cyrilzakka/clinical-trials huggingface dataset:
Coronaphobia in Rheumatic Diseases

COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). The most common symptoms are fever, cough and dyspnoea. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine.

COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Therefore, pandemic caused changes in routine life for millions of people. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. The aim of this study is to investigate coronaphobia in rheumatic diseases and compare with healthy people.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 65
* Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia

Exclusion Criteria:

* Being pregnant
* Diagnosed with malignancy
* Had changes of medical treatment in the last 3 months
* Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
Indocyanine Green for Central Nervous System Tumors

This study is a single center, open-label, two-part study to assess image guided surgery of intramolecular imaging in nervous system tumors. Subjects with a diagnosis of a resectable nervous system tumor who are at risk of recurrence are included. The primary goal is to observe what tissues fluoresce in the OR, and then to identify if that tissue is cancerous/tumor or normal when the histopathology is performed.


Eligibility Criteria:
Inclusion Criteria:

Adult patients 18 years of age and older Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment Good operative candidate as determined by the treating physician and multidisciplinary team Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations Patients unable to participate in the consent process (children and neonates) Patients with non-MRI compatible implanted metallic foreign bodies Patients who due to severe claustrophobia cannot tolerate MRI scanning Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium
Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns

Novel oral anticoagulant drugs (NOACs) are now increasingly used in clinical practice. Although there are outstanding advantages of NOACs, there are also some shortcomings in use. The behavioral pattern of patients using novel oral anticoagulant drugs can directly affect the effect of anticoagulant therapy.

However, at present, there is no study on behavioral patterns of compliance and cognition in patients using NOACs in China. There are few reports on the management outcomes of NOACs anticoagulant therapy as well. Above all, exploring whether pharmacists change behavioral patterns in patients using NOACs is of great significance to improve the effectiveness and safety and to prove the value of pharmacists who provide pharmaceutical care.

The study is a prospective randomized controlled trial. Patients who will use NOACs are prospectively divided into routine group and pharmacist intervention group.

For the intervention group, pharmacists regularly provide telephone and outpatient follow-up combined with patient medication education, establishing database system, telephone reminder, etc. At the 12-week follow-up, behavioral patterns of compliance, self-anxiety, depression status and satisfaction with the pharmacist service will be evaluated in both groups. Pharmacodynamic substitution indicators and endpoints will be collected as well.

Clinical data is designed to be collected from 400 patients, 200 patients each group. Data will be recorded by Epidata dual-track, analyzed by SPSS19.0 software. P\<0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients or inpatients with anticoagulation indications of novel oral anticoagulant drugs (NOACs).
2. New prescriptions for NOACs, or previous prescriptions for NOACs, not received any intervention by pharmacists before.
3. Written informed consent was obtained from patients or their families.

Exclusion Criteria:

1. Patients who did not use novel oral anticoagulants.
2. Patients who had received interventions from pharmacists, such as medication education.
3. Written informed consent was not obtained from patients or their families.
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female from 6 to 12 years of age at the time of screening, inclusive.
* Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.
* A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.
* Subject must have been in need of pharmacological treatment for ADHD.
* Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.
* For subjects taking any daily medication at screening aside from ADHD medication: parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).

Exclusion Criteria:

* Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination Disorders, Sleep Disorders, and Adjustment Disorders.
* Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator. In cases where this was not clear, study staff were permitted to administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the intelligence quotient (IQ). Significant cognitive impairment for this protocol was defined as an estimated IQ below 80.
* Subjects with chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), severe hypertension, thyroid disease, structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma, Tourette's Disorder, family history of Tourette's Disorder or tics.
* Use of monoamine oxidase inhibitors within 30 days of the screening visit.
* Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of stimulant medication for control of ADHD at screening was permitted if inclusion criterion number 6 was met.
Dose Escalation Study of Kylo-0603 in Healthy Subjects

This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.

The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 55 years old, inclusive;
* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive；
* Having no clinically significant disorder, condition or disease at screening and before first dosing;
* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
* Willing to comply with protocol required visits and assessments, and provide written informed consent.

