cyrilzakka/clinical-trials huggingface dataset:
Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC

HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem.

Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are at high risk of HCC.
2. The ages of patients are between 18 and 80.
3. Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI).
4. The number of lesions is less than or equal to 3.
5. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
6. Patient signs the informed consent.

Exclusion Criteria:

1. Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
2. Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
3. Patient is with severe cardiopulmonary insufficiency.
4. Patient is a pregnant or breastfeeding women.
5. Patient is considered to be unsuitable to participate in the study.
Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2

Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.

Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.

Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.

This longitudinal observational study will involve a repeated measure analysis of 6 different tobacco carcinogen biomarkers. Fifty current smokers who intend to continue smoking for the duration of the study will be recruited through advertisements. Participants will be compensated for their time. Blood samples will be collected every two months for one year. All samples will be analyzed for the 6 different carcinogen biomarkers and individual variability in biomarker levels will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Currently smokes
* Intends to continue smoking for the 12 months following enrollment

Exclusion Criteria:

* Unstable physical or mental condition
Physical Activity as a Complementary Treatment in POTS

Postural orthostatic tachycardia syndrome (POTS) is a disorder of unknown origin characterized by orthostatic intolerance and increased heart rate (HR) of ≥ 30 beats/minute during orthostasis in the absence of orthostatic hypotension. In addition to the orthostatic intolerance and tachycardia, patients with POTS experience several debilitating symptoms including light-headedness, nausea, blurred vision, fatigue, mental confusion ("brain-fog"), chest pain and gastrointestinal problems. Several potential underlying mechanisms have been suggested for POTS including autonomic denervation, hypovolemia, hyperadrenergic stimulation and autoantibodies against adrenergic receptors. However, none of these proposed mechanisms has yet led to an effective treatment. Physical activity is recommended as a complimentary treatment in POTS in international guidelines. However, less is known regarding how physical activity could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week specialized physical activity program in POTS.

A total of 100 patients diagnosed with POTS are asked to participate in the study. Prior to start of the training program a special POTS questionnaire (based on the symptoms reported in The BIG POTS Survey), the orthostatic hypotension questionnaire and SF-36 (general health questionnaire) will be completed by the participants. Orthostatic tests are performed during 10 minutes, measuring heart rate and blood pressure after 0, 1, 3, and, if possible, 10 minutes of standing. On a separate occasion, patients will perform a submaximal biking exercise test, while noting symptoms, degree of exertion, achieved effect, pulse and blood pressure reaction. Following this initial evaluation, the training program will be performed during a total time of 16 weeks, which may be non-consecutive but within 6 months in total. The training program consists of 2-3 visits per week, and 60 minutes per visit. The training may be performed on specialized exercise bicycles in supine position or upright position depending on the severity of POTS symptoms. These exercises will be done under the supervision of physiotherapists with special interest in POTS. After the final training session the POTS questionnaire, the orthostatic hypotension questionnaire and SF-36 will be completed once again. In addition, orthostatic tests and submaximal biking exercise test will be performed on a separate occasion soon after the last training session. The present study will be using longitudinal comparisons, meaning that the 100 POTS patients are their own controls. The POTS questionnaire, the orthostatic hypotension questionnaire, SF-36, hemodynamics and exercise capacity will be compared before and after the 16-weeks training program.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with POTS who have given written informed consent for participation in the study.

Exclusion Criteria:

* Patients with myalgic encephalomyelitis are excluded from the study.
Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over

In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

This is a prospective cohort including 100 patients \> 70 year-old treated by surgery for lower-limb soft-tissue sarcoma. Data on clinical and geriatric characteristics of the patient as well as functional and quality of life assessment will be collected among patient participation (3 years). Primary endpoint is to describe evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status.

Eligibility Criteria:
Inclusion Criteria:

1. Aged more than 70 years,
2. Soft tissue sarcoma histologically proven,
3. Sarcoma of the soft tissues of the lower limbs,
4. Operable disease (first-line treatment or neo-adjuvant therapy),
5. ECOG, Performance Status ≤ 2,
6. Decision of surgery validated in Multidisciplinary Consultation Meeting,
7. Reports of the non-opposition documented in the patient file before any procedure specific to the study,
8. Affiliation to system of Social Security (accordance with article L1121-11 of the Code of Public Health).

Exclusion Criteria:

1. Metastatic disease from the onset or relapse
2. Participation in another study involving a similar geriatric assessment.
3. Geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures.
4. Persons deprived of liberty or placed under judicial protection
Longitudinal Study of a Bionic Eye

This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.

To observe and assess visual, orientation and mobility behavior with primary and adjunct vision processing (AVP) methods that may enhance the performance with the suprachoroidal retinal prosthesis (ScRP). To investigate the effectiveness of primary and AVP methods in the laboratory and real-world environments with the ScRP. Assess structural and functional ScRP stability with objective and subjective assessments. Record participant experiences and feedback with the ScRP.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide signed informed consent;
* Implanted with a suprachoroidal retinal prosthesis;
* Be available for the study visits;
* Willing to comply with study assessments;
* In good general health and mobile.

Exclusion Criteria:

* Medical condition that prohibits mobility;
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-063)

A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression.

The duration of treatment is 8 weeks.

Eligibility Criteria:
Major depressive disorder
Vibrotactile Stimulation in Parkinson's Disease

The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing.

Patient will be phone screened and/or have a physical and neurological examination to determine if it is appropriate for them to participate in this study. This testing includes the Unified Parkinson's Disease Rating Scale, Part III (UPDRS III). Research assistants will explain the study and obtain informed consent. There will be three consecutive days of testing, as well as 2 follow up visits at 1 and 4 weeks. Visits include the following: Patients will have sensors put on their hands, feet, and chest. These sensors measure their movement while they perform kinematic tasks such as forward walking, wrist movements, and the UPDRS III. Patients will also be given vibrotactile stimulation for a total of 4 hours throughout the day. During this time, patients will be provided with books/movies as entertainment, and they may move around freely. Patients will also be asked to complete several questionnaires throughout the visits about their Parkinson's symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years of age.
2. Speaks and understands English.
3. A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III
4. Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks)
5. Able and willing to stop therapy during the daytime for the days they come to the clinic for the study.
6. Have improvement in motor signs ON versus OFF dopaminergic medication.
7. If on medication, the patient should be on stable doses of Sinemet and/or Stalevo (Carbidopa/Levodopa Parkinson's medication) as part of their medicinal regimen (Patient does not need to be on medication to be included in the study).

Exclusion Criteria:

1. Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
2. Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory).
3. Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic.
4. Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump.
5. Subjects who have an inability to comply with study follow-up visits.
6. Subjects who are unable to understand or sign the informed consent.
7. Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder.
8. Have an active infection.
9. Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle.

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During the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. At the beginning of the third year, the bundle will be implemented and data on 4,238 additional patients will be collected. The incidence rate on surgical site infection before and after the intervention will be compared. We hypothesize that this intervention will reduce the infection rate within the first 3 months after surgery from 6% to 4.5% (5% to 3.75% in closed fractures and from 10% to 7.5% in open fractures).

Eligibility Criteria:
Inclusion Criteria:

* • Age \> 18 years

  * Recent fracture (\< 10 days) located in femur, tibia or humerus

    * Any type of open or closed fracture
    * Produced by high or low energy trauma
  * Primary fracture treatment with surgery and use of any of the following:

    * Intramedullary or extramedullary devices including cases in which a temporary external fixator is used
    * Joint replacement
  * Informed consent obtained (if required by local EC/IRB), i.e.:

    * Ability to understand the content of the patient information/ICF
    * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
    * Signed and dated EC/IRB approved written informed consent

Exclusion Criteria:

* Pathologic fracture secondary to tumors, infection or cysts
* Patients with an underlying chronic, bone and joint infection or prior history of a bone and joint infection
* Refracture and non-union
* Peri-implant fractures
* Patients with terminal illness
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease

The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to:

* Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE results for fibrosis staging.
* Validate the use of Velacur and attenuation cut offs in a patient cohort with all types of chronic liver disease, against MRI-PDFF results for steatosis staging.

Participants will Study participants will attend 1 study visit, in which measurement of liver stiffness with Velacur and FibroScan, will be performed by a certified technician. As part of Visit 1, Patients will also complete an MRI exam which will include both MRE and MRI-PDFF measurements (MRI imaging can take place within 28 days of the Velacur scan).

This will be a prospective, open label, validation study of the Velacur system in comparison to MRE and MRI-PDFF in patients with liver disease or suspected liver disease.

Approximately 100 subjects may be enrolled in this study. Participants should span all levels of fibrosis and steatosis.

The study is comprised of: Screening Period (up to 8 days) and Visit 1. There are no safety follow-up visits in this study.

The primary objective of the study is to compare the results of Velacur against MRE and MRI-PDFF results for liver stiffness and steatosis. As part of prior studies, using MRE as the gold standard, clinical cut-off for Velacur have been developed. The primary objective of this study is to validate these cut-offs to see if Velacur can correctly classify patients.

Secondary objectives include correlating the stiffness and attenuation results of Velacur with other clinical measures of fibrosis and steatosis such as Fib-4, and correlations with other clinical measurements collected through clinical care or clinical trials, such as Enhance Liver Fibrosis (ELF) test, FibroScan, MRI, or ultrasound based shear wave elastography (SWE) as they are available.

Eligibility Criteria:
Inclusion Criteria:

Patients with evidence of NAFLD or other chronic liver disease such as one of the following:

Biopsy proven chronic liver disease OR

Evidence of hepatic steatosis or chronic liver disease on non-invasive assessment by one or more of the following criteria:

* Abdominal ultrasound within 12 months
* MRI-PDFF (greater than 12%) within 12 months
* FibroScan CAP score \> 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (\>8kPa) within 12 months

Exclusion Criteria:

* BMI greater than 40 kg/m2 (or unable to fit into MRI bore)
* Subject with current, significant alcohol consumption or history of significant alcohol consumption
* Subjects with evidence of decompensated liver disease
Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR

The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* suspected coronary artery disease
* hemodynamically stable condition

Exclusion Criteria:

* hemodynamic instability
* atrial fibrillation
* morbid obesity (BMI≥40 kg/m2)
* previous stent implantation
* recent myocardial infarction (within 30 days)
* age \<40 years
* renal insufficiency (eGFR \<60mL/min/1.73m2)
* bronchospastic lung disease requiring long term steroid therapy
EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.

To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.

The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.

The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.

Eligibility Criteria:
Inclusion Criteria:

Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.

Exclusion Criteria:

* Pregnancy
* Patients unwilling to undergo follow-up assessments
* Patients with suspected gangrene or perforation of the gallbladder
* Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
* Patients with duodenal obstruction
* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
* Patients with liver cirrhosis, portal hypertension and/or gastric varices
* Abnormal coagulation: international normalised ratio (INR) \> 1.5 and/or platelets \< 50.000/mm3
* Previous drainage of the gallbladder
Methoxyflurane vs Standard Analgesic Treatment for Trauma Pain in Spanish Emergency Units

Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in Spanish emergency units.

Open, randomized clinical trial to compare emergency pain relief between methoxyflurane and standard of care in patients with trauma and associated pain, treated in Spanish emergency units.

Methoxyflurane is a fluorinated ethyl methyl ether, with the chemical name 2:2-dichloro-1:1-difluoroethyl methyl ether. It belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to achieve an analgesic effect for the management of pain.

In Europe countries, where methoxyflurane is already marketed, it is indicated for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.

On the other hand, current clinical practice includes a variety of analgesic agents, with the choice of which to employ based on consideration of the risk-benefit factors of each class of drug, as well as the type of pain, its severity, and the risk of adverse effects.

The main objective of this study is to assess Methoxyflurane's significant advantage in terms of anaglesic effectiveness, as it is known as a rapidly acting, non-narcotic analgesic for the treatment of emergency pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients: ≥ 18 years of age
* Moderate to severe pain (NRS 0-10; \>=4) secondary to trauma
* Without anticipating surgery due to the trauma, requiring hospitalization (hospital stay 12h)
* Conscious patient.
* Giving informed consent in writing

Exclusion Criteria:

* Hypersensitivity to methoxyflurane (MEOF) or any fluorinated anaesthetic.
* Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
* Patients who have a history of showing signs of liver damage after previous MEOF use or halogenated hydrocarbon anaesthesia
* Known clinically significant renal impairment
* Known pregnant or likely to be pregnant women at the time of inclusion.
* Clinically evident cardiovascular instability
* Clinically evident respiratory depression
* Patients taken any analgesic for the traumatic pain before inclusion
* Altered level of consciousness due to any cause, including head injury, drugs or alcohol
* Degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity
* Patients to be unable to understand the purpose of the study and perform self-assessments, following investigator's criteria.
* Participation in another clinical trial within 30 days prior to randomization