[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Albania\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":246},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,72,106,147,179,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100543874","phase-3-study-of-iv-human-plasma-derived-c1-esterase-inhibitor-concentrate-in-patients-with-congenital-c1-inh-deficiency-for-treatment-and-pre-procedure-preventing-of-acute-hereditary-angioedema-attacks-100543874",false,"NCT06361537","Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks","Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks","Inclusion Criteria:\n\n1. Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)\n2. Has confirmed diagnosis of HAE type I or II\n3. Has had at least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months before the Screening Visit. For participants ≥2 and ≤12 years of age, has had at least 1 moderate or severe HAE attack (excluding extremity attacks) in the last 6 months before Screening Visit\n4. Has a documented congenital C1-INH functional activity \\\u003C50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range\n5. Participant or the participant's legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable\n6. States willingness to comply with all study procedures and availability for the duration of the study\n7. If the participant is of childbearing potential (CBP), has a negative pregnancy test and must have been using a highly effective method of contraception and continue to do so until at least 2 weeks after their last dose (for both blinded and open-label doses of IMP). Not of CBP is defined as surgically sterilized (hysterectomy, bilateral oophorectomy) or who are postmenopausal (defined as women with no menses for 12 months without an alternative medical cause). Highly effective methods of contraception:\n\n   * Combined hormonal contraception (estrogens and progesterone) methods such as oral, implantable, intravaginal, injectable, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (hormonal contraceptives must inhibit ovulation) and for at least 4 weeks before screening\n   * Progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n   * Intrauterine device\n   * Intrauterine hormone-releasing system inserted at least 4 weeks before screening\n   * Bilateral tubal ligation\u002Focclusion or vasectomized partner (with surgical success confirmed by medical assessment) OR Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the participant's usual lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception\n   * Note: If a participant of CBP has a positive or suspected positive urine pregnancy test within 72 hours prior to treatment, a serum pregnancy test will be required\n   * Male participants must not plan to father a child or donate sperm for 90 days after their last dose of study drug (for both blinded and open-label doses of the IMP). However, there are no official contraception requirements for male participants during the study.\n\nInclusion Criteria for IMP Dosing for QAT:\n\n1. Has confirmed QAT per definition criteria\n2. Has a swelling episode that is new and not the continuation of a previous HAE attack\n\nExclusion Criteria:\n\n1. Has a history of clinically relevant antibody development against C1-INH\n2. Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 year, no family history, no known HAE mutation, low C1q level in plasma)\n3. Has a history of allergic reaction to C1-INH or other blood\u002Fplasma product\n4. Has a history of B-cell malignancy that was unresolved in the past 5 years\n5. Has a narcotic and\u002For alcoholic addiction\n6. Has participated in any other investigational drug evaluation within 30 days before screening\n7. Is pregnant or breastfeeding\n8. Has any clinically significant medical or psychiatric condition that, in the investigator's opinion would interfere with the participant's ability to participate in the study\n9. Has a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within one year before screening\n10. (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml\u002Fmin per 1.73 m2)\n\nExclusion Criteria for IMP Dosing for QAT:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. started or changed hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) within 14 days before IMP dosing\n3. Started or changed androgen therapy (e.g. testosterone, dehydro- epiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) within 14 days before IMP dosing or is not willing to maintain a stable dose throughout the study\n4. Started or changed the dose of monoclonal antibodies e.g. lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing for a QAT\n6. Has received OCTA-C1-INH within 14 days before IMP dosing\n\nExclusion Criteria for IMP Dosing for PK:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. Is receiving hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) and has had their dose changed within 14 days before IMP dosing\n3. Is receiving or has received androgen therapy (e.g., testosterone, dehydroepiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) IN ANY DOSE within 14 days before dosing\n4. Started or changed the dose of monoclonal antibodies e.g lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing\n6. Has received IMP within 14 days before IMP dosing\n7. Has planned dental, medical, or surgical procedures during the PK Period that will require pre-procedural prevention","ALL","2 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks",[26],"Acute Hereditary Angio Edema",[28,29,30,31,32],"Edema","Swelling","Angio Edema","Hereditary","Congenital Angioedema","RECRUITING","2026-08-04",{"date":36,"type":37},"2026-08-06","ACTUAL",{"date":39,"type":37},"2024-04-30",{"date":41,"type":20},"2027-06",{"name":43,"class":44},"Octapharma","INDUSTRY",23,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100484459","phase-1-safety-and-pharmacokinetics-study-of-naldemedine-in-paediatric-participants-receiving-opioids-100484459","NCT05588323","Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids","A Phase 1\u002F2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids","Inclusion Criteria:\n\nDisease Characteristics\n\n* Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.\n* Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.\n* Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.\n\nWeight\n\n* Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.\n* Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.\n* Inability to eat\u002Fswallow or have need of a nasogastric tube.\n* No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).\n* History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.\n* Participants who need mechanical ventilation.\n* Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.\n* Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.\n\nPrior\u002FOngoing Medications\n\n* Currently receiving the first cycle of chemotherapy.\n* Previously received naldemedine.\n\nOther Exclusions\n\n\\- Positive pregnancy test for females of childbearing potential.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","18 Years",{"count":55,"type":20},24,[57,58],"PHASE1","PHASE2","The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.",[61],"Opioid-Induced Constipation (OIC)","2026-07-25",{"date":64,"type":37},"2026-07-28",{"date":66,"type":37},"2023-01-04",{"date":68,"type":20},"2028-06-15",{"name":70,"class":44},"Shionogi",16,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100505212","clinical-effectiveness-of-biologic-agents-as-an-adjunct-to-non-surgical-periodontal-therapy-of-intrabony-defects-100505212","NCT05858411","Clinical Effectiveness of Biologic Agents as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects","Evaluation of the Efficacy of rhPDGF, L-PRF and EMD as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients with a diagnosis of periodontitis stage III or IV (grades A to C),\n* non-smokers or former smokers who quit at least 1 year ago, and\n* had not received any periodontal treatment in the 3 months prior to recruitment;\n* Presence of at least 1 Infrabony defect (PPD ≥ 5 mm with infrabony defect depth of ≥3mm at screening radiograph);\n* One and two wall infrabony defects at screening radiograph and periodontal charting.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\\>7%, rheumatoid arthritis or any form of immunosuppression;\n* Subjects requiring antibiotic prophylaxis;\n* 3-wall infrabony defects;\n* Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment;\n* Presence of furcation defect;\n* Chronic intake of NSAIDs or steroids, currently;\n* Patients undergoing orthodontic treatment, having removable prosthetic appliances, pregnancy, tumors of the oral cavity or the presence of any psychiatric condition that could affect participation.",{"count":80,"type":20},88,[82],"NA","The aim of the present study is to clinically and radiographically compare the efficacy of recombinant human platelet-derived growth factor (rhPDGF), Leukocyte-Platelet Rich Fibrin (L-PRF) and Enamel Matrix Derivatives (EMD) in intrabony defects following minimally invasive non surgical peridoontal therapy (MINST).\n\nThis study will be designed as a randomized clinical trial of 12-month duration. A total of 88 patients (each with a single infrabony defect) will be recruited and randomly equally distributed into 4 groups: an experimental group treated with MINST and rhPDGF, a second group treated with MINST + L-PRF, a third group treated with MINST and EMD and and a control group treated with MINST alone.\n\nEach defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following MINST experimental and control sites will be randomly chosen. The test sites will be treated by inserting a collagen plug soaked for at least 15 minutes in a 1.5cc solution containing hPDGF-BB. In the second group the infrabony defects will be treated with MINST and L-PRF. In the third group the infrabony defects will be treated with MINST and EMD. The control group will be treated with MINST alone.\n\nPre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.\n\nStandardized radiographs of selected study sites will be taken at baseline and at the 6 and 12 months follow-up visits using the long-cone technique with a customized holder and a thermoplastic occlusal reference to allow reproducible positioning. All radiographs will be analysed by a dedicated dental software (Carestream Dental LLC Atlanta, GA, USA) to make linear measurements. The defect bone level (DBL), the defect angle (DA), the intra- and suprabony components of the defect and the radiographic defect area (RDA) will be evaluated.",[85,86,87,88],"Periodontal Diseases","Periodontal Attachment Loss","Pocket, Periodontal","Intrabony Periodontal Defect",[90,91,92,93,94],"rhPDGF","Growth factors","Periodontal regeneration","L-PRF","Enamel Matrix Derivatives","2026-05-25",{"date":97,"type":37},"2026-05-28",{"date":99,"type":37},"2023-01-08",{"date":101,"type":20},"2027-09-01",{"name":103,"class":104},"G. d'Annunzio University","OTHER",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100611777","effect-of-mi-paste-plus-on-streptococcus-mutans-and-white-spot-lesions-in-fixed-orthodontics-100611777","NCT07244991","Effect of MI Paste Plus™ on Streptococcus Mutans and White Spot Lesions in Fixed Orthodontics","Effect of MI Paste Plus™ on Streptococcus Mutans Counts and White Spot Lesions in Patients With Fixed Orthodontic Appliances: A Triple-Blind Clinical Trial","MIPASTEORTHO","Inclusion Criteria:\n\n* Age between 5 and 45 years.\n* Indication for fixed orthodontic treatment, either with fixed auxiliary appliances (including orthopedic devices) or brackets with or without auxiliary components.\n* General good health with no systemic diseases affecting oral health.\n\nExclusion Criteria:\n\n* Advanced white-spot lesions with untreated dentin involvement.\n* Presence of active untreated dental caries at baseline.\n* Antibiotic therapy within the previous two months.\n* Previous diagnosis of molar-incisor hypomineralization (MIH).\n* History of immunosuppression.\n* Iron-deficiency anemia or other clinically relevant hematological disorders.\n* Parafunctional habits such as lip sucking or finger sucking.\n* Use of any type of dental prosthesis.\n* Smoking or tobacco use.\n* Documented allergy to nickel.\n* Requirement for orthodontic treatment using removable appliances or clear aligners.",true,"5 Years","45 Years",{"count":118,"type":20},200,[82],"Background This study is part of a doctoral research project at Universidad Cardenal Herrera CEU (Spain), directed by Prof. Santiago Arias de Luxán and conducted by doctoral candidate Shirli Kelmendi within the PhD program in Translational Medicine.\n\nFixed orthodontic appliances complicate oral hygiene by creating retention areas that favor bacterial colonization and alter microbial balance. These conditions increase plaque accumulation and Streptococcus mutans (S. mutans) proliferation in saliva and plaque. The frequent low-pH environment favors aciduric bacteria such as S. mutans and lactobacilli, promoting enamel demineralization and formation of white spot lesions (WSLs) or cavitations. WSLs appear as opaque white areas due to subsurface mineral loss, mainly in the gingival third of the crown. They may develop as early as one month after bracket placement, while in patients without appliances, progression occurs after at least six months. Increased S. mutans levels have been reported as early as six weeks after treatment start. Risk factors include poor brushing, lack of floss or rinse use, time since last cleaning, and presence of caries or lesions.\n\nIntervention MI Paste Plus (GC, Japan) is a remineralizing cream with 0.20% sodium fluoride (900 ppm) and 10% CPP-ACP (RECALDENT™), providing calcium and phosphate stabilized by casein phosphopeptides. It has antibacterial and remineralizing effects, suitable during or after orthodontic treatment to prevent or reduce WSLs.\n\nObjective To evaluate whether MI Paste Plus during fixed orthodontic treatment reduces S. mutans counts in saliva and\u002For WSL incidence.\n\nStudy Design A prospective, triple-blind, randomized clinical trial, approved by the Ethics Committee of the Ministry of Health of Albania and the Ethics Committee for Human Research of Universidad Cardenal Herrera CEU, Spain.\n\nThe study will include 200 patients (100 per group) from two orthodontic clinics in Tirana, Albania. Participants will be stratified by age, risk level, and appliance type, then randomized by third parties.\n\nOutcome Measures Primary variables: S. mutans counts in saliva and number of WSLs after 3 months.