louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05458921: Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus
Official title: Study CARPUS : " Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus "
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perilunate Dislocation
Keywords: Perilunate dislocation
Carpus dislocation
Radiocarpal osteoarthritis
mid-carpal osteoarthritis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 10100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subjects (≥18 years old) treated at the University Hospitals of Strasbourg for a carpal dislocation between 01/01/2012 and 31/12/2022.

Brief summary: Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist.

Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.


Eligibility criteria: Inclusion criteria :

* Major subjects (≥18 years old)
* Treated at the University Hospitals of Strasbourg for a carpal dislocation
* Presence of carpal radiographs that may indicate the presence of a lesion
* Subjects who have not expressed their opposition, after information, to the re-use of their data for the purposes of this research

Exclusion criteria :

* Subject having expressed his opposition to participate in the study
* Subject under legal protection, guardianship or curatorship

Primary outcomes:
measure: Retrospective analysis of carpal X-rays for the development of an algorithm to automatically identify the presence of pathology in the carpal anatomical area
timeFrame: Files analysed retrospectively from January 01, 2012 to December 31, 2022 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie de la main - CHU de Strasbourg - France
Study officials:
affiliation: Service de Chirurgie de la main - CHU de Strasbourg - France
name: Philippe LIVERNEAUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06069921: Using Deep Learning and Radiomics to Diagnose Benign and Malignant Breast Lesions Based on Ultrasound
Official title: Ultrasound-based Deep Learning Signature and Radiomics Signature Nomogram for Diagnosis of Benign and Malignant Breast Lesions of BI-RADS Category 4 Using Intratumoral and Peritumoral Regions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Diseases
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast lesions attending the First Affiliated Hospital of Shandong First Medical University were selected.

Brief summary: This retrospective study aimed to create a prediction model using deep learning and radiomics features extracted from intratumoral and peritumoral regions of breast lesions in ultrasound images, to diagnose benign and malignant breast lesions with BI-RADS 4 classification.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.


Eligibility criteria: Inclusion Criteria:

* female patients with US-visible solid breast masses who underwent biopsy and/or surgical resection, and were classified as having BI-RADS 4 lesions in medical US reports.

Exclusion Criteria:

* preoperative endocrine therapy, chemotherapy, or radiotherapy, preoperative invasive breast operation, insufficient image quality, and no pathological results.

Primary outcomes:
measure: radiomcis prediction model and the model evaluation
timeFrame: Immediately evaluated after the radiomcis prediction model was built
Secondary outcomes:
measure: deep learning prediction model and the model evaluation
timeFrame: Immediately evaluated after the deep learning prediction model was built
Other outcomes:
measure: the combination prediction model and the model evaluation
timeFrame: Immediately evaluated after the combination prediction model was built
Locations:
city: Jinan
country: China
facility: QianfoshanH
state: Shandong
Study officials:
References:
Clinical trial NCT04242121: The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
Official title: The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myeloma Multiple
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed multiple myeloma (both with and withous auto-SCT groups) at the different stages of treatment

Brief summary: The main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. This clinical study is observational and does not involve drugs. 100 subjects with newly diagnosed multiple myeloma will be enrolled in this study and followed for 3 years.

Detailed description: The presence of circulating plasma cells in patients with multiple myeloma is considered as a marker for highly proliferative disease and associated with a worse prognosis.

Plasma cell counting is conventionally done by means of peripheral blood film morphology using light microscopy. However, this manual method is laborious as well as imprecise due to the low number of cells counted, and inter-observer variability. Flow cytometry with monoclonal antibodies is unsuitable as a screening test. The procedure is not automated, and it is expensive and time consuming. Therefore, new rapid, effective and inexepensive methods are needed for risk-stratification in patients with multiple myeloma.

Automated antibody-synthesizing or secreting cells counting from routine haematology systems (XN-1000/20) without sample preparation and in less than 1 minute will further reduce the workload in haematology laboratories and it can be used for counting circulating plasma cells in peripheral blood in patients with multiple myeloma.

Eligibility criteria: Inclusion Criteria:

* Diagnosis: Newly diagnosed symptomatic multiple myeloma
* Signed informed consent
* No second tumors

Exclusion Criteria:

* Monoclonal gammopathies of undefined significance
* Smoldering Multiple Myeloma
* Plasma cell leukemia

Primary outcomes:
measure: Time-to-progression according to circulating plasma cells
timeFrame: [Time Frame: 3 years]
Secondary outcomes:
measure: Progression-free survival
timeFrame: [Time Frame: 3 years]
measure: Overall survival
timeFrame: [Time Frame: 3 years]
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Boris V Afanasyev, MD, Prof.
Study officials:
References:
Clinical trial NCT06093321: A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement
Official title: A Randomized, Blinded, Active-Controlled, Matched Pairs, Single-Institution, Non-Inferiority Trial to Compare and Evaluate the Efficacy and Safety of SYB PDO Thread and MINT Lift® for Temporarily Improvement of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds.


Eligibility criteria: Inclusion Criteria:

1. Those desiring temporary improvement of central facial nasolabial folds and having a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4.
2. Individuals willing to discontinue all dermatological procedures or treatments, including wrinkle improvement in the central facial nasolabial fold, throughout the duration of this clinical trial.

Exclusion Criteria:

1. Individuals who need to take anticoagulants from 2 weeks before the application of the clinical trial medical device to 2 weeks after (low-dose aspirin 100mg, maximum 300mg/day, is allowed).
2. Those who need to take Vitamin E supplements, NSAIDs, or collagen supplements from 1 week before the application of the clinical trial medical device to 1 week after.
3. Individuals with a history of bleeding disorders, either past or present.
4. Those who have received treatments such as deep chemical peels, skin rejuvenation procedures, plastic surgery (including Botox injections), wrinkle improvement, or acne scar treatment on the face within 24 weeks from the screening date.

