cyrilzakka/clinical-trials huggingface dataset:
The Use of Immunohistochemical Staining for the Prediction of Wilms Tumour Progression and Recurrence

Wilms' tumour staging and grading are used to give an idea about the prognosis. Advanced staging, diffuse anaplasia, predominant blastemal elements and lymph node invasion are indicators of poor prognosis. In spite of using the previously mentioned parameters, some tumours which were considered of low risk did not respond to therapy and eventually resulted in mortality. In contrast, other tumours assumed to be of poor prognosis responded dramatically to treatment.

In light of the above, it is crucial to search for predictors of Wilms' tumour prognosis other than tumour staging and grading. Many immunohistochemical (IHC) stains have been studied as prognostic markers for nephroblastoma in literature.

P53 is a tumour suppressor gene, and its mutation is identified in various types of human cancer. P53 protein accumulation in certain tumours is associated with tumour aggressiveness. The role of P53 expression in Wilms' tumour is not clear; however, most studies confirmed its correlation with advanced stages and anaplasia.

Ki67 is a nuclear antigen related to cell proliferation, and high Ki67 proliferation index (PI) is accompanied by tumour aggressiveness, distant metastasis and death. Advanced stages and clinical progression of WT were found to be associated with high Ki67 PI. On the other hand, some authors concluded that it may not be a dependable prognostic marker.

The cyclin-dependent kinases (CDKs) have a role in transitions between cell cycle phases with the need of cyclins association for their activity. IHC assessment of cell cycle proteins has a diagnostic use in histopathology. Correlation between poor prognosis and overexpression of cyclin A was confirmed in different entities of human cancer such as medulloblastoma and ovarian carcinoma. A recent study deduced that cyclin A overexpression may be associated with the poor prognosis of WT.

Eligibility Criteria:
Inclusion Criteria:

* All children presented with Wilms' tumour at the Urology and Nephrology Center, Mansoura University, Mansoura, Egypt from 2000 to 2014.

Exclusion Criteria:

* Preoperative chemotherapy (due to areas of necrosis and haemorrhage hindering immunohistochemical staining).
* Patients with incomplete follow-up data.
Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)

The purpose of this study is to collect long-term safety and tolerability data of LCZ696 and to provide open-label LCZ696 to eligible participants who completed CLCZ696G2301 study (PARADISE-MI) if LCZ696 is shown to have a positive benefit-risk profile in comparison to ramipril in reducing risk of cardiovascular (CV) mortality and development of heart failure in participants enrolled in the PARADISE-MI study.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI.
3. Participant is safe to be enrolled in the extension study and may benefit from the treatment of LCZ696 per investigator's clinical judgement.

Exclusion Criteria:

1. Participant with a known history of angioedema
2. History of hypersensitivity to the study drug or drugs of similar chemical classes or known intolerance or contraindications to study drug or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
3. Symptomatic hypotension at screening
4. Serum potassium \> 5.2 mmol /L (or equivalent plasma potassium value) at screening
5. Known hepatic impairment (as evidenced by total bilirubin \> 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
6. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
7. Other protocol-defined inclusion/exclusion criteria may apply
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.

The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.

The main question it aims to answer are:

* Patency of the semibranch
* Feasibility of the technique regarding cannulation and stentgrafting

The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Presence of pararenal or thoracoabdominal aortic pathology
* Treatment planned a semibranch device branch from Artivion
* Availability of the patients during the follow up period
* Informing patients about the study and providing written informed consent

Exclusion Criteria:

* Women of childbearing age
* Patients under 18 years
Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients

REPRESS is an open label, pragmatic, multicenter, randomized controlled phase III trial with blinded endpoint with 1:1 (intervention to control arm) allocation ratio.

The REPRESS trial is aimed to determine the efficacy of an educational intervention aimed at reducing dietary salt intake in elderly people (60+) with moderate hypertension and exposed to polypharmacy (3+ drugs) in improving systolic BP control compared to an attention arm.


Eligibility Criteria:
Inclusion Criteria:

1. Community-dwelling patients aged ≥60 years;
2. Prescribed ≥3 drugs;
3. A) Systolic blood pressure ≥130 and ≤160 mmHg for patients prescribed stable antihypertensive therapy (at least 1 drug (ATC code: C02\*, C03\*, C07\*, C08\*, C09\*)); B) Systolic blood pressure ≥140 and ≤160 mmHg for those patients not prescribed any antihypertensive drug;
4. Capable of feeding independently;
5. Own a smartphone;
6. Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the weekend per month);
7. Giving signed informed consent.

Exclusion Criteria:

1. Living in a nursing home or having applied for nursing home admission;
2. Being prescribed (adding, switching or changing dosage) an antihypertensive drug in the three months before enrollment;
3. Undergoing renal replacement therapy with dialysis or having renal impairment with estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73 m2 (assessed by CKD-EPI formula) \[30\] within previous six months or at the screening assessment;
4. Following a low-sodium dietary regimen;
5. Being unable or refusing to sign informed consent.
PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia

This study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection. The investigators will use individual patient data from four recently published large observational COVID-9 studies, including the 'Practice of VENTilation in COVID-19 patients' (PRoVENT-COVID) study, the 'Epidemiology of COVID-19 patients in the ICU' (EPICCoV) study, the 'SATI-COVID-19 - Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study' and the CIBERESUCICOVID - Personalized Risk and Prognosis Factors and Follow-up at One Year of the Patients Hospitalized in the Spanish Intensive Care Units Infected with COVID -19' study. The investigators will use the individual patient data from ARDS patients with another pulmonary infection from the 'LUNG -SAFE - Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE' study and the 'ERICC - Epidemiology of Respiratory Insufficiency in Critical Care' study.

Early on in the pandemic, it was frequently proposed that ARDS caused by COVID-19 and ARDS caused by another cause were distinct in a number of ways. COVID-19 related ARDS phenotypes have been suggested, based on differences in respiratory system compliance (Crs) and the severity of the hypoxemia. Other reports have even suggested that lung-protective ventilation strategies for patients with ARDS caused by COVID-19 should differ from those used before the pandemic.

The use of low tidal volumes (VT) and prone positioning, which have been shown to be useful in reducing death in patients with ARDS prior to the pandemic, were also shown to be effective in patients with COVID-19 related ARDS, according to several reports. In the discussion of how to ventilate patients with COVID-19 related ARDS, the disagreement over other ventilatory settings, such as the best positive end-expiratory pressure (PEEP) and the use of recruitment manoeuvres, remains remarkably lively.

To compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection, the investigators will use individual patient data from PRoVENT-COVID, EPICCoV, SATI-COVID-19, CIBERESUCICOVID, LUNG-SAFE and ERICC.

Eligibility Criteria:
Inclusion Criteria:

1. Cause for ARDS is COVID -19 (confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT) and/or X-ray) or a pulmonary infection from another origen
2. Meeting a Berlin criteria for ARDS
3. Invasive ventilation

Exclusion Criteria:

1. Age \< 18 years
2. Any form of non-invasive ventilation
Viral Biofilms: Hijacking T Cell Extracellular Matrix to Regulate HIV-1 Spread?

This project aims at characterizing HIV-1 viral biofilms structural and functional properties and at deciphering its role as a new viral reservoir and as a new mode of viral spread. The prospective national study will be conducted on cells isolated from blood samples from 20 patients infected with HIV.

The investigators' preliminary data indicate that besides " free " infectious viral particles, HIV-1 infected cluster of differentiation 4 (CD4+) lymphocytes also produce extracellular viral assemblies wrapped in an extracellular matrix cocoon and tightly bound to the surface of the cell. Importantly, these structures are infectious, transferred to target cells upon intercellular contacts and they are key role in HIV-1 spread between T lymphocytes. HIV-1 viral biofilm could be important not only for direct transmission of the virions but also for " trans-infection ", a process our objectives are:

* to better characterize the molecular composition and the architecture of this biofilm (using proteomics, glycomic superresolution cell imaging approaches) with regard to its properties (infectivity, adhesiveness, protection of virions) and to determine whether cells from infected patients produce such structures.
* to delineate the viral factors regulating the formation of these new infectious structures (with a particular attention on Tat, Vpu and Nef HIV-1 encoded using mutant viruses or expression vectors).
* to investigate the lymphocyte pathways regulating the viral biofilms formation and composition in extracellular matrix (ECM) proteins (using quantitative polymerase chain reaction (qPCR) and siRNA).
* to determine whether those viral biofilms are involved in HIV-1 transmission by transinfection
* to study the contribution of those infectious structures and the dynamics of their transmission in lymph nodes.

This project may contribute to decipher the role of viral biofilms in HIV-1 transmission. Ultimately, we intend to determine how the interference of retroviral infections with T cell activation pathways modulates the pattern of ECM production by T cells, tuning viral biofilm composition and regulating viral dissemination.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* able to give written consent
* HIV positive serology HIV1
* Viral load \> 10 000 copies/ml
* CD4 T cells \> 100 cells/mm3
* or Treated by antiretroviral therapy (ARV) for less than 6 months
* Covered by French Social Security

Exclusion Criteria:

* Involved in a clinical trial
* Pregnancy (inclusion can be postponed)
* No covered by French Social Security
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL

Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib

This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.

Observationnal and biological study

Eligibility Criteria:
Inclusion Criteria:

* patients included in the ATU (epidemiology)
* under treatment at 3 years of ibrutinib
* more than 18 years old

Exclusion Criteria:

* no ibrutinib treatment
Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)


Eligibility Criteria:
Inclusion Criteria:

* Has signed and dated written informed consent prior to performing any study procedure, including screening
* Diagnosis of AML or MDS/AML according to the ELN, refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell transplantation (HCT)
* Age ≥18 years old on the day of signing informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
* Anticipated life expectancy ≥ 12 weeks by investigator judgement
* Adequate renal and hepatic function:
* Is using highly effective contraception, for females of childbearing potential and for men

Exclusion Criteria:

* Allogeneic HCT within the last 3 months
* Active GvHD requiring immune-suppressive therapy
* Use of immunosuppressive drugs
* Symptoms of leukostasis (prior hydroxyurea allowed)
* Clinical signs of AML in the central nervous system
* Major surgery within 28 days prior to start of study medication
* Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
* Any active infection requiring the use of parenteral antimicrobial agents or that is grade \>2
* Treatment with investigational agents and/or agents targeting CD33, CD123 or CD70 within 4 weeks prior to start of trial medication
* Left ventricular ejection fraction of \< 50% on echocardiographic exam at screening
* History or evidence of clinically significant cardiovascular disease
* Pulmonary disease with clinically relevant hypoxia
* Concurrent enrolment in another clinical trial, unless it is an observational (non-interventional) study or it is the follow-up period of an interventional study
* Known hypersensitivity to any of the excipients of the investigational medicinal product (IMP), i.e. finished MP0533 drug
Impact of a Nurse Implemented Sedation and Analgesia Algorithm in Surgical Intensive Care Unit

To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.

Outcome Measures : The primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. The goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. For this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the ICU stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). The primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in ICU and in hospital, mortality and other complications.

Methods: The two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. Quantitative comparisons of data following a normal distribution will be done using a Student's t test. Otherwise quantitative data will be compared using a Mann-Whitney test or Wilcoxon. The comparison of qualitative data will be done using a Fisher exact test. To increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.

Eligibility Criteria:
Inclusion Criteria:

* Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.
* Age greater than 18 years.

Exclusion Criteria:

* Patient under guardianship or \<18.
* Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy
* Neuromuscular blocking agents at the time of inclusion

Secondary Exclusion criteria:

* Extubation \<48 hours after inclusion
* Deaths \<48 hours after inclusion
Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin

Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range 20-50 years). Ethical approval, which included informed consent, was from Cardiff University, Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for seven days and then provided a repeat blood sample. Following a 2-month period, participants were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.


Eligibility Criteria:
Inclusion Criteria:

* two-week washout period from any non-steroidal anti-inflammatory drugs (NSAIDs) use.
* Ability to take aspirin 75 mg once daily for seven days and sampled thereafter, before stopping the aspirin.
* Willingness to repeat this process after two months and four months of the initial sampling date.

Exclusion Criteria:

\* Recent NSAID use
Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single.

This is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks.

4 visits are planned. The maximum duration of the study is 74 days from inclusion visit to the End-of-study visit.

The study area is the whole scalp.

4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase

Eligibility Criteria:
Inclusion Criteria:

Criteria related to the population:

- Subject aged between 18 and 60 years included

Criteria related to the disease:

Subject having a squamous state of the scalp :

* clinically visible (Squire score ≥ 20),
* with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
* recurrent (at least twice a year)
* associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)

Exclusion Criteria:

Criteria related to the diseases / skin condition:

* Subject having frizzy hair
* Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage\> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment

Criteria related to treatments and/or products:

* Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
* Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
* Any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion