cyrilzakka/clinical-trials huggingface dataset:
Artificial Intelligence in Breast Cancer Screening Programs in Córdoba (AITIC)

The use of artificial intelligence software in breast screening (Transpara®) makes it possible to identify studies with a very low probability of cancer.

The hypothesis raised in this work is that reading strategies based on artificial intelligence (single or double reading only of cases with a score\> 7 with Transpara®), allow reducing the workload of a screening program by more than 50 % with respect to the standard reading of the program (double reading of all cases without Transpara®), without presenting inferiority in terms of detection rates and recalls of the program, both with the use of 2D digital mammography and with the use of tomosynthesis or 3D mammogram.


Eligibility Criteria:
Inclusion Criteria:

* Any woman between the ages of 50 and 69, from the hospital area of the Reina Sofía University Hospital, invited to the Breast Cancer Early Detection Program, summoned in rooms 2024 and 2001 and who agrees to participate in the study by signing the consent informed.
* Women studied in the program in the set period and who have previously participated.
* Women who are studied in the program for the first time in the set period.

Exclusion Criteria:

* Women invited to the program who do not agree to enter the research study by signing the informed consent.
* Women with breast prostheses.
* Women with symptoms or signs of suspected breast cancer.
Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease

Head and neck cancers usually occur in patients who have a history of long tobacco use. Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. COPD and head \& neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck.

The investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head \& neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. The patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance.

This study is a joint effort of the Pulmonology Institute and the Department of Otolaryngology, Head \& Neck Surgery in Israel and the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

1. group of adult COPD patients.
2. Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic.
3. Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine

Exclusion Criteria:

1. Patients with an acute disease or COPD exacerbation
2. Pregnant patients
3. Patients who were intubated ≤3 months prior to inclusion
4. Patients with a medical history of surgical intervention in the upper airway
5. Patients with a medical history of malignant disease in the upper airway
6. Patients who underwent radiotherapy of head and neck
System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System

The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.

However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.

Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)


Eligibility Criteria:
Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.
* If blood glucose values \< 80 mg/dl or \> 300 mg/dl shall be measured after short term alteration in insulin therapy:
* Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
* Signature of subjects to document consent with these procedures on informed consent form.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
* Being committed to an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent on investigator or sponsor
* If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2, see Fehler! Verweisquelle konnte nicht gefunden werden.), subjects with type 1 diabetes, suffering from:
* Coronary heart disease
* Condition after myocardial infarction
* Condition after cerebral events
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness
Outcomes of Coronary Artery Bypass Grafting in Israeli Jews and Arabs

Retrospective study of adult patients with multivessel disease undergoing isolated CABG in three centers between January 1st, 2009, and December 31st, 2023. The primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE). Patients were grouped according to their ethnic origin, Arabs and Jews.


Eligibility Criteria:
Inclusion Criteria:

* isolated CABG

Exclusion Criteria:

* members of different HMO
Effect of Cervical Spinal Stabilization Exercise Programs by Magnetic Resonance Imaging in Healthy Individuals

The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals.

In the prevention and treatment of cervical region pathologies, various exercise methods are applied in the clinic. The clinical exercises vary according to the time and severity of the pathology but also according to the pathology itself. These exercises include exercises focusing on flexor or extensor muscles. The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals. At least 27 healthy male subjects between the age of 18-30 are planned to be included in the study. Individuals will be divided into 3 groups by simple randomization method. In one group cervical stabilization exercise program focused on the flexor muscles will be applied and the other group cervical stabilization exercise program focused on the extensor muscles will be applied for 8 weeks. Individuals in the control group will only be evaluated without exercise. In the study, by using magnetic resonance imaging (MRI) method as the main evaluation, muscle anatomical cross-sectional area and T2 relaxation time measurements will be made and morphological changes in muscles will be determined. These evaluation procedures will be performed on longus colli, sternocleidomastoid, semispinalis cervicis, multifidus and upper trapezius muscles. As additional evaluation methods, muscle strength and muscle endurance tests, normal joint motion measurements, posture evaluation and MRI measurement of cervical spine curvature will be performed. All evaluations will be performed at the beginning and at the end of these 8 weeks and the effects of the exercises applied on the muscles in the two groups will be examined.

Eligibility Criteria:
Inclusion Criteria:

* being healthy
* age between 18 to 30 years
* agree to participate in the study

Exclusion Criteria:

* to undergo any surgical procedure of the vertebral column
* inflammatory disease
* rheumatological disease
* history of malignancy
* congenital spinal cord anomaly
* congenital and/or spinal deformities
* radiculopathy
* myelopathy
* other neurological disorders
* vestibular disorders and/or trauma history
Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

* Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.
* During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL;
* Have received methotrexate for 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study;
* If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least 4 weeks prior to screening;
* If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to screening;
* Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year;
* Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug.
* Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and
* Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments.

Exclusion Criteria:

* Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate;
* Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents);
* Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening;
* Previous use of the study drug GLPG0634;
* Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening;
* Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator;
* Positive serology for HIV1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A;
* History of any inflammatory rheumatological disorders other than RA;
* History of tuberculosis (TB) infection
Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4

a prospective, multicenter (outpatient clinics of the three participating hospitals in Beijing), double blinded and randomized placebo-controlled study.

The study consisted of a 2-week run-in period and a 12-month treatment period.


Eligibility Criteria:
Inclusion Criteria:

(1) Signed informed consent and aged from 18 to 75 years old. (2) Chronic renal diseases with Glomerular Filtration Rate (GFR) estimated using the CKD Epidemiology Collaboration (CKD-EPI) equation between 15 and 59 ml/min per 1.73 m2 on at least 2 dates separated by at least 90 days but no more than 6 month (the CKD defining window period). (3)Not received other TCM treatment for at least 2 weeks.

Exclusion Criteria:

(1) 50% increase in serum creatinine occurring within 2 month before screening. (2) Immediate need for dialysis. (3) Myocardial infarction or cerebrovascular accident in the 6 month preceding the trial. (4) Connective-tissue disease, obstructive uropathy and renal transplantation. (5) Patients with severe disease in other organs or cancer, psychotic diseases, and active tuberculosis. (6) Treatment with corticosteroid and immunosuppressive agents in recent 3 month. Hemoglobin (Hb) less than 80 g/L. (7) Diabetes Mellitus with uncontrolled Blood Sugar ( glycated hemoglobin （HbA1c） \>8.0%). (8) Enrolled in other trials. (9) Women in pregnancy or lactation.
Smoking Cessation Intervention for Cancer Patients

The purpose of this study is to see if we can find ways to improve the treatment of tobacco dependence in patients who have cancer or may have cancer. We will compare two ways to help people quit tobacco use before surgery and to stay quit after surgery. One way is a scheduled reduced smoking program followed by use of the nicotine patch. In this program, the tobacco user will gradually cut down on their tobacco use until they quit. Once they quit, they will be offered the nicotine patch. We will compare this approach to our current program of counseling and use of nicotine patch. What we learn from this study may help us to develop new ways to help tobacco users and improve our current smoking cessation program.

Smoking cessation offers an important way for newly diagnosed cancer patients to take an active role in their treatment and recovery. Quitting tobacco use decreases cancer patients' risk of disease recurrence and development of second primary cancers. In addition, preoperative tobacco cessation may reduce the likelihood of perioperative pulmonary, cardiovascular, and wound healing complications. Due to increased awareness of the health hazards of tobacco use, rates of cessation after cancer diagnosis are high. However, 35% to 69% of patients continue to use tobacco and this is largely due to strong barriers to quitting (low-self efficacy, psychological distress) rather than lack of positive intentions to quit. Previous attempts to increase smoking cessation among the medically ill have provided intervention either during or after hospitalization.

We propose that the period immediately prior to hospitalization and surgery represents a unique window of opportunity, or "teachable moment," for smoking cessation that could take full advantage of patients' enhanced health awareness and quitting motivation, strong physician quitting advice, and patients' heightened desire to take an active role in their care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Smokers who typically smoke \> 8 cigarettes per day who have smoked within the last 7 days or other tobacco users with high frequency of use (\> 8 per day) within the last 7 days;
* Diagnosed with cancer or have a mass suspicious of cancer that is NOT distant metastatic cancer at the time of enrollment;
* Likely candidate for surgical treatment no sooner than 7 days from study entry;
* Absence of gross psychopathology or cognitive impairment;
* Can be reached by telephone;
* Have manual dexterity and sensory (i.e., visual and auditory) acuity sufficient to use a Personal Digital Assistant (PDA);
* Provide informed consent.
Determinants of Chronic Inflammatory Skin Disease Trajectories

Although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. There are currently no reliable markers that could predict or delineate patient subgroups to support patient management. The aim of this project is to identify clinical and molecular factors that correlate with disease, disease subtypes and progression through in-depth long-term clinical characterization of patients with chronic inflammatory skin diseases and examination of individual biomaterials.

Chronic inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis (Pso) are exceptionally heterogeneous diseases. Clinical manifestations, disease severity, and individual trigger factors vary widely between patients and over time, presenting a clinical challenge for diagnosis, counseling, and individualization of treatment strategies. With the growing interest in inflammatory skin diseases, the need has been recognized to better investigate their natural history and associations with environmental and lifestyle factors, and to conduct research to identify the clinical and, where appropriate, molecular features underlying heterogeneity. Initial small pilot studies suggested disease subtypes that differ molecularly and/or clinically; however, molecular profiles in particular are subject to variation over time and not necessarily. To confirm and extend such preliminary observations, a larger cohort of patients will be studied with careful longitudinal clinical characterization as well as repeatedly obtained specimens, in order to gain deeper insights into disease dynamics. In particular, we will search for clinical and molecular factors that correlate with disease progression and subtypes, and investigate variability in the regulation of molecular mechanisms over time and at resolution and flare-ups.

Eligibility Criteria:
Inclusion Criteria:

* dermatologist-diagnosed inflammatory skin disease
* informed consent

Exclusion Criteria:

* subject and/or the legal guardians are not able to give written informed consent
* pregnant and breastfeeding women
* concurrent participation in a clinical trial
* use of systemic immunosuppressive therapy or phototherapy during the last 4 weeks or receipt of biologics therapy (e.g. dupilumab, tralokinumab) within the last 3 months
* treatment of the target skin areas with topical corticosteroids, calcineurin inhibitors or emollients 24 hours before sample collection
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students

The team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more favorable change in knowledge, attitudes, and behaviors.

People with serious mental illness (PSMI; i.e. Schizophrenia and bipolar disorder) die, on average, 25 years earlier than the general population. Suicide is a key factor for this disparity as it is the leading cause of unnatural deaths among this population. Research identifies Latinos as a particularly vulnerable group, accounting for one of the highest rates (over 30%) of serious mental illness (SMI) among ethnic minorities in the United States (US). Latinos also hold one of the highest prevalence of suicide ideation and attempts (SIA) with rates of 10.1% and 4.4% respectively. This scenario worsens for one Latino subgroup, Puerto Ricans, who have the highest prevalence of SMI (36%) and SIA among Latinos in the US (7.9% and 3.5% respectively). Taken together, these facts present a concerning scenario for Latinos, especially Puerto Ricans with SMI/SIA. Health professionals play a key role in identifying SMI/SIA among patients; unfortunately, SMI/SIA stigma hinders this process.

The proposed study aims to: 1) develop the content of an intervention to reduce SMI/SIA stigma among medical students, 2) determine the acceptability and feasibility of implementing the intervention among medical students by examining recruitment/screening procedures, participation/refusal/retention rates, and participant satisfaction, and; 3) pilot test the preliminary efficacy of the intervention in reducing SMI/SIA stigma among medical students by increasing knowledge of SMI and SIA, reducing negative attitudes towards SMI/SIA and increasing behavioral skills for providing healthcare to PSMI.

Eligibility Criteria:
Inclusion Criteria:

* Medical student currently in third year of medical school training

Exclusion Criteria:

* Do not speak English
Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)

The study pilots an outreach service for Acute kidney injury (AKI) patients, based on electronic alerts. Using the alerts we will contact the primary clinician caring for the patient with AKI in the Intervention group. The study has a control group of patients receiving good standard care, but without Outreach. The aim is to reduce morbidity and mortality in the syndrome, and also to reduce healthcare costs.

Lay summary:

About one in six hospital inpatients suffer Acute Kidney Injury (AKI), also called acute renal failure. About a third of patients with AKI die. The large majority of patients with AKI are managed by doctors who are not kidney experts. Effective AKI advice and treatments are available but not currently integrated into routine care. A recent National review of the care of patients who died from AKI showed poor management of many patients. Early diagnosis of AKI can avoid complications, dialysis (which affects the quality of life of patients, and is costly) or death. AKI is diagnosed by a change in a blood test. We have developed computer software to diagnose AKI earlier. It sends a warning or 'Alert' about the test to our team of kidney experts. We will further develop the settings of the Alert system. It needs to send an Alert for the right patients. We will also study the best way to make clinicians pay attention to their patients who are developing AKI. When our expert Outreach team receive an Alert, they will call the doctor or nurse looking after the patient with AKI. We will advise on the best treatment for that patient, to reduce their risk of death, dialysis and other complications. We will do a pilot study in one large hospital, to further develop the system, and check it reduces the risk of death or complications from AKI. We will use this work to develop a larger trial of this new system of care for patients with AKI in different hospitals. This will convince the wider NHS of the need to change, and show how to prevent or reduce AKI. Ultimately we aim to improve patients' lives by reducing avoidable death and illness from AKI , and also save the NHS money.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with an Alert for AKI issued in accordance with the national algorithm for AKI alerts (NHS England)
* AKI stage 2 or 3 (this criterion is under review during the preparatory phase of the study)

Exclusion Criteria:

* patients already on dialysis for AKI at the time of alert
* patients with End stage renal disease
* patients \<18 years of age
* patients with no evidence of AKI on review of the automated Alert
* patients dissenting from participation according to the Ethics application