cyrilzakka/clinical-trials huggingface dataset:
Predictors of Improvement and Deterioration of Community Acquired Pneumonia in Children

Predictors of improvement and deterioration of community acquired pneumonia in children Community-acquired pneumonia (CAP) is the most prevalent respiratory infectious disease. It is defined as an acute infection of the lung parenchyma that is acquired outside the hospital. Community-acquired pneumonia (CAP) is one of the most common disorders faced in clinical practice . \[1,2\] Childhood CAP is the leading cause of death in children younger than five years globally\[3\] .

Acute phase reactants (APR) are inflammatory mediators that show significant alternations in serum levels in response to inflammation, these markers are responsible for some adverse effects such as anorexia, fever, fatigue, and anemia of chronic illness \[4\] APR can be applied for the assessment of disease severity in CAP in collaboration with clinical evaluation and pneumonia severity scores \[5\]. The most common APR are (NLR), CRP, and ESR, changes in the level of these indices can be used in the diagnosis and prognosis of inflammatory and infectious diseases \[5\] NLR is a rapid, simple, and cheap maker of the systemic inflammatory process, it is calculated as the ratio between neutrophil count to lymphocyte count from peripheral blood sample. Numerous researches have assessed the role of NLR in many infectious diseases such as sepsis, bacteremia, and septic shock, in addition, it can predict the severity and outcome of CAP \[6\] CRP is one of the best indicators of the acute phase response to inflammation. This serum protein is synthesized by hepatocytes and is classified as an acute-phase protein based on its increased serum concentration during inflammation and infection\[7\] So, the aim of the current study was to assess levels of APR such as total leucocytic count (TLC), platelets, neutrophils, neutrophils-to-lymphocyte ratio (NLR), CRP, D-dimer, Ferritin, and ESR in patients with CAP (as a primary outcome) and to correlate between their measured values and disease severity (as a secondary outcome)

Assessment of community-acquired pneumonia (CAP) severity in association with various pneumonia severity scores. So, the aim of the study was to assess levels of APR such as total leucocytic count (TLC), platelets, neutrophils, neutrophils-to-lymphocyte ratio (NLR), CRP, D-dimer, ferritin, and ESR in patients with CAP and to correlate between their values and disease severity.

Eligibility Criteria:
Inclusion Criteria All patients above a month and below 18 years old, both sexes, fulfilling diagnosis of CAP

Exclusion Criteria:

* Non-pulmonary infections, liver, renal, and cardiac diseases.and neonates with age less than a month
Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients

The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years)
* Admitted on the intensive care unit
* Starting a treatment with beta-lactams antibiotics
* Signed informed consent
* Expected to live \> 3 days

Exclusion Criteria:

* renal insufficiency (estimated clearance \< 20 ML /MIN)
* renal replacement therapy
* ANC \< 1000 103 µl
* pregnancy
* drug abuse
Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps

The purpose of this randomized controlled double-blinded trial is to determine if the addition of an oral antifungal to typical post-operative medical therapy can prevent or reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

CRSwNP patients scheduled for medically-indicated sinus surgery will undergo screening ELIspot assay to identify patients with fungal sensitivity based on positive fungal induced interleukin 4 (IL-4) ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and randomized into either placebo or itraconazole 200 mg taken by mouth twice a day (PO BID) for 24 weeks in addition to standardized post-surgical regimen (9 days of perioperative prednisone, saline irrigations and pain medication as needed). Patients will be followed as outpatient in rhinology clinic for 48 weeks total. During these post-op visits, compliance with medications will be determined. Patients will be questioned about any possible side effects or adverse events to post-operative medications. Then, the patients will be evaluated by 2 nasal specific quality of life questionnaires and nasal endoscopy. The goals of the nasal endoscopy are to evaluate the state of the sinus mucosa and to determine recurrence of nasal polyps.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery

Exclusion Criteria:

* cystic fibrosis
* aspirin exacerbated respiratory disease
* uncontrolled or unstable chronic diseases such as uncontrolled diabetes
* active or history of cancer
* HIV positive
* history of liver or kidney disease
* history of disease with effects on immune system
* pregnant
* allergy to triazole antifungals
Surgical Ablation of Long-standing Persistent AF During CABG

Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.

Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.

This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.

