louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01557205: Research and System Development on Functional 3D Optical Tomography for Skin Cell Imaging
Official title: Research and System Development on Functional 3D Optical Tomography for Skin Cell Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optical Coherence Tomography
Skin Cell Imaging
Keywords: optical coherence tomography
cell imaging
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aged between 20 to 100. People who received benign skin tumor removal in dermatological surgical unit. OR people who received skin grafts (full thickness or split thickness) for reconstruction of surgical wounds after removing malignant skin cancer.

Brief summary: The investigators will obtain human skin specimen (sized approximately 1 cm x 1 cm) for dermatological surgical patients in National Taiwan University Hospital, after informed consent was obtained. Human skin keratinocytes, fibroblasts, and melanocytes will be cultured from the human skin specimen. The three dimensional images of these cultured cells will be observed by a ultra-high resolution 3-dimensional optical coherence tomography.

Detailed description: The investigators will obtain human skin specimen (sized approximately 1 cm x 1 cm) for dermatological surgical patients in National Taiwan University Hospital, after informed consent was obtained. Human skin keratinocytes, fibroblasts, and melanocytes will be cultured from the human skin specimen. The three dimensional images of these cultured cells will be observed by a ultra-high resolution 3-dimensional optical coherence tomography.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 to 100.
* People who received benign skin tumor removal in dermatological surgical unit. OR
* People who received skin grafts (full thickness or split thickness) for reconstruction of surgical wounds after removing malignant skin cancer.

Exclusion Criteria:

* Age less than 20 years old,
* Psychiatric patients,
* Pregnant women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02640105: Cluster Headache, Addictions and Vascular Function
Official title: Cluster Headache (CH), Addictions and Vascular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cluster Headache
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 95
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: Patient with cluster headache

Brief summary: Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.

Detailed description: Several studies have shown an association between Cluster headache (CH) and smoking. However, no data exists on the link between CH and other addictions, and impact of these addictions on clinical characteristics of the disease. In addition, despite the strong biological link between CH and the vascular system, systematic investigations about vascular functions in CH patients are lacking.

This will be a prospective cohort study of 150 patients with CH, conducted in the Headache Center in Bordeaux, France.

Eligibility criteria: Inclusion Criteria:

* Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) criteria, in active or inactive phase.

Exclusion Criteria:

* Other primary headaches
* Subjects without social insurance

Primary outcomes:
measure: Duration of active periods of cluster headache
timeFrame: Day 0 (Inclusion visit)
measure: Number of active periods
timeFrame: Day 0 (Inclusion visit)
measure: Duration of cluster headache
timeFrame: Day 0 (Inclusion visit)
measure: Severity of attacks
timeFrame: Day 0 (Inclusion visit)
measure: Duration of active periods of cluster headache
timeFrame: one year after inclusion
measure: Number of active periods
timeFrame: one year after inclusion
measure: Duration of cluster headache
timeFrame: one year after inclusion
measure: Severity of attacks
timeFrame: one year after inclusion
Secondary outcomes:
measure: Existence of an addiction
timeFrame: Day 0 (Inclusion visit)
measure: Existence of an addiction
timeFrame: One year after inclusion
measure: Severity of Addiction
timeFrame: Day 0 (Inclusion visit)
measure: Severity of Addiction
timeFrame: One year after inclusion
measure: Reactive Hyperemic Index (RHI)
timeFrame: Day 0 (Inclusion visit)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References:
Clinical trial NCT01705405: Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
Official title: Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: cancer
prostate
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2012-10-12
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Visualize surgical needles inserted in the prostate, under the ultrasound modality.

Detailed description: In order to help the surgeon to remove the prostate during a laparoscopic intervention, our goal is to provide an innovative medical device that merges intra-operative ultrasound and endoscopic images.

We have already achieved the proof of concept of a device that merges ultrasound and endoscopic images. The objectives of this clinical trial are to accompany the maturation of the fusion device and to make the initial assessments of its Medical Service.

The main difficulty is to visualize markers (surgical needles) under both modalities , in order to merge them.

Eligibility criteria: Inclusion Criteria:

* of-age patient
* patient for whom a radical prostatectomy is planned
* patient with a prostate volume between 30g and 100g
* patient affiliated to the social security or equivalent
* Written informed consent

Exclusion Criteria:

* contraindication
* patient who has undergone a significant prostate resection
* patient who has undergone a prostate irradiation
* patient concerned by the L1121-6 à 8 of the health public code

Primary outcomes:
measure: Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
timeFrame: 1year
Secondary outcomes:
measure: Percent of data(ultrasound and endoscopic) on which the merging works
timeFrame: 1year
measure: Percent of accurate merging
timeFrame: 1year
measure: Percent of mistaken segmentation of the vesical neck in the endoscopic image
timeFrame: 1year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Urology, University hospital of Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Alexandre Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05336305: Polydextrose for Patients With Chronic Kidney Disease
Official title: Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Constipation
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Chronic Kidney Disease
* Hemodialysis patients for more than 6 months
* Aged 18 years or older

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Autoimmune diseases
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS

Primary outcomes:
measure: Change constipation status after supplementation with polydextrose
timeFrame: 2 months
measure: Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
References:
Clinical trial NCT00583505: Emergency/Compassionate Use - Membranous VSD Occluder
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Membranous
Ventricular
Septal
Defects
VSD
Keywords: membranous
ventricular
septal
defects
VSD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-12-31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Emergency/Compassionate use of the AMPLATZER Membranous VSD Occluder


Eligibility criteria: Inclusion Criteria:

* Emergency/compassionate use for patients not meeting the inclusion critera for the AMPLATZER Membranous VSD clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04907305: Next-Gen MS: Feed-forward PRO Data for MS Research
Official title: Next-Gen MS: A Prospective, Cluster-randomized Study Evaluating the Impact of "Feed-forward" Patient Reported Outcomes Data to Clinical Teams Managing Adults Living With MS in a Learning Health System for MS Research
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis (MS)
Keywords: Multiple Sclerosis
Patient Reported Outcomes
Patient Determined Disease Steps
Learning Healthcare System
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 1594
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: Participants from United States with Multiple sclerosis (MS) will be included.

Brief summary: This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).


Eligibility criteria: Inclusion Criteria:

* Participants willing and able to provide written informed consent
* Participants with clinical diagnosis of Multiple Sclerosis (MS)

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)
timeFrame: Baseline up to 18 Months
Secondary outcomes:
measure: Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months
timeFrame: Baseline up to 18 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates
state: Alabama
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Atlanta
country: United States
facility: Atlanta Neuroscience Institute
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Owosso
country: United States
facility: The Memorial Hospital, d.b.a Memorial Healthcare
state: Michigan
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Austin
country: United States
facility: The University of Texas of Austin
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
Clinical trial NCT04812405: Automated Caries Detection Using a 3D Intraoral Scanner. An in Vivo Validation Study.
Official title: Assessment of the Difference of Fluoresce of the TRIOS 4 Intraoral Scanner of the Same Surface at In Vivo and In Vitro Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Patients
Keywords: caries detection
in vivo
intraoral scanner
ICDAS
histology
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This in vivo study with in vitro validation assessed four different algorithms (ALG1-ALG4) implemented in the intraoral scanner system for automated caries detection and classification. 3D scans of the examined teeth were obtained both in vivo and vitro, i.e. before and after tooth extraction, in order to assess any possible differences in the performance of the algorithms at different conditions. The latter could potentially help drawing some conclusions regarding i) the validity of the in vitro studies assessing fluorescence method for caries detection, and ii) the in vivo applicability of in vitro results obtained in the past and the future. Additionally, visual-tactile examination using the ICDAS (ICDAS II) criteria19 was conducted on the same teeth in vivo and histological assessment was used as reference test in vitro.


Eligibility criteria: Inclusion Criteria:

* Patients with permanent molars / premolars,
* Sound teeth or with caries lesions on the occlusal surfaces.

Exclusion Criteria:

* Front teeth / deciduous teeth
* Teeth with fillings
* Teeth with broken crown
* Teeth with extensive lesions on the lateral surfaces.

Primary outcomes:
measure: Agreement of In vivo validation with in vitro caries detection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Dentistry
Study officials:
References:
Clinical trial NCT03629405: Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
Official title: Assessment of the Long-Term Efficacy and Barrier Protection of Two Skin Care Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged Skin
Keywords: pH of the skin
SDS
Lipbarvis
TEWL
Skin hydration
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: proDERM Institut für Angewandte Dermatologische Forschung GmbH
name: Microscopy Services Dähnhardt GmbH
First posted: 2018-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female and male (at least 30% male subjects)
* From 50 to 75 years of age, equally distributed

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS or infectious hepatitis if known to the subjects
* Conditions which exclude a participation or might influence the test reaction/ evaluation
* Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
* Active skin disease at the test area
* One of the following serious illnesses that might require regular systemic medication: insulin-dependent diabetes
* Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the Investigation

Primary outcomes:
measure: Skin pH
timeFrame: baseline, Day 29, Day 30
Secondary outcomes:
measure: Transepidermal Water Loss
timeFrame: baseline, Day 29, Day 30
measure: Skin Hydration
timeFrame: baseline, Day 29, Day 30
measure: Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)
timeFrame: baseline, Day 29, Day 30
measure: Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))
timeFrame: baseline, Day 29, Day 30
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proDERM Institute for Applied Dermatological Research
Study officials:
affiliation: proDERM Institute for Applied Dermatological Research, Germany
name: Prof. Klaus-Peter Wilhelm, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01935505: Study on the Model of Smoking Cessation Intervention and Service Ability Improvement
Official title: Study on the Model of Smoking Cessation Intervention and Service Ability Improvement in General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking Cessation
Keywords: smoking cessation
intervention model
Chinese
quitting rate
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital-based population

Brief summary: This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

Detailed description: This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

To study the intervention methods of smoking cessation in a general hospital and to evaluate their effects. Four methods of specialist intervention of smoking cessation clinic, short-time intervention in out patients, free medical intervention and group intervention were adopted for different smokers, with health counseling, psychological intervention and drug treatment. The intervention effect was evaluated by standard methods.

The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each quitter received follow-up at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview, an expected average of 2 years.

Eligibility criteria: Inclusion Criteria:

* current smoker aged 18 years or above, Chinese,
* agreed to participate in the follow-up and signed an informed consent form.

Exclusion Criteria:

* cognitively impaired and with severe diseases,
* occasional or daily smoker,
* Disagree and non-signed an informed consent form.

Primary outcomes:
measure: quitting rate
timeFrame: up to 10 years
Secondary outcomes:
measure: decrease of tobacco consumption
timeFrame: up to 10 years
Other outcomes:
measure: changes of Knowledge Attitude and Practice
timeFrame: up to 10 years
Locations:
Study officials:
affiliation: Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China
name: Yao He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang B, He Y, Zuo F, Wu L, Liu QH, Zhang L, Zhou CX, Cheng KK, Chan SS, Lam TH. Effectiveness of varenicline and counselling for smoking cessation in an observational cohort study in China. BMJ Open. 2016 Jan 6;6(1):e009381. doi: 10.1136/bmjopen-2015-009381.
Clinical trial NCT04721405: Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
Official title: Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elective Surgical Procedures
Lead sponsor: Nanowear Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 30
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: Male or female over the age of 18 years, healthy adults scheduled to undergo BodyTite and/or FaceTite procedures.

Brief summary: The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery


Eligibility criteria: Inclusion Criteria:

* Signed informed consent to participate in the study.
* Female and male subjects, at least 18 years of age at the time of enrolment
* The patient is scheduled to undergo BodyTite and/or FaceTite procedures.
* The patients should be willing to comply with the study procedure and schedule.

Exclusion Criteria:

* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Pregnancy and nursing.
* Subject unwilling or unable to comply with wearing the Nanowear System 12 hours daily for at least 48 hours Up to 7 days
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Primary outcomes:
measure: Subject assessment of comfort and compliance
timeFrame: 7 days
Secondary outcomes:
measure: Investigator assessment of device usability and satisfaction
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Zucker School of Medicine, Hofstra University
state: New York
Study officials:
References: