cyrilzakka/clinical-trials huggingface dataset:
EDoF IOLs vs Monofocal IOL

prospective, comparative (3 arms), randomized, multicentric clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent;
* Patients of any gender, aged 50 to 80 years;
* Assured follow-up examinations;
* clinically significant bilateral cataract;

Exclusion Criteria:

* Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial;
* Patients whose freedom is impaired by administrative or legal order;
* Current participation in another drug or device investigation;
* Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
* Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
* Pseudoexfoliations syndrome
* Pathologic miosis or Pharmacotherapy with miotic agent
* Keratoconus
* Chronic or recurrent uveitis
* Diabetic retinopathy
* Uncontrolled glaucoma and or IOP\>24mmHg
* Choroidal hemorrhage,
* All kind of infections (acute ocular disease, external/internal infection, systemic infection)
* Traumatic cataract
* Aniridia
* Microphthalmia
* Amblyopia
* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
* Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
* Previous intraocular and corneal surgery
* Expected postop. astigmatism greater than 1 D
* Any type of corneal disorder
* Systemic or ocular pharmacotherapy, which can impact the visual acuity,
* Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
* Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
* Dementia
* pregnancy or lactation period for female patients
Impact of Rotavirus Vaccine Introduction for South Australian Children

This project aims to assess the impact of rotavirus vaccine introduction on severe gastroenteritis in South Australian children. Prevalence of rotavirus coded hospitalisations and all-cause gastroenteritis hospitalisations will be compared for a two year period prior to introduction of the vaccine and a two year period following introduction of the vaccine. Severity of rotavirus coded admissions during the periods will also be assessed.

Hypotheses:

1. Introduction of the rotavirus vaccine will result in an 80% reduction in hospitalisations for rotavirus positive gastroenteritis (ICD code A0.80) in children less than two years of age.
2. Introduction of rotavirus vaccine will result in an 80% reduction in Paediatric Emergency presentations for rotavirus positive gastroenteritis in children under two years of age.
3. Introduction of the rotavirus vaccine will result in a 50% reduction in hospitalisations for all cause gastroenteritis (ICD codes A0.00-A0.90) in children less than two years of age.
4. Introduction of the rotavirus vaccine will result in a 50% reduction in Paediatric Emergency presentations for all cause gastroenteritis in children less than two years of age.
5. Introduction of rotavirus vaccine will result in a reduction in hospitalisation and Paediatric Emergency presentations in children aged four and five years with rotavirus positive gastroenteritis (unvaccinated cohort).
6. There will be no difference in severity of disease as scored by the Vesikari and/or clark severity score prior to and post introduction of rotavirus vaccine

This project aims to assess vaccine effectiveness in the field following introduction of the rotavirus vaccine in South Australian children. It is important to confirm the benefits of the vaccine post licensure to ensure the best health care options for children. Between July 2007 - June 2008 at the Women's and Children's Hospital, there were approximately 2000 gastroenteritis patient samples analysed, with approximately 200 of these confirmed as rotavirus positive (10%). The current vaccines available in Australia (Rotarix® and RotaTeq® ) are licensed for administration in infants up to six months of age as safety data is not yet available for older children. It is therefore important to determine whether vaccination according to the current Australian Standard Vaccination Schedule can also demonstrate a positive change (less disease and less severe disease) in the burden of rotavirus disease in older unvaccinated children.

Eligibility Criteria:
Inclusion Criteria:

* males and females aged 0-less than 6 years of age admitted to SA hospital with ICD10-AM separation codes consistent with rotaviral infection or gastroenteritis of any cause.
* for severity component, only admissions to the Women's and Children's Hospital will be examined

Exclusion Criteria:

* nosocomial rotaviral infections (defined as onset \>48 hours post admission date) will be reported separately in the severity analysis
A Comparison of Two Daily Disposable Contact Lenses

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Comparison of Outcomes Between Intraosseous Femoral and Tibial Injection in Simultaneous Bilateral Total Knee Arthroplasty Patients

In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Pain management after total knee arthroplasty TKA is an important consideration to improve patient outcomes and reduce length of stay. Periarticular injections of the knee are one of the techniques used to reduce pain after surgery. Studies have shown that compared to other methods of pain relief, they are effective and safe. At present, no studies to compare between multimodal intraosseous femoral injection \& multimodal intraosseous tibial injection in Simultaneous Bilateral TKA patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo bilateral Total knee Replacement due to osteoarthritis of both knees
* Used of a cemented, PS design TKA surgery.
* Able to give informed consent

Exclusion Criteria:

* Revision TKA
* History of previous knee or hip surgery
* History of allergic reaction or side effects to the drug that will be used in the experiment
* Underlying diseases of chronic kidney disease or chronic liver disease (Child Pugh B or C)
* Pregnancy
* History of coagulopathy or abnormal blood coagulation profile(INR \>1.4 or aPTT ratio \> 1.4)
* History of platelet dysfunction or platelet count \< 140,0000/mm3
* History of Thromboembolism
* Use of Anticoagulants.
Clinical, Physiological and Prognostic Implication of Microvascular Status

There are several physiologic parameters in evaluating cardiovascular disease. This study will reveal which parameter is the most proper value in predicting disease severity and risk factors of patients.

Fractional Flow Reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) will be measured in stable angina patients before coronary intervention.

Relationship between angiographic characteristics of patients and FFR, IMR, CFR will be analyzed. Comparison of risk factors and prognosis between parameters will be also analyzed. This study will evaluate that which parameter is correlate with disease severity and risk factors of patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients with stable angina
* FFR, IMR, CFR were measured before coronary intervention

Exclusion Criteria:

* Patients who have severe side effects or contraindication to hyperemic agents (ex. adenosine)
* Patients with hemodynamic instability
* elevation of cardiac enzymes, evidence of acute MI, or a culprit vessel of acute coronary syndrome
Risk Profile for Patients With Atrial Fibrillation

The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.

Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.

Eligibility Criteria:
Inclusion Criteria:

* Short-lasting symptomatic paroxysmal or persistent AF;
* Rhythm control strategy is preferred;
* No contra-indication for oral anticoagulation;
* Age \> 18 years;
* Written informed consent

Exclusion Criteria:

* Total history of heart failure and/ or of severe valvular disease \> 3 years;
* Severe valvular disease;
* Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
* Post-operative AF.
A Study to Evaluate SHR-1210 in Combination With Capecitabine + Oxaliplatin Sequenced by SHR-1210 + Apatinib as First-line Therapy in Treatment of Advanced Gastric Cancer

This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by apatinib with or without SHR-1210 versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or mestastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ)
* Age ≥ 18 years old, male or female
* NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER-2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
* Has measurable disease per RECIST 1.1
* Eastern Cooperative Group (ECOG) performance status of 0 to 1
* Has adequate organ function
* Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.

Exclusion Criteria:

* Has known HER2-positive status
* Has known active central nervous system metastatases
* Has received a live vaccine within 4 weeks prior to the first dose of study treatment
* With any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
* Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), orventricular arrhythmia which need medical intervention.
* Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.
VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment

This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.5-40.0 kg/m2 with a minimum weight of 45 kg
* Able and willing to abstain from alcohol from 48 h before admission until the follow-up visit
* Suitable veins for cannulation/multiple venipunctures, as assessed by the Investigator at Screening
* Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration.
* Laboratory values meeting defined entry criteria

Subjects with normal renal function (Group 1) must also meet the following criteria:

* Match to one or more subjects with renal impairment by gender, age, and weight

Subjects with renal impairment (Groups 2-5) must also meet the following criteria:

* Stable, pre-existing renal impairment.

Exclusion Criteria:

* Employee of the study site, Contract Research Organization (CRO) or the IND Sponsor
* Female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
* Male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
* Use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent)
* The subject has a congenital or acquired immunodeficiency syndrome
* Screening or Day -1, clinically significant abnormal ECG values
* Active malignancy; exceptions are permitted for carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted
* History of drug allergy of a severity that required urgent medical treatment, such as treatment with epinephrine in an Emergency Department
* Known immediate hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
* History of donation of more than 450 mL of blood within 60 days before dosing in the site or planned donation before 30 days has elapsed since ingestion of study drug
* Plasma or platelet donation within 7 days of dosing and throughout the study
* Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year
* Oral temperature \>38.5˚C or acute illness on Day -1
* Previous participation in a study of VNRX-5133
* Excluded concomitant medication
Optimal Value Increase of Egg Products

The aim of this project is to evaluate daily intake of eggshell membrane taken as supplement (capsule), will reduce markers of inflammation in older people.


Eligibility Criteria:
Inclusion Criteria:

The study will include home-dwelling men and women ≥ 70 years. All subjects have to be in a good enough condition to meet up at the Department of Nutrition, University of Oslo at two occasions during the study period.

Exclusion Criteria:

* CRP \>10 mg/L
* Egg allergy
* Use of medication affecting inflammation
* Unstable use of medication or supplements last 3 months
* Unwilling to keep the physical activity level, habitual dietary intake, tobacco use and weight stable during the study period
* Severe illness last 3 months
* Unwilling to perform physical tests
* Eligibility
* Diabetes type I or II, HbA1c ≥ 6.5 %
Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients

The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Chinese patients
* Heart rate ≥ 65bpm
* Has been diagnosed as Stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose criteria of Stable angina on Appendix C)
* With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;
* Has been on beta-blockers for at least 4 weeks\*, on the dose equivalent to Betaloc ZOK® 23.75-47.5mg/day.

Exclusion Criteria:

* Acute myocardial infarction within 6 months
* Unstable angina or Prinzmetal's angina
* II degree of AV block or greater
* Significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the Investigator's opinion) including:
* Significant renal impairment (serum creatinine \> 2.0 mg/dL)
* Serum Alanine Aminotransferase or Aspartate Aminotransferase \> 3 x upper limit of reference range
* Serum potassium \< 3.0 mEq/L
* Serum sodium ≤ 130 mEq/L
* Acute or chronic hepatitis or cirrhosis (clinical diagnosis)
* Uncontrolled hyperthyroidism (clinical diagnosis)
* Systolic blood pressure ≥ 180 mmHg, or \< 100mmHg at enrolment
* Patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion or hypotension)
REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma

This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany.

This observational disease study aims to improve the understanding of the real-world situation of patients with severe uncontrolled asthma, the influence of environmental factors on the risk of exacerbations as well as the patients' quality of life. The patients will provide self-reported information about their asthma control and medication use in a 12 months period after study enrollment. Additional patient information will be collected from existing electronical records (EMRs). Furthermore, patient- and provider-reported attitude towards healthcare and monitoring (measured through patient- and provider-reported experience measurements \[PREMs\]) will be collected to measure the level of satisfaction with the healthcare provision, digital and analog healthcare support programs, and the preferences in monitoring tools. The information will be collected either digitally with an application or analogically with paper-based questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at the time of consent
* Therapy within GINA/NVL steps 4 or 5 and uncontrolled disease in the previous 12 months as per the healthcare provider's assessment
* Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate
* Able to read, understand, and speak German sufficiently to complete all the questionnaires

Exclusion Criteria:

* According to the assessment of the study physician: cognitive impairment, psychiatric diseases, severe hearing or vision impairment, insufficient knowledge of the German language, if these factors could influence the ability to provide written consent and correct completion and assessment of the questionnaires.
* Current participation in an observational study that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 30 days.