louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05823038: Risk and Aesthetic Assesment in Implant Patient
Official title: Evaluation of Implant Patients by Peri-implant Disease Risk Analysis and Aesthetic Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Assesment
Keywords: Implant disease risk assesment
Pink esthetic score
Implant quality scale
Periodontal health
Periodontal disease
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 298 dental implants for at least 6 months after functional prosthetic loading were included in the study. Patients are primarily divided into smokers and non-smokers.

Brief summary: This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers.

: After completion of the examination, 298 dental implants for at least three months after functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes, were included in the study. Patients are primarily divided into smokers and non-smokers. In all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in sequence.


Eligibility criteria: Inclusion Criteria:

* 18-70 years old patients
* Patients who are systemically healthy and have a controlled medical condition
* Patients with fixed prosthesis on the implant at least 6 months after the functional prosthetic loading of the dental implant

Exclusion Criteria:

* Patients with uncontrolled systemic diseases
* Those who have the habit of bruxism

Primary outcomes:
measure: Implant disease risk assesment
timeFrame: baseline
measure: Pink esthetic scale
timeFrame: baseline
measure: Dental implant health scale
timeFrame: baseline
measure: Keratinized tissue thickness
timeFrame: baseline
measure: Keratinized tissue width
timeFrame: baseline
measure: Periodontal depth
timeFrame: baseline
measure: Bleeding on probing
timeFrame: baseline
measure: Vestibular depth
timeFrame: baseline
Secondary outcomes:
measure: Plaque index
timeFrame: baseline
measure: Gingival index
timeFrame: baseline
measure: Clinical attachment level
timeFrame: baseline
measure: Gingival recession
timeFrame: baseline
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06510738: Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images
Official title: Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images and Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Artificial Intelligence
Lymph Node Metastasis
Digital Pathology
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital of Shantou University Medical College
First posted: 2024-07-19
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators plan to retrospective collect 700 patients with breast cancer and prospective collect 150 patients with breast cancer

Brief summary: The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:

Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?

Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?

Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?

Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Patients with primary breast cancer
2. Positive sentinel lymph node biopsy and axillary lymph node dissection.
3. No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
4. MRI within 3 weeks prior to surgery.

Exclusion Criteria:

1. recurrent breast cancer or history of surgery or radiation therapy in the axilla
2. Inflammatory breast cancer
3. Bilateral breast cancer or metastatic breast cancer
4. previous or current history of other malignant tumors
5. Sentinel lymph node count \> 5

Primary outcomes:
measure: Non-sentinel lymph node metastatic status
timeFrame: 2024-2025
measure: Accuracy, Sensitivity, Specificity，Area under the curve
timeFrame: 2024-2025
measure: Positive predictive value，Negative predictive value
timeFrame: 2024-2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06586138: Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test
Official title: Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Tests Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Narcolepsy
Obstructive Sleep Apnea (OSA)
Keywords: Obstructive Sleep Apnea
Maintenance of Wakefulness Test (MVT)
Anxiety
Alertness
Sleepiness
Narcolepsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
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: Consecutive patients referred for Maintenance of Wakefulness test at the center for Sleep Medicine in Lyon University hospital (HCL - Croix Rousse)

Brief summary: The predictors of objective impaired alertness assessed by Maintenance of Wakefulness Tests (MWT) are poorly understood. Identifying such predictors are essential from a clinical point of view and from a pathophysiological perspective, to better understand the determinants of residual Excessive Daytime Sleepiness (EDS) and the complex link between subjective and objective impairments.

Also, the objective of this study is to describe psychological but also sociological and professional factors associated with Maintenance of Wakefulness Tests results.


Eligibility criteria: Inclusion Criteria:

* Adult (i.e. age ≥ 18 y.o)
* referred for Maintenance of Wakefulness test at Lyon University hospital (HCL - Croix Rousse Hospital)

Exclusion Criteria:

* do not consent
* unable to answer the questionary
* cognitive impairments

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI) score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Médecine du Sommeil - Hopital Croix Rousse
Study officials:
References:
Clinical trial NCT05044338: Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease
Official title: China Degenerative Valve Disease II Cohort Study (China-DVD2 Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-09-14
Enrollment: 6000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients in each research center

Brief summary: The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.

Detailed description: Establish clinical and Imaging Database

Eligibility criteria: Inclusion Criteria:

Patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements

One of the following criteria:

* (1)Severe mitral stenosis: valve orifice area \< 1.0cm2;
* (2)Severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area \> 50%; Or effective reflux port area (eroa) ≥ 0.4cm2;
* (3)Severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orValve orifice area \< 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis;
* (4)Severe aortic regurgitation: constriction neck width \> 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation Flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2；
* (5)Severe tricuspid stenosis: mean cross valve pressure difference ≥ 5mmhg;
* (6)Severe tricuspid regurgitation: constriction neck width ≥ 7mm, or effective regurgitation orifice area (eroa)≥0.4cm2；
* (7)Severe pulmonary stenosis: the forward blood flow velocity is ≥ 4m / s, which should be differentiated from right ventricular outflow tract stenosis; Severe pulmonary valve regurgitation: massive regurgitation, wide constriction neck

Exclusion Criteria:

* Patients unwilling to accept registration and follow-up;
* Patients with mental illness who cannot cooperate with information collection and follow-up

Primary outcomes:
measure: all-cause mortality
timeFrame: Time Frame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
name: yongjian wu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04935138: Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss
Official title: Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Early Pregnancy Loss
Lead sponsor: Quest Diagnostics-Nichols Insitute
Sponsor class: INDUSTRY
Collaborators: name: Illumina, Inc.
First posted: 2021-06-22
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously pregnant women that have recently miscarried.

Brief summary: The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.


Eligibility criteria: Inclusion Criteria:

* 5-20 weeks of gestation by ultrasound
* Miscarriage diagnosed by ultrasound
* Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

Exclusion Criteria:

* Maternal age \< 18 years
* No visible pregnancy tissue on ultrasound
* Multiple fetal gestation (\> than singleton)
* Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
* No microarray testing is planned on the product of conception
* Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
* Patient unable to provide consent

Primary outcomes:
measure: microarray analysis of products of conception (POC)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan Capistrano
country: United States
facility: Quest Diagnostics
state: California
Study officials:
affiliation: Quest Diagnostics-Nichols Insitute
name: Pranoot X Tanpaiboon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quest Diagnostics-Nichols Insitute
name: Karen E Racicot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Practice Committee of the American Society for Reproductive Medicine. Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2012 Nov;98(5):1103-11. doi: 10.1016/j.fertnstert.2012.06.048. Epub 2012 Jul 24.
citation: Barisic I, Zergollern L, Muzinic D, Hitrec V. Risk estimates for balanced reciprocal translocation carriers--prenatal diagnosis experience. Clin Genet. 1996 Mar;49(3):145-51. doi: 10.1111/j.1399-0004.1996.tb03274.x.
citation: ESHRE. European Society of Human Reproduction and Embryology guideline: recurrent pregnancy loss. Human Reproduction Open 2018: 1-12.
Clinical trial NCT06889038: Hyperbaric Oxygen Therapy Combined With Polarized Light Therapy Effect on Neuropathic Foot Ulcer
Official title: Hyperbaric Oxygen Therapy Combined With Polarized Light Therapy Effect on Neuropathic Foot Ulcer Regarding Transcutaneous Oxygen Saturation (TcpO2) and Healing Rate ( A Randomized Control Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathic Diabetic Ulcer - Foot
Keywords: Hyperbaric oxygen therapy
polarized light therapy
neuropathic foot ulcer
Lead sponsor: Al-Zaytoonah University of Jordan
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neuropathic ulcers develop due to nerve damage (neuropathy), commonly seen in conditions like diabetes, leading to loss of sensation, repetitive trauma, and poor wound healing. These ulcers typically occur on weight-bearing areas, hyperbaric oxygen and polarized light therapies may have a synergistic effect, improving oxygenation, cellular activity, and overall healing outcomes in neuropathic ulcers, particularly in diabetic foot ulcers.


Eligibility criteria: Inclusion Criteria:

* All patients had cardiac ejection fraction (CEF) 50%
* blood pressure (BP) 150/90mmHg.
* Chest X-ray was reported normal
* all patients were clinically evaluated by a specialized ear, nose, and throat (ENT) physician to ensure suitability for the hyperbaric chamber.

Exclusion Criteria:

* chronic obstructive pulmonary disease, malignancy
* cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
* chronic peripheral arterial disease.

Primary outcomes:
measure: Ulcer volume using Saline injection method
timeFrame: 4 weeks
Secondary outcomes:
measure: Tcpo2 at ulcer edge using Pulse Oximeter
timeFrame: 4 weeks
measure: Emg pre and at end (Sensory NCS (Sural nerve)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Modern University For Technology and Information
city: Cairo
country: Egypt
facility: Modern university for technology and information
Study officials:
References:
Clinical trial NCT05999838: HR Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of ILD Patients
Official title: High-resolution Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of Interstitial Lung Disease Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases

Brief summary: To establish a simplified approach for assessment of severity of interstitial lung disease by evaluating the relationship between HRCT findings, the clinical severity score,spirometry and quality of life.

Detailed description: The interstitial lung diseases are a group of parenchymal pulmonary disorders that affect the interstitium causing progressive fibrosis of lung tissue. These disorders characterized by dyspnea aggravated by exertion . This group of diseases is associated with substantial morbidity and mortality. Thus, a multi-disciplinary approach including clinical, pathological, and radiological correlation is required to reach accurate assessment. The high-resolution computed tomography \[HRCT\] images of the chest are considered the main platform for the diagnostic approach .High-resolution CT (HRCT) scans offer the possibility of measuring disease severity more accurately and sensitively by focusing on fibrotic changes. HRCT images illustrate the presence and extent of parenchymal abnormalities including: reticular opacities, ground-glass opacities, traction bronchiectasis and honeycombing. Most patients with suspected ILDs are likely to undergo complete Pulmonary Function Testing. Usually there is restrictive pulmonary function with decreased TLC (Total Lung Capacity) , FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in One Second) and a normal or increased FEV1/FVC ratio.

Eligibility criteria: Inclusion Criteria:

* All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases among both sexes

Exclusion Criteria:

* patients under 18 years old.
* pregnant patients.
* patients with a history of previous lung resections.
* presence of bronchial carcinoma or lobar consolidation.
* patients contraindicated to perform pulmonary function will be excluded.

Primary outcomes:
measure: Correlation of visual based scoring system of HRCT and pulmonary function test.
timeFrame: 1 year
Secondary outcomes:
measure: assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01890538: Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo
Official title: Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Vertigo
Keywords: vertigo
dimenhydrinate
piracetam
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo.

The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:

* Numeric rating scale (1 to 10): Admission
* Numeric rating scale (1 to 10): After the study drug (No ambulation)\*
* Numeric rating scale (1 to 10): After the study drug (Ambulation)\*

  * Ambulation refers to head movements or walking in the room, if applicable.


Eligibility criteria: Inclusion Criteria:

* Presenting to emergency department with vertigo symptoms
* Adult patients (over 18)
* Agree to participate to study (understanding the study protocol and signing the informed consent form)

Exclusion Criteria:

* Patients under 18 years
* Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
* Patient diagnosed with transient ischemic attack
* Pregnants
* Patients taking any analgesics or antihistaminic drugs last 24 hours
* Documented or declared allergy to dimenhydrinate, piracetam or benzodiazepines
* Patients who do not agree to participate to the study

Primary outcomes:
measure: Change in numeric rating scale
timeFrame: Change from baseline in numeric rating scale at 30th minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Nurettin Özgür Doğan, M.D., Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scholtz AW, Schwarz M, Baumann W, Kleinfeldt D, Scholtz HJ. Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: a double-blind, randomized, parallel-group clinical study. Clin Ther. 2004 Jun;26(6):866-77. doi: 10.1016/s0149-2918(04)90130-0.
citation: Dogan NO, Avcu N, Yaka E, Yilmaz S, Pekdemir M. Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial. Emerg Med J. 2015 Jul;32(7):520-4. doi: 10.1136/emermed-2014-204006. Epub 2014 Jul 22.