Exclusion Criteria:

* History of cardiovascular, respiratory, digestive, liver, urinary, hematological, endocrine, metabolic, immune, cutaneous, or psychoneurotic diseases；
* History of evidence of malignant tumor or Gilbert syndrome;
* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
* History of tuberculosis infection;
* History of alcohol abuse within 12 months before dosing;
* History of drug abuse within 3 months before screening;
* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
* Pregnant or breast-feeding women;
* Other exclusion criteria applied per protocol.
UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning

The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.


Eligibility Criteria:
Inclusion Criteria:

* Disease: Prostate cancer
* Treatment site:
* Prostate or prostate and seminal vesicle
* No regional lymph node is involved
* Patient's body weight: Patient's body weight is less than 350 lbs to consider the total weight limit that the ProteusONE treatment table and the robotic arm can operate
* Treatment volume size: maximum size less than 15 x 15 cm in a cross-section and a thickness less than 20 cm to consider 2D transducer matrix size
* Provision to sign the consent form and understand the non-invasiveness of iRAI
* Patient agreement on tolerance on placing a water bag to acquire iRAI during treatment
* Treatment modality: Proton radiation therapy with UFHPTI's ProteusONE gantry using PBS

Exclusion Criteria:

* A patient who would not be tolerable or will feel nervous about being touched on the skin with a water bag
* A patient with a significant medical implant or hardware in the treatment area
Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

This is a randomised, cross-over, open-label, confinement study conducted in 25 adult male or female smokers of combustible cigarettes (CCs). The study investigates combustible cigarettes, heated tobacco products (HTPs), and Heated Herbal Products (HHPs), with endpoints including pharmacokinetic evaluation, and subjective effects.

Subjects will perform a Screening Visit and one Study Visit, including a 6-day confinement period.


Eligibility Criteria:
Inclusion Criteria:

* Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
* Has a positive urine cotinine (\>500 ng/mL) at Screening
* Has an exhaled carbon monoxide \>10 ppm at Screening
* Female subjects of childbearing potential must use contraception
* Male subjects must use contraception

Exclusion Criteria:

* Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
* Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
* Has a body mass index (BMI) \> 30.0 kg/m\^2 or \< 18.0 kg/m\^2 at Screening
* Has a fever (\>38.05°C) at Screening or check-in
* Has a history or presence of drug or alcohol abuse within 24 months of Check-in
* Pregnant or lactating females
* Has used any prescription smoking cessation treatments within 3 months prior to Check-in Is planning to quit smoking during the study or within the next 3 months
The Effect of Active Choice on Nurse Visit Participation

The goal of this project is to see if behavioral nudges will increase an individual's likelihood of participating in a nurse visit. The behavioral nudges under consideration are encouraging subjects to make an active choice and sending reminders.

The employees in our sample will schedule their nurse visit time slot via e-mail and a health service provider website. Much as is the case in the current system, the control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and given instructions for scheduling an appointment. The treatment group, the active choice only arm, will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening. The treatment group will also receive email reminders one week before their appointment.

Eligibility Criteria:
Inclusion Criteria:

* Harrah's employee
* Registered e-mail address with Harrah's
* Part of Harrah's Choosing Wellness Program

Exclusion Criteria:

* Under 18
* Already participated in a nurse visit
Interstitial Lung Diseases in the Veterans Administration

The primary objective of this research project is to describe the characteristics, diagnosis, management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3

Exclusion Criteria:

* Inadequate documentation of patient receiving care for ILD in the health records
Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial

Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being and for the providers of the birth services. Avoiding a long, protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the childbirth experience.

Prolonged labor can lead to increased maternal and neonatal morbidity and mortality such as rupture of the uterus, postpartum hemorrhage, puerperal sepsis, and maternal death. Prolonged labor may be due to maternal age, premature rupture of membrane, epidural analgesia and the secretion of high levels of maternal stress hormones.

Several studies showed that active management of labor could shorten the duration of labor, and the safety of this method has been demonstrated.

Metoclopramide binds to dopamine receptors acting as a receptor antagonist, and it is also a mixed serotonin receptor agonist and antagonist.

Metoclopramide could potentially reduce spasms of the smooth muscle of the cervix that remains richly innervated at birth and thus have a regulatory effect on cervical contractility, an interaction that might be important in aiding maximal tissue compliance, promoting cervical dilatation during labor, and helping to reduce dystocia. Dopamine and other catecholamines have been identified in rabbit, rat, guinea-pig, sheep, and human uteri.

The purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.

Eligibility Criteria:
Inclusion Criteria:

* primigravida
* singleton pregnancy
* termgestation (37-42 weeks)
* sure reliable dated
* vertex presentation , occipito-anterior position
* regular uterine contractions at every 5 minutes,each lasting for 20 seconds
* cervical dilatation of 5 cm
* with or without rupture of membrane
* no evidence of maternal or fetal distress

Exclusion Criteria:

* chorioamnionitis
* scarred uterus e.g. myomectomy
* cephalopelvic dispropotion
* history of cervical surgery or injury
* hypersensitivity to metoclopramide
Integrated Supported Employment in Mainland China

In this randomized controlled trial, the researchers investigated the effectiveness of integrated supported employment (ISE) as compared with individual placement and support (IPS) and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland China.

One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n = 54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure, and psychological outcomes were conducted at admission, completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older;
* Diagnosis of schizophrenia for at least 2 years
* Being unemployed
* Willing to give informed consent
* Having no obvious cognitive, learning, or neurological impairment
* Having completed primary school education
* Having a desire to work

Exclusion Criteria:

• Having score lower than 18 on the 30-item Mini-Mental State Examination
a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer

This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old
* Confirmed diagnosis of Extensive small cell lung cancer
* Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
* The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
* have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
* The estimated survival period is more than 8 weeks
* The subjects voluntarily joined the study, signed informed consent,

Exclusion Criteria:

* Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
* Leptomeningeal diseases
* Uncontrolled or symptomatic hypercalcemia
* Active, known or suspected autoimmune diseases
* have received any T cell co stimulation or immune checkpoint therapy
* Corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
* Subjects had active infections
* Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
* Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
* According to the researcher's judgment, there are other factors that may lead to the termination of the study
Factors Influencing the 3-Year Recurrence of Liver Carcinoma After Surgery

Objective:

1. To study the factors that influence the 3- year recurrence of liver carcinoma after surgery
2. To study the related factors affecting recurrence of liver carcinoma after surgery

Liver carcinoma including 80% Hepatocellular carcinoma (HCC) and 20% Cholangiocarcinoma (CCA) becomes the leading causes of death in East and South-East Asia. Though hepatectomy is the treatment of choice for early stage cancer, the recurrence has been reported as 30%, 62% and 79% in 1st, 3rd and 5th year respectively. Chulabhorn hospital, a cancer institute established in 2011, has been performing a 3-years retrospective study on the influencing factors and its correlation to liver carcinoma after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients underwent liver resection for Hepatiocellular carcinoma and Cholangiocarcinoma respectively including having pathology results between February 2010 to December 2013. Data was received from Cholabhron Hospital's patient database.

Exclusion Criteria:

* All patients having no pathology results were not included.
* All patients having no show for follow up recording were excluded.
The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy

Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and venules in diabetic patients. Due to the impacts including glycol-metabolism disorder, disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is one of the most common and serious chronic microvascular complications of diabetes, and becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure of the kidney, one the other hand, the presence of albuminuria is associated with other vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly being challenged.

Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood vessels, is evaluated in a semi-quantitative manner and provides an effective means to study structure and function of microcirculation. Different from biochemical markers like albuminuria, SDF provides a visual information about vessel structure, density, and quality of diffusion. At present the research of sublingual microcirculation by SDF technique is mainly applied to microcirculation monitoring in patients in the intensive care unit or laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool of diagnosis and treatment prognostic indicator, no relevant research has been carried out to evaluate the predictive value of diabetic microangiopathy in literature so far.

Herein, the investigators designed the study based on SDF imaging to collect scientific data, thus providing strong support for the early assessment and diagnosis of diabetic nephropathy and possibly guiding individual therapy in the future.


Eligibility Criteria:
Inclusion Criteria:

* age ranges from 18 to 70 years old
* signed informed consent

Exclusion Criteria:

* Younger than 18 years old or older than 70 years old
* Shock patients who have low blood pressure under 90/60mmHg
* Patients with mental abnormality who are uncooperative with this study
* Having difficulty in mouth opening
* Patients with Ketoacidosis
* Oral mucosal inflammation or injury, which could locally influence the sublingual microvasculature
* Pregnant or lactating women
* Refuse to sign informed consent