louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06655025: The Effects of Dexmedetomidine on Postoperative Cognitive Function in Open Heart Surgery
Official title: The Effects of Dexmedetomidine on Postoperative Cognitive Function and Neuron-Specific Enolase Levels in Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Heart Sugery
Neuronal Damage
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the impact of Dexmedetomidine on postoperative cognitive function and serum Neuron Specific Enolase levels as an indicator of neuronal injury in patients undergoing open heart surgery


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes undergoing elective open-heart surgery

Exclusion Criteria:

* Patients with a history of neurological disorders, severe renal or liver dysfunction, or contraindications to Dexmedetomidine as in patients with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia, and in patients receiving other drugs known to prolong the QT interval.

Patients with cognitive impairment, mental and psychological illness and chronic alcoholics, drug addicts, abuse of psychotropic substances, illiterate education

Primary outcomes:
measure: postoperative cognitive function
timeFrame: pre- oprerative , Mini-mental state examination (MMSE) will be performed at 1, 3 and 7 days after operation.
Secondary outcomes:
measure: serum Neuron Specific Enolase levels
timeFrame: pre-operative ,post-operative 12 hours
Other outcomes:
measure: Bispectral index-guided anesthesia depth
timeFrame: BIS will be recorded at induction of anaesthesia (T0), immediately after intubation (T1), when incision will be made (T2), at time of cardiopulmonary bypass (T3) and when operation will be completed (T4).
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT04959630: Immersive Virtual Reality Environment for Complex Cognitive Skills Curricular Training in Liver Surgery
Official title: Effectiveness of an Immersive Virtual Reality Environment on Curricular Training for Complex Cognitive Skills in Liver Surgery: A Multicentric Crossover Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatobiliary Neoplasm
Keywords: surgical education
3D reconstruction
virtual reality
surgical planning
cognitive knowledge training
decision making
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Investigators hypothesize that a virtual reality (VR) environment enhances general surgery residents' performance compared to Desktop Interface (DI)-based visualization of 3D models in decision making for patients with liver tumors. To determine this, a proficiency-based stepwise training curriculum for preoperative planning has been developed using both modalities. The overall objective of the curriculum is that by the end of the training program, residents would be able to formulate a treatment plan for patients with liver tumors.


Eligibility criteria: Inclusion Criteria:

• General surgery residents irrespective of their postgraduate year

Exclusion Criteria:

* No inform consent
* Residents of other specialties

Primary outcomes:
measure: Residents' decision-making accuracy
timeFrame: Immediately after completing the educational intervention
Secondary outcomes:
measure: Cognitive knowledge retention
timeFrame: Baseline and immediately after completing the educational intervention
measure: Residents' scores in recognizing intrahepatic structures and liver segments
timeFrame: Immediately after completing the educational intervention
measure: Time needed to devise a surgical plan using the DI or VR platform
timeFrame: Immediately after completing the educational intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Naples
country: Italy
facility: Federico II University
Study officials:
affiliation: University Hospital, Ghent
name: Wouter Willaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federico II University
name: Roberto Troisi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rashidian N, Giglio MC, Van Herzeele I, Smeets P, Morise Z, Alseidi A, Troisi RI, Willaert W. Effectiveness of an immersive virtual reality environment on curricular training for complex cognitive skills in liver surgery: a multicentric crossover randomized trial. HPB (Oxford). 2022 Dec;24(12):2086-2095. doi: 10.1016/j.hpb.2022.07.009. Epub 2022 Jul 21.
Clinical trial NCT06275230: Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD
Official title: Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
organoid
human lung stem cells
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD Patients with indications of bronchoscopic biopsy

Brief summary: The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:

* Can human lung stem cell proliferate in vitro.
* Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment.


Eligibility criteria: Inclusion Criteria:

* 1. Age under 55, regardless of gender
* 2. Patients with COPD lung disease who are going to undergo bronchoscopic biopsy
* 3. No genetic diseases and other respiratory diseases

Exclusion Criteria:

* Other conditions determined by the investigators to be unsuitable for inclusion, such as difficult sampling, difficult follow-up, and complicated with other serious diseases

Primary outcomes:
measure: Number of Patients completed bronchoscope.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03705130: Evaluation of Visual Performance With Contact Lenses
Official title: Evaluation of Visual Performance With Contact Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: Multifocal Contact Lens
Myopia
Visual Performance
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects between the ages of 18-39 (inclusive) without significant ocular disease.

Brief summary: This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).

Detailed description: The study will examine visual acuity with various contact lenses, with and without glare source, in myopes between the ages of 18-39 years old (inclusive) to determine the effect of different multifocal optical designs on visual performance in the post-fit period.

Eligibility criteria: Inclusion Criteria:

* 18 to 39 years of age
* Best corrected visual acuity of at least 20/30
* Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters sphere after vertexing to the corneal plane

Exclusion Criteria:

* Greater than -1.00 diopter of refractive astigmatism at the corneal plane
* Any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a soft contact lens
* History of ocular trauma or surgery causing abnormal or distorted vision
* Current Rigid Gas Permeable (RGP) contact lens wearers
* Unwilling to have eyes photographed or video recorded
* Pregnant and/or lactating females, by self-report

Primary outcomes:
measure: Low Contrast Visual Acuity with Glare
timeFrame: Through study completion, an average of 3 hours
Secondary outcomes:
measure: Low Contrast Visual Acuity without Glare
timeFrame: Through study completion, an average of 3 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
References:
citation: Nti AN, Gregory HR, Ritchey ER, Wolffsohn JS, Berntsen DA. Contrast Sensitivity with Center-distance Multifocal Soft Contact Lenses. Optom Vis Sci. 2022 Apr 1;99(4):342-349. doi: 10.1097/OPX.0000000000001874.
Clinical trial NCT04755725: Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain
Official title: Comparison Between Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain Following Laparotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: rectus sheath catheter, pain following laparotomys.
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled in this study. Patients were randomly assigned to two groups 60 in epidural group and the other 60 patients in rectus catheter group. epidural catheter inserted pre induction but rectus sheath catheter inserted by the surgeon at the end of surgery.

Detailed description: One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled in this study. Patients were randomly assigned to two groups 60 in epidural group and the other 60 patients in rectus catheter group. epidural catheter inserted pre induction but rectus sheath catheter inserted by the surgeon at the end of surgery. In both groups we activated with10 ml bupivacain25% before patient recovery then 10 ml bupivacain.125% each 6 hours. If patient still in pain 1gm perflgan injected. If patient still in pain 10 mg nalufine for 70 kg patient injected. we will record pulse, blood pressure and visual analogue scale at 0,6,12,24 and 36 hours postoperative. Also Occurrence of nausea and vomiting, Time of return of bowel movement, Time of discharage and amount of analgesia used will be recorded. Results, discution will be later.

Eligibility criteria: Inclusion Criteria:

* patients at age rang from 18 to 60 undergoing laparotomy
* patients ASA1,2 physical status

Exclusion Criteria:

* any known coagulopathy
* morbid obesity
* kyphosis or scoliosis
* those with known sensitivity to local anesthetic drugs
* lack of cooperation and inability to understand or perform verbal or physical assessments.

Primary outcomes:
measure: Postoperative pain relief
timeFrame: 36hours
Secondary outcomes:
measure: Side effects
timeFrame: 36hours
measure: Total of analgesic consumption
timeFrame: 36 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Menoufia University
state: Governorate
city: Cairo
country: Egypt
facility: Menoufia University
state: Governorate
Study officials:
affiliation: Menoufia University
name: Ahmed M Raouf, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06609525: Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
Official title: A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pupillary Dilation Effect During Cycloplegic Refraction
Keywords: pupillary dilation
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 156
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective randomized study compared with active control arm.

Detailed description: This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).

Eligibility criteria: Inclusion Criteria:

* Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative)
* Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent

Exclusion Criteria:

* Subjects with a history of severe systemic reaction or increased sensitivity to atropine
* Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others)
* Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product
* Subjects with contact lens

Primary outcomes:
measure: pupillary dilation effect at 30 minutes after administration
timeFrame: From enrollment to the end of treatment at 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
References:
Clinical trial NCT01127425: Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
Official title: Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sigmoid Neoplasms
Keywords: nursing hours
length of hospital stay
reconvalescence
colorectal surgery
laparoscopic
sigmoid neoplasms
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.

Detailed description: CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track. Length of hospital stay and recovery seems to be reduced as well.

OBJEKTIVE: To compare laparoscopic and open colonic resection concerning nursing hours, length of hospital stay and recovery.

DESIGN, SETTING AND PATIENTS: triple blinded study (Patient, nursing staff and data collector) including 2 x 12 patients needing sigmoid resection due to cancer. Nursing hours, length of hospital stay and recovery (postoperative pain, questionnaire, actigraph ect.)

Eligibility criteria: Inclusion Criteria:

* sigmoid resection without stoma
* sigmoid neoplasms localized 20 cm from anus
* age 40-90

Exclusion Criteria:

* conversion from laparoscopic to open surgery
* stoma
* severe postoperative complications (anastomosis leak, intraabdominal abscess, reoperation, stay at intensive care unit, heart attack, pulmonary embolism)
* no informed consent

Primary outcomes:
measure: primary: Length of stay
timeFrame: 1 year
Secondary outcomes:
measure: secondary: Nursing hours, pain and recovery
timeFrame: 1 year
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: University Hospital of Gentofte, gastroenterologic surgery
Study officials:
affiliation: University of Gentofte
name: Britta Kaltoft, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02582125: ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
Official title: ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Keywords: ONO-4538
Advanced non-small cell lung cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 20 years of age
* Histologically or cytologically confirmed non-small cell lung cancer
* Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
* Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

Exclusion Criteria:

* Current or prior severe hypersensitivity to another antibody product
* Multiple primary cancers

Primary outcomes:
measure: Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Response rate (centrally assessed)
timeFrame: Approximately 6 months
measure: Response rate (study site assessment by investigator)
timeFrame: Approximately 6 months
measure: Overall survival
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Clinical Site 1
city: Taichung
country: Taiwan
facility: Taichung Clinical Site 2
city: Tainan
country: Taiwan
facility: Tainan Clinical Site 1
city: Tainan
country: Taiwan
facility: Tainan Clinical Site 2
city: Tainan
country: Taiwan
facility: Tainan Clinical Site 3
city: Taipei
country: Taiwan
facility: Taipei Clinical Site 1
city: Taipei
country: Taiwan
facility: Taipei Clinical Site 2
city: Taipei
country: Taiwan
facility: Taipei Clinical Site 3
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References:
citation: Chen YM, Chih-Hsin Yang J, Su WC, Chong IW, Hsia TC, Lin MC, Chang GC, Chiu CH, Ho CC, Wu SY, Hung JY, Wang CC, Yang TY, Yu CJ. Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan. J Formos Med Assoc. 2020 Dec;119(12):1817-1826. doi: 10.1016/j.jfma.2020.01.004. Epub 2020 Feb 22.
Clinical trial NCT04760925: Cascade Clinical Data Collection Protocol
Official title: Single Arm, Open Label, Retrospective and Prospective Clinical Data Collection to Assess CascadeTM, Non-Occlusive Remodeling Net, in Providing Temporary Assistance for Coil Embolization of Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Perflow Medical
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were planned to undergo, or underwent coil embolization procedure of intracranial aneurysms assisted by the Cascade device

Brief summary: This study is a multi-center, single arm, open label, retrospective and prospective clinical data collection of CascadeTM, Non-Occlusive Remodeling Net, in adults with intracranial aneurysms, demonstrating the effectiveness and safety of the CascadeTM in providing temporary assistance for coil embolization of intracranial aneurysms.

All consecutive eligible patients from all participating sites will be included in this clinical data collection. The relevant data of the coil embolization procedure will be collected via an eCRF system.

Peri procedural data on the coil embolization procedure as well as discharge, 30 days and at 3-6 months status will be collected.


Eligibility criteria: Patients must fulfill the following eligibility criteria to be included in the study:

1. Patient has been treated or planned to be treated with Cascade (Cascade device was opened).
2. Patient or patient's legally authorized representative or patient's family member (if approved by IEC) has signed and dated an Informed Consent Form (ICF), unless ICF is waived by local IEC.
3. Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated

Primary outcomes:
measure: Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device
timeFrame: During procedure
measure: Main Safety Endpoint - Incidence of Serious Adverse Device Effects (SADE)
timeFrame: within 30 days post procedure
Secondary outcomes:
measure: Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion
timeFrame: 3-6 months post procedure
Other outcomes:
measure: Other Safety Endpoint - Incidence of all Adverse Events
timeFrame: 30 days post procedure
Locations:
city: Sofia
country: Bulgaria
facility: UH St. Ivan Rilski
city: Magdeburg
country: Germany
facility: Medical Faculty of the Otto von Guericke University Magdeburg
city: Solingen
country: Germany
facility: radprax MVZ GmbH
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the MSWiA
city: Barcelona
country: Spain
facility: Hospital Universitari De Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
Study officials:
References: