louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05731453: Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
Official title: Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: risk based screening
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2023-02-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.

Detailed description: The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.

Eligibility criteria: Inclusion Criteria:

* Women referred for clinical mammography in the Vestre Viken Breast Centre
* Breast density BI-RADS a or d
* 40-50 y.o.

Exclusion Criteria:

* Prior history of breast cancer or premalignant breast disease
* Prior genetic counselling/testing

Primary outcomes:
measure: Assessment of breast cancer risk by polygenetic risk score in the study population
timeFrame: 10 years
Secondary outcomes:
measure: Compliance to individual recommedations for breast cancer screening
timeFrame: 10 years
measure: Correlation of polygenetic risk score and breast cancer risk assessed by family history
timeFrame: 10 years
measure: Participants´ experience with study participation
timeFrame: 10 years
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust
Study officials:
affiliation: Vestre Viken HT
name: Tone Hovda, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653753: Assessment of the Safety and Performance of a Patellofemoral Brace
Official title: Assessment of the Safety and Performance of a Patellofemoral Brace
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Patellar Instability
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2020-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has patellofemoral syndrome
* The current condition of his/her knee allows the subject to keep a regular physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (18 weeks)
* Subject is affiliated to the French social security regime

Non-Inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (knee brace or articulated orthosis) in the last month during his/her sport practice
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, cotton, elastane, elastodiene, polyester)
* Adult subject to a legal protection measure

Primary outcomes:
measure: Functional score
timeFrame: 18 weeks of follow-up
Secondary outcomes:
measure: Confidence level
timeFrame: At baseline and 18 weeks of follow-up
measure: Knee instability
timeFrame: At 6 weeks, 12 weeks and 18 weeks of follow-up
measure: Knee pain
timeFrame: At 6 weeks, 12 weeks and 18 weeks of follow-up
measure: Safety (adverse events)
timeFrame: 18 weeks of follow-up
Other outcomes:
Locations:
city: Faches-Thumesnil
country: France
facility: Centre de rééducation et de balnéothérapie Kinés Faches
city: Levallois-Perret
country: France
facility: Physio Sport Levallois
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Paris
country: France
facility: Cabinet de kinésithérapie du Belvédère
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02997553: Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
Official title: Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Carcinoma
Head and Neck Cancer
Melanoma (Skin)
Squamous Cell Carcinoma, Skin
Cervix Cancer
Endometrium Cancer
Ovary Cancer
Vulva Cancer
Anus Cancer
Rectum Cancer
Keywords: Indocyanine green (ICG)
Sentinel lymph node biopsy
Technetium99
Tumors
Optonuclear probe
Surgery
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 744
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: This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* cancer histologically proved
* patient eligible for sentinel node detection
* contraceptive methods for men and women of childbearing age
* signed informed consent form
* patient affiliated to the social security system

Exclusion Criteria:

* neoadjuvant chemotherapy or hormone therapy
* adenopathy (s) clinically suspicious or positively cytopenic
* women who are pregnant or breast-feeding
* associated pathology that may prevent patient of receive indocyanine green
* ongoing participation in another clinical trial with an investigational drug
* patients deprived of liberty or under supervision
* impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons

Primary outcomes:
measure: Non-inferiority of indocyanine green guided sentinel lymph node biopsy
timeFrame: 1 day
Secondary outcomes:
measure: Total number of sentinel lymph node detected
timeFrame: 1 day
measure: Number of false negative result
timeFrame: 1 day
measure: Allergic reactions
timeFrame: 8 days
measure: Evaluation of pain
timeFrame: 1 day
measure: fluorescence imaging
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: MARCHAL FREDERIC, MD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169153: Clinical Comparison of Silicone Hydrogel Monthly Lenses
Official title: One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: contact lenses
lipids
deposits
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.


Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent;
* Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
* Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
* Screening lenses worn 10 hours exhibiting high lipid uptake.

Exclusion Criteria:

* Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
* Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
* History of herpetic keratitis, corneal surgery, or irregular cornea;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Abnormal ocular conditions or findings, as specified in the protocol;
* Known pregnancy and lactation.

Primary outcomes:
measure: Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
timeFrame: Day 30 after 10 hours of wear, each product
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Medical Clinical Trial Services
role: STUDY_DIRECTOR
References:
Clinical trial NCT01948453: Effect of Garlic Tablet Some Indicators Related to Atherosclerosis
Official title: Effect of Garlic Tablet on Carotid Intima Media Thickness and Flow-mediated Dilation in Patients Undergoing Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CAD
CIMT
FMD
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether garlic in adjunct to conventional medical treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease (CAD) patients.


Eligibility criteria: Inclusion Criteria:

* angiography confirmed coronary artery disease
* lack of consistent use of the garlic in the last month

Exclusion Criteria:

Change in type of medication during study

Primary outcomes:
measure: Carotid Intima Media Thickness
timeFrame: 12 weeks
Secondary outcomes:
measure: Flow-mediated dilatation
timeFrame: 12 weeks
Other outcomes:
measure: plasma levels of Alanine Aminotransferase, Aspartate Aminotransferase, creatinine, lipid profile, C-Reactive Protein
timeFrame: 12 weeks
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaei Cardiovascular, Medical & Research Center
Study officials:
affiliation: Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
name: Javad Nasrollahzadeh, Ph.D.
role: STUDY_CHAIR
affiliation: Department of Cardiology, Rajaei Cardiovascular, Medical & Research Center
name: Ali Z Mehr, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
name: Marjan M Roshan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327453: Effect of Removal of Double Antibiotic Paste on Post Operative Pain
Official title: Influence of Different Methods of Removal of Double Antibiotic Paste as an Intracanal Medication on Post Operative Pain:a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of the Elements
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recruited patients with necrotic pulp after application of double antibiotic paste are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

Detailed description: The investigator will recruit patients who are found eligible to the criteria, double antibiotic paste will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.

After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

Eligibility criteria: Inclusion Criteria:

* Medically free patients.
* Patient's age between 20-50 years.
* Both sexes.
* Necrotic pulp as indicated by thermal or electric pulp testing.
* No history of previous endodontic treatment of the tooth.
* Enough crown structure for adequate isolation.

Exclusion Criteria:

* Pregnancy or lactation
* Medically compromised patients
* Previous endodontic therapy of the affected tooth.
* Teeth diagnosed with vital pulp.
* Teeth with periodontal pocket more than 3mm deep.
* Teeth with abnormal anatomy or calcified canals.
* Teeth with caries below the bony level (non-restorable tooth).
* Immature teeth with open apices.

Primary outcomes:
measure: change in post operative pain (Visual Analogue Scale)
timeFrame: Intrappointment at 4,24,48,72 and 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Oral and dental medicine, Minia University
Study officials:
affiliation: Dean of faculty
name: Magdy Mohamed Ali, Professor
role: STUDY_CHAIR
References:
citation: Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
citation: Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
citation: Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
Clinical trial NCT02671253: Myomectomies:Tumor Characteristics and Clinical Implications
Official title: Myomectomies:Tumor Characteristics and Clinical Implications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Myomectomy
Genetics
Quality of Life
Gynecologic Surgical Procedures
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2016-02-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women at age under 46 years undergoing myomectomy.

Brief summary: This project focuses on myomectomy patients in reproductive age. The aim is to study both the molecular characteristics of uterine fibroids and to characterize the clinical effects of surgical treatment.

Patient series is mainly retrospective and consists of individuals who have undergone myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the investigators have started a prospective sample collection starting in October 2015, collecting samples from myomectomies.

Clinical data sources include medical records, specific questionnaires and a quality of life -questionnaire filled by patients.


Eligibility criteria: Inclusion Criteria:

* Uterine leiomyoma
* Seeking for surgery

Exclusion Criteria:

* Language proficiency in Finnish, Swedish or English

Primary outcomes:
measure: Quality of life measured by a validated questionnaire (UFS-QOL)
timeFrame: Two years
Secondary outcomes:
measure: Pregnancy rate after myomectomy, data collected with questionnaire
timeFrame: Five years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Kätilöopisto Maternity Hospital, Helsinki University hospital
state: Huch
Study officials:
affiliation: Helsinki University Central Hospital
name: Päivi I Pakarinen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457453: Comparison of Direct and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position
Official title: Comparison of Direct Laryngoscope and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position to Prevent Pulmonary Aspiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: Trendelenburg position
Sellick position
pulmonary aspiration
video laryngoscope
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory complications. Takenaka's study of mannequins reported that the risk of airway contamination by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position and a Sellick position with neck extention. However, the clinical performance of tracheal intubation in this position has not been studied. Also, the difference between the effects of direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.

Therefore, this study aims to compare the intubation time among intubation through direct laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation in the conventional sniffing position.


Eligibility criteria: Inclusion Criteria:

* Age \>= 19 years old
* ASA I or II
* Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

* Anatomical deformity in head and neck
* Patients who have risk of pulmonary aspiration
* Patients with cervical deformities or pain
* BMI \>35

Primary outcomes:
measure: Intubation time
timeFrame: within 5 minutes
Secondary outcomes:
measure: Intubation difficulty score
timeFrame: within 5 minutes
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Ajou universitiy school of medicine
state: Gyeong-gi Do
Study officials:
affiliation: Ajou University School of Medicine
name: yun jeong chae, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04879953: Effect of the PIPAC on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin
Official title: Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinomatosis, Peritoneal
Lead sponsor: Association Francaise de Chirurgie
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of adult patients with adenocarcinoma-type gastric non-resectable PC, without metastasis other than peritoneal, treated either with PIPAC administered in alternation with systemic chemotherapy or by systemic chemotherapy alone. All patients receiving PIPAC in our hospital during the study period were included. The patients in the group had been treated during the same period and were carefully selected according to age, general state of health (WHO performance status \<3) and absence of extra-peritoneal metastases so as to match as closely as possible the patients in the PIPAC group.

Brief summary: Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status \<3.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or over
* Patients with adenocarcinoma-type gastric non-resectable péritonéale carcinomatosis.
* Patients without metastasis other than peritoneal.
* WHO performance status \<3
* Patients treated either with PIPAC administered in alternation with systemic chemotherapy (PIPAC_CHEM) or by systemic chemotherapy alone (ONLY_CHEM)
* Patient informed

Exclusion Criteria:

- Patients opposed

Primary outcomes:
measure: Overall survival at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: 6 months
measure: overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.
timeFrame: 3 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHUGA
Study officials:
affiliation: Grenoble Hospital
name: Catherine Arvieux
role: PRINCIPAL_INVESTIGATOR
References: