cyrilzakka/clinical-trials huggingface dataset:
Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions

This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.

Following angiography, patients with significant diameter stenosis \>50% and lesion length(\> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be at least 18 years of age.
* Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm)
* Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
* Acute ST-segment-elevation MI or cardiogenic shock
* Terminal illness with life expectancy \<1 year
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted) Patients with EF\<30%.
* Serum creatinine level \>=3.0mg/dL or dependence on dialysis.
* Patients with left main stem stenosis (\>50% by visual estimate).
OCT-angiography in Diabetic Patients

Around the world there is an increasing incidence of diabetes mellitus, with millions of people affected. In this population, diabetic macular edema (DME) is the most common cause of visual impairment. While the visual impairment caused by EMD is variable, its early treatment can improve visual acuity and quality of life. The objective of this project is to use the new OCT-angiography technology, which evaluates macular capillary network without the need of intravenous injection of contrast, to assess macular microcirculatory network in its response to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be helpful in understanding the pathophysiology of visual loss associated with DME and in determining prognosis.

Patients who participate in this study will be selected among adults treated at the Retina Clinic and Ocular Oftalmologia clinics and will be aware of all stages of the research, formalizing the approval of their participation by informed consent term. The tests will be performed after pupillary dilation with 2 eye drops of tropicamide 1% (Mydriacyl, Alcon Laboratories), in Cirrus 5000 HD-OCT devices (Carl Zeiss Meditec - Dublin USA). Image acquisition protocols Optic Disc Cube 200x200 and 512x128 Macular Cube will be used, with analysis by RNFL protocols and NGO Analysis Report and Macular Cube Analysis Report, respectively. Subjective analysis of the examinations will be performed by the three authors of this project independently and then compared between them.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of diabetes mellitus type 1 or 2;
* Age equal or greater than 18 years;
* At least one eye with diabetic macular edema and central thickness greater than or equal to 290 microns (female patients) or 305 microns (males) measured by OCT and subjected to intravitreal pharmacotherapy.

Exclusion Criteria:

* Aphakic patients;
* History of major eye surgeries (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery) in the last 4 months;
* Tractional retinal detachment involving the macula, vitreomacular traction syndrome or other concurrent macular diseases;
* Advanced or uncontrolled glaucoma (according to the investigator's judgment); Evidence of angle neovascularization;
* Presence of an eye condition (besides diabetic retinopathy) which, in the opinion of the investigator, may alter the visual acuity during the study course (e.g. venous or arterial retinal occlusions, uveitis or other ocular inflammatory diseases, neovascular glaucoma, etc.);
* Significative cataract which, in the opinion of the investigator, may be decreasing visual acuity in 3 lines or more;
* History of YAG Laser capsulotomy in the last 2 months;
* Severe renal disease, defined as chronic renal failure requiring dialysis or a kidney transplant;
* Blood pressure higher than 180/110 mmHg, acute myocardial infarction, other acute cardiac events requiring hospitalisation, stroke, transient ischemic attack or treatment for congestive heart failure;
* Systemic treatment with anti-VEGF or pro-VEGF in the last 4 months.
Cost-effectiveness of Topical Fluoride in Preventing Deciduous Dental Caries in Preschool Children

Fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. However, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. This study aims to evaluate the relative clinical effectiveness and cost-effectiveness of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk.

This 24-month randomized clinical trial aims to compare the clinical efficacy and cost-effectiveness of topical fluoride application of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk in Harbin,Heilongjiang Province,China.

Preschool children (3-4 years) with high caries risk will be invited to participant in this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study.Parental concent will be sought.

The children will be randomly divided into three groups: the control group-no intervention; the intervention group 1 - applications of 1.23% fluoride foam every 6 months; the intervention group 2- applications of 2.26% fluoride varnish every 6 months.

Dental clinical examination of the children will be performed at the beginning of the study,12 months and 24 months later.The dental examiners will receive unified training and consistency test of dental caries survey.Only when the Kappa value reached 0.8 can oral examiners participate in the oral examination.Dental caries condition will be recorded. Approximately 5% of children will be re-examined to determine the reliability of the results.

The status of any possible side/adverse effects will be recorded in the follow-up examinations.

The data of the study will be analysed by SPSS Statistical Analysis Software.The differences among the groups will be calculated and compared. And p\<0.05 will be considered statistically significant.

Eligibility Criteria:
Kindergartens Inclusion Criteria:

* Kindergartens which are all located in Harbin, Heilongjiang Province, China;
* Kindergartens which are basically the same in terms of school scale, student source structure, economic level and sanitary conditions;
* Kindergartens with the same source of domestic water, or with the same fluoride concentration in water , and the fluoride concentration in water less than 1.0mg/L.

Children Inclusion Criteria:

* Children aged over 3-year and under 4-year at the time of the survey;
* Children in good health;
* Children with a certain degree of understanding and good compliance;
* Children whose parents sign the informed consent form.

Exclusion Criteria:

* Children who are unable to cooperate or have a strong vomiting reflex;
* Children with a history of asthma or allergies;
* Children with other contraindications specified in the product manual.
Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion

This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged \> 50
2. Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
3. Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
4. The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be \> 50% of the total lesion area
5. The total lesion area must be \< 12 disc areas
6. Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
7. Subjects with visual acuity of 20/32 to 20/200 in the study eye
8. Written informed consent obtained from the subject prior to inclusion in the study

Exclusion Criteria:

1. Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
2. Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
3. Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
4. Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
5. Subjects with high myopia (\> 8D) or aphakia in the study eye
6. Subjects who have had ocular surgery in the study eye in the prior three months
7. Subjects who have had a vitrectomy in the study eye at any time.
New CSF Biomarkers for Alzheimer's Disease

Today, the Alzheimer's disease (AD) diagnosis is founded not only on clinical criteria but also on complementary examinations to confirm a physiopathological process of AD. In complex cases, lumbar punction could be necessary in order to measure Aβ peptides and Total and phosphorylated Tau but new biomarkers could be useful. The main objective of this project is to conserve these cerebrospinal fluids, collected in usual practice in order to validate new biomarkers for diagnosis, prognosis or therapeutic following of Alzheimer's disease and other dementia.


Eligibility Criteria:
Inclusion Criteria:

* Lumbar punction collected in usual practice in the context of dementia diagnosis

Exclusion Criteria:

* Absence of consent
Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ambulatory outpatients 18-85 years old at screening
* Have a history of hypertension
* Qualifying laboratory results

Exclusion Criteria:

* Severe hypertension, including chronic kidney disease
* Documented congestive heart failure
* Have clinically significant respiratory, liver, or heart disease
* History of stroke, heart attack, or heart surgery in the last 6 months
* Have a history of hypersensitivity to nebivolol or other beta blockers.
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.

Autoimmune encephalitis is a diagnostic challenge, and requires early diagnosis for improved neurological outcomes. FDG PET has shown very high sensitivity, suggesting better performances than MRI, but almost exclusively in small sized retrospective studies. Brain FDG PET is therefore not included in current diagnostic criteria, conversely to brain MRI. This study will include 56 patients with confirmed - seropositive or seronegative - autoimmune encephalitis, based on 2016 Graus criteria for autoimmune encephalitis and 2021 criteria for paraneoplastic neurological syndromes. The main objective is to conduct a prospective evaluation of the diagnostic value of FDG PET performed in the acute phase before treatment initiation, or within 10 days of treatment initiation. A follow-up PET performed 3 months after treatment initiation will also be performed and analysed for all patients as part of secondary objective analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :

  1. " Definite limbic autoimmune encephalitis " according to 2016 Graus et al. criteria
  2. " Possible autoimmune encephalitis " according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF
  3. " Probable or certain paraneoplastic neurological syndrome " according to Graus et al. 2021 criteria (excluding peripheral neurological syndromes)
* Less than 6 months since first neurological symptoms imputable to autoimmune encephalitis
* Affiliated or entitled to a social security system (except AME)
* Obtaining free, written and informed consent (patient or legal representative or the close relative)

Exclusion criteria

* History of brain tumor, head trauma, infarction or cerebral hematoma likely to result in altered cerebral carbohydrate metabolism on PET
* Patients who hae been on immunotherapy (corticosteroid bolus, IVIg, plasma exchange, endoxan, rituximab or other immunotherapy) fr more than 10 days
* Pregnant or breast-feeding woman
* Ventilated intubated patient
* Absolute contraindication to MRI (Pacemaker, cochlear implant, etc.)
* Presence of cognitive disorders incompatible with goog cooperation with the PET scan
* Algic or agitated patient unable to remain immobile in supine position for 30 minutes
* Deprived of liberty or under a protective measure (guardianship or curatorship)
* Patient taking part in other interventional research involving radiopharmaceutical injections
ATTR Expanded Access Program (EAP) by Ionis

The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).

The Program is intended to provided expanded access to Inotersen for eligible patients with hATTR who have limited or no available treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age with a diagnosis of hATTR
* Symptoms consistent with polyneuropathy
* Meet Polyneuropathy Disability (PND) Stage I-III requirements

Exclusion Criteria:

* Known Primary Amyloidosis, Leptomeningeal Amyloidosis or Monoclonal Gammopathy of Undetermined Significance or Multiple Myeloma
* Have inadequate cardiac function
* Have low platelet counts
* Have inadequate renal function
Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

The purpose of this study is to measure whether CPM (continuous passive motion) usage improves outcomes following arthroscopic hip surgery that includes labral repair. Investigators tested the hypothesis that CPM usage reduces pain levels and pain medication use and improves function in individuals who undergo hip arthroscopy.

Subjects undergoing primary hip arthroscopy for acetabular labral repair were randomized to determine whether they would receive a CPM. Those subjects receiving a CPM were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks. The total number of pain medications and average pain scores over the two weeks, as well as Hip Outcome Score Activity of Daily Living (HOS ADL) scores at standard time points were compared via a two sample t-test and intention-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

* pregnancy
* revision surgery
* bilateral surgery
An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)

This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis, defined as DAS28 \>/= 3.7
* Inadequate clinical response to current treatment with \>/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for \>/= 3 months, or inadequate clinical response to anti-TNF therapy
* Eligible for RoActemra/Actemra treatment in daily clinical practice
* Absence of evolutive tuberculosis (TB)

Exclusion Criteria:

* Hypersensitivity to tocilizumab or any of the excipients
* Active, severe infections
* Pregnant or lactating women
* Participation in any other interventional study
* Patients with major depression
The Norwegian Stroke in the Young Study II

NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.

NOR-SYS II is as far as possible standardized concerning patients' history, ultrasound examination of pre-cerebral and femoral arteries, and standardized examinations performed by speech therapists, occupational therapists and physiotherapists.

The ultrasound-protocol for carotid and femoral arteries is the same as previously performed in the NOR-SYS study. The Methods have been published before.

Eligibility Criteria:
Inclusion Criteria:

* Documented acute, arterial ischemic stroke
* Speaks Norwegian fluently

Exclusion Criteria:

* Post-traumatic and procedure related stroke
* Sinus venous thrombosis, sepsis and endocarditis
* Serious co-morbidity, such as advanced cancer with "end-of-life stroke".
* Patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics.
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hepatitis B virus (HBV). LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.

This study is an extension study of the Phase IIb (Protocol No. LG-BVCL007), the treatment period of this study is 48-week with 24-week of follow-up period

Eligibility Criteria:
Inclusion Criteria:

* The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study

Exclusion Criteria:

* Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
* Decompensated liver disease
* ALT \> 10 x ULN
* Creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min
* Alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC
* Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
* Pregnancy or breast-feeding
* Patient is currently abusing alcohol or illicit drugs
* Significant systemic illnesses other than liver diseases
* Presence of other causes of liver disease
* Plan for liver transplantation
Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon

The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in suspicious appendicitis patients.

We would give morphine or placebo to the patients suspected of appendicitis randomly and in double-blinded manner, and then surgeons would exam the patient and give the impression for the possibility of the appendicitis(grading 1 to 4).

With this grading, we compare these impression between two groups.


Eligibility Criteria:
Inclusion Criteria:

* the patients suspected of acute appendicitis over 15 years

Exclusion Criteria:

* less than 15 years
* pregnant
* allergic to morphine
* systolic blood pressure\<100mmHg
* received pain killer prior to ED visit
* do not consent
Efficacy of Bioceramic Materials for Bone Defects Repair

The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who voluntarily take the test and sign the informed consent form;
2. Patients aged 18-65 years old with no history of allergies;
3. Patients able to communicate well with the investigator and follow the requirements of the entire trial.

Exclusion Criteria:

1. Patients who refuse to sign the informed consent form to participate in the trial;
2. Patients who are not in the age range of 18 to 65 years;
3. Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
4. Patients in the acute phase of local or systemic bacterial infections;
5. Patients who cannot cooperate with the operation and evaluate the effect;
6. Other conditions that are considered inappropriate by the investigator to participate in the study.