louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06895187: Catheter Ablation Using a Novel Navigation and Imaging System
Official title: Catheter Ablation Using a Novel Navigation and Imaging System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: LUMA Vision Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 100
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: * Subjects who have undergone a previous cardiac ablation for the treatment of PAF
* Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
* Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
* Unrecovered/unresolved Adverse Events from any previous invasive procedure
* Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)

Brief summary: The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation (PAF).


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law
* Subjects is eligible for a catheter ablation procedure with the VERAFEYE System as navigation and imaging system in the treatment of PAF (according to VERAFEYE System IFUs, current international and local guidelines and per physician discretion)
* Subject is able to understand and willing to provide written informed consent
* Subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center

Exclusion Criteria:

Primary outcomes:
measure: Acute procedural success rates during the index procedure
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01596387: Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients
Official title: Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: anaesthetics iv
propofol
pharmacokinetics
pharmacodynamic
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model to administer propofol in obese patients.

Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing weight and that mathematical models to administer drugs in obese patients can be developed to accurately predict dose schemes in this population.

Detailed description: Propofol is the most frequently used IV anesthetic today. Propofol TCI is commonly used for induction and maintenance of general anaesthesia in obese and non obese patients. However, current propofol PK models, used in TCI devices, were derived from studies that did not include obese patients. A controversial issue for propofol dose adjustment in this population has been the selection of an adequate size descriptor to scale PK parameters, as drug administration based on total body weight can result in overdose, and conversely, administration based on ideal body weight can result in a sub-therapeutic dose. In a previous study from our group, we developed a PK model capable of characterizing the influence of obesity on propofol disposition. The purpose of this study is to validate this model to administer propofol in obese patients.

Eligibility criteria: Inclusion Criteria:

* IMC \> 35 kg m-2
* Scheduled for laparoscopic bariatric surgery
* ASA I-II patients
* Between 18 and 60 yr of age.

Exclusion Criteria:

* Patients with allergy to study drugs
* Uncontrolled hypertension
* Heart block greater than first degree
* Take any drug acting in the central nervous system within 24 hrs before surgery.

Primary outcomes:
measure: Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients
timeFrame: During the intraoperative period and until 120 min after stopping propofol infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad Catolica
state: Region Metropolitana
Study officials:
affiliation: Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
name: Luis I Cortínez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cortinez LI, De la Fuente N, Eleveld DJ, Oliveros A, Crovari F, Sepulveda P, Ibacache M, Solari S. Performance of propofol target-controlled infusion models in the obese: pharmacokinetic and pharmacodynamic analysis. Anesth Analg. 2014 Aug;119(2):302-310. doi: 10.1213/ANE.0000000000000317.
Clinical trial NCT01888887: Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser
Official title: Cetaphil Daily Facial Cleanser: 200 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Irritation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin


Eligibility criteria: Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating

Primary outcomes:
measure: area of erythema and edema to test reaction of skin to product
timeFrame: 3 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New City
country: United States
facility: AMA Laboratories
state: New York
Study officials:
affiliation: AMA Laboratories
name: Mayya Tastene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375687: Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
Official title: Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Lead sponsor: Kaunas University of Medicine
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 61
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
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 early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.

Detailed description: The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.

Eligibility criteria: Inclusion Criteria:

* preoperative PSA\>20ng/ml
* postoperative PSA \>0.2 ng/ml
* Gleason \> 7
* pT3b
* signated infomed consent

Exclusion Criteria:

* neoadjuvant hormonaltherapy before RP
* R1 RP
* N+ RP
* unstable cncomitant conditions

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: PSA dinamics
measure: quality of life
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Urology dep. of Kaunas University of Medicine
Study officials:
affiliation: Urology dep. of Kaunas University of Medicine
name: Mindaugas Jievaltas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03517787: The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life
Official title: The Effect of Functional Electrical Stimulation and Therapeutic Exercise on Functional Properties of Skeletal Muscles, Sitting Postural Stability and Quality of Life in Traumatic Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Tartu
First posted: 2018-05-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim of the current study is to evaluate the effect functional electrical stimulation and therapeutic exercise on traumatic spinal cord injured participants'skeletal muscle characteristics, sitting balance, lung function and quality of life.


Eligibility criteria: Chronic spinal cord injury (12 months post injury) Injury in cervical region resulting in tetraparesis Able to sit on a custom made chair without support Does not have any contraindications for functional electrical stimulation

Primary outcomes:
measure: Change of median power frequency (MPF) and amplitude (A)
timeFrame: Change from baseline measure at 6 weeks
Secondary outcomes:
measure: Change of muscle tone
timeFrame: Change from baseline measure at 6 weeks
Other outcomes:
measure: Change of sitting balance
timeFrame: Change from baseline measure at 6 weeks
measure: Health Related Quality of life
timeFrame: Change from baseline measure at 6 weeks
Locations:
city: Tartu
country: Estonia
facility: University of Tartu
Study officials:
affiliation: University of Tartu
name: Doris Vahtrik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06921187: Study of Auditory Perception After Progressive Exposure to Aversive Sounds in People With Misophonia
Official title: Etude de la Perception Auditive après Exposition PROgressive Aux Sons Aversifs Chez Des Personnes MISophonEs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Misophonia
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut de l'Audition
First posted: 2025-04-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: exposure to unpleasant sounds at home is the focus of this study
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.


Eligibility criteria: Inclusion Criteria:

For all participants

* Obtain oral consent from the participant after receiving information about the study,
* Be 18 years or older on the day of inclusion,
* Be fluent in French (spoken and written),
* Have no known hearing loss, verified by pure tone audiometry.
* Declare that they do not have tinnitus,
* Declare that they do not have hyperacusis, verified by measuring discomfort thresholds.
* Be affiliated to the social security or equivalent scheme.

For participants with misophonia:

- Declare discomfort, reduced tolerance to specific sounds (mouth noises, throat clearing, breathing, etc.).

Exclusion Criteria:

* Bear the after-effects of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
* Be under guardianship,
* deprived of liberty by judicial or administrative decision, or subject to legal protection.

Primary outcomes:
measure: score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)
timeFrame: 1 week after enrollment
measure: score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense)
timeFrame: 1 week after enrollment
Secondary outcomes:
measure: Measuring the consistency of the psychoacoustic test
timeFrame: 1 week after enrollement
measure: the number of redundant themes in the semi-structured interviews
timeFrame: 1 month after enrollment
measure: score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort)
timeFrame: 1 month after enrollment and 2 months after enrollment
Other outcomes:
Locations:
city: Marseille
country: France
facility: Centre de Recherche en Psychologie et Neuroscience (CRPN)
city: Paris
country: France
facility: CEntre de Recherche et d'Innovation en Audiologie Humaine
Study officials:
References:
Clinical trial NCT01709487: Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
Official title: Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Carcinoma
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Keywords: HIPEC
ovarian carcinoma
Bordet
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Detailed description: Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

Eligibility criteria: Inclusion Criteria:

* stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion Criteria:

* incomplete surgery poor performance status bad general condition

Primary outcomes:
measure: mortality rate
timeFrame: 24 weeks
Secondary outcomes:
measure: progression free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Liège
country: Belgium
facility: Hopital de la Citadelle
Study officials:
affiliation: Institut Jules Bordet, Brussels, Belgium.
name: Joseph Kerger, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de la Citadelle, Liège, Belgium.
name: Frédéric Goffin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05669287: Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
Official title: Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
Keywords: Pancreas
Pancreatic cancer
CT perfusion
Histopathology
Imaging Biomarker
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2022-12-30
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome.

The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.


Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of pancreatic cancer
* 18 years and older
* written (signed and dated) informed consent

Exclusion Criteria:

* Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment)
* Previous treatment for pancreatic cancer
* Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years
* Insufficient command of the Dutch language to be able to understand the patient information

Primary outcomes:
measure: Classification of vascular phenotype using CT-perfusion
timeFrame: Baseline
measure: Correlation of CT-perfusion features with histopathological features
timeFrame: Baseline, Time of Resection
Secondary outcomes:
measure: Association between survival and CT-perfusion features
timeFrame: Baseline, at 2 Years
measure: Prediction of chemotherapy response
timeFrame: Baseline, 3 Months
measure: Prediction of chemotherapy response compared to RECIST
timeFrame: Baseline, 3 Months, 6 Months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Hospital
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: John Hermans, MSc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Henkjan Huisman, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Lodewijk Brosens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06017687: Data Collection and Evaluation of OptiBP Under Investigational Use
Official title: Data Collection and Evaluation of a Mobile, Machine-learning-based Solution for Blood Pressure Estimation - the OptiBP Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Population
Lead sponsor: Biospectal
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to collect data to develop and evaluate the use of state-of-the-art machine learning approaches within a mobile phone application for the estimation of blood pressure.

Detailed description: Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor on the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm.

Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
2. Live in the United States of America
3. Have an Android smartphone
4. Have access to an arm-worn blood pressure monitor (cuff)
5. Have access to the Google Play store to download the OptiBP study app on their phone
6. Be comfortable communicating in written and spoken English
7. Be willing and able to provide informed consent to participate in the study

Exclusion Criteria:

1. Known contact dermatitis to nickel/chromium
2. Lesion or deficiency on hand, preventing placing a finger on the smartphone camera
3. Known dysrhythmia like bigeminy, trigeminy, isolated VPB, atrial fibrillation

Primary outcomes:
measure: Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models
timeFrame: 12 months
Secondary outcomes:
measure: Safety by assessing inconvenience and adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Truckee
country: United States
facility: Decentralized Trial
state: California
Study officials:
affiliation: Biospectal
name: Frederic Frappereau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450587: Intraocular Pressure Data Collection With Tonometers
Official title: Intraocular Pressure Data Collection With Tonometers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Icare Finland Oy
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).

The intraocular pressure of the participants will be measured with four different tonometers.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Subjects with only one functional eye
* Subjects having poor or eccentric fixation in the study eye(s)
* High corneal astigmatism \&gt;3D in the study eye(s)
* Central corneal scarring
* History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
* Microphthalmos
* Buphthalmos
* Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
* Dry eyes (clinically significant)
* Lid squeezers - blepharospasm
* Nystagmus
* Keratoconus
* Any other corneal or conjunctival pathology or infection relevant to this study
* Cataract Extraction within last 2 months in the study eye(s)

Primary outcomes:
measure: Primary Objective
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kromberk
country: Slovenia
facility: Vid d.o.o.
state: Nova Gorica
city: Bled
country: Slovenia
facility: Optika Mesec d.o.o.
Study officials:
References: