louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05231525: Comparison of the TOFScan and the WiTOF During Recovery of Neuromuscular Function
Official title: Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Residual Curarization
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.

Detailed description: The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.

Eligibility criteria: Inclusion Criteria:

* All programmed surgery with intraveinous injection of ATRACURIUM
* American society of anesthesiology patient score of I, II or III
* Patient being free of tutorship or curatorship
* Acceptance of the patient after clear and loyal information

Exclusion Criteria:

* Surgery without access simultaneously to the two arms
* Emergency surgery
* Rapid sequence induction
* Usage of an other curare than ATRACURIUM
* Contraindication on ATRACURIUM usage
* Patient with pace maker
* Patient with Arné score \> or = to 11
* Patient without social security coverage
* Pregnant of breastfeeding women
* Patient under social protection

Primary outcomes:
measure: Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.
timeFrame: During the whole period of the surgical operation maximum 8 hours
Secondary outcomes:
measure: Evaluate the performance of the monitors for the follow up of neuromuscular recovery
timeFrame: During the whole period of the surgical operation maximum 8 hours
measure: Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor
timeFrame: During the whole period of the surgical operation maximum 8 hours
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: CHU de Poitiers FRANCE
name: Matthieu BOISSON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031625: Metastatic Colorectal Cancer Database
Official title: Prospective and Retrospective Metastatic Colorectal Cancer Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regular clinical metastatic colorectal patient management in Centre Georges François Leclerc, Dijon

Brief summary: The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon.

Detailed description: The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution, ...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes.

All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal cancer
* Age \>= 18

Exclusion Criteria:

* Non metastatic colorectal cancer
* Objection to the use of medical data records

Primary outcomes:
measure: Patient survival
timeFrame: 2 years
Secondary outcomes:
measure: Collection of patient and treatment characteristics
timeFrame: 2 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Methodology, Biostatistics and Data Management
Study officials:
References:
Clinical trial NCT05572125: Iron Therapy in Erythropoietic Protoporphyria
Official title: Oral Iron Therapy in Erythropoietic Protoporphyria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythropoietic Protoporphyria
Iron-deficiency
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Alfred Benzon Foundation
First posted: 2022-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with EPP taking oral iron tablets due to iron deficiency

Brief summary: Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with EPP
* Taking standard dose of iron tablets due to iron deficiency

Exclusion Criteria:

* Pregnant
* Lactating

Primary outcomes:
measure: Change in erythrocyte protoporphyrin concentration
timeFrame: Before treatment and after 6-8 weeks of treatment
Secondary outcomes:
measure: Change in hemoglobin and iron parameters
timeFrame: Before treatment and after 6-8 weeks of treatment
measure: Adverse event
timeFrame: 6-8 weeks of treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT05889325: To Evaluate the Performance of HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy on Unresectable Colorectal Liver Metastases
Official title: Efficacy and Safety of Irinotecan-eluting HepaSphere Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy for Unresectable Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Liver Metastases (CRCLM)
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a retrospective observation study. All of the patients included in this study were diagnosed as advanced colorectal carcinoma with unresectable liver metastasis. In additional, they received only HepaSphere DEB-TACE plus HAIC as the interventional therapy in a period of time from 2018 to 2022 . There is no any intervention in this study

Brief summary: Both drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) are recommended for unresectable colorectal liver metastases (CRLM) treatment. However, the combined application of DEB-TACE and HAIC is not widely accepted. The aim of this single-center retrospective study was to evaluate the efficacy and safety of Irinotecan-eluting HepaSphere chemoembolization combined with HAIC for unresectable CRLM


Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years old
* Gender: no limitation
* Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable)
* Subjects must have at least one measurable lesion per RECIST v1.1
* Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) as interventional therapy during the observation period
* Child-Pugh: A-B
* ECOG: 0-2.

Exclusion Criteria:

* Other malignant tumors in the past 5 years
* Drug-eluting beads from other manufacturers were used during DEB-TACE
* DEB-TACE combined with HAIC was used as postoperative adjuvant therapy
* Pre- or post-surgery relevant examination results were unavailable
* Imaging information for effectiveness evaluation was unavailable
* Follow-up failure due to patient information errors, loss, refusal, etc

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 3 years
measure: Duration of Response (DoR)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05984225: Impact of an Online Program in Ethics in Physiotherapy
Official title: Assessing the Impact of an Online Program Regarding Professional Ethics in Physiotherapy. A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ethics, Narrative
Keywords: Learning
Ethics
Students
Knowledge
Physiotherapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional
Primary purpose: OTHER

Brief summary: Given the continuing ethical problems faced by physiotherapists, improving their students' ethical competence is relevant. The development of ethical decision-making skills is particularly important for students preparing to enter professional health careers like physiotherapy. According to the Bologna process, the education of physiotherapists includes the cultivation of relevant generic/transversal competencies, including ethical competence. To achieve this, diverse teaching, learning, assessment, and feedback strategies are necessary and helpful in facilitating the acquisition of these competencies.

The physiotherapist needs to carry out ethics efficiently through ethical reasoning and critical thinking to develop ethical decision-making abilities. Active learning methods allow us to get students to follow the highest ethical standards and successfully manage ethical situations in the workplace. Despite some studies showing physiotherapists have a deficit in clinical practice ethics.

However, there is a lack of research focusing on online learning (OL) physiotherapy ethics education, and studies of review on mixed health professionals many times do not include physiotherapy studies.

Considering this, the primary objective of this study is to assess the effectiveness of an OL program in developing ethical competence in physiotherapy students. Specifically, the study aims to evaluate the impact of the program on generic competences, knowledge acquisition, ethical sensitivity, engagement, and instructional design within the OL environment.


Eligibility criteria: Inclusion Criteria:

* To be studying the Physiotherapy Degree at the University of Valencia.

Exclusion Criteria:

* Not willing to participate.
* Students with previous ethics training.
* Not willing to provide the written consent.

Primary outcomes:
measure: Generic competencies
timeFrame: 0 week, 5 week, 10 week
Secondary outcomes:
measure: Knowledge acquisition of Professional ethics
timeFrame: 0 week, 5 week, 10 week
measure: Ethical sensitivity
timeFrame: 0 week, 5 week, 10 week
measure: Engagement
timeFrame: Week 10
measure: Design of the Online Learning program instructions
timeFrame: Week 10
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy of the University of Valencia
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén, PT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02276625: One-visit Multi-site Intradermal Rabies Vaccination - Dose Finding
Official title: One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rabies Pre-exposure Prophylaxis
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Good health according to the investigator
* Willingness and ability to adhere to the study regimen
* Able to give informed consent

Exclusion Criteria:

* Known or suspected previous vaccination against rabies
* Known or suspected allergy against any of the vaccine components
* History of unusual or severe reactions to any previous vaccination
* Immunocompromized state due to illness or medication
* Administration of plasma or blood products three months prior to inclusion in the study
* (hydroxy)chloroquine or mefloquine use
* History of any neurological disorder including epilepsy or febrile seizures
* Pregnancy or breastfeeding
* Any current infectious disease other than seasonal cold
* Bleeding disorders or use of anticoagulants

Primary outcomes:
measure: Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South-Holland
Study officials:
affiliation: LUMC
name: Leo Visser, M, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481025: Efficacy and Safety for Cimicifuga/Hypericum Product
Official title: Phase 3 Study - Efficacy and Tolerance for the Mixture of Dry Extracts Black Cohosh and Saint John's Worth Versus Isolated Black Cohosh Extract for the Climacteric Symptoms' Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Perimenopausal Disorder
Keywords: Climacteric
Depression
Herbal treatment
Lead sponsor: Phytopharm Consulting Brazil
Sponsor class: NETWORK
Collaborators: name: Herbarium Laboratorio Botanico Ltda
name: Complexo Hospitalar Santa Casa de Misericordia de Porto alegre
First posted: 2011-11-29
Enrollment: 210
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.

Detailed description: 2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life.

The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator.

This protocol was performed for the best of our volunteers.

Eligibility criteria: Inclusion Criteria:

* Climacteric women 45-60 years old - pre and postmenopausal
* Climacteric complains for at least 3 months
* No treatments for at least 2 months
* MRS score 0.4 or more for at least 3 items
* Hamilton's Scale score from 15-23

Exclusion Criteria:

* Hormon Therapy or any other for the last 3 months
* Antidepressive and Hypnotic medication for the last 3 months
* Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration
* History for allergies and hipersensitivity to any component of the drugs formulations
* No knowledge for reading or writing
* Suicide risk

Primary outcomes:
measure: Menopause Rating Scale
timeFrame: 8 months
Secondary outcomes:
measure: Hamilton's Depression Scale
timeFrame: 8 months
measure: WHOQOL
timeFrame: 8 months
measure: Health Numbers
timeFrame: 8 months (T-2 to T6)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: ISCMPA's Gynecology Ambulatory
state: RS
Study officials:
affiliation: Phytopharm Consulting Brazil - karla@phytopharm.com.br
name: Karla F Deud José, Pharm PhD
role: STUDY_CHAIR
affiliation: Federal University of Health Science of Porto Alegre
name: Carla Vanin, MD MSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre
name: Raquel P Dibi, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04149925: Endostapler Hemostasis Study
Official title: Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Lead sponsor: Lexington Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Surgical Specialists of Louisiana
First posted: 2019-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See above

Brief summary: The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
* Informed consent for study obtained and signed from each subject

Exclusion Criteria:

* Planned open surgical approach
* Prior bariatric operation (i.e. revisional bariatric surgery)
* Use of staple line reinforcement material (buttress)
* Patients taking anticoagulants
* Patients under the age of 18 on the date of the surgery

Primary outcomes:
measure: Staple Line Bleeding
timeFrame: 10 seconds after last staple line
Secondary outcomes:
measure: Staple Line Leaking
timeFrame: 1 month following procedure
measure: Adverse Events
timeFrame: 1 month following procedure
measure: Product Malfunction
timeFrame: During surgery
measure: Blood Transfusion
timeFrame: Within 72 hours of surgery start
measure: Pain Level
timeFrame: 1 week following procedure
Other outcomes:
Locations:
city: Covington
country: United States
facility: Avala Hospital
state: Louisiana
city: Metairie
country: United States
facility: Crescent City Surgical Centre
state: Louisiana
city: Slidell
country: United States
facility: Southern Surgical Hospital
state: Louisiana
Study officials:
References:
Clinical trial NCT04012125: The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
Official title: The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Brace
Scoliosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 14
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial


Eligibility criteria: Inclusion Criteria:

* GMFCS level III, IV, V of the Cerebral palsy
* 20-45 degree of Cobb's angle

Exclusion Criteria:

* less than 20 degree or more than 45 degree of Cobb's angle
* Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
* Acute lumbar pain
* Fixed scoliosis

Primary outcomes:
measure: Change of scoliosis
timeFrame: 6months
Secondary outcomes:
measure: Pain of the back (thorax)
timeFrame: 6 months
measure: change of quality of life (aspect of the parents)
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Bundang-gu
Study officials:
affiliation: Seoul National University Bundang Hospital
name: JUSEOK RYU, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06807125: Wear Measurement of Opposing Enamel to Milled Resin Matrix Ceramic Versus Bulk Fill Resin Composite After 2 Years
Official title: Intraoral Wear Measurement of Opposing Enamel to Indirect Milled Resin Matrix Ceramic Versus Direct Bulk Fill Resin Composite in Posterior Teeth After Using 2 Years: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Wear
Keywords: Wear measurements, resin matrix ceramic, Bulk fill composite, Digital scanner.
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: This clinical trial conducted to measure the amount of wear of opposing enamel to indirect milled resin matrix ceramic versus direct bulk fill resin composite intraorally using Digital Scanner after two years of using

Detailed description: Indirect milled resin matrix ceramic overlay versus direct bulk fill resin composite overlay was utilized in a clinical trial to compare the amount of enamel wear on endodontically treated molars using a Panda P2 digital scanner and Geomagic Control X 3D software. After one and two years, measurements of enamel wear were taken.

Eligibility criteria: Inclusion Criteria:

* ● Patients with non vital badly decayed posterior teeth.

  * 18 -55years.
  * Males or Females.
  * Good oral hygiene.
  * Co-operative patients approving to participate in the study

Exclusion Criteria:

* High caries index.

  * Severe medical complications.
  * Pregnancy.
  * Allergic history concerning methacrylates Disabilities.
  * Heavy smoking.
  * Xerostomia.
  * Lack of compliance.
  * Evidence of parafunctional habits.
  * Temporomandibular joint disorders.

Primary outcomes:
measure: Amount of Enamel Wear
timeFrame: two years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology
Study officials:
affiliation: Misr University for Science and Technology
name: Esraa EE Hussien, PhD
role: PRINCIPAL_INVESTIGATOR
References: