cyrilzakka/clinical-trials huggingface dataset:
Performance Evaluation of Artificial Intelligence Screening Model in Coronary Heart Disease Detection

To determine whether an integrated AI decision support can save time and improve accuracy of assessment of obstructive coronary heart disease (CHD), the investigators are conducting a randomized controlled study of AI guided measurements of obstructive CHD probability compared to clinical assessment in preliminary evaluations by physicians.

This is a randomized controlled trial (RCT) evaluating the effectiveness of an AI-based decision support tool in the preliminary assessment of obstructive CHD by physicians. Retrospectively collected medical records of participants with chest pain or dyspnea will be randomly assigned to either guideline group or AI group after baseline assessment:

There are three settings:

1. Clinical Intuition (baseline assessment) Physicians assess obstructive CHD probability without any external assistance. Assessment relies solely on the physician's clinical judgment and experience.
2. Guideline-Based Group (Guideline Group) Physicians use a RF-CL table (risk factor weighted clinical likelihood table) to calculate the probability of obstructive CHD.

   This approach aligns with current clinical guidelines to assist in decision-making.
3. AI-Assisted Group (AI Group) Physicians receive CHD probability estimates and diagnostic recommendations from an AI model based on retinal photographs.

The AI tool provides individualized obstructive CHD probabilities, leveraging retinal biomarkers associated with cardiovascular risk.

Primary Objective To evaluate whether AI-guided decision support could improves diagnostic accuracy of obstructive CHD to a greater extent than standard clinical assessments, both compared to clinical intuition.

Secondary Objective To assess whether AI-guided decision support reduces the time required to complete preliminary assessments of obstructive CHD.

Participants, Readers and Randomization Participants: Case records of participants with chest pain or dyspnea, all underwent CT coronary angiography or invasive coronary angiography.

Readers: Physicians performing preliminary evaluations of obstructive CHD patients.

Randomization: Participants and readers will be randomized into one of the groups (RF-CL or AI) after clinical assessment at baseline using block randomization to ensure balanced group sizes.

Eligibility Criteria:
Inclusion criteria:

* Individuals with symptoms of coronary heart disease
* Age range: 18-75 years old
* Can accept and cooperate with the examination and potential follow-up work after being selected for clinical trials

Exclusion criteria:

* Severe hypertension (\>180/110mmHg)
* Complex arrhythmia (atrial fibrillation, atrial flutter, frequent premature beats)
* Severe lung disease and chest malformation or surgery patients
* Acute myocardial infarction occurring less than 3 months ago
* Individuals with severe liver and kidney dysfunction and electrolyte imbalance
Preventing COVID-19 Complications With Low- and High-dose Anticoagulation

The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS.

The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.


Eligibility Criteria:
Inclusion Criteria: adult patient with COVID-19 infections, admitted to:

* an acute non-critical medical ward with admission D-dimer levels \>1,000ng/mL, or
* an acute critical ward (ICU, intermediate care unit)

Exclusion Criteria:

* ongoing or planned therapeutic anticoagulation for any other indication
* contra-indication to therapeutic anticoagulation
* hypersensitivity to heparin
* personal history of heparin-induced thrombocytopenia
* suspected or confirmed bacterial endocarditis
* bleeding events or tendency due to a suspected or confirmed hemostatic bleeding disorder
* organic lesion prone to bleeding
* platelet count \<50G/L, Hb level \<80g/L
* ongoing or recent (\<30 days) major bleeding, ischemic stroke, trauma, surgery
* use of dual antiplatelet therapy
* pregnancy
* bodyweight \<40kg or \>150kg.
* end of life care setting
* unwillingness to consent
* ongoing participation in a COVID-19 randomized clinical trial testing another therapeutic intervention
Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.

An immediate perioperative parameter that assess the integrity of the Erythrocytes Membrane and therefore their structural quality isn't available in clinical practice and medical diagnostics except through indirect clinical biochemical tests or through the scanning electron microscope. The red blood cell (RBC) membrane contains proteins and glycoproteins embedded in a fluid lipid bilayer that confers viscoelastic behavior. Sialylated glycoproteins of the RBC membrane are responsible for a negatively charged surface which creates a repulsive electric zeta potential (ζ) between cells. These charges help prevent the interaction between RBCs and the other cells and especially between each other. The zeta potential is a physical property which is exhibited by all particles in suspension. The development of a net charge on any particle affects the distribution of ions in the surrounding interfacial region resulting in an increased concentration of counter ions of opposite charge to that of the particle, close to the surface. In this context we present a new parameter that studies the interactions of the Erythrocytes membrane treated with positive ions and their maintenance of the charge. We compared the measured polarization values with the Erythrocyte Sedimentation Rate (ESR), expression of speed with which RBCs tend to settle inside a particular graduated capillary called Westergren's tube and Plasma Free Hemoglobin (pFHb).


Eligibility Criteria:
Inclusion Criteria:

* Elective, primary cardiac surgery
* Minimally invasive cardiac surgery
* Mitral Valve Surgery (MVS)
* Conventional cardiac surgery (CCS)
* Coronary Arterial Bypass Grafting (CABG).

Exclusion Criteria:

* Abnormal plasma lactate levels (\>2 mmol/L)
* Renal
* Liver failure,
* Obesity,
* Uncompensated diabetes,
* Autoimmune disease, active infection
* Immunosuppressant therapy
* Coagulation disorder
* Surgery with circulatory arrest
* Preoperative hematocrit (Hct) \<27%
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Pain, Anxiety and Fear

This work; It was planned as a randomized controlled study to determine the effect of watching cartoons with virtual reality glasses during burn dressing of children aged 5-10 years who applied to the Training and Research Hospital Burn Unit Polyclinic on the feeling of pain, anxiety and fear in children.

The study will be applied to children in the 5-10 group who will undergo burn dressing. During the dressing, children will be watched cartoons with virtual reality glasses and pain, anxiety and fear will be looked at before and after the dressing. The children in the control group will be given routine applications of the clinic.

Eligibility Criteria:
Inclusion Criteria:

* The child and family agree to participate in the research,
* The child does not have a disease that causes chronic pain,
* The child is between the ages of 5-10,
* 1st and 2nd degree burns of less than 10% of the body surface area of the child,
* Local burn, no facial burn
* The child has no mental or neurological disability
* Failure to intervene in the child with general anesthesia
* The child has no eye problems

Exclusion Criteria:

* Child and family refusal to participate in the study
* 3rd and 4th degree burns of more than 10% of the body surface area of the child,
* The child is less than 5 years old and over 10 years old
* The child has a mental or neurological disability
* Intervention of the child with general anesthesia
* The child has an eye problem
Infections Associated With the Use of Alemtuzumab

The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab


Eligibility Criteria:
Inclusion Criteria:

* Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia

Exclusion Criteria:

* Patients did not receive alemtuzumab
Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects

It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 65 years old；
2. Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
3. No major organ dysfunction；normal heart, liver and kidney function;
4. Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial;
5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent

Exclusion Criteria:

1. Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
2. Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study
3. Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion;
4. Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。
5. With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration；
6. A history of sudden decrease or loss of hearing；
7. A history of postural hypotension；
8. Blood loss ≥400 mL within 3 months before inclusion；
9. Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration；
10. Drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(Drink alcoholics defined as 125 mL of wine, 220 mL of beer, or liquor50mL； Alcoholism is defined as 5 or more drinks in approximately 2 hours) ;
11. A history of drug use or have been screened positive for drug abuse;
12. Smoked more than 10 cigarettes a day within 6 months prior to inclusion;
13. hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive;
14. Other factors that the investigator considered inappropriate for the study.
Safety and Efficacy of AGN201781 in Neuropathic Pain

This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
* Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia

Exclusion Criteria:

* Women of child-bearing potential
* Any other uncontrolled diseases
Evaluation of the Healthy Apple Program in San Francisco

This randomized controlled trial uses administrative public health screening data to test whether the Healthy Apple program (HAP), designed to support local implementation of national Let's Move! Child Care guidelines in San Francisco (SF), improves child care center nutrition and physical activity practices and child weight change.

In the USA, First Lady Michelle Obama started a nationwide child care initiative called 'Let's Move! Child Care' which aims to improve nutrition and physical activity practices in child care centers to promote healthy weight for children ages 0-5y.

The San Francisco Child Care Wellness Collaborative, including the San Francisco Department of Public Health (SFDPH) and SF Children's Council, developed a citywide Healthy Apple Program (HAP) to support local implementation of the Let's Move! initiative.

The San Francisco Department of Public Health (SFDH) has an existing Child Care Health Program (CCHP) which provides nurse consultation and health education materials for child care centers and annual health screenings for children.

The aim of this analysis is to see whether child care centers offered the HAP in addition to usual CCHP services can improve child care center nutrition and physical activity practices and child weight change better than usual CCHP services alone.

Eligibility Criteria:
Inclusion Criteria:

* Child care center received nutrition screening services from the SFDPH Child Care Health Program in 2011-2012.

Exclusion Criteria:

* Child care center declines CCHP services in 2012-2015.
* Child care center is ineligible for CCHP services (based on funding source)
* Child care center is closed or not serving children
* Child or family decline the voluntary services
Zero-fluoroscopic Cryoballoon Ablation

This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.

Patients (n=100) undergoing de novo CBA for paroxysmal AF were randomly assigned (1:1) to zero-fluoroscopic (Zero-X) and conventional fluoroscopy groups.

Radiation exposure, procedural time, acute and long term outcome were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation

Exclusion Criteria:

* age \< 18 years
* history of AF ablation or cardiac surgery
* contraindication to oral anticoagulants
* presence of intracardiac thrombus or significant coronary artery disease on cardiac computed tomography prior to the procedure.
Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

The purpose of this study is to test a stress management program for men with early-stage prostate cancer.


Eligibility Criteria:
Inclusion criteria:

* Men who had undergone either a radical prostatectomy or radiation therapy (i.e., external beam or seed implant) for stage I or II prostate cancer in the preceding 18-months
* 50 years of age or older
* Ability to speak, read, and write in English
* Having a ninth grade reading level or greater
* Being free of cognitive impairment that would interfere with the study
* No active psychiatric symptoms in the previous three months.

Exclusion criteria:

* Previous history of non-skin cancer
* Have received adjuvant treatment, including hormone treatment, for prostate cancer
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

This study is an observational study evaluating the clinical outcomes of mucosal sparing proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No study-specific visits or evaluations will be required. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 24 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.


Eligibility Criteria:
Inclusion Criteria:

* Resection of oropharyngeal tumor by transoral surgery using frozen section margin analysis resulting in a negative margin resection
* No extensive perineural invasion after review by head and neck pathologist
* No lymphovascular invasion after review by head and neck pathologist
* Pathologic stage T1-2 N1-3 M0 disease

Exclusion Criteria:

* T3 or T4 primary stage disease
* Prior radiation therapy to the head and neck
Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine:

1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells.
2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).


Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

* pregnant
* have a current gynecological infection or discharge
* have had any cervical surgery
* had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
* currently enrolled in any research studies involving the application of vaginal formulations
* employed or supervised by the study investigators
* have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study
Ublituximab + Ibrutinib in Select B-cell Malignancies

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
* Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector

The goal of observational study is to Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector.

Participants will use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
* FEV1 ≤ 45% pred and FEV1/FVC\<70%
* TLC\>100% pred and RV\>175% pred
* CAT≥18
* \>50% of emphysema destruction
* Smoking prohibition\>6 months
* Sign the informed consent form

Exclusion Criteria:

* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
* 6-minute walking test\<160m
* Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
* Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
* Previous lobectomy, LVRS or lung transplantation
* LVEF\<45% and or RVSP\>50mmHg
* Anticoagulant therapy that cannot be stopped before surgery
* The patient has obvious immune deficiency
* Participated in other lung drug studies within 30 days before this study
* Pulmonary nodules requiring intervention
* Any disease or condition that interferes with the completion of the initial or subsequent assessment
Cardiovascular Disease Risk Factors Prevalence Among Bayer's Employees in São Paulo, Brazil

Introduction: As employees spent most part of their time at the worksite, it provides a venue to address multiple individual risk factors and promote health. The America Heart Association (AHA) defined cardiovascular health using as metrics smoking status, body mass index, physical activity, diet, total cholesterol, blood pressure and fasting blood glucose.

Objective: Evaluate Bayer employees' cardiovascular health according to the AHA definition and the acceptance to engage in lifestyle change programs.

Methods: By the time of the annual occupational safety periodic medical examination, employees will receive an email with information about the cardiovascular health screening, exams requisition (fasting blood glucose and total cholesterol) and a copy of the written informed consent. If the employee accepts to participate, after providing a written informed consent, he will be evaluated according to the AHA cardiovascular health metrics. Data will be collected at the occupational safety electronic health record. After medical evaluation, employees will receive a printed feedback with their cardiovascular health score and will be referred to indicated lifestyle change programs (healthy weight, smoking cessation, diabetes control, high blood pressure control, dyslipidemia control).

After 12 months we will evaluate the percentage of employees who accept to participate; prevalence of the cardiovascular risk factors and distribution according to the AHA classification in ideal, intermediate and poor; adherence to lifestyle change programs.


Eligibility Criteria:
Inclusion Criteria:

* Employees with 20 years of age or more that daily work at Bayer's site in São Paulo
* Provide written informed consent

Exclusion Criteria:

* Employees that will no longer work for Bayer in 30 days
* Employees that are retired from work during the study period