louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05294016: Smart Bra for Diagnosing Breast Cancer
Official title: Smart Bra for Diagnosing Breast Cancer: Pilot Study - CBRA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Medical Device
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Non-specific invasive carcinoma diagnosed by biopsy
* X-ray images available
* Tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically
* Patient with a breast size compatible with the study bra size

Exclusion Criteria:

* Contralateral breast cancer
* Inflammatory breast cancer
* History of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling)
* History of breast cancer or mastectomy
* Presence of dermatological pathology or breast skin ulceration
* Hematoma post biopsy
* History of thoraco-abdominal radiotherapy
* Known allergy to one of the materials of the device
* Fever (body temperature \> 37.8°C)
* Pacemaker port

Primary outcomes:
measure: Assess the ability of the device to detect breast abnormalities or not, in healthy women or women with a non-specific invasive carcinoma diagnosed.
timeFrame: 20 minutes of recording
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: ICANS (Institut de Cancérologie de Strasbourg)
city: Trevenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT02946216: ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC
Official title: Frequency and Abundance of ALK/ROS1/MET Mutations on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer Using Single Molecule Amplifcation and Re-sequencing Technology: a Perspective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer Stage III
Non-Small-Cell Lung Cancer Metastatic
Adenocarcinoma of Lung
EGFR Wildtype
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Non-small cell lung cancer (NSCLC)

Brief summary: The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC;
* Histologically confirmed adenocarcinoma;
* EGFR-wildtype NSCLC;
* Provision of blood (plasma) sample for ctDNA testing;
* Patient must be able to comply with the protocol;
* Provision of blood (plasma) sample for ctDNA testing;

Exclusion Criteria:

* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
* Histologically confirmed small cell lung cancer or other metastatic tumors;
* Patient with no histologic or cytological diagnosis;

Primary outcomes:
measure: Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART)
timeFrame: up to 2 years
measure: Proportion of patients with ALK/ROS1/MET mutations detected by single molecule amplifcation and re-sequencing technology (cSMART) after crizotinib resistance
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital, Nanjing Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03879616: Optimizing Gastrointestinal Procedure Appointments
Official title: Optimizing the Use of Reminders for Gastrointestinal Procedure Appointments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disease
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 15974
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will address the question:

Does an "enhanced" IVR-T protocol differ in effectiveness from the standard IVR-T protocol in reducing missed appointments and late cancellations for GI endoscopy? Hypothesis: The enhanced IVR-T protocol will be more effective.

Detailed description: This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol.

Randomization: Beginning in March 8, 2019, a randomization algorithm will be used in the Structured Query Language program that manages the IVR relational database to assign each visit for a procedure at all three sites to control or intervention. Since members with multiple procedures on different days during the study period could receive control or intervention for different visits, the statistical analysis will be limited to the first randomized appointment during the project period. Randomization will be stratified by clinic site.

Eligibility criteria: Inclusion criteria:

* Members scheduled for any GI procedure (upper endoscopy, colonoscopy, or both), with or without anesthesia, at all three clinical sites (Franklin, Rock Creek, Lone Tree) will be included if their procedure is scheduled ≥ 2 days prior to the procedure. The IVR-T protocol will be adapted based on the wait time between appointment scheduling and the date of the procedure.
* Members with all clinical indications (screening, diagnosis, or surveillance), will be included.

Exclusion criteria:

* KPCO members who request not to participate in research or not to receive IVR-T or email outreach
* KPCO members in the "break the glass" or "code pink" protocols.
* Members whose procedure is scheduled \< 2 days prior to the procedure.

Primary outcomes:
measure: Rate of Cancellation and Rate of Missed Appointments
timeFrame: 6 months
Secondary outcomes:
measure: The Boston Bowel Preparation Measure
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: John Steiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538716: Retroseptal Transconjunctival Blepharoplasty for GIR
Official title: Orbital Fat Graft Retroseptal Transconjunctival Blepharoplasty for Treatment of Groove in the Infraorbital Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Diseases
Keywords: tear trough, blepharoplasty,orbital fat
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options

Detailed description: Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition

Eligibility criteria: Inclusion Criteria:

* tear trough deformity

Exclusion Criteria:

* Eyelid diseases and previous eyelid surgery

Primary outcomes:
measure: skin-periosteal depth
timeFrame: 2 years
Secondary outcomes:
measure: global aesthetic improvement scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine
name: TAREK ELHAMAKY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06659016: Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections
Official title: EFFICACIA DI UN INTEGRATORE A BASE DI D-MANNOSIO, PROPOLI, QUERCETINA, COLLAGENE E BACILLUS COAGULANS NEL RIDURRE L'INCIDENZA E MIGLIORARE LA QUALITA' DI VITA IN DONNE CON CISTITE RICORRENTE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection (Diagnosis)
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: pharmaSuisse
First posted: 2024-10-26
Enrollment: 148
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate whether a dietary supplement based on D-mannose, collagen, hyaluronic acid, chondroitin sulphate, enhanced by the properties of quercetin plus propolis (Proqutin ®) and Bacillus Coagulans, eventually associated with antimicrobial prophylaxis, could be effective in preventing recurrent UTIs and improving related quality of life.


Eligibility criteria: Inclusion Criteria:

* a history of rUTIs (defined by EAU guidelines as a frequency of at least three UTIs per year, or two UTIs in the past six months in the last 12 months, confirmed by positive urine cultures
* not undergone any previous treatment for their condition.

Exclusion Criteria:

* age under or over limit
* concurrent antimicrobial treatment
* any ongoing treatment that could influence study outcomes,
* congenital or post-surgical urinary tract anomalies
* immunodeficiency or HIV infection
* ongoing pregnancy.

Primary outcomes:
measure: Number of urinary tract infections per month
timeFrame: 6 and 12 months
Secondary outcomes:
measure: ICIQ-FLUTS scores
timeFrame: 6 and 12 months
measure: Number of women matching recurrent urinary tract infection criteria
timeFrame: 12 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT04368416: Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Official title: Prevalence of Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety State
Sleep Disturbance
Alcohol Abuse
Aging
Dementia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of memory clinics in Normandy.

Brief summary: The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints.

In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use disorder. They also perform a neuropsychological assessment. Questionnaires are given to the patient and his/her caregiver to be filled in at home.

Levels of anxiety/depression, sleep quality and alcohol consumption are related to neuropsychological performance, diagnosis and responses to the questionaires.


Eligibility criteria: Inclusion Criteria:

* To have cognitive complaints
* To have french as native language
* Not to be opposed to be included
* To be affiliated to the social security

Exclusion Criteria:

-To be under tutorship or curatorship

Primary outcomes:
measure: Anxiety and depression
timeFrame: At inclusion
measure: Sleep quality
timeFrame: At inclusion
measure: Alcohol use disorder
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
affiliation: CHU CAEN
name: Pierre BRANGER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883816: Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Official title: Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically.

This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.


Eligibility criteria: Inclusion criteria :

* Infant aged 11 weeks

Exclusion criteria :

* Gestational age lower than 35 weeks of gestation,
* Background invasive mechanical ventilation in positive pressure
* Documented -Obstructive Sleep Apnea, heart defect, neuromuscular disease

Primary outcomes:
measure: Change from respiratory function at 7 months and 11 months
timeFrame: 7 months and 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
References:
Clinical trial NCT05187416: Correlation Between Elastic Modulus of Ultrasonic Shear Wave and Tumor Stromal Component in Pancreatic Cancer
Official title: Correlation Between Elastic Modulus of Ultrasonic Shear Wave and Tumor Stromal Component in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Keywords: 2D-SWE
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive cases of pancreatic cancer in Xijing Hospital

Brief summary: Pancreatic cancer is a gastrointestinal tumor with a high degree of malignancy. Currently, there are many first-line chemotherapy regimens in clinical practice, but the individual selection of chemotherapy regimens has not been unanimously recognized.This study is aimed at exploring the correlation between the two-dimensional shear wave elastography (2D - SWE) parameters and pancreatic cancer stromal elements proportion through an ultrasound scan for resectable pancreatic cancer cases and postoperative pathological specimen analysis. Then determine if the pancreatic cancer two-dimensional shear wave elastography can guide clinicians selecting chemotherapy scheme by predicting tumor stromal elements .These results are expected to provide an effective non-invasive diagnostic basis for individualized treatment of pancreatic cancer.