Primary outcomes:
measure: The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Jun Park, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826521: Radiological and Functional Outcomes of Internal Fixation Methods for Ipsilateral Femoral Neck and Shaft Fractures in Young Adult Patients
Official title: Radiological and Functional Outcomes of Internal Fixation Methods for Ipsilateral Femoral Neck and Shaft Fractures in Young Adult Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ipsilateral Neck and Shaft Fractures and Internal Fixation Method and Follow Up At One Year Postoperative for Radiological and Functional Outcomes
Keywords: Radiological and functional outcomes of internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adult patients from 18- 55 years old not more than and not less Not with comrbodities like uncontrolled diabetes,renal disease and neurological deficits.

Brief summary: Does the single construct produce more favourable radiological and functional outcomes with less complication when it is compared to dual constructs for fixation of ipsilateral femoral neck and shaft fractures in young adult patients at one year follow up?

Detailed description: The investigators will do follow up for internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients at one year and observe does single construct will give favourable outcomes versus dual constructs?

Eligibility criteria: Inclusion Criteria:

* Age of the patients from 18 to 55 years
* Recent fracture within one week
* Ipsilateral Neck and shaft femur fractures according to AO Classification including 31 B (all types of neck ) and 32 A,B and C ( all types of shaft femur )

Exclusion Criteria:

* Open fractures GIII
* patients more than 55 and less than 18 years old
* Patient with comorbidities: uncontrolled D.M, renal patient, neurological deficits.

Primary outcomes:
measure: Radiological union evaluation
timeFrame: Assessment of radiological union and the time will be taken at one year follow up
Secondary outcomes:
measure: Functional outcome
timeFrame: One year follow up
measure: Complications
timeFrame: One year follow up
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT04168021: Remote Ischemic Conditioning of the Human Brain in Dementia Patients
Official title: Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Intermittent Claudication
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Greek Alzheimer's Association and Related Disorders
First posted: 2019-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients

Detailed description: The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.

This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment
* Clinical diagnosis of mild dementia
* Clinical diagnosis of moderate dementia
* Peripheral arteriopathy

Exclusion Criteria:

* Clinical diagnosis of severe dementia
* Not being able to follow the exercise program for more than two days for any reason

Primary outcomes:
measure: Measurements to Assess General Cognitive Function
timeFrame: Baseline, 1 and 6 months
measure: Neuropsychological Assessment
timeFrame: Baseline, 1 and 6 months
measure: Changes in Functional Cognitive State
timeFrame: Baseline, 1 and 6 months
Secondary outcomes:
measure: NeuroImaging
timeFrame: baseline, 1 month, 6 months
measure: Neurophysiology
timeFrame: Baseline, 1 month, 12 months
measure: Electroencephalography recording
timeFrame: Baseline, 1 month, 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01597921: A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
Official title: Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Radiation Dermatitis
Erythema
Keywords: Breast conserving surgery
Radiation dermatitis
Lead sponsor: Water-Jel
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 75

Brief summary: The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

Detailed description: All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.

Eligibility criteria: Inclusion Criteria:

1. Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.
2. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.
3. Patient able to understand the study designed and cooperate with instructions of use.
4. Patient able to sign informed consent

Exclusion Criteria:

1. Woman with lactose allergy (lactose intolerance are eligible)
2. Woman with known connective tissue disorder
3. Woman with uncontrolled diabetes
4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
5. Woman who is unable to sign an informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: La Sheba Hospital
name: Merav Ben David
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00875121: Peer Interactions and Food Are Substitutable in Youth
Official title: Peer Interactions and Food Are Substitutable in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Activity Choices
Caloric Intake
Social Time
Keywords: Food reinforcement
social reinforcers
overweight
children
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2009-04-03
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Boys and girls ages 9-11.

Brief summary: This study examines the effects of increasing the cost of social interactions and food on overweight and non-overweight youth. Using a computerized operant task youth will earn points exchangeable for food and social activity.

The investigators predict that both overweight and non-overweight children will substitute food for interactions with an unfamiliar peer when this alternative is made expensive. Also, the investigators predict that both overweight and lean participants will defend their choice to spend time with a friend even when this alternative is made expensive.


Eligibility criteria: Inclusion Criteria:

* Boys and girls ages 9-11
* Children must have a BMI equal to or greater than 15th percentile for their age
* Children must report at least a moderate liking of the study foods

Exclusion Criteria:

* Children should not have any food allergies
* Children should not have any dietary restraint
* Children should not a cold or upper respiratory distress
* Children should not have any psychopathology
* Children should not have any developmental disabilities
* Children should not be taking any medications that could influence their sense of smell and taste and activity level

Primary outcomes:
measure: Caloric Intake
measure: Social Time
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Division of Behavioral Medicine
state: New York
Study officials:
affiliation: University at Buffalo
name: Sarah J Salvy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01727921: Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass
Official title: Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: ProCore FNA biopsy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Background:

EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.

Aim:

To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)

Detailed description: Patient and methods:

Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.

Procedure:

They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.

The number of patients required:

We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with power of 80% and significance level of 5%.

Eligibility criteria: Inclusion Criteria:

* Patients who agree to participate in research
* 18 years of age and older patients
* Patients who have pancreatic or peripancreatic mass in imaging studies

Exclusion Criteria:

* Contraindication to endoscopy
* Patients younger than 18 years old
* Bleeding tendency
* Cardiopulmonary dysfunction

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: October. 2014
Secondary outcomes:
measure: Technical success
timeFrame: October. 2014
Other outcomes:
measure: Complications
timeFrame: November. 2014
Locations:
city: Seoul City
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
name: Kwanghyuck Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: