cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects

This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.

Eligibility Criteria:
Inclusion Criteria:

* Has a signed and dated informed consent, prior to initiation of any study-related activities.
* Is at least 18 years of age.
* Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes.
* Is willing and able to comply with protocol-required scans.

Exclusion Criteria:

* Is pregnant or lactating.
* Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, which could interfere with the intended field of view.
* Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
* Is currently undergoing phototherapy.
* Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
* Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
* Has had a history of contact dermatitis induced by gold or chrome metal contact with skin.
* Has an acute or chronic hematoma and/or acute ecchymosis of the breast.
* Has had prior benign excisional breast biopsy within the past 18 months.
* Has nipple rings that cannot be removed or are not removed during Imagio evaluation.
* Currently has mastitis.
* Has focal pain in the breast.
Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.

This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to optimized outcome compared to manually controlled clinical anesthesia and computerized Electroencephalogram (EEG).


Eligibility Criteria:
Inclusion Criteria:

* Offered patient information and written informed consent
* Male/female patients with intended ratio of 1:1
* patients aged greater than or equal to 60 years
* scheduled duration of surgery longer than or equal to 60 minutes
* elective surgery (general/abdominal surgery, traumatological/orthopedic surgery, gynecology, urology) in general anesthesia

Exclusion Criteria:

* Persons without the capacity to consent
* Unability of German language use
* Lacking willingness to save and hand out data within the study
* Participation in another study according to the German Medicinal Products Act within 30 days before participation in the Smart-Outcome study
* Accommodation in an institution due to an official or judicial order
* (Unclear) history of alcohol or substances disabuse
* Member of staff of the Charité
* Neurological or psychiatric disease
* American Society of Anaesthesiologists (ASA) classification greater than or equal to class IV
* Moribund patients

Due to the underlying PKPD models of the SmartPilot® system, patient with the following characteristics cannot be anesthetized using SmartPilot®:

* Height \< 150 or \> 200 cm, respectively
* Weight \< 40 or \> 140 kg, respectively
* Body Mass Index \> 30
* Age \< 18 or \> 90 years of age, respectively
Role of Endothelin-1 in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. The investigators could recently show that Endothelin-1 is a key metabolite in the regulation of vascular tone in the eye and plays an important role in the blood flow autoregulation of the choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the present study is designed to test the hypothesis that Endothelin-1 plays also a role in optic nerve head blood flow autoregulation.

Therefore, subjects will perform squatting to increase systemic perfusion pressure during administration of either an endothelin A-receptor blocker (BQ-123) or placebo. Optic nerve head blood flow will be continuously measured during the procedure to investigate optic nerve head autoregulation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Men and women will be included in equal parts
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Pregnancy
A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients

In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability.

The study was a single-centre, prospective study. Data prospectively accrued were employed to evaluate the concordance between observed patient outcomes, with respect to lymph node metastasis status post-curative gastrectomy, and the prognostications tendered by the established risk scoring model, thereby appraising the model's clinical applicability and validity.

Eligibility Criteria:
Inclusion Criteria:

1. Primary gastric adenocarcinoma;
2. Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis).

Exclusion Criteria:

1. Patients with autoimmune diseases, inflammation, or hematological disorders;
2. Patients with a history of or concurrent other cancers;
3. Presence of active infection and inflammation (based on WBC count, patients with count of 10×10\^9 or higher should be evaluated through medical record examination for the presence of infection);
4. Active bleeding (as determined by endoscopic ultrasound and HGB ≤ 90);
5. Post neoadjuvant radiotherapy or chemotherapy;
6. History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw;
7. Incomplete clinical and pathological data.
Markers of Favorable Response to Complement Inhibitors Therapy

Myasthenia gravis is an autoimmune neurological disease caused by autoantibodies primarily directed against components of the postsynaptic membrane of the neuromuscular junction. Approximately 85% of patients have antibodies directed against the acetylcholine receptor (anti-AChR).

Anti-AChR antibodies act through three distinct mechanisms:

1. Activation of the classical complement pathway: Formation of membrane-attack complexes (MACs) results in the destruction of the postsynaptic membrane.
2. Mechanical blockade: Anti-AChR antibodies block the acetylcholine binding site on its receptor.
3. Internalization and lysosomal degradation: Bivalent IgG causes cross-linking of adjacent receptors leading to internalization and degradation of AChRs (antigenic modulation).

Patient mortality has significantly reduced due to effective treatments preventing severe exacerbations of myasthenic symptoms.

In the past five years, the FDA and EMA have approved complement inhibitors for the treatment of generalized myasthenia gravis with anti-AChR antibody positivity. Eculizumab, a humanized monoclonal antibody, binds to the complement fragment C5, inhibiting its cleavage into C5a and C5b, and preventing the formation of the terminal complement complex C5b-9 (MAC).

Currently, Eculizumab is approved in Italy for generalized myasthenia gravis associated with anti-acetylcholine receptor antibody positivity.

This class of drugs is generally more effective than conventional immunosuppressive therapies, though it comes with higher costs.

There is heterogeneity among patients in their response to complement inhibitor therapies. Currently, there is no specific evidence indicating which patients may benefit most from this class of treatments. Personalized therapy, considering the predominant pathogenic mechanisms of anti-AChR in individual patients, seems necessary. Interindividual heterogeneity in the autoantibody repertoire could underlie different responses to complement inhibitor therapies. For example, inhibition of the complement cascade in patients whose autoantibodies also block receptors might result in an unsatisfactory treatment response. Moreover, C5 gene polymorphisms could explain a lack of response to these new drugs. Investigating the immune, genetic, and cellular profile of myasthenic patients eligible for these new pharmacological therapies could be useful for identifying predictive markers of response and personalizing therapeutic choices.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Diagnosis of generalized anti-AChR positive Myasthenia Gravis;
* Need for therapy with complement inhibitor drugs according to the therapeutic indications approved by AIFA (16);
* Ability to perform follow-up at the reference center;
* Signed informed consent to the study.

Exclusion Criteria:

* Age \<18 years;
* Poor compliance with drug therapy;
* Concomitant autoimmune diseases;
* Insufficient availability of clinical information;
* Ongoing neoplasia or infection at the time of biological sample collection;
* Refusal to sign the informed consent to the study
Rhythmical Massage Compared With Heart Rate Variability Biofeedback in Women With Menstrual Pain (Dysmenorrhea)

A study to explore whether rhythmical massage and heart rate variability biofeedback can help to reduce pain in women suffering from menstrual pain (dysmenorrhea).

This is a three-arm randomized controlled trial to evaluate the efficacy of rhythmical massage and HRV biofeedback in women with primary dysmenorrhea compared to a control group. The main focus is on pain intensity during menstruation. Moreover, analgesics intake, SF-12 mental and physical scores and parameters of a 24h-HRV measurement are assessed before and after the three-month intervention.

Eligibility Criteria:
Inclusion Criteria:

* At least one year of primary dysmenorrhea (physician-confirmed).
* Written informed consent (also from parents/legal guardians of underage girls).
* Menarche at least one year ago.

Exclusion Criteria:

* Secondary dysmenorrhea.
* Participation in another study.
* Mental retardation.
* Addiction.
Atralin Gel for the Treatment of Rosacea

Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age and older of any race.
2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
3. Willing and able to understand and sign informed consent.
4. Able to complete study and comply with study procedures.

Exclusion Criteria:

1. Severe self reported facial sensitivity
2. History of allergy to fish
3. Severe sun sensitivity
4. Severe erythematotelangiectatic rosacea requiring systemic treatment
5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
6. Unwilling to undergo facial biopsies
7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
8. Use of topical rosacea treatments in the past 2 weeks.
9. Use of systemic antibiotics in the past 4 weeks.
10. Use of systemic retinoids within the past 6 months.
11. Use of topical retinoids within the past 3 months
12. Use of laser or light based rosacea treatments within the past 2 months.
13. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
15. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
16. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
17. If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
18. Subjects who are lactating.
19. Use of any investigational therapy within the past 4 weeks.
20. Known hypersensitivity or previous allergic reaction to retinoids
21. Carcinoid, Pheochromocytoma or other systemic flushing causes
Using a Geriatric Oncology Assessment to Link With Services

The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the Duke Cancer Network, located in the rural, low resource Scotland County community of North Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by comparing historical and post-GOA service referral patterns and adherence to planned cancer therapy. For this study, the investigators will prospectively enroll up to 60 patients who have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these 60 patients, the investigators will also conduct retrospective chart reviews on 120 patients that would be eligible for this study to evaluate past referral patterns. Eligible and consented patients will complete the brief GOA at the Scotland Cancer Treatment Center alongside their normal clinic appointment. The investigators will assess impact on the healthcare system by evaluating referral patterns (i.e., how many, what type of services) using the brief GOA data and EHR data. The study value includes the possibility for recognition and access to additional health care referrals if needed.


Eligibility Criteria:
Inclusion Criteria:

In order to be included in the project, patients must be:

1. Diagnosed for a solid tumor cancer (breast, lung, colon, rectal, colorectal (unspecified), pancreas, esophageal)
2. Diagnosis date within 12 months of identification
3. Receiving care at Scotland Cancer Treatment Center
4. Aged 60 years or older at the time of the visit
5. Planned therapy in the medical oncology clinic at the Scotland Cancer Treatment Center

Exclusion Criteria:

1. Diagnosis of metastatic cancer with \<12 months life expectancy
2. Planned cancer therapy as surgery only
3. Receiving palliative or hospice care services (i.e., proxy for \<12 months life expectancy)
4. Language (not proficient in English)
5. Nursing home/long-term care facility resident
6. Active diagnosis of psychosis (has been hospitalized in the last 30 days), schizophrenia, severe intellectual or developmental disabilities, or dementia
7. Patient deemed not fit/good candidate for study per provider recommendation
Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway

Irritable bowel syndrome is a functional bowel disorder that affects many Canadians. The syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. Primary care physicians are dissatisfied with current referral processes, and patients may wait a long time to receive the correct diagnosis. Diet is known to exacerbate symptoms of IBS. In Canada, accessing dietary treatment for IBS is a challenge due to lack of resources. Some patients lack access to dietary interventions, and others are given advice that is not evidenced based. Use of eHealth technology, such as virtual education delivered by a dietician, may allow for more widespread access to dietary interventions for IBS. Virtual education can include one on one dietary education, online group-based education, and the use of apps. Currently, there is a gap in knowledge whether dietary intervention for IBS, delivered virtually by a dietician, is effective in treating IBS.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent abdominal pain on average at least 1 day/ week in the last 3 months associated with two or more of the following criteria: related to defecation, or association with a change in frequency of stool or associated with a change in form (appearance) of stool
* Willingness to change diet
* Access to a device for accessing virtual dietary education

Exclusion Criteria:

* New onset symptoms within past year in age 50 and above
* Rectal bleeding
* Inflammatory Bowel Disease
* Unexplained recent weight loss
* Gastrointestinal surgery with removal of gallbladder or segments of the bowel
* Having an eating disorder
Retrospective Foot and Ankle Data Collection

A retrospective post-market data collection study of the following implant devices :

* DARCO™ Headed Cannulated Screw
* ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
* ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module

A retrospective post-market data collection study designed to collect safety and performance Standard of Care data on patients who have undergone routine lower limb surgery that involved one of the following implant devices as per the indication for use:

* DARCO™ Headed Cannulated Screw
* ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
* ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module

Eligibility Criteria:
Inclusion Criteria:

Patients 18 years or older at the time of index procedure

• Patients who previously received:

* the Charlotte™ MUC Screw System in accordance with the indications for use: for fixation of bone fractures or for bone reconstruction.
* the CROSSCHECKTM in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
* the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
* a DARCO™ Headed Cannulated Screw in accordance with the indications for use: for bone fracture fixation and bone fragment fixation.

Exclusion Criteria:

* None
Correlation Between Access Blood Flow and Extracorporeal Blood Flow

The purpose of this study is to determine if Effective Extracorporeal Blood Flow(eEBF) has correlation with Access Blood Flow (Qa), when eEBF adjusts with Dynamic Arterial Line Pressure (DALP) in patients with Arteriovenous fistulae in hemodialysis treatment.

Accesses that show a large (\>15%) decrement over time in vascular access blood flow are associated with a high risk of thrombosis. Serial measurements of vascular access blood flow predict access thrombosis. At the moment, the measurement of access flow is time consuming, operator dependent, so that it cannot be done with every treatment. We hypothesized that extracorporeal blood flow at pressure of -200 to -260 mmHg in arterial line has correlation with access blood flow and this can be used to estimate access blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Kidney Disease K-DIGO 5d in hemodialysis treatment)
* Permanent vascular accesses with native arteriovenous fistulas (AVF)
* AVF that were at least 12 weeks old

Exclusion Criteria:

* Inflammation and pain in AVF
* Negation to participate in the study
GenLab: Unveiling the Genetic Landscape of Brugada Syndrome: Novel Biomarker Discovery for Precise Diagnosis

This research makes several significant contributions to the field of BrS. It employs advanced genetic sequencing techniques to develop a genetic signature to improve the accuracy and efficiency of BrS diagnosis. The identification of specific biomolecular profiles and genetic signatures enhances our understanding of the syndrome's molecular mechanisms, facilitating targeted therapies and refined risk stratification. These advancements optimize patient care by enabling personalized treatment plans and risk assessment. Overall, this research adds value by advancing diagnostic methods, providing molecular insights, optimizing patient care, and positively impacting public health outcomes in BrS.

Our work on BrS is dedicated to decipher the pathogenic mechanism and to ameliorate diagnostic approaches by developing a non-invasive test. Employing a multi-omic strategy, we've identified potential biomarkers across proteins, metabolites, and lipids, leading to a filed patent for a promising biomolecular signature. Additionally, we've discovered associated gene mutations. This grant proposal aims to enhance our preliminary findings by studying a larger BrS cohort, supported by a meticulously curated patient registry. By integrating advanced whole-exome sequencing (WES) and machine learning , we aim to identify a genetic signature for BrS diagnosis and uncover altered pathways integral to BrS etiology. This could refine risk stratification strategies, contributing to improved diagnostic accuracy and deeper understanding BrS molecular mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients affected by Brugada Syndrome
* Patients who signs the Informed Consent

Exclusion Criteria:

* None