cyrilzakka/clinical-trials huggingface dataset:
Mobile Stroke Unit for Pre-hospital Emergency Care

Emergency department overcrowding is a major challenge in medicine, leading to a delay in diagnosis and treatment for the patient due to long waiting times. This is very relevant for diseases like acute stroke and other emergencies. The Advanced Mobile Stroke Unit is an ambulance equipped with additional devices to diagnose and treat patients at the emergency site. Patients with less severe conditions can be diagnosed and safely left at home. The objectives of this project are to investigate whether the Advanced Mobile Stroke Unit compared to a normal ambulance enables more accurate triage of patients (treatment at home vs hospital vs specialist vs A\&E). The Advanced Mobile Stroke Unit ambulance will be used in a random order of weeks and this will be compared to weeks with normal ambulances. The study will be carried out by the East of England Ambulance Service NHS Trust in collaboration with the East Suffolk and North Essex NHS Foundation Trust in the East of England. The project is a collaboration with Saarland University, Germany,


Eligibility Criteria:
Inclusion Criteria:

* acute emergency patients 18 years or older, who are identified via the national emergency telephone number 999 or 111with suspected severe medical emergency condition, which is categorised as: breathing problem, seizure, falls with head trauma, headache, sick person with suspected infection, stroke, unconsciousness
* calls Monday to Friday 9am to 5 pm
* written informed consent

Exclusion Criteria:

* terminally ill patients
* pregnant patients
* patients in cardiac arrest
* patients in custody of Her Majesty's prison service
Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)

The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in African-American subjects with primary hypercholesterolemia. This study is being performed to better define the efficacy of ezetimibe coadministered with simvastatin in this population.


Eligibility Criteria:
Inclusion Criteria:

* Adult African-American or Black subjects with diagnosis of primary hypercholesterolemia with plasma LDL-C \>=145 mg/dL and \<=250 mg/dL, and plasma TG \<=350 mg/dL
* Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable HRT or raloxifene regimen for at least 6 weeks and throughout the study
* Female subjects of non-childbearing potential
* Willingness to give written consent, participate and complete all study-related procedures, and ability to follow a stable NCEP Step I (or stricter) diet regimen and keep a diet diary when required.
* Clinical laboratory tests (CBC, blood chemistries, and urinalysis) within normal limits (except as noted below) or clinically acceptable.
* ALT (SGPT) and AST (SGOT) concentrations \<=2 times the upper limit of normal (ULN) and creatine phosphokinase \<=2 times the ULN.

Exclusion Criteria:

* Pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study
* Secondary forms of hyperlipidemia or underlying disease likely to limit life span to less than one year
* Known hypersensitivity or any contraindication to simvastatin or ezetimibe
* Use of investigational drugs within 30 days of study entry
* Concomitant illnesses: congestive heart failure NYHA Class III or IV; obstructive cardiomyopathy; uncontrolled cardiac arrhythmias; severe aortic stenosis; MI, CABG or angioplasty within 3 months of study; unstable or severe peripheral artery disease; unstable angina pectoris; study-limiting disorders of the hematologic, digestive or central nervous systems including cerebrovascular disease and degenerative disease; uncontrolled or newly diagnosed diabetes mellitus; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for enrollment); uncontrolled hypertension; known impairment of renal function (plasma creatinine \>2.0 mg/dL), dysproteinemia, nephrotic syndrome or other renal disease (24-hour urinary protein 3+ or 1 gram); hepatobiliary or hepatic disease (AST or ALT \>2 times the upper limit of the reference range); HIV positive; known coagulopathy.
DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine

This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests.

PRIMARY OBJECTIVE:

I. To assess the accuracy of MDM candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of CAP.

OUTLINE: This is an observational study.

PHASE I: Participants undergo urine sample collection on study.

PHASE II: Participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study.

All participants complete a questionnaire and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* \* Patient is 18 years or older

  * Patient has a histologically confirmed diagnosis of prostatic carcinoma/adenocarcinoma with a corresponding Gleason score OR is scheduled for a prostate biopsy for an elevated Prostate Specific Antigen (PSA), palpable prostate nodule, an abnormal imaging finding, or worrisome PSA velocity

Exclusion Criteria:

* \* Patient has had a transplant prior to sample collection

  * Patient has had Androgen (e.g. Flutamide, Androcur, Casodex, Nilandron) or Luteinizing hormone-releasing hormone (LHRH) (e.g. Lupron, Zoladex) therapy
  * Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
  * Patient has chronic indwelling urinary catheter
  * Patient has had a urinary tract infection within the 14 days prior to sample collection
  * Patient has immunotherapy (e.g. Kwon study drugs) for prostate cancer prior to sample collection
  * Patient has a history of bladder cancer
  * Patient has had a biopsy within the last 6 weeks (excluding non-melanoma skin biopsies) of sample collection
  * Patient has had surgery to completely remove current target pathology prior to sample collection
  * Patient has a prior history of prostate carcinoma/adenocarcinoma
  * Patient has received chemotherapy class drugs (e.g. Docetaxel, Methotrexate) within the 5 years prior to sample collection
  * Patient has received therapeutic radiation prior to sample collection
  * Patient has had focal ablation \[e.g. High-intensity focused ultrasound (HIFU) or cryoablation\] of prostate cancer prior to sample collection
  * Patient has known primary cancer outside of the prostate within the last 5 years (not including basal cell or squamous cell skin cancers) of sample collection
Activating Media for Salt Reduction

Mass media plays more and more important role in health education, especially in some chronic diseases which related closely with the behavior and habits. Past experience tells us that with the help of related health education in mass media such as newspaper articles, advertisements and videos on television, peoples can change their behaviors and habits in a short period of time. But when these educational information were stopped, peoples usually return to their original habits. Besides the national policy of the country how to improve the long-term health education in the mass media should be considered.This study hopes to seek an effective method to keep the mass media long-term focus on health education.

In this study, reporters just like researchers were in charge of the low-sodium salt intervention. Reporters are responsible for recommended objects and measure their blood pressure personally. By observing personally the change of blood pressure pre and post low-sodium salt intervention, reporters will increase their confidence and come to the conclusion that the low salt diet is an economical way to reduce blood pressure. Those reporters would share their experiment with other people including their colleagues, Hopefully, those reporters that took part in the trial would consciously keep a sustained focus to this topic, thereby retaining a long-time education in mass media.There were two interventions. One is low-sodium salt intervention and the other is informational intervention. Low-sodium salt intervention was carried out on those family members recommended by reporters, and informational intervention. Low-sodium salt intervention was only on the reporters. The evaluation criteria of low-sodium salt intervention is the blood pressure value, and the evaluation criteria of informational intervention are the numbers of related articles in certain newspaper and the awareness of related knowledges in local population.

Eligibility Criteria:
Inclusion Criteria:

* Come from local only Daily company;
* With a national press card;
* Health Column reporters preferred;
* Without leaving plan in the next 12 months;
* With easy access to at least 4 families, including relatives, friends or neighbour;
* Volunteered to participate.

Exclusion Criteria:

* n/a
Predicting Colorectal Cancer - Tissue Samples to Evaluate Tumour Characteristics and Treatment Response

All adult patients with colorectal cancer presenting within the Sahlgrenska University Hospital or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. We already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. Biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. Biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams.

Blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. If it is not possible to take biopsies prior treatment blood samples will still be drawn.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer

Exclusion Criteria:

* Not colorectal cancer
An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II Enzymes

This study will investigate the effect of Spanish Black Radish on phase I and phase II enzyme activity in healthy adult males. The primary objective is to determine the effect on phase I and phase II enzyme activity by measuring plasma and urine acetaminophen metabolite concentrations prior to and after a 28 day supplementation period with Spanish black radish product.


Eligibility Criteria:
Inclusion Criteria:

* Male age 25 - 35 years
* BMI 18 - 25 kg/m2
* Healthy as determined by laboratory results, medical history
* Agrees to avoid the consumption of cruciferous vegetables for 14 days prior to baseline and during the study treatment period
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Chronic diseases or any medical conditions
* Gall bladder disorders and /or bowel obstruction
* Use of prescribed or over the counter medications for the treatment of any acute or chronic conditions
* Use of muscle building steroids or body building aids
* Use of products containing ingredients derived from the Cruciferae (Brassicaracea) plant family within 14 days prior to randomization
* Use of natural health products other than vitamins or minerals within 14 days prior to randomization
* Any clinically significant abnormal laboratory value. Meaning a disease process, an exacerbation or worsening of an existing condition, requires further or more frequent monitoring or requires further action(s) to be taken. Clinical significance can only be determined by the Qualified Investigator.
* Participation in a clinical research trial within 30 days prior to randomization
* Allergy or sensitivity to test product ingredients, Cruciferae/Brassicaracea plant family (includes mustard, cabbage, radish), acetaminophen or foods and beverages provided during the study
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
* Cannot take acetaminophen within 48 hrs of the baseline appointment or final 4-wk appointment.
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
* Aged greater than 18 years;
* Written informed consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
* Non-Caucasian patients;
* Personal history of melanoma or dysplastic nevus syndrome;
* Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
* Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
* Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
* Patients unable to give informed consent;
* Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.
Clinical, Histological and In-depth Molecular Characterization as Well as Experimental Models of Liver Metastasis From Patients With Breast Cancer in Order to Identify New Potential Treatment Avenues.

The goal of this observational study is to learn about breast cancer liver metastasis in patients who met the following criteria:

* female;
* be ≥ 18 years of age on the day of signing informed consent;
* confirmed diagnosis of breast cancer liver metastases. Newly diagnosed patients with de-novo liver metastases are eligible;
* be planned for liver surgery.

The main questions it aims to answer are:

1. To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level;
2. To determine the levels and patterns of immune infiltrates in liver metastases from BC patients;
3. To identify biological features associated with the histopathological growth patterns in liver metastases.
4. To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC;
5. To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient

Participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.


Eligibility Criteria:
Inclusion Criteria:

* be willing and able to provide written informed consent for this study;
* female;
* be ≥ 18 years of age on the day of signing informed consent;
* confirmed diagnosis of breast cancer liver metastases. Newly diagnosed patients with de-novo liver metastases are eligible;
* be planned for liver surgery;
* be willing to provide tissue samples for research purposes.

Exclusion Criteria:

* unwillingness to provide the samples or clinical information needed for the study;
* History of radiofrequency destruction (RF), stereotactic Body Radiotherapy (SBRT) or intra-arterial treatment such as chemoembolization (TACE) or selective internal radiation therapy (SIRT) performed on the metastasis to be examined (accepted if performed in other metastasis);
* Has an active autoimmune disease that has required systemic treatment in the past 2 years prior to the surgery (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
* Presence of immunodeficiency or immune dysregulatory diseases and conditions which require active immune modulatory treatment of any kind, or required treatment in the past two years from date of diagnosis of breast cancer;
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results in the opinion of the treating investigator.
Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen

This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 12 months
* Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 6 months
* HbA1c: 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
* BMI (Body Mass Index) less than 40.0 kg/m\^2

Exclusion Criteria:

* Previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (Visit 1)
* Use of GLP-1 (Glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to prior to screening visit (Visit 1)
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, MAO (Monoamine oxidase) inhibitors, etc.)
* Cardiovascular disease, within the last 12 months prior to screening visit (Visit 1), defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure sitting at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg). For Argentina: systolic blood pressure sitting at least 150 mmHg and/or diastolic blood pressure at least 90 mmHg
* Impaired liver function, defined as ALAT (Alanine aminotransferase) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
* Impaired renal function defined as serum creatinine above 135 micromol/L (above 1.5 mg/dL) for males and above 110 micromol/L (above 1.2 mg/dL) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula). One retest within a week is permitted with the result of the last sample being conclusive
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
* Treatment with OADs (Oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local OAD label)
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)

The goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with surgery for treatment of pancreatic insulinoma. The main questions it aims to answer are: 1) What is the safest treatment? 2) Is efficacy comparable? Patients will be randomized to undergo EUS-RFA or surgical resection. Researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if EUS-RFA result safer and effective compare with surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of pancreatic insulinoma (38) (e.g., fasting test, insulin blood levels, C-peptide blood levels)
* Presence of a visible single pancreatic nodule on imaging (computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound).
* No evidence of distant localizations visualized at computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound
* Tumor ≤ 2cm
* Informed consent provided by the patient or closest relative.

Exclusion Criteria:

* G2 with Ki-67 \>5% on histological examination at EUS-guided biopsy samples (if performed)
* Distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of the main pancreatic duct
* Metastatic tumor at the time of diagnosis
* Multiple pancreatic nodules
* Diagnosis of multiple endocrine neoplasia type 1 according to guidelines
* Unfit for surgery or high-risk surgical patients
* Endoscopic ultrasound not feasible for surgical altered anatomy
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
* Use of anticoagulants that cannot be discontinued
* International normalized ratio \>1.5 or platelet count \<50.000
* Pregnancy or breast feeding
* Failure to sign the patient's or closest relative's informed consent
Progesterone Variation on the Final Day of Oocyte Maturation.

The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.


Eligibility Criteria:
Inclusion Criteria:

* Healthy oocyte donors according to spanish law for oocyte donation
* Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone.
* Informed consent signed

Exclusion Criteria:

* Detection of luteinizing hormone surge before triggering