greater than or equal to 30
* Abnormal lab values at baseline
* Hypertension
* Significant medical abnormality
* Regular alcohol consumption
* Significant nicotine use

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)
timeFrame: 5 or 30 minutes post start of infusion on Day 3
measure: Area Under the Curve From 48 to 72 Hours [AUC(48-72)]
timeFrame: 0-24 hours after 3rd ertapenem dose
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days
measure: Probability of Target Attainment (PTA)
timeFrame: Simulated Steady-State Exposure
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Josepth L Kuti, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hartford Hospital
name: Dora E Wiskirchen, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04949971: A Comparative Study of High and Low Tidal Volume in Preventing Hypoxemia in Patients With Mechanical Ventilation After Cervical Spinal Cord Injury
Official title: Peking University Third Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spinal Cord Injury
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ① Above the age of 18;

② Patients with cervical spinal cord injury requiring mechanical ventilation admitted to hospital.

Brief summary: This study in order to best tidal volume mechanical ventilation in patients with cervical spinal cord injury (sci) as the research point, through higher low volume Settings to find the difference of two groups of patients to prevent the incidence of hypoxemia, to find suitable Settings, tidal volume in patients with lower mechanical ventilation in patients with cervical spinal cord injury (sci) the incidence of pulmonary complications, live less intensive care unit (ICU).


Eligibility criteria: Inclusion Criteria:

* All critically ill adult patients with cervical spinal cord injury who require mechanical ventilation and informed consent to be admitted to the Department of Critical Care Medicine of Peking University Third Hospital were selected by the subjects or their close relatives to enter the clinical study.

Exclusion Criteria:

* previous chronic obstructive pulmonary disease, diagnosis of acute respiratory distress syndrome at admission, presence of pneumothorax at admission, subjects or close relatives who refused to participate in the study, and non-signed informed consent."

Primary outcomes:
measure: The incidence of hypoxemia
timeFrame: during machinical ventilation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuelei
state: Beijing
Study officials:
References:
Clinical trial NCT03152071: Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer
Official title: Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer: a Prospective Trial With Control Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Postoperative Pain
Blood Loss
Inflammatory Response
Keywords: thoracoscopic surgery
RATS
VATS
Robot
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.

The perioperative circumstances and postoperative outcome will be compared.

Detailed description: Participants are randomly subdivided (1:1) to either undergo robot assisted lobectomy or video assisted thoracoscopic lobectomy in case of lung cancer. At the end of both surgical interventions the anaesthesiologist administers the same technique of pain relief: paravertebral blockage.

The data that are going to be investigated are: operative time, conversion to spreading of the ribs/thoracotomy, blood loss, lymph node dissection, prolonged air leak, chest tube drainage, length of stay, inflammatory reaction (through inflammatory parameters CRP, IL-3, IL-6, TNF), lung recuperation (through a lung function test) and postoperative pain (VAS score questionnaire).

Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years old or older
* Patients can be male or female
* Patients with a lung tumour which is treatable with surgery

Exclusion Criteria:

* Pregnancy
* Inoperable lung tumour
* Patients which are at risk for general anaesthesia

Primary outcomes:
measure: Postoperative pain
timeFrame: 2 months
Secondary outcomes:
measure: blood loss
timeFrame: up to 4 hours
measure: operative time
timeFrame: up to 4 hours
measure: conversion to spreading of the ribs/thoracotomy
timeFrame: up to 4 hours
measure: lymph node dissection
timeFrame: up to 4 hours
measure: prolonged air leak
timeFrame: up to 7 days
measure: chest tube drainage
timeFrame: up to 7 days
measure: length of stay
timeFrame: up to 7 days
measure: pulmonary function
timeFrame: 2 months
measure: Inflammatory reaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Wietske Renckens, MD
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Dirk Smets, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Eef Vanderhelst, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01658371: Preference of Genetic Polymorphism and Pharmacokinetics
Official title: Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Southern Chinese HIV patients

Brief summary: Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients. The investigators investigate the prevalence of genetic polymorphism affecting efavirenz metabolism and the corresponding pharmacokinetics of different genotypes.

Detailed description: Eligible patients are invited to donate blood samples for pharmacokinetic study and genotype analysis

Eligibility criteria: Inclusion Criteria:

* Southern Chinese HIV patients on efavirenz

Exclusion Criteria:

* Refuse to sign consent, HIV patients not on efavirenz

Primary outcomes:
measure: pharmacokinetics
timeFrame: 24 hour
Secondary outcomes:
measure: genotypes frequency
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: S S Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538571: Association of Near Infrared Spectroscopy With Interstage Outcomes
Official title: Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Single-ventricle
Lead sponsor: Advocate Hospital System
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 20
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Infants under 6 months of age
* Infants with single ventricle heart disease and parallel circulation
* Infants who are awaiting the Glenn operation
* Infants who are outpatient

Exclusion Criteria:

* Infants over 6 months of age
* Inpatients
* Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
* Infants with ongoing hyperbilirubinemia

Primary outcomes:
measure: Unexpected admissions
timeFrame: 1 year
measure: Unexpected interventions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Childrens Hospital
state: Illinois
Study officials:
affiliation: Advocate Children's Hospital
name: Joshua Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542471: Plating Versus Nailing in Pediatric BB Forearm Fractures
Official title: Dual Intramedullary Nailing Fixation Versus Dual Plating of Pediatric Both Bone Forearm Fracture: a Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Intramedullary Nail
Plate Fixation
Forearm Fracture
Randomized Controlled Trial
Keywords: forearm fractures
pediatric fractures
flexible nail
plate fixation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.


Eligibility criteria: Inclusion criteria:

1. Both-bone Forearm Diaphyseal Fracture.
2. age more than or equal nine years old with open distal radius physis.
3. Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.

Exclusion criteria:

1. Neurovascular injury.
2. Open fractures
3. Comminuted fractures
4. Pathological fractures

Primary outcomes:
measure: Time to union
timeFrame: 6 months
measure: Elbow range of motion
timeFrame: 6 months
measure: Quick DASH score
timeFrame: 6 months
measure: patient satisfaction questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: 6 months
measure: Re-operation rate
timeFrame: 6 months
measure: size of wound scar in millimeters
timeFrame: 6 months
measure: Deformity (malunion rate)
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Mahmoud Mahran, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Ahmed Saeed Younis
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Abdelrahman Hani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514071: Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minor Head Injury
Keywords: head injury
CT
emergency
radiation
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 746
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is difficult for Pediatric Emergency Department providers to recognize clinically significant head injuries that are likely to require neurosurgical intervention or close monitoring from those that can be safely discharged.

Research Question How do a combination of education and an animated picture depicting the PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT scans?

Design This is a within subject, repeated measures study design.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to Children's ED will be included if they:
* Are between 0 and 18 years of age (inclusive)
* Receive a discharge diagnosis of head injury
* Present to the ED within 24 hours of the head injury
* GCS of 14 or greater

Exclusion Criteria:

* Patients will be excluded if they :
* Had a CT scans done in an outside transferring institution
* Have obvious penetrating head injuries
* Had a trivial injury mechanisms such as ground-level falls or walking or running into stationary objects
* Have no signs or symptoms of head trauma other than scalp abrasions and lacerations.
* Have known brain tumors, pre-existing neurological disorders complicating assessment, ventricular shunts, bleeding disorders

Primary outcomes:
measure: Compliance to the PECARN CT Scan Head Injury rules
timeFrame: 3 months
Secondary outcomes:
measure: Decreased rate of CT scans
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Twin Cities
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
References:
citation: Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.