cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Firmagon®

Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

- contraindications according to SPC
How Future Surgery Will Benefit From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Related Measures Perspective From Italian Young Surgeon Society (SPIGC)

The coronavirus 2019 pandemic (COVID-19) strongly affected clinical care worldwide. Due to a shortage of hospitals and beds in intensive care units (ICU), in Italy during outbreaks, surgical resources were temporarily and partially shifted to COVID-19 patients. In addition, the risk of cross-infection could have determined a shit in surgical perioperative care.

To counterbalance these limitations, many centers routinely changed their clinical practice, which could be maintained by surgeons across Italy. The aim of the present study is to evaluate how the COVID-19 pandemic determined a change in daily clinical practice among all specialties.

The purpose of this investigation, organized by the Italian Young Surgeon Society (S.P.I.G.C.), is to establish the impact of the coronavirus 2019 pandemic (COVID-19) on clinical care in Italy.

There will be collected from any Italian surgeon (resident, Fellow, Doctor of Philosophy (Ph.D.) candidate, attending surgeon, professor) impressions by completing a survey on this topic.

The analysis is divided into three study periods. For each question, participants must answer for each period. Time frames were divided according to three distinct phases of the pandemic: pre-COVID-19 period, COVID-19 pandemic period, COVID-19 Endemic period.

The pre-COVID-19 period was defined between eighth March 2019 and seventh March 2020, whereas the COVID-19 pandemic period was identified between the declaration of Italian lockdown measures (eighth March 2020) until the release of this questionnaire (sixteenth March 2022) with the periodic pandemic outbreaks. Finally, COVID-19 endemic period was described as a future phase where lockdown measures and social distancing will be removed.

Eligibility Criteria:
Inclusion Criteria:

* Resident, Fellow, PhD candidate, consultant or attending surgeon in Italy in the following surgical specialties: cardiothoracic surgery, colon and rectal surgery, general surgery, gynecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery

Exclusion Criteria:

* undergraduate students
* Non-Surgical consultant
Gastrointestinal Bleeding and Atmospheric Pressure Relationship

This study aims to investigate whether atmospheric pressure has an effect on upper gastrointestinal bleeding (UGIB), which includes causes such as peptic ulcer disease, esophagitis, gastritis, gastrointestinal varices, Mallory-Weiss tears, and gastric cancer. The goal is to determine the impact of atmospheric pressure and gather information on its role in high-risk UGIB.

ur study aims to investigate the potential effects of changes in atmospheric pressure on gastrointestinal bleeding, and if such effects exist, to review treatment adjustments based on weather forecasts for hypertensive patients to prevent potential hypertensive emergencies and enhance patient comfort. This research poses no risk to patients and is purely observational and clinical in nature.

After initial evaluation upon presentation to the emergency department, patients will undergo routine emergency department monitoring for gastrointestinal bleeding, including physical examination, vital sign monitoring, evaluation of coagulation parameters, and hemoglobin levels. Apart from routine tests, no additional invasive or non-invasive procedures will be performed by us.

Obtained data from patients and atmospheric pressure data will be analyzed and evaluated. Results will be analyzed to determine any relation between gastrointestinal bleeding and atmospheric pressure changes

Eligibility Criteria:
Inclusion criteria:

Patients aged 18 and above Patients presenting to the emergency department with complaints of gastrointestinal bleeding, whether active or resolved Patients willing to participate in the study Patients from central districts of Ankara

Exclusion criteria:

Patients under the age of 18 Pregnant individuals Patients with a history of trauma at the time of admission Patients declaring they are from a city other than Ankara
Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects aged 18 to 75 years (inclusive)
* Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence
* Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline
* ES ≥ 2 within 14 days prior to randomization
* RBS ≥ 1.

Exclusion Criteria:

* Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
* Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
* Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
* Bacterial or parasitic pathogenic enteric infection;
Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis: a Longitudinal Analysis

Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal hemodialysis

Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.

In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. A still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques (HD, PD) seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.

Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).

It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.

The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.

Eligibility Criteria:
Inclusion Criteria:

* Start hemodialysis during 2007
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Non consent
BREATHE 2 Clinic Stop-Smoking Treatment Outreach Study

The purpose of this research study is to see if offering adult primary care patients who smoke combustible cigarettes more frequent outreach, more choices about how they receive that outreach, and more smoking treatment options will increase the use of smoking treatments and help more people quit smoking, when compared against a standard outreach approach. Only patients at participating adult primary care clinics will be eligible for the study. Five clinic sites will be randomized to an enhanced outreach approach, while another 5 will be randomly assigned to standard smoking treatment outreach. Eligible patients at these clinics will be in this study for up to 18 months.

This 2-arm cluster-randomized clinical trial will compare a standard approach to smoking cessation treatment outreach in adult primary care to an enhanced approach offering more frequent outreach, multiple ways to request treatment, and a broader array of treatment options.

The researchers hypothesize that enhanced outreach comprising quarterly messages offering both standard, person-to-person treatment options (quitline services, care from a primary care provider, phone coaching and medication through a clinical trial) and self-guided treatment options (nicotine replacement therapy sampling (2 week supplies of nicotine replacement therapies and/or enrollment in text-message based cessation support via Smokefree.gov text-message programs) will attract more adult primary care patients who smoke to treatment, and will help more participants achieve abstinence from smoking, as indicated by a change in their smoking status from current to former smoking in their electronic health records. The comparison condition is a standard outreach approach comprising a mailed letter informing participants of person-to-person treatment options (quitline services, care from a primary care provider, and/or phone coaching and medication through a clinical trial).

Up to 12,000 adult participants who receive primary care at 10 participating clinic sites and whose electronic health records suggest they smoke will receive smoking cessation treatment outreach for up to 18 months, unless they opt out of participation. Randomization will occur at the clinic site level rather than at the participant level, and an opt-out approach to recruitment will be adopted.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years or older
* Meet criteria for inclusion on a smoking registry (based on current smoking status and/or recent diagnosis of nicotine dependence or treatment of nicotine dependence)
* Being seen in a participating clinic in the past 1-3 years, as documented in the EHR
* Having a valid address
* Not having a language other than English listed as preferred language

Exclusion Criteria:

* Invalid address
* Participant opted out of the study within 18 months of initial outreach letter (or were opted out of the study by a legally authorized representative or an activated power of attorney for health care)
* Participant clarification that they did not meet criteria for the smoking registry at the time of initial outreach
The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population

The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Chronic rhinitis

Exclusion Criteria:

* Active smoker
* Anatomic source of nasal symptoms
* Chronic rhinosinusitis or other nasal infection
* History of sinonasal malignancy
* Pregnancy or lactation
* Use of medication affecting nasal function (topical steroids, topical anticholinergics, oral antihistamines) in the previous 4 weeks
* Use or abuse of nasal decongestants.
* Positive skin prick test for allergic rhinitis
Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application

The MRI perfusion imaging using arterial spin labeling (ASL)'s non-invasive technique (i.e. without injection of contrast medium) allows, thanks to recent technological improvement of the spatial resolution, measuring several perfusion parameter of the retinal tissue such as the regional Blood Flow (rBF) or the cerebral blood flow (cBF) expressed in ml/100g/min. Reliable application of ASL thus requires the precision and specificity of the MRI protocol to be tested.


Eligibility Criteria:
Inclusion criteria:

* Carrier of target pathologies: TAO optic neuropathy, inflammatory optic neuropathy, ischemic optic neuropathy.
* no cardiovascular risk factors or other ophthalmological pathology
* adhere to the study protocol after reading the patient information document
* signe the informed consent form to participate in the study
* do not have any contraindications to an MRI examination

Exclusion criteria

* Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,...)
* Severe claustrophobia
Validation of an Adjusted Dosing Algorithm of Carboplatin

An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function. The hypothesis is that this new dosing algorithm provides a more accurate and safe dose than dosing according to the old standard of care.

Carboplatin is an alkylating anticancer drug that is used for the treatment of various types of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), malignant mesothelioma, ovarian cancer, and breast cancer. It is mostly given in combination with other chemotherapeutic drugs, but it can also be given as single agent.

Since carboplatin is highly eliminated by the kidneys, the dose needs to be adjusted for renal dysfunction. Furthermore, as there is clear correlation between the area under the concentration-time curve (AUC) of carboplatin and haematological toxicity and response rate, carboplatin is dosed per target AUC. For this, the standard pharmacokinetic formula \[dose = clearance carboplatin x target AUC\] is used.

the clearance is typically calculated using the cockcroft and gault (C-G) formula. In patients with high weight, or very low serum creatinine values the C-G-formula may overestimate the renal function, resulting in a potential overdose of carboplatin. the new developed dosing algorithm to be studied adjusts for high BMI and low serum creatinine values, in order to provide a more safe dose of carboplatin

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven advanced NSCLC, SCLC or ovarian cancer
* to be treated with carboplatin with a target AUC of 4, 5 or 6
* age 18 years or older
* WHO performance status 0 - 2
* adequate bone marrow and liver function defined as

  * haemoglobin ≥ 6.0 mmol/L
  * white blood cell count ≥ 3.0 \* 109/L
  * absolute neutrophil count (ANC) ≥ 1.5 \* 109/L
  * platelets ≥ 100/L
  * bilirubin ≤ 1.5 times ULN
  * ALAT and ASAT ≤ 2.5 times ULN (in case of liver metastases ≤ 5.0 times ULN).
* estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* Treatment with carboplatin with a target AUC of \<4
* active clinically serious infection
* history of a kidney allograft
* pregnant
* patients not suitable for follow-up
* pregnancy or breast-feeding
FluLaval® Quadrivalent Pregnancy Registry

The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively.

Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.

Pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD from 30 November 2013 to 31 May 2018.

Eligibility Criteria:
Inclusion Criteria:

A subject will be included in the Registry if all of the following criteria are met:

* Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
* Subject is a US resident.
* A HCP is identified (name, address and phone number).
* Subject can be identified (by GSK or HCP).

Data from registered subjects will be included in the analyses if the following criterion is met:

• Pregnancy is ongoing and the outcome is unknown.

Exclusion Criteria:

Data from registered subjects will not be included in the analyses if the following criterion is met:

• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies \> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
Blood Loss Evaluation Using a Novel Device

The study´s aim is to evaluate the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario.

In an operating theatre blood loss will be simulated in different scenarios. Expired whole blood donations (provided by the German Red Cross, Institute of Transfusions Medicine, Goethe University Frankfurt) will be used. Blood will be diluted by full electrolyte solutions . Sponges and canisters will be prepared with a predetermined amount of blood.

Study participants will estimate total blood loss on sponges and canisters. Study members not knowing the correct amount of prepared blood will measure the blood loss in sponges and canisters by Feature Extraction Technology (FET) and by gravimetric method before and after estimation of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Health care professionals

Exclusion Criteria:

* None
The Effect of Tele-Nursing Based Motivational Interviewing in Individuals With Type 2 Diabetes:RCT

This study carried out to examine the effect of tele-nursing based motivational interviewing on diabetes self-efficacy, diabetes self-management and metabolic control parameters (Body mass index, waist circumference, HbA1c%,fasting blood glucose, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride) in individuals with type 2 diabetes.

The first researcher of the article who applied Motivational Interviewing Techniques has a "Motivational Interviewing Techniques Training" certificate. A motivational interview (MI) program based on the telenursing approach was prepared by the researchers based on the literature for the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.

Eligibility Criteria:
Inclusion Criteria:

1) being over 18 years old, 2) receiving insulin or insulin + oral therapy, 3) diagnosis of type 2 diabetes at least one year ago, 4) having a BMI of 25 and above, 5) HbA1c value of 7 and above, 6) access to phone, 7) voluntarily agreeing to participate in the study.

Exclusion Criteria:

1) have a physical disability.
Reactivation of Varicella Zoster Virus and Risk of Vascular Disease

The purpose of this study is to investigate whether there is an association between stroke or heart attack and reactivation of varicella zoster virus, measured by antibody levels, using linked data from the Health Survey for England and secondary care.

This study will use a case control design to investigate whether adult participants in the Health Survey for England between 2009 and 2013 who were admitted to hospital with either a stroke or heart attack had higher preceding levels of varicella zoster virus antibodies measured in stored serum samples compared to matched controls with no history of heart attack or stroke, controlling for a range of potential demographic, lifestyle and clinical confounders.

This study is funded by the University College London Hospitals Biomedical Research Centre Fast Track grant scheme and has received ethics approval (ref 15/NW/0456).

Eligibility Criteria:
Inclusion Criteria:

* Previous participant in the HSE between 2009 and 2013 with stored serum available.
* Either a record of stroke or TIA or MI in linked HES data between 01/01/2009 and 31/12/2013 or selected as a matched control for those with a record of stroke/ TIA/MI in HES data.
* Male or female, aged 16 years or above.

Exclusion Criteria:

* HSE participant with no stored serum sample