Eligibility Criteria:
Inclusion criteria:

* American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for CABG
* At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF within last 12 months
* The patient's consent to participate in the study

Exclusion Criteria:

* Intolerance of antiarrhythmic drugs
* Heart valve disease requiring invasive treatment
* Left atria more than 6.5 cm
* Prior cardiac surgery
* Active pacemaker treatment
* Active anti-arrhythmic treatment (AAD) class I and III
* Contraindication to oral anticoagulant/heparin treatment
* Ejection fraction less than 30 % (EF \< 30 %) assessed by transthoracic echocardiography
Molecular Analysis of the Sloane Project

The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater).

The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer.

All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional \~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis.

The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.


Eligibility Criteria:
Inclusion Criteria:

* DCIS (Ductal Carcinoma in situ)
* LCIS (Lobular Carcinoma in situ)
* Atypical hyperplasias
Study of Vitamin D for the Prevention of Acute Respiratory Infections in Children

The main purpose of this study is to determine whether weekly oral vitamin D supplementation is effective to prevent acute respiratory tract infections in children. The hypothesis of the study is that vitamin D supplementation reduces the incidence and severity of acute respiratory tract infections in children.

Acute respiratory tract infections (ARTIs) are associated with high levels of morbidity and socioeconomic impact, particularly affecting young children. Observational studies have shown an association between vitamin D (VD) deficiency and higher incidence and severity of respiratory infections. Chile has a high prevalence of VD deficiency, particularly in the southern regions of the country. The objective of this study is to evaluate the safety and efficacy of oral VD supplementation to decrease the incidence of ARTIs in 275 preschool children. A randomized, placebo-controlled, double-blind study will be performed in Santiago, Coyhaique and Punta Arenas. Children aged 18 to 36 months will be given weekly oral 5600 IU of vitamin D3 (VD3), 11200 IU of VD3, or placebo doses during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 18 to 36 months attending daycare in Santiago, Coyhaique or Punta Arenas.

Exclusion Criteria:

* History of chronic illness requiring immunosuppression
* History of metabolic bone disease
* Use of vitamin D supplementation greater than 400 IU daily, either by milk formula or vitamin supplements in the last 3 months.
* Use of fish oil supplements in the last 3 months.
* Immunodeficiency
* Planned trip to sunny climate during study period.
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure

A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure


Eligibility Criteria:
Inclusion Criteria:

* pre-dialysis patients with chronic renal failure stage
* patient for holding the stable state in serum creatinine 2.0mg/dl - 5.0mg/dl of MDRD GFR 15-60ml/min/1.73m2 for 3 months before screening
* patients haven't experienced dose spherical carbon adsorbent for 3months before screening
* patients who were no noticeable change for 4weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(type of blood pressure medication and dose -related, diet therapy)
* patients spontaneously written consent to participate in this clinical trial

Exclusion Criteria:

* patients with passes through the digestive tract disorders
* patients with uncontrolled constipation symptoms
* kidney transplant patients
* patients who are taking immunosuppressive drugs
* patients suffering from digestive tract ulcers and esophageal varices
* patients with uncontrolled hypertension
* patients hospitalized with cardiovascular disease within 3 months of the screening
* patients with current infections
* patients who do not fulfill therapies of chronic renal failure (taking medicine and diet) as appropriate
* patients with hepatic impairment (2.5 times greater than the upper limit of normal levels of AST, ALT)
* uncontrolled diabetes (HbA1c \> 10 % or a fasting glucose \> 180mg / dL)
* patients with malignant tumors (However, if you do not relapse within five years after completion of therapy can be registered)
* pregnant women, nursing mothers
* those who do not agree to a contraceptive method allowed for the possibility of pregnancy in women
* patients participating in another clinical trial in addition to the current clinical trial
* subjects with dependency on drugs or alcohol
* subjects who took any other investigational drugs within 30 days before participating this clinical trial study
* patients expected to starting the dialysis within three months
* other patients deemed unsuitable tester
Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping

The purpose of this study is to compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19) polymorphism.

Clopidogrel has anti-platelet activity by irreversible inhibition of the P2Y12 platelet receptor. Clopidogrel must be converted into an active metabolite in order to show anti-platelet activity. Hepatic CYP2C19 enzyme is one of the key hepatic enzymes which convert clopidogrel into active metabolite and its genetic polymorphism is related to clopidogrel resistance. CYP2C19 poor or intermediate metabolizer groups show reduced anti-platelet activity of clopidogrel compared to extensive metabolizer group.

This study is designed to prove the superiority of the triflusal in preventing recurrent stroke over the clopidogrel in ischemic stroke patient with poor or intermediate metabolizer of CYP2C19 polymorphism. Also we plan to prove that clopidogrel resistance is related to CYP2C19 polymorphism by comparing the ischemic preventive effect of clopidogrel between groups of different CYP2C19 polymorphism.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening
2. ≥ 20 years of age; adult, at the date of signing the informed consent
3. Written informed consent

Exclusion Criteria:

1. History for bleeding tendency or recent major bleeding within 2 weeks
2. Chronic liver disease (ALT \> 100 IU/L or AST \> 100 IU/L) or renal dysfunction (creatinine \> 4.0 mg/dl)
3. Thrombocytopenia (platelet \< 100,000mm3)
4. Any contraindication of antiplatelet agent
5. Severe congestive heart failure
6. Patients who need to take anticoagulants or two or more antiplatelet agents
7. Severe concomitant disease with the expected survival less than 2 years
8. Pregnant or nursing
9. Any drug clinical trials within 30 days of signing the informed consent
Digital Healthcare App After Total Hip Arthroplasty

This study examines the effectiveness of rehabilitation after hip replacement surgery using a specialised app called Akina Cloud. Medical professionals at the Schulthess Clinic will provide detailed information about the study. Participants must meet certain eligibility requirements. There will be time for consideration before enrolment. A demonstration of how to use the app will be provided upon agreement. Participants will be shown how to set up their profile and interact with a real therapist who will provide feedback. The initial 30-minute introduction is scheduled to take place a few days after surgery while still in hospital. Participants will be asked to complete several questionnaires. The rehabilitation process involves using the app for at least 12 weeks, at least three times a week, for 20-30 minutes per session. Direct communication with the therapist via the app is available for any queries. Follow-up questionnaires will be emailed at 6 and 12 weeks, after training, and again at 26 weeks to assess progress and feedback on the use of the app. Each session with the app lasts about 20 minutes and the questionnaire takes about 30 minutes to complete.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Unilateral initial implantation of a minimally-invasive hip endoprosthesis
* Age between 18 and 75 years old
* Ownership of a private laptop or desktop computer
* Stable internet connection at home
* Familiarity with the use of laptop or desktop computer

Exclusion Criteria:

* Bilateral initial implantation of a minimally-invasive hip endoprosthesis
* Not fluent in German or English
* Other conditions where active therapy is contraindicated
* Neurological diseases that limit the ability to walk
* Chronic lower limb pain
* Rheumatological diseases
* Other inflammatory diseases
Study Comparing Two Methods of TransversusAbdominis Plane

Interventional, randomised, prospective, multicentric study

Interventional, randomised, prospective, multicentric and single blind study

Primary objective :

demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia

Secondary objective :

* Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup
* Compare the running time of the c-TAP Block to the us-TAP Block
* Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups:
* Arm A : c-TAP Block performed by the surgeon
* Arm B : us-TAP Block performed by the anesthesist under ultrasound control

Schedule :

* Inclusions start at: 16/09/2019
* End date of inclusions: 31/03/2022
* End date of follow-up: 01/04/2022
* Study report: 30/09/2022

Eligibility Criteria:
Inclusion Criteria:

Patient over 18 years old

* Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
* Patient mastering the French language
* Patient who received informed information about the study and signed a consent
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Patients with chronic pain
* Patients with opioid dependence
* Patients allergic to local anesthetic
* Patient who has not signed the consent of the study.
FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.
* Clinical suspicion of adenoviral etiology.
* At least three (3) years of age.
* Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent.
* Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis:

  1. conjunctival injection/inflammation, and
  2. conjunctival discharge/exudates.

Exclusion Criteria:

* Conjunctivitis longer than 7 days after initial ocular symptoms.
* Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
* Patients taking ocular anti-inflammatory medications on a chronic basis.
* Active herpes ocular infection.
* Known or suspected pregnancy.
* Known allergy to PVP-I.
* Known allergy to dexamethasone.
* Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes

Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism

This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up

Eligibility Criteria:
Inclusion Criteria:

* Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.

Exclusion Criteria:

* Patients who previously went through heart surgery should be excluded from the study.
Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

Each participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients with DCIS or invasive breast cancer
* Undergoing breast conserving surgery and adjuvant radiation
* Subjects must be willing and able to provide breast skin samples

Exclusion Criteria:

* Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)
* Refuse or are unable to sign informed consent form
* Past history of breast cancer