Eligibility criteria: Inclusion Criteria

1. Patients with resectable pancreatic cancer underwent ultrasound examination before surgery
2. Conventional ultrasound can clearly show pancreatic space-occupying lesions and the elastic measurements show good images
3. The patient agrees to receive ultrasound elasticity examination and signs informed consent
4. All patients had no history of radiotherapy or chemotherapy before ultrasound examination
5. All clinical case data and auxiliary examination data are complete and accessible.

Exclusion Criteria

1. Ultrasound evaluation was not performed before ultrasound-guided needle biopsy
2. Conventional ultrasound could not clearly show pancreatic space-occupying lesions or poor elastic measurement images
3. Patients who refuse to accept examination or give up treatment
4. Patients receiving neoadjuvant chemotherapy or radiotherapy before ultrasound examination
5. Incomplete clinical data and auxiliary examination data.

Primary outcomes:
measure: Elastic modulus measured by Ultrasonic shear wave and tumor stromal component assessed by pathological analysis in pancreatic cancer
timeFrame: Baseline (Preoperative ultrasound elastography examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT00117416: Mean Arterial Pressure (MAP) and Renal Perfusion: Evaluation of Critically Ill Patients With Normal Creatinine or Reduced Renal Function
Official title: MAP and Renal Perfusion: Evaluation of Critically Ill Patients With Normal Creatinine or Reduced Renal Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Failure, Acute
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-07-06
Enrollment: 0
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 evaluate the renal perfusion depending on the MAP.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Intensive care patient
* Treated with vasopressor
* Given informed consent
* Arterial infusion
* A bladder catheter

Exclusion Criteria:

* Anamneses of hypertension
* Neurological trauma
* Acute renal insufficiency other than prerenal or acute tubular necrosis etiology
* Hepatorenal syndrome
* Treated with diuretics
* Mechanical ventilation and unstable

Primary outcomes:
measure: creatinine clearance after 4 hours
Secondary outcomes:
measure: resistance index
measure: diuresis
measure: urinary indices of renal function
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Eric Hoste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725616: Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography
Official title: Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography: Comparative Non-inferiority Study With the Radial Arterial Approach to the Wrist
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Angiography
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes

Detailed description: Coronary angiography is the reference examination for anatomical exploration coronary arteries to determine the presence or absence of a predominantly obstructive coronary disease.

Historically, the femoral approach was the most common approach used in interventional cardiology. The radial approach to the forearm presents multiple advantages over the femoral route, and it became the gold standard approach to coronary angiography and intervention percutaneous coronary. Although uncommon, vascular complications related to the radial pathway exist.

This is why a more distal radial approach, above the long tendon extensor of the thumb (at the level of the anatomical snuff box) or downstream (at the back of the hand) was suggested more than 10 years ago. This pathway is now an advantageous alternative to the radial approach of first intention, both for the patient and for the practitioner.

The two procedures are common today but few studies have been developed to compare the two approaches. Therefore, the main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes

Eligibility criteria: Inclusion Criteria:

* Patient, male or female, aged 18 and over
* Patient having a diagnostic coronary angiography programmed by radial route.
* Patient with a radial pulse at the anatomical snuff box and at the wrist noticeable

Exclusion Criteria:

* Patient requiring emergency coronary angiography or having an acute coronary syndrome
* Patient with severe arteriopathy of the supra-aortic trunks
* Patient with a history of coronary bypass surgery
* Tall patients (\>1.90m)
* Patient allergic to xylocaine
* Patient presenting a contraindication to the realization of a coronary angiography:

terminal IRC, pregnancy, severe sepsis....

Primary outcomes:
measure: Success rate of coronary angiography without changing puncture route.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Cardiologie Tonkin
Study officials:
References: