cyrilzakka/clinical-trials huggingface dataset:
Open Label Study Using OsteoProbe System

Prospective, Single Center, Open Label Clinical Study. The purpose of the study is to collect safety data associated with the use of the OsteoProbe System. Study Duration is expected to take approximately 3 months from first subject enrolled to the last follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Be greater than or equal to 22 years of age;
2. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
3. If female and of child-bearing potential, must have a negative pregnancy status.

Exclusion Criteria:

1. Active skin infection at the procedure site as identified during a SOC physical examination.
2. Subject-reported or known systemic infection;
3. Subject-reported or known allergy to local anesthetic;
4. Subject-reported or known allergy to stainless steel or nickel materials;
5. Subject-reported or known current use of systemic antibiotics, or topical antibiotics administered to the procedure site;
6. Subject-reported or known history of needle phobia;
7. Significant soft tissue at the procedure site which would preclude use of the OsteoProbe in the judgement of the Investigator;
8. Known instance of hardware in the tibia that is intended to be measured based on radiographic imaging;
9. Known instance of a previous or current fracture in the tibia that is intended to be measured based on radiographic imaging;
10. Are known to be actively participating or known to have participated in another clinical investigation for which they received an investigational product (including but not limited to a drug or vaccine) within the last 90 days, or reports that they intend to participate in another clinical investigation during the course of the study;
11. Are known to be currently abusing drugs or alcohol or have a known history of the same within the last 12 months;
12. Have any known or subject reported mental or psychological disorders that, in the judgement of the Investigator, would impair their ability to accurately complete the NRS Pain Score surveys;
13. Are currently a prisoner;
14. Have a condition which, in the judgement of the Investigator, would preclude adequate evaluation of the device's safety and performance. Conditions include but are not limited to:

    1. Regional or systemic pain syndromes
    2. Radicular pain syndromes
    3. Chronic or intermittent leg pain
    4. Migraine headaches
Telemedicine Consultation in Trauma and Orthopedic

The purpose of this study is to determine whether telemedicine consultations (lead by standard scheme)allows to increase quality of anatomical and functional outcomes and improve clinical work-flow at patients with acute bone and joint trauma, hip pathology and congenital orthopedics abnormalities.

Levels of bad outcomes, untimely death and disability due to acute trauma, specific orthopedic pathology (congenital, coxarthrosis) and non-efficient organisation of clinical work-flow are still very high (especially in rural areas). Standard telemedicine work stations (with special protocols and manuals for original approach to telemedicine activity organisation and management) will be placed into small municipal and rural hospitals. Telemedicine links will be established between 3rd level Trauma\&Ortho center and remote sites. Synchronous and asynchronous teleconsultations will be perform for help in evidence-based timely clinical decisions, continual support of clinical wor-flow and treatment process.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of injury of locomotorium (isolated or polytrauma)
* Clinical diagnosis of bone and joint congenital abnormalities or intranatal injury
* Clinical diagnosis of knee, hip arthrosis
* Clinical diagnosis of complication of surgery (unstable, fracture of construction etc)
* Diagnosis is already present
* Primary decision of clinical strategy have to be done (transportation, level of care, method of treatment, surgery peculiarities)
* Indications for teleconsultations determined by physician

Exclusion Criteria:

* Diagnosis is not present
* Patient's self-request for teleconsultations
* No reliable feed-back with attending physician
Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial

The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in mediastinal endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:

1. A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
2. Whether the AI system can improve the quality of mediastinal scans for EUS endoscopists.

Participants will conduct mediastinal EUS with or without the assistance of the AI system.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, \<80 years old 2.Patients who need endoscopic ultrasonography; 3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be selected for this trial:

First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:

Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc. Anesthesia assessment failed Pregnancy or breastfeeding In the acute stage of chemical and corrosive injury, it is very easy to cause perforation Recent acute coronary syndrome or clinically unstable ischemic heart attack Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.

Second. Disagree to participate in this study.

Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:

1. Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy;
2. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.
Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.

This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven pCCA.
2. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
3. Preoperative staging work up performed by upper abdomen enhanced CT scan.
4. The subject understands the nature of this trial and willing to comply.
5. Ability to provide written informed consent.
6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
2. Subjects undergoing any part for hepatectomy.
3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
4. Synchronous malignancy in other organs.
5. Palliative surgery
3D Placental Volume in Placenta Accreta

Placenta Accreta spectrum is a major obstetric disease nowadays. Different methods are used for antenatal diagnosis. In our study, investigators are aiming to compare 2 common ways for diagnosis, i.e; 3D Ultrasound and 2D with color Doppler.

