cyrilzakka/clinical-trials huggingface dataset:
Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen

The recurrence of endometriosis after surgery a formidable challenge for the gynecologist. Recurrence rates reported in the literature are very high, being 21.5% at 2 years and 40-50% at 5 years. Several theories attempt to explain these high figures. The three most widely accepted are:

* The presence of residual endometriotic tissue or residual endometriotic cells not completely eradicated during surgery
* The growth of undetected microscopic endometriosis during surgery
* The development of endometriotic lesions de novo Patients with symptomatic endometriosis diagnosed by ultrasound or MRI and suitable for surgery will participate in the study. The surgical specimens sent for pathology from bladder, vagina, uterosacral, sigma or rectum will be properly marked for studying the presence of endometriosis.

Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for deep endometriosis will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study.

Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic endometriosis superior to 6 in a visual scale (VAS; Huskisson, 1974)diagnosed by ultrasound or MRI and suitable for laparoscopic surgery

Exclusion Criteria:

* previous surgeries for deep endometriosis
* Non complete surgery
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors

The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.
* Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.
* At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.

Key Exclusion Criteria:

* Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.
* Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-1000.
* Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.

Note: Other protocol-defined inclusion and exclusion criteria may apply.
Personalized Detection of CtDNA for Patients with HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR)

Anti-HER2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in HER2-positive breast cancer. The updated data of the CLEOPATRA trial showed significant Kaplan-Meier curves, suggesting the potential for a cure. However, the efficacy of maintenance therapy in long-term responders remains unexplored. This study will assess MRD in unresectable HER2-positive breast cancer cases with long-term response using the Signatera™ ctDNA assay, which could contribute to future treatment strategy development.

More than 20 years have passed since the introduction of trastuzumab as a treatment for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The additive effect of trastuzumab, an anti-HER2 antibody, was evaluated in combination with chemotherapy (paclitaxel or anthracycline plus cyclophosphamide) in previously untreated, unresectable HER2-positive breast cancer. The number of cases achieving long-term survival with anti-HER2 therapy has been increasing, and this trend is also observed in our institution.

The treatment for unresectable breast cancer is systemic therapy, which is typically continued as long as it remains effective and side effects are tolerable. However, in cases of long-term response in HER2-positive breast cancer, the impact of continuing anti-HER2 therapy alone as maintenance therapy on prognosis and the safety of treatment discontinuation remains unclear.

In recent years, the clinical application of circulating tumor DNA (ctDNA) has attracted attention for early diagnosis and detection of minimal residual disease. Signatera™, an assay developed by Natera Inc., detects minimal residual disease. It is a personalized ctDNA test for individual patients, and a study targeting breast cancer patients post-surgery reported a detection sensitivity exceeding 90% for variant allele frequencies (VAF) as low as 0.01%. This high sensitivity has been reported not only in breast cancer but also in other cancer types. However, there have been no reports of Signatera analysis in unresectable breast cancer.

In this study, investigators will use Signatera™ to evaluate and analyze ctDNA status (ctDNA positive or negative) in cases of unresectable HER2-positive breast cancer that have achieved long-term response. By assessing ctDNA in such cases, this study may lead to new therapeutic strategies, such as de-escalating anti-HER2 therapy in ctDNA-negative cases.

Eligibility Criteria:
Inclusion Criteria:

* HER2 + metastatic breast cancer
* Pre / post menopausal
* Previously treated with anti-HER2 therapy
* Continuing CR or PR for more than 2 year

Exclusion Criteria:

* Patients who were deemed inappropriate as research subjects based on the physician's judgment, such as those possibly receiving inappropriate treatment.
Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases

The aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples were obtained from 90 systemically healthy non-smoker individuals with periodontitis (P, n=30), gingivitis(G, n=30) and healthy periodontium (S, n=30). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine IL-38, IL-36γ, IL-17 and MMP-9 levels in the biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* At least twenty permanent teeth in the mouth
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.
* For the periodontitis group that has not received periodontal treatment in the last 6 months

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers
Citrus Beverages and Gastrointestinal Function

The purpose of this study is to evaluate the effect of daily intake of orange pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health, diet quality, and fasting blood glucose and lipid concentrations. Possible explanations for the mechanism of the pomace will be explored in microbial ecology analyses.

In this randomized, double-blind, controlled trial, healthy adults will be asked to consume daily servings of orange juice containing either 0 g (n=120; control) or 180 g (i.e. 10 g fiber; n=120) of orange pomace for 3 weeks to assess the effect of the pomace on stool frequency. Blood samples will be obtained to assess the effect of the pomace on metabolic markers. Stool samples will be collected for analyses of the effect of the pomace on fecal bacteria known to be associated with health benefits (e.g., bifidobacteria). For exploratory analyses, additional groups will be asked to consume orange juice containing 90 g of pomace (i.e. 5 g fiber; n=40) or orange-flavored, calorie-matched water (n=40); outcomes from the water group will be compared to those of the 0 g pomace juice group to assess any effects of the juice alone, and outcomes from the 90 g pomace group will be compared to those of the 180 g and 0 g groups in microbiota analyses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-60 years of age
* Willing and able to consume 16 oz. of a citrus beverage daily for the 3-week study intervention
* Willing and able to avoid consumption of any orange, grapefruit, tomato or V-8 juice and whole oranges or grapefruits during the two weeks leading up to the study and during the study, not including the study beverage
* Willing and able to complete daily questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided
* Willing to discontinue any prebiotic, probiotic, and fiber supplements after consenting
* Willing to provide blood via finger prick and a stool sample twice each, once at the beginning and once at the end of the study

Exclusion Criteria:

* Women who are lactating, know that they are pregnant, or are attempting to get pregnant
* Currently being treated for any physician-diagnosed diseases or conditions
* Vegetarians/vegans
Molecular Determinants of Coronaruy Artery Disease

The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD) or Arteriovenous Malformation (AVM).

The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD) or Arteriovenous Malformation (AVM). Many human diseases are inherited or passed from parent to child in families. These diseases occur because of damage to a gene(s), the genetic material that is also called DNA. Scientists can now use modern molecular techniques to locate and to find certain genes within the DNA (genetic material) of a person, and to follow their inheritance in a family. To find these disease-causing genes requires studies of many affected with the disease and their family members. The purpose of this study is to locate and to find the genes for coronary artery disease (CAD) which occurs when one or more of the arteries that carry oxygen-rich blood from your heart to the rest of your body develop blockages; or, arteriovenous malformation (AVM) which causes abnormal vascular connections between arteries and veins, particularly near the heart. Findings of the genes causing CAD and AVM will have far-reaching effect on the diagnosis, treatment, and prevention of coronary artery disease and arteriovenous malformation. These studies will lead to possible genetic diagnosis, early detection of persons at risk for developing CAD or AVM (even in the absence of symptoms), development of effective drugs, more rational and specific therapeutic interventions, treatments and ultimately, prevention of coronary heart disease. Approximately 3-5 years are required to find one human disease gene.

Eligibility Criteria:
Inclusion Criteria:

* Males at least 45 years old and premenopausal females at least 50 years old at the time of onset of any of the following:
* PTCA
* MI
* CABG
* Must have a living sibling meeting the same criteria.

Exclusion Criteria:

* Substance Abuse in the absence of angiographic coronary stenosis
* Congenital Heart Disease
Ocular Hypertension Treatment Study (OHTS)

The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the National Eye Institute, designed to determine the efficacy and safety of topically administered eye lowering medication


Eligibility Criteria:
Inclusion Criteria:

* Qualifying IOP in at least one eye of each participant must be more than or equal 24 mmHg but less than or equal to 32 mm HG calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart.
* Normal and reliable 30-2 Humphrey Visual Fields in both eyes.
* Normal Optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the Optic Disc Reading Center.

Exclusion Criteria:

* Visual acuity worse than 20/40 in either eye on qualifying exam.
* Previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.
Risk Management in Interventional Cardiology - a Quality Management Single-center Registry

The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.

Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* \>18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany

Exclusion Criteria:

* no written informed consent
A Novel Approach for Transmuscular Quadratus Lumborum Block

a novel approach for TQL (anterior Q.L) block aiming mainly for terminal branches of lumbar plexus. The technique is described as Para-Spinous Saggital Shift Q.L block, done at L4 transverse process level in saggital orientation.

With this approach, we think it has advantages of easy identification, better caudal LA spread till under fascia iliaca, with the psoas major muscle provides a better protective barrier against accidental needle entry into the peritoneal cavity, the endpoint is injection within a fascial plane, rather than a specific motor response contact where the lumbar plexus stimulation is not sought, so there is minimal risk of nerve injury, inadvertent dural cuff puncture and intrathecal spread of local anesthetic. And finally optimal insertion of catheter in long axis of Q.L and psoas major if continuous analgesia is planned.

Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral hip surgery.

Exclusion Criteria:

* History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.
* Patients with Body Mass Index (BMI) \<18.5 or \>30 kg/m2.
* Coagulation disturbances (INR\>1.4, platelet count\<100 000).
* History of opioid dependence (opioid use within the last 4 weeks).
* History of allergies to study medications.
A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.

The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with post FEV1=\<30% of predicted normal and\< 80% predicted normal and post FEV1/FVC \<70%
3. Male or female Japanese patients, 40 years of age or older
4. Smoking history of more than 10 pack years

Exclusion criteria:

1. Significant disease other than COPD
2. Clinically relevant abnormal lab values
3. History of asthma
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. A marked baseline prolongation of QT/QTc interval
7. A history of additional risk factors for Torsade de Pointes (TdP)
8. History of myocardial infarction within 1 year of screening visit
9. Unstable or life-threatening cardiac arrhythmia
10. Hospitalization for heart failure within the past year
11. Known active tuberculosis
12. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
13. History of life-threatening pulmonary obstruction
14. History of cystic fibrosis
15. Clinically evident bronchiectasis
16. History of significant alcohol or drug abuse
17. Thoracotomy with pulmonary resection
18. Oral ß-adrenergics
19. Oral corticosteroid medication at unstable doses
20. Regular use of daytime oxygen therapy for more than one hour per day
21. Pulmonary rehabilitation program in the six weeks prior to the screening visit
22. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
23. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
24. Pregnant or nursing women
25. Women of childbearing potential not using a highly effective method of birth control
26. Patients who have previously been randomized in this study or are currently participating in another study
27. Patients who are unable to comply with pulmonary medication restrictions
28. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc
29. Patients being treated with medications that prolong the QT/QTc interval
3D Resin Printed Fracture Models for Anatomy Education

Resin printing is an emerging technology with a wide array of applications. This research seeks to assess the practicality of incorporating 3D resin printed models into anatomy education while investigating how fractured models impact students' decision-making and quiz scores.

Over the past decade, 3D printing has become increasingly accessible and cost-effective, offering systems and materials suitable for home use. 3D printing is a technology that streamlines production by translating computer-generated models into physical objects, layer by layer. In comparison to other tissue engineering and rapid prototyping methods, 3D printing boasts numerous advantages, such as exceptional precision, rapid production, cost-effectiveness, and seamless integration. Utilizing 3D models can significantly enhance the comprehension of intricate structures for medical professionals and students alike. Common materials used in 3D printing include robust nylon, aluminum, gypsum, textile components, polylactic acid, and resin. Among these, photosensitive resin stands out, as it enables the creation of higher-quality, more intricate structures that closely resemble real tissues, offering a smoother finish devoid of visible raw material textures.

This study's primary objective was to assess the suitability of tissues produced by a 3D resin printer in anatomy education, with the aim of enhancing hands-on training through direct manipulation of fractured bone models.

Eligibility Criteria:
Inclusion Criteria:

* having stereopsis above 40 arc/seconds according to the Titmus Stereopsis Test

Exclusion Criteria:

* having partial or total vision loss
* having a history of traumatic injury to the upper extremities within the last six months
* having used wrist anatomy models in virtual or real environments
Exploring the Effects of Genetic Variants and Inflammation on Vitamins Supplementation Treatment Outcomes in Epilepsy

The management of patients with epilepsy is focused on controlling seizures, avoiding treatment side effects, and restoring quality of life. However, about 30% of people are antiepileptic drugs (AEDs) resistance epilepsy after the adequate trials of two AEDs treatment. Genetic factors may contribute to the high interindividual variability in response or adverse effects (such as weight gain and altered lipid profiles) to AEDs. What's more, previous observational studies indicated that vitamin deficiency, such as vitamin B6, is common in patients with epilepsy due to epilepsy itself, AEDs use, or both. Therefore, investigators aim to (1) evaluate the impact of genetic variants on AED and multi-vitamins supplementation in epilepsy, and (2) establish the pharmacogenomics knowledge base of AED and multi-vitamins supplementation on clinical effectiveness in patients with epilepsy.

In the current study, investigators will evaluate the association among the genetic polymorphisms, epilepsy, and multi-vitamins supplementation from Taiwan Biobank and will further investigate potential genes related to vitamins signal pathways (especially vitamin B6, B9, D, E, and Q) involved in epilepsy. These results will not only generate the field of AEDs pharmacogenomics for further study, but also provide new potential treatment targets that may involve in epilepsy therapeutics. The clinical outcomes indicate disease severity, body weight, metabolic indices (i.e., the fasting levels of lipid), HRQoL, anxiety and depression scores. All outcome indicators will be repeated measured at baseline and after 1, 3 and 6 months multi-vitamins supplementation. All of the participants will be assessed the genotypes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria of epilepsy
* Receive anti-epileptic drugs (AEDs)

Exclusion Criteria:

* Have an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
* Have a surgical condition or a major physical illness
* Pregnant or breast-feeding