cyrilzakka/clinical-trials huggingface dataset:
CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.

Identification of biomarkers (Circulating Tumor Cells (CTC), free DNA, Stem Cells and EMT-related antigens) that may be predictive of outcome of activity of cabazitaxel treatment in castration-resistant prostate cancer.

Circulating Tumor Cells, free DNA, Stem Cells and EMT-related antigens as biomarkers of activity of cabazitaxel in castration-resistant prostate cancer

Primary objectives: To evaluate the prognostic role of response of the copy number of androgen receptor (AR) and Phosphatase and tensin homolog (PTEN) and AR-V7 and other gene expression biomarkers in CTC and the investigators will compare these results with those obtained in plasma cell free DNA and RNA.

Eligible patients must have histologically or cytologically confirmed prostate cancer or unequivocal increased PSA . Metastatic and/or inoperable disease and received prior therapy with docetaxel and candidate to cabazitaxel treatment.

All patients receive cabazitaxel at standard schedule 25 mg/m2 q21. Blood sample will be collected for CTC evaluation at baseline, after the first cycle of therapy (optional), at first radiological evaluation (after 3 months), at disease progression (optional) or after 9-12 months of treatment for patients who did not show disease progression (optional). Disease progression defined according to Prostate Cancer Working Group 2 (PCWG2) criteria. On blood samples from Castration-Resistant Prostate Cancer (CRPC) patients the investigators will investigate the presence of the previously presented CTC, DNA and RNA free markers.

As an option, it will be possible to require a sample of the tumor collected during prostate surgery or during the biopsy.

All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document
2. Male aged \>18 years with metastatic castration-resistant disease with documented clinical (imaging) and/or biochemical progression (PSA increasing values) during or after a previous docetaxel-based chemotherapy
3. Patients must have metastatic and/or inoperable disease
4. Patients must have received prior therapy docetaxel based and must be candidate to cabazitaxel
5. Life expectancy of greater than 3 months
6. Eastern Cooperative Oncology Group (ECOG) performance status \<2

Exclusion Criteria:

1. Participants who are unable to provide informed consent
2. Participation in another clinical trial
Impact of Ischemic Post-conditioning

Study will investigate \& compare the left ventricular remodeling \& systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them.

Among re-perfusion strategies for the management of ST-elevation myocardial infarction , primary per-cutaneous coronary intervention is the preferred one within 120 minutes from the first medical contact.However , restoration of the coronary blood flow can paradoxically reduce the beneficial effects of myocardial re-perfusion , a phenomenon known as myocardial re-perfusion injury.Ischemic post-conditioning has been described as a measure for myocardial salvage , performed by making cycles of briefly interrupted perfusion during the early moments of coronary re-flow.Post-conditioning may be performed immediately after the early re-flow by creating cycles of interrupted inflation \& deflation of the angioplasty balloon in patients undergoing primary per-cutaneous coronary intervention.In this study investigators aim to compare the left ventricular remodeling and global systolic function immediately \& 6 months after re-perfusion between two groups of 100 patients presenting with acute ST-elevation myocardial infarction, using ischemic post-conditioning in one group of patients undergoing primary per-cutaneous coronary intervention (n=50 patients) by making 4 cycles of repeated occlusion \& re-perfusion 30-second each by inflation/deflation of an appropriately sized per-cutaneous trans-luminal coronary angioplasty balloon.The other group will be investigated after re-perfusion by primary per-cutaneous coronary intervention without ischemic post-conditioning (n=50 patients)

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset \< 12 hours \& meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019):

   * Detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.(URL)
   * Ischemic ECG changes; New or persistent ST-segment elevation with development of pathological Q waves
   * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
2. Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy.

Exclusion Criteria:

1. Patients with transient ST segment elevation in the surface electrocardiography.
2. Patients presenting within \> 12 hours from the onset of maximal symptoms.
3. Patients with evidence of pre-infarction angina.
4. Patients with evidence of collateral blood flow to the infarct region on their angiogram.
5. Patients with history of old myocardial infarction causing chronic impairment of LV systolic function.
6. Patients presenting with ST-segment elevation myocardial infarction other than type 1 according to the fouth universal definition of myocardial infarction
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.


Eligibility Criteria:
INCLUSION CRITERIA:

1. Participant must be ≥ 18 years at the time of screening.
2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
3. Provision of a tumour tissue sample obtained prior to CRT
4. Documented tumour PD-L1 status ≥ 1% by central lab
5. Documented EGFR and ALK wild-type status (local or central).
6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
9. WHO performance status of 0 or 1 at randomization
10. Adequate organ and marrow function

EXCLUSION CRITERIA:

1. History of another primary malignancy, except for:

   * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
   * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
   * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
2. Mixed small cell and non-small cell lung cancer histology.
3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
9. Active EBV infection, or known or suspected chronic active EBV infection at screening
10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Impact of Mindful Eating and Movement on University Students' Food and Physical Literacy, and Social-Emotional Competencies

The goal of this clinical trial is to investigate if the mindful eating and movement program can improve food literacy, physical literacy, and social-emotional competencies in university students aged 18-25 years. The main questions it aims to answer are:

1. Will the mindful eating and movement program lead to significant improvements in food literacy?
2. Will the mindful eating and movement program enhance physical literacy?
3. Will the mindful eating and movement program improve social-emotional competencies?

Researchers will compare an intervention group receiving the combined mindful practices with a control group participating in standard physical education to see if the intervention group shows greater improvements in these areas.

Participants will:

Engage in mindful eating exercises during the break of physical education classes for 10 minutes.

Participate in mindful movement exercises before each physical education class end for 10 minutes, in pairs or in groups.

Complete baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after) assessments to measure changes in food literacy, physical literacy, and social-emotional competencies.


Eligibility Criteria:
Inclusion Criteria:

1. University undergraduate students aged 18 to 25 years old who are not pregnant;
2. Chinese-speaking adults;
3. Willing to sign the consent form;
4. Willing to attend mindful practice regularly;
5. No prior experience with formal mindfulness practices such as mindful eating or mindful movement.

Exclusion Criteria:

1. Not university undergraduate students;
2. Below 18 years old or above 25;
3. Non-Chinese speaking adults;
4. Unable or refuse to sign the consent form;
5. Refuse to attend mindful practice regularly;
6. History of eating disorders;
7. Severe mental health disorders requiring ongoing treatment;
8. Physical conditions limiting participation in physical activities.
Quality of Life After Conservative Oncoplastic Surgery in Breast Cancer Patients (IRONY: lIfe afteR ONcoplastic surgerY)

Evaluation of quality of life after conservative oncoplastic surgery in patients with breast cancer

The aim of the study is the evaluation of the oncological, aesthetic and functional results after conservative oncoplastic breast surgery using unilateral or bilateral remodeling techniques in a prospective sample of 250 patients.

Endpoints:

* evaluation of post-surgical histopathological data with a selective focus on the achievement of oncological radicality in relation to the surgical technique ( resection volume, locoregional extension / TNM / multifocality and tumor biological profile) and any major , minor, delayed associated complications (dehiscence, liponecrosis, infection, seroma, hematoma, fibrosis, scar hypertrophy).This data will be collected through the compilation of a database by the health personnel.
* evaluation of aesthetic and functional results related to the quality of life after oncoplastic conservative surgery (unilateral or bilateral), as data perceived by the surgeon (technical analysis), and by the patient (psychosocial well-being, physical discomfort, adverse effects of radiotherapy). This data will be collected through the administration of a questionnaire whose data will be entered into the database by the healthcare personnel.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast cancer
* Must be able for conservative oncoplastic surgery with type 1 and 2 procedures who give informed consent to the study.

Exclusion Criteria:

* Patients who are pregnant or breastfeeding
* Patients in emergency situations
* Subjects unable to understand and want
Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets):

1. Calcium
2. Calcium and 25-hydroxy-vitamin D
3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D

The endpoints are:

* Serum vitamin D
* Parathyroid hormone
* ionized calcium
* T-lymphocyte fractions (naïve, mature, Tregs)
* Osteocalcin (bone metabolism)


Eligibility Criteria:
Inclusion Criteria:

* male
* HIV-positive
* at least 18 years old
* receiving HiglyActiveAntiRetroviral Therapy (HAART)

Exclusion Criteria:

* hypercalcemia
* tuberculosis
* osteoporosis or other bone disease
* cancer with bone metastasis
Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)

This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.

Patients will reply to two questionnaires, at inclusion and two months after inclusion. Primary care physician will also be contacted by phone to reply to two questionnaires, at inclusion and two months after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years old
* Patients with onco-hematologic solid tumor (locally advanced or metastatic) against which specific and systemic treatments are outdated or have been stopped (symptomatic palliation with radiotherapy is allowed)
* Patients admitted in full hospitalisation
* Patients able to speak, read and understand French
* Patients able to answer the phone
* Signed informed consent from the patient
* Patients must have a social security coverage

Exclusion Criteria:

* Patients \< 18 years old or incapable person ≥ 18 years old
* Patients admitted for any surgical intervention
* Patients unable to read French
* Patients whose physical or psychological condition do not allow them to answer orally or in writing
* Patients deprived of liberty
* Patients placed under judicial protection
* Women that are pregnant or breast-feeding
Tongzhou Cohort Study

The present study aimed to investigate the impact of obesity on long-term cardiovascular risk in elderly patients with hypertension.

Overweight status and obesity are important risk factors leading to hypertension, poor blood pressure control, and poor prognosis. However, the studies focused on elderly patients with hypertension are limited. Therefore, the aim of the present study was to evaluate the long-term impact of obesity on cardiovascular risk in elderly patients with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Ages of ≥ 60 years
* History of hypertension and treatment with anti-hypertension drugs for more than 4 weeks
* Availability for follow-up until 2026
* No major barriers to provide written consent

Exclusion Criteria:

* NA
Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma

The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).

This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RCC of predominantly clear cell histology
* Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)
* At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)
* Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)

Exclusion Criteria:

* Presence of acute infection or other significant systemic illness
* Central nervous system involvement by malignancy
* History of other cancer within 5 years
* Previously received rIL-21 or sorafenib
Iron Absorption Trial

Introduction: There are indications that the absorption of oral iron supplementation is reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to a insufficient treatment of oral iron suppletion.

Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients. Two groups will be created.

Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives a daily dose Losferron (1390mg).

Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron including ferritin, transferrin and transferrin saturation will be measured. After intake of losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron absorption. All patients undergo a Roux- en -Y gastric bypass.

Postoperatively; one month postoperatively the same absorption test will be repeated in the same patients.


Eligibility Criteria:
Inclusion Criteria:

* patients who are eligible for a primary Roux- en -Y gastric bypass and who have no pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)

Exclusion Criteria:

* blood transfusion one month before ans in the study period. The use of iron containing nutritional supplements, except our standardized multivitamin supplements. Decreased function of the kidney with a GFR of \< 30ml/min and a serum creatinin below 50 micromol/L. Hb\< 7.4 mmol/L in females en Hb\< 8.4 mmol/L in males. Accumulation of iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness. Pregnancy
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification


Eligibility Criteria:
Inclusion Criteria:

Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history \< 10 pack years and \>= 1 year smoking cessation; Patients must be symptomatic

Exclusion Criteria:

Patients

* with a recent history (i.e., six months or less) of myocardial infarction,
* who have been hospitalized for heart failure (NYHA class III or IV) within the past year,
* with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year,
* with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years,
* who have undergone thoracotomy with pulmonary resection,
* with moderate to severe renal impairment (creatinine clearance = 50 mL/min)
Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning

This retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. Two groups were included : a surgery-alone group (control group) and a PreopAE group (study group) treated with an embolization procedure before esophagectomy. Collected data included patient characteristics, embolization procedure details, surgical outcomes, and postoperative complications.

The primary outcome was the efficacy of preoperative ischemic conditioning in preventing anastomotic leakage, assessed through CT scans. Secondary outcomes included analyzing safety of ischemic gastric conditioning, hypertrophy of the gastroepiploic artery in embolized patients and comparing hospital stay length and postoperative mortality.


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years with an indication for surgical esophagectomy with cervical anastomosis using the Lewis Santy technique or three stages approach.

Exclusion Criteria:

* Esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.