The word placenta accreta spectrum disorders (PASD) implies an atypical implantation of the placenta into the uterine wall and has been used to express placenta accreta, increta and percreta. Placenta accreta is a placenta where the placental villi sick on directly to the myometrium. Placenta increta is a placenta where the placental villi attack into the myometrium and placenta percreta is a placenta where the villi invade through the myometrium and into serosa. No antenatal diagnostic method gives the clinician 100% assurance of either ruling in or ruling out the existence of placenta accreta. The definitive diagnosis of placental accreta spectrum is frequently ended postpartum on hysterectomy specimens when an area of accretion shows chorionic villi which make direct contact with the myometrium and absence of deciduae. Antenatal ultrasound is the method of choice used to establish the diagnosis and direct clinical management.The combined use of power Doppler with three dimensional (3D) ultrasound provides the possibility of quantifying moving blood within a volume of interest. Three indices are calculated, namely vascularization index (VI), flow index and vascularization flow index

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with placenta previa

Exclusion Criteria:

* congenital anomalies of placenta Placental separation Uterine anomalies
The Etiology of New-onset Status Epilepticus

This study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Status Epilepticus
* Sign the informed consent form

Exclusion Criteria:

* Patients with previous epilepsy
* Missing information such as basic information and treatment history
* Long-term smoking, alcohol and drug abuse
* Pregnant and breastfeeding women
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

The point estimate and its 95% confidence interval will be calculated using the exact binominal method. Identification of suspicious cancer tissue in a 12 prostate zone schema: Participants will undergo USE: Aixplorer® ShearWave Elastography (SWE™), (SuperSonic Imagine). Areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. For study purposes the prostate will be divided into Zone 1(Left Lateral Base), Zone 2 (Left Base), Zone 3 (Right Base), Zone 4 (Right Lateral Base), Zone 5 (Left Lateral Mid), Zone 6 (Left Mid), Zone 7 (Right Mide), Zone 8 (Right Lateral Mid), Zone 9 (Left Lateral Apex), Zone 10 (Left Apex), Zone 11 (Right Apex), Zone 12 (Right Lateral Apex).

Eligibility Criteria:
Inclusion Criteria:

* Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center.
* Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis.
* Location of cancer specified in the pathology report.
* Pathology reviewed by Moffitt pathologist

Exclusion Criteria:

* Less than ten biopsies obtained at time of diagnosis.
* Location of cancer not specified.
* Pathology not reviewed by Moffitt pathologist.
Acute Effects of Low Temperature Exposure on Respiratory System

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on respiratory health and the underlying mechanisms.

The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include lung function tests and exhaled breath test. Investigators plan to collect blood, pharyngeal secretion, exhaled breath condensate and urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Living in Shanghai during the study period;
* Body mass index \> 18.5 and ≤ 28;
* right-handed;
* receiving or having received higher education;
* with the ability to read and understand Chinese smoothly.

Exclusion Criteria:

* Smoking and alcohol abuse;
* Current drug and dietary supplements intake;
* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;
* Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Subjects with color vision disabilities.
Prospective Cohort With Hemopathy in Languedoc-Roussillon

Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.

Prospective Cohort Study of clinical and laboratory data of patients with hemopathy in LR.

Eligibility Criteria:
Inclusion criteria:

* Age over 18
* Consultant or hospitalized patient for suspected malignant hemopathy and justifying further exploration or patient with a diagnosis of malignant hemopathy less than 6 months old at the time of signing the consent
* Having signed an informed consent
* Affiliated with a social security scheme

Exclusion criteria:

* Minor or major protected
* Patients who have received treatment for hematological pathology
Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula

The purpose of this study is to assess the value of preoperative objective modalities such as endoscopic ultrasound elastography and magnet resonance imaging in predicting development of postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or malignant disease.

One of the most generally accepted causes of postoperative pancreatic fistula (POPF) is soft texture of the pancreas. The stiffness of organs depends on histologic features such as content of fat, fibrotic tissue and micro vascular structures. Yet, pancreatic stiffness was evaluated only subjectively. Endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) may allow objective quantification of pancreatic stiffness prior to surgery.

Endoscopic ultrasound elastography (EUE) is based on real-time Doppler technology. Image colors are derived from vibration patterns which depend on the stiffness of a specific region of the investigated organ. The retrieved images could be converted into numeric matrix using a specially designed program.

Magnetic resonance imaging (MRI) is a non-invasive method for quantitatively assessing the mechanical properties of tissues based on fat tissue content.

In this trial the investigators will assess at first the value of EUE and MRI in predicting development of postoperative pancreatic fistula and in a next step the value EUE and MRI as an objective method in prediction of pancreatic stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Adult (more than 18 years) with resectable pancreatic lesion(s)

Exclusion Criteria:

* Total pancreatectomy
* Unresectable pancreatic lesion(s)
* Pregnancy
Evaluation of a CAM System for Colorectal Polyp Size Measurement

Accurate polyp size measurements are essential for risk stratification, selection of polypectomy techniques, and surveillance interval assignments. Evidence indicated that the clinical implementation of artificial intelligence is an optimal tool to improve the measurement of polyps during colonoscopy. This study aimed to evaluate the performance of a computer-aided measuring (CAM) system (EndoDASS) and compare its accuracy with routine sizing methods during real-time colonoscopy.

This study will be conducted in 2 phases: the first phase will evaluate the value of the application of the computer-aided measuring (CAM) system for polyp size measurement accuracy in a small sample of clinical videos, recording the corresponding clinical videos for CAM measurements after measuring polyp size using real-time visual assessment and non-scaled device (open biopsy forceps or snare) assessment, and comparing the different methods of polyp size measurement through a video-based analysis \[Autonomous artificial intelligence (AI) measurement, AI-assisted human measurement, non-scaled device assessment, and visual assessment\] with different groups of endoscopists ( experts, gastroenterologists, surgeons, fellows) evaluating the corresponding clinical videos during real-time measurements, to obtain pilot data on the relative accuracy of polyp size measurement when using the CAM system, to test the feasibility of size measurement of freshly resected polyp specimens and to determine the sample size and reference for evaluating the CAM system in the subsequent phases of a randomized controlled trial of the study. The second phase will assess the value of using the AI-assisted human measurement versus the non-scaled device assessment for polyp size measurement accuracy in a clinical randomized controlled trial using a prospective, multicenter, patient-single-blind, randomized controlled trial design in which subjects are randomly assigned to the CAM group and the non-scaled device measurement group in a 1:1 ratio. Each patient will have a maximum of 3 polyps included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-75, any gender; 76-85 years eligible case-by-case based on health status.
2. Colonoscopy screening, surveillance, or diagnostic participants.
3. Informed consent obtained.

Exclusion Criteria:

1. Anticoagulant use (e.g., aspirin, warfarin) within 7 days prior to colonoscopy or coagulopathy.
2. Inflammatory bowel disease.
3. Aronchick score \>3 at entry.
4. Incomplete Case Report Form (CRF) data.
5. Emergency colonoscopy.
6. Pregnancy or lactation.
7. Gastrointestinal obstruction.
8. Refusal to participate.
Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery

The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery.

The objectives are to assess the safety and feasibility of venous thromboembolism (VTE) prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days.

All clinically thromboembolic events will be assessed by ultrasound or CT, respectively, as soon as apparent. In addition, patients are screened for VTE at day 28 by ultrasound to detect clinically inapparent thromboses.

In a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.

The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery.

Rivaroxaban as an oral anticoagulant could be an attractive option for thromboprophylaxis compared to subcutaneous standard treatment after bariatric surgery. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable.

The objectives are to assess the safety and feasibility of VTE prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable.

After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days.

In a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.

Eligibility Criteria:
Inclusion Criteria:

* Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions
* Written informed consent

Exclusion Criteria:

* DVT and/or PE in the patient history
* Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry
* Uncontrolled hypertension
Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer

Endometrial cancer is the most common pelvic gynecological cancer in so-called developed countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95% for early forms, which represent more than 70% of diagnoses. The main risk factors are obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing incidence. Half a million new annual cases are expected in 2035.

The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the disease is estimated between 10 and 15%. Currently the recommendations are to make an evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type is the main predictor of the severity of the disease and acts as guideline for the treatment.It is therefore essential to have precise biopsy results before starting therapeutic management.

The most widely used technique is the blind biopsy by aspiration using a pipette because it is inexpensive, easy, without any specific equipment. However, recent studies showed that this technique has a poor sensitivity in the target population of postmenopausal women. Other studies have shown that targeted biopsies under hysteroscopic control could have a much higher sensitivity.

The main objective of this study is thus to compare the performance of the targeted biopsy under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the diagnosis of endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal patient.
* patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)

Exclusion Criteria:

* patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.