cyrilzakka/clinical-trials huggingface dataset:
Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Prostatic Neoplasms.

By enrolling patients with unresectable Prostatic Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Prostatic Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Prostatic Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests

The purpose of the study is to determine if any of Mother's Choice' all-natural personal-care products cause either irritation or allergic reaction when applied to both normal or sensitive skin.

Each product will be tested on the skin using patch tests.

Volunteers will be seen on Day #0 and the study purpose will be explained. Each volunteer will be interviewed to determine if he/she has any exclusion criteria.

If there is no contraindication, and agreement is achieved,consent forms will be signed.

Volunteers will be examined by a lactic acid test to determine if he/she has normal or sensitive skin. In this test, a Finn's cell (plastic cell, size 1\*1 cm) with lactic acid (50 microliter, 10%w/v) will be placed on the volunteer's cheek for ten minutes. The volunteer will be defined as "sensitive" or "normal" according to the degree of discomfort they report.

Patch-tests will be performed in the standard method. The materials to be tested will be placed in Finn's cells and attached to the participants healthy skin's back by a plaster (Micropore).The chambers will be left on the skin for 48 hours. The test will be read by a specialist one hour after chambers' removal and 48 hours afterwards. Any erythema,edema, blisters, pustules or erosions on the skin in the patch area will be considered a positive response, and will be evaluated by clinical tools as being of the irritant or the allergic type. in case of uncertainty we may use a confocal microscope for in vivo diagnosis.

Ingredients: appropriate concentrations and solvents of the test materials will be prepared according to accepted standards (refer to: Anton C. De Groot: Patch Testing, 3ed Edition, Wapserveen, The Netherlands, 2009).Leave on products will be tested 'as is'. Rinse off products will be diluted to 5% and 0.5%.

If the skin stays normal after the patch removal, it means that contact with the material did not cause allergy or irritation.

Eligibility Criteria:
Inclusion Criteria:

- Healthy adults

Exclusion Criteria:

* Pregnant subjects
* Subjects with an allergy or a skin disease which interferes with the proper results of the tests.
* Subjects who are taking medications which can interfere with the proper results of the tests. For example: systemic corticosteroids, topical steroids applied to the test area.
* Subjects with sun or phototherapy induced tanning at the test area.
* Subject who had been participating in allergy tests within eight weeks prior to the present tests.
SADBE for Congenital Melanocytic Nevi

A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).

Patients with CMN and plans for elective surgical resection of their nevi will be enrolled in the study. Two clinically similar areas within the planned excision site will be identified, marked and treated with SADBE or the placebo solution. Following surgical resection, samples from the excised nevi will be taken and assessed for number of melanocytes. Incidence of adverse events will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Subject or parents willing and able to give informed consent, and assent as appropriate.
* Patients who have a clinical diagnosis of CMN with plans for elective non-urgent excision of part or all of their nevus, with nevus surface area of \> 6 cm2.

Exclusion Criteria:

* Immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma).
* History of malignancy.
* History of organ transplantation.
* Known immunosuppressive disease, including infection with HIV.
* Severe medical comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA, or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease)
* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
* Subjects who have known hypersensitivity to SADBE or any of its components.
* Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with major depressive disorder and 35 healthy controls will be assessed twice with magnetic resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and once after administration of placebo.This study has a single-center, placebo-controlled, cross-over study design. During MRI, structural, resting state, and functional imaging will be performed. Functional imaging will comprise aesthetic processing, reward, and sexual arousal paradigms. In addition, various neuropsychological scales assessing depressive symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for participation will be assessed during a screening visit, a follow up visit will end study participation.


Eligibility Criteria:
Inclusion Criteria:

* General health based on medical history and physical examination
* Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy controls
* Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 and ICD-10 for patients
* Age 18 to 55 years
* Right-handedness (due to potential lateralization effects of lefthanded subjects)
* Willingness and competence to sign the informed consent form

Exclusion Criteria:

* Current or history of neurological disease
* Current medical illness requiring treatment
* Psychiatric diagnosis for healthy individuals
* Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
* Pregnancy or current breastfeeding
* Current or former substance abuse
* Previous ketamine use in lifetime
* Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
* Failure to comply with the study protocol or to follow the instruction of the investigating team
"Bio-logical" Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results

The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED composite, that is biomechanically tailored to closely match cortical bone. This IMN should promote fracture healing and prevent stress shielding osteopenia.

Case records of patients with humurus shaft fracture will be retrospectively reviewed to determine whether the implant promotes bone healing.


Eligibility Criteria:
Inclusion Criteria:

* Broken humerus shaft

Exclusion Criteria:

* All others
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study

The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.

This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.

As its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM.

Eligibility Criteria:
Inclusion Criteria:

* •Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria:

* •Female subjects that did not have known clinical status in FMSU2013-004A
Vagus Nerve Stimulation in Rheumatoid Arthritis

The purpose of this study is to examine the short-term effects of vagus nerve stimulation (VNS) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which innervates the ear) in rheumatoid arthritis (RA). RA is characterized by a chronic systemic inflammation affecting the joints but also carries an increased risk for extra-articular manifestations as well as other organ manifestations such as cardiovascular disease (CVD), which significantly contributes to morbidity and mortality in this disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of RA based on the ACR guidelines. Disease activity measured as activity score (DAS-28 CRP) will be used
2. None of the exclusion criteria (see below).

Exclusion Criteria:

1. Minors (\<18 years of age) and mentally incompetent individuals
2. One or more of the following conditions: immunosuppressive condition (which includes malignancy, chronic alcoholism, diabetes), severe chronic dementia, psychiatric illness with active psychosis, current intravenous or other serious illicit drug use
3. Pregnancy
4. Terminal status referred for palliative care only
5. Homeless status
6. IDDM and NIDDM patients will not be enrolled in this study
7. Previous history of ischemic cardiovascular disease including myocardial infarction, unstable angina, and bradytachyarrythmias
8. Moderate or severe anemia. Hemoglobin levels will be determined at screening. A cut-off level of \< 10 mg/dL in women and \< 11 mg/dL in men is selected.
9. Smoking
10. Subjects taking concomitant medications potentially affecting autonomic function such as anti-cholinergic medications and beta-blockers.
Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab

Several cancer immunotherapies that target the PD-L1/PD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Moreover, atezolizumab in combination with bevacizumab, a monoclonal antibody that targets VEGF and inhibits angiogenesis, is associated with an objective response rate of 27.3% (Cheng et al. 2021; Finn et al. 2020). This tumor response has led to FDA (Food and Drug Administration) and EMA (European Medicines Agency) approvals, in first-line treatment in unresectable HCC.

Combinations studies evaluating anti-CTLA4 and anti-PD1/PDL1 antibodies displayed greater benefits (Abou-Alfa et al. 2022). In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, a single priming dose of tremelimumab (anti-CTLA-4) plus durvalumab (anti-PD-L1) in the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen significantly improved OS versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS.

In the HIMALAYA study, STRIDE regimen induced long term survival (defined as the absence of progression above 36 months following inclusion) in 103 out of the 393 patients exposed to this strategy (26%).

The identification of biomarkers allowing the prediction of immunotherapy efficacy in HCC is still an unmet medical need.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Histologically confirmed hepatocellular carcinoma
3. Locally advanced, metastatic, or unresectable disease
4. Patient who had not previously received systemic anti-cancer treatment and are eligible to STRIDE therapy according to investigator decision in routine care and who have no contraindications to STRIDE treatment according to approved product label.
5. Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
6. Age ≥ 18 years
7. Patient affiliated to or beneficiary of French social security system
8. Ability to comply with the study protocol, in the Investigator's judgment.

Exclusion Criteria:

1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
2. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
3. Patient under guardianship, curatorship or under the protection of justice
Bioavailability of Encapsulated Omega-3 Fatty Acids

Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have anti-inflammatory properties and other documented beneficial health effects that could warrant n-3 fortification of combat rations. However, military combat rations must meet rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F), which is problematic for natural food sources of n-3s (e.g., oil and fish), which degrade when exposed to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating freeze dried n-3s with gelatin, can prevent this degradation, and Natick Soldier Research, Development and Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated n-3 technology to produce n-3 enriched ration items that withstand environmental stressors and meet shelf-life specifications for military rations. However, the bioavailability of the encapsulated n-3s in these rations is unknown, particularly when they are incorporated into high-protein food items and exposed to high temperatures and prolonged storage. In this randomized, cross-over study, civilian and/or military personnel will be asked to consume: 1) a high protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 2) a low-protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 3) a high protein food item with encapsulated n-3s (600 mg) that was not subjected to high-temperature and prolonged storage; and, 4) a low-protein food item with encapsulated n-3s (600 mg) that was not subjected to high temperature and prolonged storage. Serial blood sampling to measure acute changes in the circulating fatty acid profile will occur in the hour before and 6 hours after consumption of each ration component. The only known risks, which this study presents to participants, are those associated with venous catheter placement. The results will help military ration developers determine the ration components best suited for n-3 fortification.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 45 years old
* leave status and have approval from your supervisor (for DoD Civilians)

Exclusion Criteria:

* under the age of 18 or over the age of 45
* bleeding disorder (von Willebrand disease, hemophilia) or taking medications that impair ability to stop bleeding (heparin)
* consumed ≥1 serving (equivalent to a deck of cards) of salmon, herring, mackerel, anchovies, sardines, halibut or tuna or omega-3 enriched eggs per week over the previous past month
* regularly consume dietary supplements (for example, capsules) containing omega-3 fatty acids
Neo-TACE-HAIC for BCLC B Stage HCC

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment.

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.


Eligibility Criteria:
Inclusion Criteria:

* • Age 18-75 years;

  * BCLC B stage and tumor number \<=4;
  * Patients with resectable primary hepatocellular carcinoma;
  * Child-Pugh A or B (7 score) liver function;
  * The volume of residual liver more than 30%

Exclusion Criteria:

* • With unresectable HCC

  * Pregnant woman or sucking period;
  * With other malignant cancer;
  * Received anti-HCC therapy before this study
Promoting HIV Self-testing Among MSM During COVID-19 Pandemic

A community-based organization (CBO) recruited Chinese-speaking men who have sex with men who are HIV-negative or unknown sero-status through multiple channels in Hong Kong, China.

Participants first complete a baseline telephone survey, and then receive the following health promotion components: 1) viewing an online video promoting HIVST, 2) visiting the project webpage containing demonstration video of how to use HIVST kits, information about local HIV epidemic and benefits of HIV testing and HIVST, and a discussion forum containing positive feedback of HIVST users, and 3) having access to a chargeable HIVST services implemented by the CBO.

All participants are invited to complete a follow-up telephone survey six months after completion of the baseline survey.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* Having access to internet
* Anal intercourse with at least one man in the past six months
* Willing to complete telephone follow-up survey at Month 6

Exclusion Criteria:

* Self-reported to be HIV positive
A Study of MD-120 in Patients With Depression

The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
* Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.

Exclusion Criteria:

* Patient who meets DSM-5 criteria of the following disorders for current or past history.

Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)

* Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS) within 1 year before start of screening phase.
Electrocardiogram in General Practice : the EGG Study

Existing resources to assist interpretation of ElectroCardioGram (ECG) in general practice provide specialized and comprehensive reading based on pathologies and ElectroCardioGram (ECG) signs rather than ElectroCardioGram (ECG) indications.

Describing practices in general medicine could help prioritize the relevance of clinical and ECG signs for the general practitioner, enabling to adjust the reading given the context.

The primary objective of this study is to describe the clinical signs and ElectroCardioGram (ECG) in situations indicating an ElectroCardioGram (ECG) in general practice.

Eligibility Criteria:
Inclusion Criteria:

* Patient consulting one of the generalist practitioner investigators
* In doctor's office or at home, scheduled or not,
* During normal surgery hours or out-of-hours service,
* Whatever the reason for consultation,
* Aged 18 years or older,
* Having an indication of ElectroCardioGram (ECG) and/or request certificate of non-contra-indication to the practice of physical activity certificate of non-contra-indication to the practice of physical activity

Exclusion Criteria:

* ElectroCardioGram (ECG) not performed due to emergency context
* Patient with cognitive impairment who cannot give consent to participate in the study and / or patient under guardianship
Study of Remote Ischemic Postconditioning

Cardiac surgery is associated with cardiac and cerebral injury because of ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI). As another ischemic conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic postconditioning in children undergoing cardiac surgery, as a single-center, randomized controlled trial.

Cardiac surgery is associated with Troponin release because of ischemia/reperfusion injury in approximately one third of cases. And I/R injury may also induce cerebral insult, even Postoperative Cognitive Dysfunction (POCD).Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).And remote ischemic postconditioning(RIPoC), as another ischemic condition, limits MI size in animal models.

However, there are limited outcome to demonstrate protection from RIPoC during cardiac surgery. The purpose of this study is to investigate the cardiac and cerebral protective effect of remote ischemic postconditioning , as a single-center, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.

Exclusion Criteria:

* Simple atrial septal defect
* Bidirectional cavopulmonary shunt undergoing Fontan completion
* Chromosomal defects
* Airway or parenchymal lung disease
* Immunodeficiency
* Blood disorder