cyrilzakka/clinical-trials huggingface dataset:
Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer

Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment.

At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers.

The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence.


Eligibility Criteria:
Inclusion Criteria:

Women with TNBC breast cancer who meet the following criteria:

* Women aged 18 and over;
* Any tumor size (pT stage);
* Regional lymph node pN0 to pN3;
* Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative);
* Neo- or adjuvant chemotherapy followed by radiotherapy;
* No evidence of distant metastasis at time of diagnosis;
* Primary tumor removed by conservative surgery with negative margins;
* Patient covered by the French social security system (for French patients).

Exclusion Criteria:

* Distant metastasis at the time of diagnosis;
* Pregnant or breast-feeding women;
* Woman deprived of liberty, under guardianship or trusteeship.
* Patient unable to give consent
* Patient unable to speak French
* Patients unable to undergo regular long-term surveillance.
Effects of Moderate Intensity Soleus Push-ups vs Sustained Soleus Push-ups on Lipid Profile Among Young Population

To determine the effects of Short duration moderate intensity soleus push- ups VS Sustained Soleus Push-ups on lipid profile among Young Population.

The soleus muscle is a special type of muscle in our body that uses blood glucose for energy. It can work for a long time without getting tired. This muscle does not store energy like other muscles do. Instead, it directly uses the glucose in our blood.

Soleus push-ups are a type of exercise that targets this muscle. They could be really useful to stimulate our metabolism and keep blood lipids under control. Some studies suggest that doing soleus push-ups for a long time can positively affect our blood.

But we're not sure how different types of soleus pushups affect our blood fats. That's what this study wants to discover. We want to compare how doing sustained soleus curls for a long time compares to doing shorter, moderate intensity soleus curls. We want to see if the shorter ones can give us similar or even better results in improving our blood fats.

By conducting this study, we hope to learn more about how specific exercises can help us keep our hearts healthy and blood fats in balance. We will take a close look at the data we collect and use it to understand what type of exercise might be best for improving our blood fat levels.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age range: 18-26 )
* BMI: Healthy Young Adults.
* Equal number of gender
* Healthy young Adults.

Exclusion Criteria:

* History of metabolic diseases.
* History of recent fractures.
* Patient with any lower limb injuries.
* Knee injuries. The patient is already involved in regular physical exercise and a prescribed diet.
* Any deformity from childhood
* DVT and lower limb amputation.
* Known case of hyperlipidemia.
Laser Therapy of Benign Thyroid Nodules

Nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are listed below:

1. Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments
2. Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131I versus laser ablation
3. Interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a solitary solid thyroid nodule confirmed by ultrasonography
* Patients with a solitary cystadenoma (cystic part more than 2 mL) confirmed by ultrasonography
* Patients with an autonomous functioning thyroid nodule.

Exclusion Criteria:

* No family history of thyroid cancer
* Prior radiation towards the neck
* Fine needle biopsy without valid diagnostic criteria for benign thyroid disease
* Nodules larger than 4 cm (largest diameter)
* Suspicion of malignancy
* Increased serum calcitonin
* Pregnancy or lactation
* Alcohol, medicine or drug abuse
* No safe contraception
* Physical or psychic condition that hinders corporation
Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Eligibility Criteria:
Inclusion Criteria:

* patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers

Exclusion Criteria:

* patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and more
* Diffuse long native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
* Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

* Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
* Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
* STEMI requiring primary percutaneous coronary intervention
* Cardiogenic shock
* Restenotic lesions
* Left main
* Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
* Heavy calcification proximal to or within the target lesion
* Compromised left ventricular dysfunction (LVEF \<30%)
* At the time of screening, the subject has a malignancy that is not in remission
* Terminal illness with life expectancy \<1 year
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
* Patient's pregnant or breast-feeding or child-bearing potential
Quadruple Immunotherapy for Neuroblastoma

This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.

Included patients will receive intravenous infusion of donor NK cells on day 0, and anti-GD2 antibody (dinutuximab) on day -6 to day -2. IL-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. Subcutaneous injection of GM-CSF will be started on day 0, given daily till neutrophil count \>1000/mm3. Spironolactone will be started orally on day -1, given three times daily till cessation of GM-CSF.

Alternative anti-GD2 antibody (Naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3.

Eligibility Criteria:
Inclusion Criteria:

* relapsed or refractory neuroblastoma
* Adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal and ALT ≤500 IU/L, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air
* Karnofsky or Lansky performance status score ≥50
* Has an appropriate HLA-haploidentical NK-cell donor available

Exclusion Criteria:

* Pregnant or lactating woman
* HIV infection
* Patients for whom conventional treatment is deemed more appropriate
* Patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy \<1 month
Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

This research is being conducted to assess measurement correlations on different X-ray views on patients who have undergone or will undergo hip reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent.
* 40 patients: 20 preoperative THA, 20 postoperative THA;
* Sex: 20 men, 20 women;
* Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years.

Exclusion Criteria:

- Patients with lumbosacral hardware, contralateral THA.
Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy

This study is to investigate blood and urine kidney injury markers (especially Uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. Uromodulin is a marker to detect and monitor tubular injury and renal function.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent by their-selves (≥ 14 years) or their legal representatives (\< 14 years or in case of lacking capacity of judgement)
* cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs High Dose MTX (HD-MTX), ifosfamide, cis- and carboplatin.

Exclusion Criteria:

* critically-ill patients with inotropic and/or vasopressor drugs
* signs of severe Sepsis
* receiving other nephrotoxic drugs parallel to the chemotherapy cycle
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction

This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).


Eligibility Criteria:
Inclusion Criteria: the enrolled subjects must meet all of the following criteria:

* Aged 18-75 years old (inclusive);
* Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);
* Sign the informed consent form.

Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study:

* Ventricular fibrillation, cardiogenic shock, Killip III-IV grade;
* Sinus bradycardia (heart rate sustained \<60 beats/min), PR interval\> 240ms or II-III degree atrioventricular block;
* Continuous systolic blood pressure \<120mmHg;
* Severe breathing difficulties, aterial blood oxygen saturation \<92%;
* Thrombolytic therapy has been performed before the first medical contact in the hospital;
* Consciousness disorder or past cerebrovascular disease;
* Previous history of myocardial infarction or PCI/CABG treatment;
* Known severe liver and kidney dysfunction;
* Known allergy to dexmedetomidine;
* CMR contraindications: such as claustrophobia, pacemaker or ICD implantation;
* Pregnant or lactating women;
* Malignant tumor or expected survival time \<1 year;
* Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up);
* Participate in other randomized controlled studies at the same time.
Anticoagulation Therapy in the Very Old

This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the very old and attempt to identify risk factors which may impede safe and effective anticoagulation.

This is a prospective registry study with data being collected continuously for 24 months.

Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison.

Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* electrocardiographically confirmed atrial fibrillation
* anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services
* Subject or legally authorized representative must be willing to provide informed consent

Exclusion Criteria:

- Patients not being followed by the PBMC Anticoagulation Services
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

The purpose of this trial is to demonstrate that synbioimmunonutrition (SI) combined with omega-3 fatty acids (O3) and Vitamin D (D) is superior to conventional 7-day preoperative immunonutrition in terms of reducing overall morbidity, in cases of duodenopancreatectomy for tumoral lesion.

To the best knowledge of the Investigators, a comprehensive multimodal approach to reduce postoperative morbidity in duodenopancreatectomies has not yet been evaluated. In the study, the Investigators combine the main nutritional interventions currently available and already having an individual scientific basis, sequentially and simultaneously, for a potential synergistic effect.

In cases of duodenopancreatectomy for tumoral lesion, a group of patients taking only conventional immunonutrition regimen (CIR), for 7 preoperative days, will be compared with a second group where immunonutrition will be maximised by the addition of omega 3 for 1 week prior to the administration of CIR, synbiotics for 14 days pre- and post-operatively, and preoperative vitamin D supplementation for 6 days, in terms of postoperative overall morbidity.

Eligibility Criteria:
Inclusion Criteria:

* All cases of duodenopancreatectomy for tumoral lesions.

Exclusion Criteria:

* Distal or total pancreatectomies, as well as procedures for chronic pancreatitis
* Patient refusal or inability to provide informed consent
* Use of dietary supplements containing omega 3, pre- or probiotics within 15 days prior to protocol initiation
* Severe cardiorespiratory or renal insufficiency
* HIV
* Cirrhosis Child-Pugh B-C
* Inability to feed by mouth
* Intestinal obstruction
* Unresectable tumor or metastatic disease on preoperative work-up
* Cardiac valvular pathology
* Short bowell syndrome
* Haemophilia
* Known allergy or intolerance to fish oil, fish or shellfish, milk, soy or components of the products used
* BMI \< 16kg/m2
* Weight loss \> 15% in the last 6 months
* Little or no food in the last 10 days
* Hypercalcemia
* Pregnancy, breastfeeding
Topical Steroid Treatment For Dry Eye

Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms. epidemiologic studies estimate that as many as 15% of the population over 60 years suffer from dry eye. the disease can be treated both topically through several drugs or through mechanical closure of the lacrimal drainage system. in the past decade a few studies demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the inflammatory process that occurs in it. this treatment rises goblet cell counts but in the meantime elevates the intra ocular pressure and elevates the risk for infections. steroids that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry eye disease. we with to subjectively and objectively evaluate an FDA approved topical steroidal drug in the treatment of dry eye.

30 patients 21 year or older, from both sexes with no previous eyelid or corneal surgeries, refered to our outpatient clinics will be recruited and evaluated.

the initial examination will include schirmer1 test, Tear break up time test, a full ophthalmologic evaluation and a dry eye questionaire.

after signing a concent form patient will be treated with Loteprednol Etabonate four times a ady for a month, then a second examination will take place. after that and according to necessity patients will be treated with Loteprednol Etabonate two times daily for another month and return for a follow up examination. intraocular pressure will be evaluated in each follow up visit as well as dry eye symptoms, schirmer 1 test and tear break up time test.

Eligibility Criteria:
Inclusion Criteria:

* referral for ophthalmic examination due to dry eye symptoms
* ability to sign a concent form

Exclusion Criteria:

* former corneal, eyelid or lacrimal gland operations
* former orbital chemotherapy or irradiation treatment
Ticagrelor in Post-transplant Patients With Pediatric Hepatic Artery Thrombosis (HAT)

Hepatic artery thrombosis (HAT) represents a major cause of graft loss and mortality after Pediatric liver transplantation. Ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster onset of action and greater platelet inhibition) was used to treat patients with pediatric post-transplant hepatic artery thrombosis (HAT) compared to low molecular weight heparin.

In pediatric patients with post-transplant hepatic artery thrombosis (HAT) , low molecular weight heparin is a commonly used method. Ticagrelor, a direct-acting and reversible ADP receptor antagonist, is now the most commonly used ADP receptor antagonist in the treatment of coronary diseases. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days. The present study is to evaluate the safety and efficacy of Ticagrelor in pediatirc receipt with post-operative HAT.

Eligibility Criteria:
Inclusion Criteria:

* age from 2 months to 5 years old.
* voluntary participation in clinical trials, and informed consent;
* Contrast- Enhanced Ultrasonography proved HAT

Exclusion Criteria:

* History of sensitivity to study medications or any of their excipients
* Renal failure (eGFR \<30 or requiring dialysis)
* A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
* Prior stroke
* Active pathological bleeding
* History of intracranial haemorrhage
* Life expectancy \<12 months based on investigator's judgement
* Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular \[AV)\] block) unless already treated with a permanent pacemaker
* Anemia (hematocrit \< 27%)
* Platelet count \< 100,000/ml
* Concomitant use of strong CYP 3A inhibitors or inducers