cyrilzakka/clinical-trials huggingface dataset:
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair

Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means. Different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.

Ventral hernia repair is increasingly performed by laparoscopic means. While mesh ingrowth and shrink-age has been analysed in the experimental setting, there is scarce data available in humans. In addition, different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients.

Mesh shrinkage is assessed using two different techniques for fixation.

Blinded randomized trial using a Parietene composite mesh for laparoscopic ventral hernia repair. Patients with ventral hernias of no larger than 8 cm were assigned to either mesh fixation using transfacial nonabsorbable sutures or titan tacks. Primary endpoint was mesh migration, secondary endpoints were mesh shrinkage, surgical morbidity and pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with incisional hernia smaller than 8cm in diameter
* obtained informed consent

Exclusion Criteria:

* Pregnancy
* Residual intraperitoneal mesh
* contaminated abdominal cavity
* longterm use of corticosteroids and other immunosuppressive agents
* bodymass index \> 45
* general contradictions for laparoscopy
Effects of Onion Peel Extract on Endothelial Function

Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study was designed to investigate whether consumption of onion peel extract (OPE) improves endothelial function in healthy overweight and obese subjects.

Epidemiological studies have shown a rapid increase in the prevalence of overweight and obesity, not only in adults but also in children and adolescents, thus increasing the risk of early development of cardiovascular disease (CVD). Quercetin, found abundantly in onion, prevents the induction of endothelial dysfunction, superoxide production, and overexpression by angiotensin II in the rat aorta. Furthermore, in our previous study we showed that supplementation with quercetin-rich onion peel extract (OPE) influenced adipokine expression, thus addressing its modulatory effect on obesity-induced inflammation, and improved insulin resistance by alleviating the metabolic dysregulation of free fatty acids, suppressing oxidative stress, upregulating glucose uptake, and downregulating inflammatory gene expression. But there are limited studies on the relationship between quercetin supplementation and endothelial dysfunction in humans.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 60 years
* BMI \>23 kg/m2
* abdominal circumference \> 90 cm in males or \>85 cm in females

Exclusion Criteria:

* hypertension (\>140/90 mmHg),
* diabetes
* any cardiovascular disease,
* kidney disease,
* thyroid disease
* cerebrovascular disease
* liver disease (bilirubin level \>2 mg/dl)
* pregnancy
Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine.

This study is a retrospective observational study. The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Oswestry Disability Index(ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who has a past history of lumbar surgery and has been hospitalized for persistent or recurrent pain and discomfort
2. Patient hospitalized for more than a week
3. Pateints above 19 years old and below 70 years old
4. Patients who have agreed to participate the study

Exclusion Criteria:

1. Patients who have been diagnosed with certain serious diseases that may cause back pain or limb pain (tumor metastases to the spine, spinal infections, ankylosing spondylitis(AS), acute fractures, spinal dislocation and so on)
2. Patients who have progressive neurological defects or severe synchronic neurological symptoms
3. The cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine
4. Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
5. Patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization
6. Patient who has visited this medical institution within the last six months.
7. Patients deemed unable to participate in the clinical research by other researchers
8. Patients who haven't agreed to participate the study
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

PRIMARY OBJECTIVES:

I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment.

SECONDARY OBJECTIVES:

I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone.

II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment.

OUTLINE:

Patients undergo MR-guided LITT.

After completion of study treatment, patients are followed up at 1, 3, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical characteristics:

  * Stage T1c or T2a
  * Prostate-specific antigen (PSA) \< 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) \< 0.15 ng/ml\^3
* No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:

  * Bone scan if PSA \> 20 ng/ml and clinical stage T1c
  * Bone scan if PSA \> 10 ng/ml and clinical stage T2
* Biopsy requirements:

  * Gleason score 7 or less
  * 25% or fewer biopsies with cancer
  * At least 12 biopsy cores of the prostate
  * Within 12 months of treatment
* Imaging requirements:

  * Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s)
  * MRI within 6 months of treatment
* Karnofsky performance status of at least 70
* General health is suitable to undergo the planned minimally invasive procedures
* Risks, benefits, and alternatives discussed with informed consent given

Exclusion Criteria:

* Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
* Presence of 3 or more visible lesions on MRI
* High suspicion of seminal vesicle invasion or lymph node metastases on MRI
* Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
* Renal insufficiency with estimated glomerular filtration rate (eGFR) \< 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
* History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality
* Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study
Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer

Pancreatic cancer is a highly lethal malignant tumor of the digestive tract, especially local advanced pancreatic cancer (LAPC), which often loses the opportunity for surgical resection at the time of diagnosis. LAPC patients are often accompanied by tumor invasion of key anatomical structures such as major blood vessels, and traditional treatment methods such as radiotherapy and chemotherapy can slow down the progression of the disease, but the effect is limited, and the overall survival rate is still very low. There is a lack of effective treatment options for LAPC, especially in local control and prolonging survival, which exists a major limitation.

The surgical resection rate is low in LAPC, and the postoperative recurrence rate is high, and traditional radiotherapy and chemotherapy are difficult to completely eliminate the tumor. Immunotherapy has achieved breakthroughs in other tumors such as melanoma and non-small cell lung cancer, but the effect is limited in pancreatic cancer due to the immunosuppressive state of the tumor microenvironment (TME), which limits the efficacy of immunotherapy. In addition, the high invasiveness and rapid progression of pancreatic cancer further aggravates the treatment challenge.

Recent studies have shown that local ablation techniques such as irreversible electroporation (IRE) ablation not only can effectively ablate local tumors, but also may destroy the structural integrity of tumor cells, release tumor-associated antigens, and enhance the anti-tumor effect of the immune system. Therefore, IRE ablation may provide local control of pancreatic cancer for patients. At the same time, the combination of immune checkpoint inhibitors such as anti-PD(L)1 inhibitors may enhance the immune response in the tumor microenvironment and further improve the therapeutic effect. This combined treatment regimen is expected to overcome the limitations of single therapy and provide a new treatment strategy for local advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* The pathological diagnosis is local advanced pancreatic cancer that cannot be removed by surgery;
* Received IRE ablation treatment alone or in combination with anti-PD-1 or anti-PD-L1 immune inhibitors;
* Aged 18 years or older, gender is not limited, ECOG score 0-2;
* Have complete medical records and imaging follow-up records;
* At least 6 months of follow-up data.

Exclusion Criteria:

* Patients with other malignant tumors or severe immune system disorders;
* Patients who cannot complete follow-up or have missing data;
* Patients who have previously received immunotherapy without effect;
* Patients with severe organ dysfunction or who cannot tolerate further - - treatment.
Leiden University Medical Center Mini Donor Bank

(Bio)medical research, particularly immunological, metabolic, transcriptional or biological assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine. In order to comply with international guidelines for Good Clinical Practice, the investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or urine from voluntary donors. Recruitment of volunteers will be a continuous process. Volunteers will consent to occasional blood- or urine donation.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is aged ≥ 18 and ≤ 65 years and in good health.
2. Subject has adequate understanding of the procedures of the study.
3. Subject is able to communicate well with the investigator.
4. Subject has signed informed consent.
5. Subject refrains from donation to the Sanquin blood bank.

Exclusion Criteria:

1. Previous vasovagal collapse during venepuncture.
2. For female participants: pregnancy or lactation.
3. Presence of any chronic systemic condition, which could compromise the health of the volunteer when performing venepuncture or interfere with the interpretation of immunological or metabolic test results.
4. Chronic use of immunosuppressive drugs.
5. Total blood volume donated exceeding \>500 mL in the past 4 months.
Vitamin D Fortified Cheese and Well-being in the Institutionalized Elderly

The investigators hypotheses is that the consumption of the investigators vitamin D fortified cheese will result in an increase in serum 25-hydroxy vitamin D levels in older institutionalized adults. Also, the consumption of the cheese with the higher amount of vitamin D will result in an improvement in wellbeing scores.

The institute of medicine increased the dietary reference intakes of vitamin D for all of the age groups. The Recommended Daily Allowance (RDA) is now 800 IU for older adults over the age of 70, and the Tolerable Upper Level (UL) is 4000 IU daily. Canadians are known to have an inadequate vitamin D status, and older institutionalized adults are particularly susceptible to this. One strategy to correct this is to fortify more kinds of foods with vitamin D. We have already demonstrated that we can get vitamin D into cheddar cheese and it is as biologically available as vitamin D in the liquid supplement.

This new project aims to optimize the fortification process and deliver all of the vitamin D into cheddar cheese, and to measure its bioavailability and related changes in well-being during winter. We will assess the well being of the older institutionalized adults by administering the SF-36v2 health survey.

Eligibility Criteria:
Inclusion Criteria:

* Lactose intolerance
* Generally "Healthy", unless disease status deemed clinically significant and unable to participate by the attending physician.

Exclusion Criteria:

* Hypercalcemia/hypercalciuria
* Interfering medications
* Significant sun exposure in the months before and during the study
Acute Heart Failure in Elderly Patients Admitted to the Emergency Department with Acute Dyspnea: a Multimarker Approach Prognostic Study

Background and Rationale:

Acute dyspnea is a frequent presenting symptom in emergency departments (ED), with acute heart failure (AHF) being the most common cause leading to hospitalization in elderly patients. AHF in this population presents unique challenges in diagnosis, management, and risk stratification. Current tools for severity assessment and risk stratification (NT-proBNP and echocardiography) have shown limited evolution over the past 20 years and remain insufficient, particularly for elderly patients who predominantly present with heart failure with preserved ejection fraction (HFpEF). Recent European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines specifically call for research on biomarkers within a multi-marker strategy for AHF risk stratification.

Research Hypothesis:

The study hypothesizes that a combination of biomarkers (NT-proBNP, High-sensitivity Troponin I, ST2, Galectin-3, CD146 and suPAR) will provide prognostic value and effectively stratify risk for early outcomes (90-day mortality and hospital readmission) in patients aged ≥75 years presenting to the ED with acute dyspnea and diagnosed with AHF.

Primary Objective:

To evaluate the prognostic value of six biomarkers, both individually and in combination, for predicting 90-day all-cause mortality or ED readmission in elderly patients (≥75 years) presenting with acute dyspnea and diagnosed with AHF.

Study Design:

This is a prospective prognostic study including patients from 7 emergency departments from university and non-university hospitals in France.

Study Population:

(I) Patients aged ≥75 years presenting to the ED with acute dyspnea meeting at least two criteria:

* Respiratory rate ≥25/min
* PaO2 ≤70 mmHg
* SpO2 ≤92% on room air
* PaCO2 ≥45 mmHg and pH ≤7.35
* Oxygen requirement

(ii) Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo

Primary Endpoint:

Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.

Analysis plan includes:

* ROC curves for optimal biomarker thresholds
* Kaplan-Meier survival analysis with log-rank tests
* Univariate and multivariate Cox regression analyses
* Bootstrap methods for confidence intervals


Eligibility Criteria:
Inclusion Criteria: Patients aged ≥75 years from the READ cohort (NCT04240067) who:

1. Present to the ED with acute dyspnea meeting at least two criteria:

   * Respiratory rate ≥25/min
   * PaO2 ≤70 mmHg
   * SpO2 ≤92% on room air
   * PaCO2 ≥45 mmHg and pH ≤7.35
   * Oxygen requirement
2. Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo
3. Provided written consent for data use in the READ-MA-PRONO study

Exclusion Criteria:

* No written consent for data use in the READ-MA-PRONO study
Green Tea Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

Patients with non-small cell lung cancer who met the inclusion and exclusion criteria were screened and randomly divided into control group and experimental group. Control group: chemotherapy plus water ,test group: chemotherapy plus green tea.

