louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06971471: Artificial Intelligence to Solve the MissINg of Gastric Cancer (AIMING)
Official title: Gastric Cancer and Artificial Intelligence: a National-level Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 6600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel/Crossover Study Model; Patients will be randomized 1:1:1:1
Primary purpose: PREVENTION

Brief summary: Our AIMING project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.

The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).


Eligibility criteria: Inclusion Criteria:

* All \>60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications at high-risk of gastric cancer..

Exclusion Criteria:

* contraindications to upper-GI endoscopy.
* contraindications to biopsy.
* active upper-GI bleeding or urgent upper-GI endoscopy.
* patients with previous upper-GI surgery involving the stomach.
* patients who were not able or refused to give informed written consent.

Primary outcomes:
measure: Miss rate reduction
timeFrame: 2025: 12 months enrollment
Secondary outcomes:
measure: Change number of Detections
timeFrame: 1 day procedure and follow up for 2 years
measure: patient satisfaction
timeFrame: 2025: during the 12 months enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04069871: Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Tissue Perfusion for the Critically Ill Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Function Disorder
Critical Illness
Critical Illness Myopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.


Eligibility criteria: Inclusion Criteria:

* Recently intubated patient.
* Adult and both gender.
* Hemodynamic stability

Exclusion Criteria:

* Vascular diseases
* Diabetic patients
* Patients who receive vasoactive drugs
* Patients with varicose vein
* Systemic scoliosis

Primary outcomes:
measure: tissue perfusion of the lower limb.
timeFrame: 5 ICU days
measure: Renal perfusion
timeFrame: 5 ICU days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT02626871: Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
Official title: Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Transient Ischemic Attack
Bleeding
Aortic Stenosis
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Oulu University Hospital
name: Kuopio University Hospital
First posted: 2015-12-10
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers design of patients undergoing aortic valve bioprosthesis implantation

Brief summary: The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.


Eligibility criteria: Inclusion Criteria:

* patients undergoing aortic valve bioprosthesis implantation

Exclusion Criteria:

* mechanical heart valves in any position

Primary outcomes:
measure: Stroke
timeFrame: 10 years
measure: Mortality
timeFrame: 10 years
measure: atrial fibrillation
timeFrame: 10 years
measure: major bleeding
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Tuomas Kiviniemi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmi SJ, Nieminen T, Hartikainen J, Biancari F, Lehto J, Nissinen M, Malmberg M, Yannopoulos F, Savolainen J, Airaksinen J, Kiviniemi T. Indications and predictors for pacemaker implantation after isolated aortic valve replacement with bioprostheses: the CAREAVR study. Interact Cardiovasc Thorac Surg. 2020 Sep 1;31(3):398-404. doi: 10.1093/icvts/ivaa119.
Clinical trial NCT06398171: Exercise-induced Hypoalgesia in Patients With Knee Osteoarthritis
Official title: Exercise-induced Hypoalgesia in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the differences in the phenomenon of exercise-induced hypoalgesia in patients with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)

Exclusion Criteria:

* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
* undergone another hip or knee joint replacement in the previous year
* any medical condition in which exercise was contraindicated

Primary outcomes:
measure: Algometry
timeFrame: Before and after exercise (1 month)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03668171: Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure
Official title: Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Keywords: Acute-On-Chronic Liver Failure, mesenchymal stem cell,
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 200
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: Mesenchymal stem cells (MSC) has been reported to improved outcomes of acute-on-chronic liver failure(ACLF). More randomization controlled studies are needed to confirm the effect of MSC treatment for ACLF. This study aimed to investigate the efficacy of mesenchymal stem cells in ACLF patients. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with ACLF will be randomly assigned to receive MSC treatment (experimental) or standard medical treatment (control). Three times of MSC infusion (0.1-1x10E6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). The primary outcome is 12 week mortality. Secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.


Eligibility criteria: Inclusion Criteria:

* Age between 18-70 years old
* Meeting the criteria of ACLF defined as: 1. definitive chronic liver diseases, acute decompensation within 4 weeks; 2. Significant GI symptom as such fatigue, jaundice,; 3. total bilirubin (TBIL) ≥170 µmo1/L or daily increase of TBIL ≥17.1 µmo1/L; 4. PTA≤40% or INR≥ 1.5; 5. Decompensation of liver functions such as ascites or hepatoencephalopathy;
* MELD score between 17-30. (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643)
* Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
* Informed consent

Exclusion Criteria:

* Sever complications with 30 days ( GI bleeding, severe infection)；

  --liver cancer or other malignancies
* patients on liver transplantation list
* patients with uncontrolled infections
* severe renal failure
* Severe chronic obstructive pulmonary disease COPD (GOLD III-IV)
* Extrahepatic cholanstasis patients due to biliary obstruction.
* HIV infection
* Pregnant or breast-feeding females.
* Enrolled in other clinical trials with 3 months
* other conditions considered inappropriate for the study

Primary outcomes:
measure: Efficacy: 12 week mortality rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical remission rate at week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Changcun Guo
state: Shaanxi
Study officials:
References:
Clinical trial NCT01741571: Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Official title: Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.

Detailed description: Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.

Eligibility criteria: Inclusion Criteria:

* Adult undergoing EBUS at AUBMC for suspected malignancy

Exclusion Criteria:

* Coagulopathy
* The lesion cannot be sampled because of intervening tumor or blood vessels.

Primary outcomes:
measure: Sensitivity of each needle aspiration technique for diagnosis of malignancy
timeFrame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
measure: Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy
timeFrame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
Secondary outcomes:
measure: Adequacy of the needle aspiration sample
timeFrame: Adequacy will be assessed within 1 week from procedure
measure: Negative predicted value of each needle aspiration technique for diagnosis of malignancy
timeFrame: Diagnosis of malignancy will be ascertained after 6 month of clinical follow up
measure: Specificity of each needle aspiration technique for diagnosis of malignancy
timeFrame: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
measure: Positive predicted value of each needle aspiration technique for diagnosis of malignancy
timeFrame: Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Hassan Chami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840771: Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery
Official title: Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 4 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.

Brief summary: This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed description: The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Eligibility criteria: Inclusion Criteria:

* age older than 40 years
* diagnosis of pituitary adenoma
* treatment-naïve with Endoscopic Endonasal Pituitary Surgery
* absence of other neurological diseases
* absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 40 years
* No diagnosis of pituitary adenoma
* previous treatments with Endoscopic Endonasal Pituitary Surgery
* presence of neurological diseases
* presence of vitreoretinal and vascular retinal diseases

Primary outcomes:
measure: Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
timeFrame: 48 hours and 1 year follow up
measure: Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
timeFrame: 48 hours and 1 year follow up
Secondary outcomes:
measure: Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery
timeFrame: 1 year follow up
measure: Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02530671: Effect of a Multi-directional Power Toothbrush on Recession
Official title: Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: multi-directional power toothbrush
manual toothbrush
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2015-08-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months

Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.


Eligibility criteria: Inclusion Criteria:

* 18 scorable teeth without orthodontic appliances or crowns and bridges
* at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)

Exclusion Criteria:

* evidence of neglected dental health
* periodontitis and/or major hard/soft tissue lesions
* any physical limitations or restrictions potentially interfering with normal oral hygiene
* therapy with any drug within 28 days prior to the study
* pregnancy or breast feeding
* any systematic condition or significant illness

Primary outcomes:
measure: Gingival Recession at Sites With Preexisting Recessions ≥2mm
timeFrame: 12 months
measure: Bristle Splay Index (BSI) After a Specific Time-of-use
timeFrame: 3, 6, 9 and 12 months
Secondary outcomes:
measure: Recession at All Buccal Sites
timeFrame: 12 months
measure: Percentage of Recession Sites Demonstrating a Change of ≥1mm
timeFrame: 12 months
measure: Pocket Probing Depths at 12months
timeFrame: 12 months
measure: Comparison of BSI Between Periods
timeFrame: 0-3, 9-12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06140771: A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices
Official title: A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2023-11-20
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Have mild to moderate gingivitis with a range of 10% to 70% bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.

Primary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 3 Months
Secondary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Baseline
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 1 Month
Other outcomes:
Locations:
city: Whittier
country: United States
facility: UHRG
state: California
Study officials:
References: