cyrilzakka/clinical-trials huggingface dataset:
Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)

Background:

CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure.

Objective:

To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world.

Eligibility:

People ages 18 years and older who need a computed tomography (CT) scan of the heart

Design:

Participants will be screened with a review of their medical records.

Participants may have a pregnancy test.

Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table.

A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.

Cardiac CT angiography is a commonly used test to take detailed pictures of the heart to diagnose heart disease; however, it is associated with radiation exposure. Several technological advances in both scanner hardware and software are now available to reduce the radiation exposure to patients. The purpose of this study is to evaluate the worldwide usage of these radiation dose saving strategies in daily practice and analyze their effect on image quality.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Clinical indication for cardiac CT angiography to evaluate coronary arteries or other cardiac structures
  2. Age equal to or greater than 18 years
  3. Able to understand and willing to sign the Informed Consent Form

EXCLUSION CRITERIA:

1) Female participants who are pregnant or nursing
Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients.

In a multicenter cross-sectional study, 73 adult patients treated with adalimumab (40 mg) every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index (PASI) before adalimumab treatment start, and prior to sampling. Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded. Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded. Percentage of PASI improvement compared to baseline (∆PASI) represents clinical response. Patients are classified as nonresponders (∆PASI\<50), moderate responders (∆PASI 50-75) or good responders (∆PASI 75-100).Serum is collected for adalimumab trough level and anti-drug antibody determination (Sanquin, The Netherlands). By receiver-operator characteristics (ROC) analysis, a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders.

Eligibility Criteria:
Inclusion Criteria:

* minimum age 18 years old
* chronic plaque psoriasis
* adalimumab (40mg) subcutaneously every other week
* at least 24 weeks of adalimumab treatment

Exclusion Criteria:

* interruption of treatment schedule during 24 weeks prior to sampling
* adalimumab for other inflammatory disease and later developed psoriasis
Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen

A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.

Before transplantation 300 patients will be randomized 1:1:1 in three groups. Group 1 will be treated with basiliximab induction and a three day course of steroids followed by a steroid free maintenance regimen consisting of standard-dose tacrolimus OD and mycophenolic acid. Group 2 will be treated with Basiliximab induction followed by standard-dose tacrolimus OD, mycophenolic acid and steroids. Group 3 will be treated with basiliximab induction followed by standard-dose tacrolimus OD for six months, whereafter the dose will be reduced plus mycophenolic acid and steroids. The total study period will be 2 years. Primary endpoint will be renal function, proteinuria and microalbuminuria measured 24 months after transplantation. Renal function will be measured by serum Creatinine, Creatinine clearances and CKD-EPI. Secondary endpoints will be the degree of tubular atrophy and interstitial fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months after transplantation. Biopsies will be evaluated according to the Banff Criteria for Renal Allograft Biopsy Interpretation. Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique. Other secondary endpoints are patient and graft survival, the incidence of allograft rejection, cardiovascular accidents, pulse wave velocity, blood pressure, the number of antihypertensives, lipid profile, the incidence of malignancies, the incidence of infectious complications, the incidence of post transplant diabetes mellitus and the development of osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* recipient of a kidney graft (first of second) from a deceased or living (non-HLA identical) donor

Exclusion Criteria:

* patients with multi-organ transplants
* patients who are receiving a third or fourth transplant
* patients who have \> 75% (current of historic) panel reactive antibodies
* patients receiving a kidney from a HLA identical living donr
* female patients who are pregnant or unwilling to used adequate contraception during the study
Anesthesia Preferences in the COVID-19 Pandemic: General Anesthesia or Regional Anesthesia?

As the COVID-19 pandemic continues, humanity has started to adapt to it. In our study, we aimed to examine the adaptation of anesthetists to the pandemic and its behavioral reflection on their work.

All surgeries and anesthesia methods performed in the university hospital were examined. The cases and anesthesia practices of the departments were examined. Years with and without pandemics were compared.

Eligibility Criteria:
Inclusion Criteria:

* all operations

Exclusion Criteria:

* those who refuse to have surgery
* non-operational
Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC

To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.


Eligibility Criteria:
Inclusion Criteria:

* woman, age \> 18 years old
* Diagnosed with HER2 +Metastatic Breast Cancer
* Pyrotinib Combined With Trastuzumab And Chemotherapy for at least one cycle, starting from 2020.11.01-2021.10.31
* Available medical history

Exclusion Criteria:

* Incomplete medical history
Real-time AI-assisted Endocyroscopy for the Diagnosis of Colorectal Lesions

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and early and resection detection of colorectal neoplastic lesions can significantly reduce colorectal cancer morbidity and mortality. In order to improve the diagnostic accuracy of endoscopy for colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy, including narrow band imaging (narrow-band imaging, NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy(EC), are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to identify the nature of the lesion during colonoscopy.

Endocytoscopy is a kind of ultra-high magnification endoscopy. Combined with chemical staining and narrow band imaging technology, endoscopists can observe the cell nucleus morphology, gland tube morphology and microvascular morphology with the naked eye, so as to avoid pathological examination and realize the purpose of real-time biopsy in the body. However, the judgment of endocytoscopic images needs a lot of experience to improve the judgment accuracy. Moreover, endoscopists have certain subjective judgments and errors in the process of judging the results. Therefore, artificial intelligence (AI) is proposed for computer-assisted diagnosis in clinic to solve this problem. In the early stage, our center has developed an AI-assisted diagnostic system based on cellular endoscopy to assist the nature of colorectal lesions, but there is still a lack of prospective clinical study to verify the effectiveness of the AI-assisted system. Therefore, the investigatorr want to carry out this clinical study to verify the clinical effectiveness of the AI.


Eligibility Criteria:
Inclusion Criteria:

* colorectal lesions

Exclusion Criteria:

* lesions lacking high-quality images;
* Inflammatory bowel disease, familial adenomatous polyposis and other special diseases;
* submucosal tumors;
* Pathological diagnosis of inflammatory polyps, Peutz-Jeghers polyps, juvenile polyps, lymphoma and other pathological types.
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers

The study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. It is similar to using Face Time on a mobile device. Asthma home assessments/interventions are used to identify things in a home that can make asthma symptoms worse, called triggers. Reducing these triggers in the home can improve asthma.

In this study, supplies will be given to some participants to help reduce or remove triggers from the home. One example is dust mites. These are microscopic bugs that are found in every home, cannot be seen by the naked eye, and make asthma symptoms worse. Part of the study includes collecting two dust samples from home to check dust mite levels at the beginning of the study and at the end. This study may help elucidate whether telemedicine home assessments work better than education alone at lowering dust mite levels and improving a child's asthma symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 5 years and ≤ 18 years
2. Have a diagnosis of persistent asthma as defined by national guidelines criteria1
3. Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
4. Patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids
5. English speaking participants/parents
6. Access to WIFI, smartphone or mobile device (tablet)

Exclusion Criteria:

1. Age \<5 or \>18 years
2. Non-English speaking participants/parents
3. Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
4. Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device
A Prospective Analysis of Biofilm in Urinary Catheters Study

To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.

After obtaining informed consent, concurrent with the changing of the Foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the Venter clinic on dry ice.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 years of age.
2. Subject is attending weekly office visits at SW Wound Care Center as an out- patient.
3. Subject must have an indwelling Foley catheter.
4. Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
5. Subject is willing and able to comply with all specified care and visit requirements.

Exclusion Criteria:

1. Subject refuses to participate in the study. 2. Subject is expected to be non-compliant. 3. Subject is a resident in a nursing home, or institutionalized. 4. Subject is pregnant. 5. Subject has a Legally Authorized Representative

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Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19

The aim of this possible study is to identify if SARS-CoV-2 can be found in the tear film and conjunctiva of a patient with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* A confirmed COVID-19 disease
* Signed and dated declaration of consent
* The patient fell ill in Tyrol

Exclusion Criteria:

* none
Bactiseal Catheter Safety Registry Study

Research Purpose:

This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.

Research Design:

This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.

The following information will be collected from subjects' medical records or hospitals' databases (if any):

1. General condition of the subjects (including previous shunting and external drainage operation)
2. Intraoperative condition and catheter implantation
3. Information on the shunt catheters
4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)
5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)


Eligibility Criteria:
Inclusion Criteria:

1. The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment.
2. A subject had an indication suitable to use Bactiseal Catheter.
3. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.

Exclusion Criteria:

1. A subject didn't have an indication suitable to use the catheter.
2. A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
3. According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
4. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
5. A subject had a contraindication of the shunt operation.
6. A subject had uncorrected coagulopathy or any bleeding disorder.
Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.

This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).


Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled in the primary study (NCT00306241) who received the placebo (aluminium hydroxide \[Al(OH)3\]).
* A female who is unable to receive all three doses of commercially available Cervarix before her 25th birthday.
* Written informed consent obtained from the subject (prior to enrolment).
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects must have a negative urine pregnancy test.
* Subjects must be of non-childbearing potential or, if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
* Pregnant or breastfeeding.
* Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
* Hypersensitivity to latex (found in syringe-tip cap and plunger).
* Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* Cancer or autoimmune disease under treatment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Previous administration of an adjuvant that used in the HPV-16/18 vaccine.
* Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
* Acute disease at the time of enrolment.
Effects of an Activity Control System in Patients With Diabetes: a Randomized Controlled Trial

Using a smart device (Beprevent) to monitor activities of daily living improves the lifestyle of patients with DM2

A 6-month randomized clinical trial to evaluate a home activity control system (Beprevent) in the management of the patient with DM2, through the individualized labeling of objects related to them. The study will include 20 patients with DM2 (10 in the intervention group and 10 in the control group) who live alone or with people who can´t move on their own. Data will be recorded to measure the degree of satisfaction of professionals and participants in the study, and clinical and epidemiological data at the start of the study (in its baseline situation) and at the end of the study (at 6 months), to assess the changes produced and Compare them between both study groups.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years, with the ability to give informed consent
* Patient who has autonomy to carry out activities of daily living (Barthel = 100)
* patient diagnosed with Diabetes Mellitus
* patient in pharmacological treatment
* To live alone or with a person who cannot move on their own
* they do not plan to change their address in the 6 months after inclusion in the study

Exclusion Criteria:

• DM2 patients whose most recent HbA1c value is ≤7%
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age above or equal to 18 years at the time of signing informed consent

  1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m\^2) or
  2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion Criteria:

* Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes
Prophylactic Antibiotics in Admitted Cirrhotics

In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.

Cirrhosis is associated with a state of immune-compromise and progressive decompensation, acute on chronic liver failure (ACLF), and death are often caused by bacterial infections. Different sub-groups of patients with cirrhosis at increased risk, i.e. active upper gastrointestinal hemorrhage, low protein ascites, history of spontaneous bacterial peritonitis (SBP), are known to benefit from prophylactic antibiotics. The investigators hypothesize that hospitalized patients with advanced cirrhosis are also at increased risk and thus may benefit from preventive treatment. Subjects will be randomly assigned to receive an antibiotic vs placebo.

Eligibility Criteria:
Inclusion Criteria:

* MELD-Na \>= 18
* Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies

Exclusion Criteria:

* Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
* Allergy to cephalosporins
* Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
* Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
* Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
* H/o recurrent C difficile infection within the past year (\>2) or requiring fecal microbiota transplant (FMT)
* Enrollment in the study protocol during a previous admission