cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Lactoferrin, Procalcitonin and Aution® Urine Dipsticks for the Diagnosis of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Bacterial infections are a major cause of mortality in cirrhotic patients in the context of gastrointestinal bleeding or spontaneous bacterial peritonitis (SBP). Rapid diagnosis of SBP is therefore an important research goal because the gold standard neutrophil count in ascitic fluid cannot be performed 24 hours a day in all healthcare structures. The use of urine dipsticks in ascites cannot be recommended at the present time due to their insufficient sensitivity with an unacceptable risk of false-negatives in the context of a fatal disease for which effective antibiotic therapy is available. Ascitic fluid lactoferrin assay has recently been demonstrated to be a very good diagnostic test for SBP. The investigators plan to conduct a prospective study on lactoferrin as well as procalcitonin (PCT) to determine the best laboratory test(s) for the rapid, automated diagnosis of SBP. These tests will be compared with the Aution® urine dipstick, which has been shown to present better diagnostic sensitivity than the Multistix® dipstick . This single-centre study (Amiens University Hospital) will be performed in the context of routine clinical practice on ascitic fluid that is usually incinerated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years, not unable major
* Cirrhosis diagnosed by liver histology (or a non-invasive test , biological, or Fibrotest Fibrometer , or physical Fibroscan® ) , or a set of clinical, laboratory , ultrasound and endoscopy .
* Presence of ascites puncture in the clinical part of routine care

Exclusion Criteria:

* Ascites noncirrhotic origins : heart , nephrotic syndrome, peritoneal dialysis, tuberculosis, cancer peritoneal carcinomatosis , acute and chronic pancreatitis
* surgical peritonitis by perforation of hollow organ
* Haemoperitoneum pure or associated with ascites.
Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

(1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score \>70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;

Exclusion Criteria:

1. Patient who have distant metastasis
2. The primary tumor or lymph node already received surgical treatment (except for biopsy);
3. Patient who received radiotherapy for primary tumor or lymph node;
4. Patient who received the the epidermal growth factor targeted therapy;
5. Patient who received chemotherapy or immunotherapy;
6. Patient who suffered from other malignant tumor;
7. Epidermal growth factor receptor（EGFR）mutation（-）;
8. Patient who have taken other drug test within 1 month;
9. Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
10. Subject with a severe allergic history or idiosyncratic;
11. Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
12. Drug abuse or alcohol addicted;
13. Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;
Blood Pressure Sensor of Watch-type Device With ECG Technology

The ASUS Blood Pressure App "ASUS HealthConnect" is a software-only mobile medical application. It is designed to be compatible with ASUS VivoWatch SP watches and mobile phones. Used together to create, record, store, and display blood pressure information. This application determines the systolic and diastolic blood pressure and pulse rate and provides numerical and historical graphs after calibration with the cuff-type upper arm blood pressure monitor. The above data is only captured when the user is resting.


Eligibility Criteria:
1. Inclusion criteria:

   This plan excludes those under 22 years of age, pregnant, and severe cardiovascular and neurological diseases. It is estimated that about 120 subjects will be admitted and divided into three groups:

   (1.1) The first group-High Range: At least 17 subjects over 22 years old with systolic blood pressure exceeding 140mmHg and diastolic blood pressure exceeding 90mmHg.

   (1.2) The second group-Middle Range: at least 17 subjects over 22 years old with systolic blood pressure ranging from 110mmHg to 140mmHg and diastolic blood pressure ranging from 60mmHg to 90mmHg.

   (1.3) The third group-Low Range: at least 17 subjects over 22 years old with systolic blood pressure lower than 110mmHg and diastolic blood pressure lower than 60mmHg.
2. Exclusion criteria:

(2.1) People younger than 22 years old. (2.2) pregnancy. (2.3) the following conditions:

* Arrhythmia
* Prior heart failure or heart attack
* Peripheral vascular disease or compromised circulation
* Valvular disease (diseases concerning the aortic valve)
* Cardiomyopathy
* Other known cardiovascular disease
* End-stage Renal Disease (ESRD)
* Diabetes
* Neurological disorder (for example, tremors)
* Clotting disorder or you are taking prescribed blood thinners
* Tattoo(s) on the wrist where you will wear the ASUS VivoWatch SP
Relation Between Oculocardiac Reflex and Laryngospasm

The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries

Background: Laryngospasm is one of the serious complications that can be seen in perioperative period, especially during anesthesia induction and extubation. The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for the strabismus surgery
* ASA 1-2 patients
* 2-65 yo patients

Exclusion Criteria:

* Patients with kidney, cardiac diseases
* Being treated with sedative or anticonvulsant drugs
* ASA 3-4 patients
* Patients with upper respiratory tract disease in the last 2 weeks
* Patients who do not want to participate in the study
* Patients with behavioral disorders
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects with Mild to Moderate Dementia with Lewy Bodies

Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.

The safety and efficacy of CT1812 at doses of 300 and 100mg will be evaluated over a 24 week double-blind treatment period in patient diagnosed with dementia with Lewy bodies.

Patients will be randomized 1:1:1 to placebo, 100mg CT1812 or 300mg CT1812. Oral CT1812 will be taken daily. Subjects meeting eligibility requirement and signing informed consent will be assessed by repeated psychometric/neurologic testing, safety procedures and PK and PD sample collection at defined intervals throughout the study. Plasma and CSF biomarkers will also be followed.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB).
* MRI, or CT scan due to contraindication of MRI if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.
* MMSE 18-27 inclusive

Exclusion Criteria:

* Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any co-morbidities detected by clinical assessment or MRI (or CT scan due to contraindication of MRI, if approved by medical monitor)
* Screening MRI (or historical MRI or CT scan due to contraindication of MRI if approved by medical monitor) or historical MRI/CT scan, if applicable. of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \> 1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.
* Clinical, laboratory findings or medical history consistent with:

  1. Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
  2. Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
  3. Seizure disorder.
  4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
* Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
* Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
Nudging Effective and Equitable Delivery of Specialty Palliative Care

This stepped-wedge, cluster randomized pragmatic trial among 9 MedStar hospitals for patients with serious illness and unmet palliative care (PC) needs will test two interventions embedded within the electronic health record (EHR): (1) a PC needs triggered alert to opt-in to PC consults nudging hospital clinicians to order specialty PC consults for eligible inpatients, and (2) a palliative care needs triggered alert with an opt-out to palliative care consults. The trial will compare the interventions effects to usual care, focusing on hospital-free days through 6 months and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older; AND
2. Inpatient status; AND
3. Meet or exceed EHR palliative care needs algorithm threshold

Exclusion Criteria:

1. Primary inpatient service: hospice, rehabilitation, psychiatry, obstetrics, neonatal
2. Signed hospital discharge order
CYP3A4 Activity and Mineral Homeostasis

The purpose of this study is to determine whether changes in the activity of the enzyme CYP3A4 can change the Vitamin D and bone mineral homeostasis.

Healthy volunteers will receive one of six interventions for 14 days (determined by randomization):a). 200 mL of water once a day; b) rifampin 600 mg once a day; c) 200 mL of grapefruit juice once a day for 8 days plus rifampin 600 mg once a day for 14 days; d) clarithromycin 250 mg twice a day; f) clarithromycin 250 mg twice a day plus rifampin 600 mg once a day.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with no history of significant medical conditions including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C
* Subjects will be males or females 18-60 years of age
* Subjects must read and understand English
* Subjects must be able to provide informed consent
* Subjects must be willing to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity
* Subjects must be willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption
* Women not currently pregnant or lactating. In addition, women participants of childbearing age must be willing to utilize a barrier method of birth control (sterilization will be acceptable)
* Subjects will have no known allergies to the study drugs to be used
* Subject's corrected QTc interval obtained by electrocardiogram will be ≤ 430 ms in men or ≤ 450 ms in women

Exclusion Criteria:

* Subjects with any significant chronic medical condition, including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C
* Subjects less than 18 or greater than 60 years of age
* Subjects unable to read and understand English
* Subjects unable to provide informed consent
* Subjects unable to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity
* Subjects not willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption
* Women who are pregnant or lactating and women participants of childbearing age not willing to utilize a barrier method of birth control (sterilization will be acceptable)
* Subjects with allergies to rifampin, clarithromycin or grapefruit juice
* Potential participants will be excluded if they are concurrently participating in another research study
* Subjects with corrected QTc interval \> 430 ms in men or \> 450 ms in women on electrocardiogram
Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence

A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(HCC) patients at high risk of post surgery recurrence.

Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Recurrence of HCC is still a great challenge and threat to the patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit.

HCC patients who meet the eligibility criteria of this clinical trial will adopt postoperative TACE combined with anlotinib hydrochloride. At Day4 of TACE,anlotinib 12mg QD PO d1-14, 21 days per cycle until disease progresses or intolerant.

Primary Efficacy Endpoint: Disease free survival (DFS);Secondary Efficacy Endpoints: 1-year DFS Rate and Time to recurrence (TTR)(According to RECIST Version 1.1).Safety will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Eligibility Criteria:
Inclusion Criteria:

* Patients participate in the study voluntarily and sign informed consent with good compliance.
* After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and \< 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).
* Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP \> 400μg/L.
* TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.
* ≥ 18 and ≤ 75 years of age.
* ECOG performance status of 0-1.
* liver function child-Pugh class A or B (≤7 points).
* Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function.

Exclusion Criteria:

* Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (\>10 mm)in baseline data or in TACE.
* Patients with absolute contraindications to TACE.
* Patients with HCV infection.
* Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed.
* Pregnant or lactating women.
* Patients with mental illness.
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with nHCM (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with LV wall thickness ≥ 15mm at Screening or ≥ 13mm with a positive family history of HCM.
* Age 18 and greater, Body weight \> 45kg
* Documented LVEF ≥ 55% at the Screening as determined by echo central lab
* LVOT gradient \< 30 mmHg at rest AND during Valsalva AND post-exercise
* NYHA functional class II or III
* Elevated NT-proBNP at rest

Key Exclusion Criteria:

* History of syncope, sustained ventricular tachyarrhythmia with exercise, obstructive coronary artery disease or myocardial infarction within the past 6 months
* History of resuscitated sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (ICD) discharge within 6 months prior to Screening
* Current treatment with disopyramide or ranolazine (within 14 days prior to Screening)
* Current or planned treatment during the study with a combination of beta-blockers and calcium channel blockers
* Has been treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening
* History of resting or post-exercise LVOT \>30 mmHg unless subsequently treated by septal reduction
* Has QTc Fridericia (QTcF) \>480 ms or any other ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II)
* Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate-controlled within 1 year of Screening
* History of clinically significant malignant disease within 10 years such as non-metastatic cutaneous squamous cell or basal cell carcinoma
* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or MyoKardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Jakarta Acute Coronary Syndrome Registry

Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to the emergency department of all health centers in Jakarta and the surrounding area.

The JAC registry is an ongoing prospective, multi center, observational study that aims to enroll ACS patients who admitted to the emergency department (ED) of all health centers in Jakarta and the surrounding area. The registry has been collecting data since 2007, and used extensively since 2014.

Currently, the JAC registry is the main source of data for measuring the performance of the STEMI network in the region, namely Jakarta Cardiovascular Care Unit Network System. The STEMI network in Jakarta has been introduced as an integral part of the government project since 2010/2011.

STEMI was diagnosed based on the typical chest pain and ST segment elevation on two or more contiguos leads. The number of primary PCI, fibrinolytic therapy and non-reperfused patients were recorded.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients that was diagnosed based on the presence of typical chest pain and ST-segment elevation in two or more contigious leads on the initial ECG

Exclusion Criteria:

* STEMI patients that was under 18 years
Effect of Strategies to Improve General Practitioner-nurse Collaboration and Communication

Previously,six measures were developed for a better collaboration of general practitioners and nurses in nursing homes in a qualitative multistep bottom-up process. These measures, summarised as the interprof ACT intervention, shall improve the flow of information and the communication between the involved parties and lead to more transparency and effectiveness regarding treatment decisions of nursing home residents.The major aim of this trial is to examine the clinical effectiveness of interprof ACT. The main hypothesis is that implementation of interprof ACT reduces the cumulative incidence of hospitalisations of nursing home residents within 12 months from 50% to 35% (15% absolute reduction).


Eligibility Criteria:
Inclusion Criteria Residents:

* at least one GP visit in recent three months or
* two GP visits in recent 6 months or
* admission to the nursing home during the precedent 6 months independently of documented GP contacts
* at least 18 years of age
* written informed consent by the resident or her/his legal guardian

Inclusion Criteria Nursing Homes:

* minimum size of 40 residents
* written consent provided by the nursing home Manager Prior to randomisation

Exclusion Criteria Residents:

- admission for short term care only

Exclusion Criteria Nursing Homes:

- participation in other projects on interprofessional collaboration.
Evaluation of the Cost of a Nosocomial Infection With Clostridium Difficile

Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode of transmission and its resistance in the environment.

Nosocomiality is defined by the apparition of an infection 48 hours after the patient's hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted directly through the hand or from the contaminated environment (during care or not). By implementing prevention and optimal treatment, nosocomial infections are preventable.

A clostridium difficile infection causes an additional cost of patient care for the hospital. This additional cost is principally due to the increase of the length of the stay. It varies according to patient risk factors,and also according to the reason of the hospitalization and can vary from 300 euros (\~317$) to more than 25.000 euros (26.460$).

By determining the increase in the length of the stay and the additional cost due to a clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut Catholique de Lille), prevention will be valued and measures against those infections should be easier to set up.

The main objective of this study is to evaluate the additional cost of an infection by clostridium difficile.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have stayed in an hospital of the GHICL between January 2013 and September 2015.

Exclusion Criteria:

* none