Primary endpoint: Assessment of changes in quality of life (QOL) after chemotherapy according to FACT-L (4th edition). A clinically significant change in the quality of life of lung cancer was defined as a FACT-L score change of ≥6 points from baseline, with \<6 points defined as no clinically significant changes;

Patients with non-small cell lung cancer who met the inclusion and exclusion criteria were screened and randomly divided into control group and experimental group. Control group: chemotherapy plus water (at least 3-5 cups per day, 100-120ml per cup), test group: chemotherapy plus green tea (patients drink tea from the beginning to the end of the test, patients drink moderately concentration of green tea 3-5 cups per day, 100-120ml per cup, and the monthly tea consumption is ≥100g. The tea concentration is defined that the amount of tea in the cup after boiling water is 50% or more which is "strong tea", 25% to 50% is "moderately concentrated tea", and less than 25% is "light tea"). The number of days of tea drinking by the patient is greater than or equal to 18 days per chemotherapy cycle.The quality of life of patients was assessed according to the Lung Cancer Quality of Life Scale (FACT-L (4th Edition)) and the Lung Cancer Symptom Scale (LCSS). Pre-chemotherapy quality of life scores were used as baseline. The evaluation was performed once before each chemotherapy, and the final quality of life assessment was performed within 1-4 weeks after the end of the fourth cycle of chemotherapy. A total of 5 quality of life assessments were completed. If the patient's condition progresses during chemotherapy, the assessment endpoint is when the disease progresses. Primary endpoint: Assessment of changes in quality of life (QOL) after chemotherapy according to FACT-L (4th edition). A clinically significant change in the quality of life of lung cancer was defined as a FACT-L score change of ≥6 points from baseline, with \<6 points defined as no clinically significant changes;

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed NSCLC have evaluable lesions.
* ECOG PS：0-2分。
* Unintentional liver and kidney and other organic diseases, no other primary malignant tumors.
* Patients with clinical stage IIIB and IV who are scheduled for chemotherapy (first or second line).

Exclusion Criteria:

* Patients who have long-term tea drinking habits (more than 4 cups of green tea per day).
* Patients who have used immunological checkpoint inhibitors for more than 50%. Pregnant or lactating woman.
* The investigator judges other conditions that may affect the clinical research and the judgment of the research results.
To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients

Pilot open label multicentric study

The population VIH1 not B is not unimportant in our region of the Seine St Denis, a tendency which seems to be in increase (47 % in 2006, 67 % in 2007).

Most of the studies evaluating the clinical, immunologic and virologic response to the ARV according to the viral subcategories are corresponding and show comparable results for patients infected by HIV 1 of subcategory B or non B. In spite of these reassuring results, it is necessary to evaluate the efficiency of a new ARV all the more a new class. It seems also necessary to observe attentively the profiles of resistance which will be selected at the carrier patient's of virus of subcategories not - B in failure of treatment. It will allow to determine if, because of the important polymorphisms of the viruses not - B, the evolution towards the resistance will be made differently.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to take part in this study, patients should meet all of the following criteria:

Patient aged at least 18 years; Treatment naive patient infected with HIV-1; Patients indicated for treatment containing raltegravir Patient has at least 2 activates molecules in combination therapy according genotype realized in the visit of selection.

Patient has not a history or current evidence of opportunist infection within the 4 weeks before the selection Patient who has received oral and written (information sheet) information about the study and who has agreed for the computer processing of his/her personal data.

Patients with chronic hepatitis, including chronic hepatitis B and/or C may enter the study as.

Exclusion Criteria:

* Patients meeting one or both of the following criteria may not take part in the study
* Patient is reproductive potential without requiring the use of contraception
* Patient is pregnant or breast-feeding
* Patient using alcohol and\\or drug and\\or the other substance that might interfere with the patient participation
* Patient infected by HIV2
* Patient has severe hepatic insufficiency. (liver enzymes \> 5N)
* Patient has the following laboratory values during selection
* Platelets \< 40.000 cell / mm3
* Haemoglobin \< 8 g / dl during the selection
* Neutrophils \< 500 / mm3
* Patient has associated treatments which can have interactions with Raltegravir (Cf RCP Isentress ®)
* Patient should be considered by the investigator able to conform to the imperatives of the study procedures