\n\nStandardized saliva collection, culturing, and bacterial quantification ensure consistency. Clinical assessments will be performed at 1 and 3 months using QRay Cam Pro (Inspektor Systems, Netherlands) for quantitative fluorescence and ICDAS for visual inspection.\n\nData will be analyzed using SPSS\u002FR Commander software.",[122,123,124,125],"Dental Caries","Streptococcus Mutans","Tooth Demineralization","Orthodontic Appliances, Fixed",[127,128,129,130,131,132,133,134,135,136],"MI Paste Plus","Remineralization","Streptococcus mutans","White Spot Lesions","Fixed Orthodontic Appliances","Quantitative Light-Induced Fluorescence","Randomized Controlled Trial","Triple-Blind Study","Albania","CEU Cardenal Herrera University","2026-03-24",{"date":139,"type":37},"2026-03-27",{"date":141,"type":37},"2026-01-04",{"date":143,"type":20},"2027-11",{"name":145,"class":104},"Cardenal Herrera University",2,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100595159","phase-3-atropine-eyedrops-for-myopia-progression-in-children-and-adolescents-moderato-study-100595159","NCT07028827","Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)","A Phase III, Randomized, Double-blind, Multiple Doses, Placebo-controlled, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Atropine for the Treatment of Myopia Progression in Children and Adolescents (MODERATO Study)","MODERATO","Inclusion Criteria:\n\n* Males and females, aged from 3 to less than 18 years.\n* Subjects showing myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline.\n* The intraocular pressure in each eye must be equal or less than 21 mmHg.\n* The parents or the legal representative must be informed about the clinical trial and must sign the informed consent form. The exception to consider is related to the individuals aged above 16 years only in the UK, who can provide their own consent according to the local regulations.\n* Women with childbearing potential (WOCBP) (after menarche) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the study will be conducted at visits 1, 2, 3, 4, 5, 6.\n* WOCBP or males who are using a highly effective birth control method to prevent pregnancies. Eligible highly effective contraceptive methods for WOCBP are combined (which contain estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal (inside of the vagina), transdermal (through the skin)); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (small devices that are placed inside uterus to prevent pregnancies); intrauterine hormone-releasing system. Sexual abstinence represents a highly effective contraceptive method, if in line with the subject's normal habits.\n\nExclusion Criteria:\n\n* Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding \\|1.5\\| D.\n* Refractive astigmatism exceeding \\|1.5\\| D.\n* Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.\n* History of amblyopia or strabismus.\n* Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)\n* Abnormalities in ocular biometry, except for axial length or previous intraocular or ocular laser\u002Fnon-laser surgery.\n* History of glaucoma or narrow angles in the anterior chamber of the eye.\n* Conditions such as Down syndrome or spastic paralysis.\n* Known intolerance or allergies to atropine eye drops or hypersensitivity to any component of the atropine eye drops.\n* Pregnancy or breastfeeding.\n* History of alcohol or drug abuse.\n* Mental or emotional instability that could interfere with study procedures.\n* Lack of reliability or cooperation from the patient.\n* Any treatment received for myopia within the past three months prior to inclusion in the study.\n* Other reasons, at the discretion of the investigator that may deem the subject's participation in the study inappropriate.\n* Patients who have consented to participate in the clinical trial, but do not meet one or more eligibility criteria required for participation in the trial during the screening procedures, and subsequently are not randomly assigned to the study treatment or entered in the study, are considered screening failures.","3 Years","17 Years",{"count":158,"type":20},234,[23],"Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors.\n\nMyopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems.\n\nProgressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized.\n\nMyopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age.\n\nThe most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%.\n\nAtropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents.\n\nMODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.",[162],"Myopia",[162,164,165,166,167,168],"Atropine sulfate","Eye drops","Short-sightedness","Eye Diseases","Paediatric population","2026-02-10",{"date":171,"type":37},"2026-02-11",{"date":173,"type":37},"2025-09-01",{"date":175,"type":20},"2027-12-31",{"name":177,"class":44},"Ocus Innovation Ireland Limited",11,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":187,"enrollmentInfo":188,"targetDuration":17,"studyType":190,"phases":4,"briefSummary":191,"conditions":192,"keywords":199,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":105},"100594996","tirana-acs-a-prospective-registry-study-for-the-targeted-investigation-of-residual-inflammation-after-non-st-st-elevation-acute-coronary-syndrome-100594996","NCT07026708","TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST\u002F ST Elevation Acute Coronary Syndrome","Target Investigation of Residual Inflammation After Non-ST\u002F ST Elevation Acute Coronary Syndrome - TIRANA (ACS) Prospective REGISTRY","TIRANA (ACS)","Inclusion Criteria:\n\n\\- All patients (undergoing PCI, aged 18-85 years) presenting to the cardiology department or\u002Fand the cardiology intensive care unit with a diagnosis of ACS\n\nExclusion Criteria:\n\n* Patients presenting to the cardiology department or\u002Fand the cardiology intensive care unit with diagnoses other than ACS and\u002For UA. Patients who died before undergoing PCI and those who did not provide a contact number.","85 Years",{"count":189,"type":20},1600,"OBSERVATIONAL","This prospective observational study aims to evaluate the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR) as a predictor of mortality in patients following an episode of Acute Coronary Syndrome (ACS). Despite advancements in interventional cardiology and medical therapy, mortality remains significant in post-ACS patients, and early risk stratification is essential for optimizing outcomes.\n\nRecent studies have suggested that systemic inflammatory markers, such as NLR, are associated with adverse cardiovascular events. It is an easily obtainable and cost-effective laboratory parameter derived from a routine complete blood count. However, its value as an independent predictor of mortality post-ACS has not yet been fully established in our population.\n\nThe study will include patients aged, admitted with a confirmed diagnosis of ACS (STEMI or Non-STEMI) and treated with percutaneous coronary intervention (PCI). NLR values will be measured from the first blood draw upon hospital admission, 24 and 48 hours post PCI. Patients will be followed up for up to 6 months after discharge through telephone interviews .\n\nFirst, primary outcomes of the study will be the association between NLR values and mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) within 6 months post-ACS.\n\nSecondary outcomes will include:\n\n1. Differences in mean NLR between STEMI and NSTEMI patients.\n2. Association between elevated NLR and the presence of multivessel coronary artery disease on angiography.\n3. Correlation of NLR with other biomarkers, including the platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), high-density lipoprotein (HDL) cholesterol, and maximum troponin levels (as an indicator of myocardial infarction size)\n\nThis study aims to contribute to the identification of easily accessible and cost-efficient biomarkers that can aid clinicians in early risk stratification of ACS survivors. A strong correlation between high NLR values and increased post-discharge mortality would suggest that inflammation plays a key role in patient prognosis and could potentially influence post-ACS management strategies.",[193,194,195,196,197,198],"ACS (Acute Coronary Syndrome)","Myocardial Infarction (MI)","Myocardial Inflammation","Inflammation Biomarkers","NSTEMI - Non-ST Segment Elevation MI","STEMI",[200,201,202,203],"Residual inflammation","Myocardial infarction","Percutaneous Coronary Intervention","Acute Coronary Syndrome","2025-09-27",{"date":206,"type":37},"2025-09-30",{"date":208,"type":37},"2024-11-01",{"date":210,"type":20},"2027-06-01",{"name":212,"class":104},"University Hospital Centre Mother Teresa",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":222,"conditions":223,"keywords":227,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100512088","validation-of-the-european-oncology-quality-of-life-toolkit-100512088","NCT05947903","Validation of the European Oncology Quality of Life Toolkit","Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.","Inclusion Criteria:\n\n* Age 18 years or more.\n* Present or past histologically confirmed diagnosis of solid tumour or haematological malignancy.\n* Being in one of these three conditions: A) Patients in active treatment; B) Survivors; C) in Palliative Care.\n* Native tongue or fluent in the language of the questionnaire\n* Written informed consent to the study.\n\nExclusion Criteria:\n\n* Cognitive impairment preventing the completion of the questionnaire",{"count":221,"type":20},4000,"The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.\n\nA comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.\n\nThe European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.\n\nThis is a multicentre observational study, with the following aims:\n\n* The primary aim is to perform the psychometric validation of the EUonQoL-Kit.\n* Secondary aims are to assess its acceptability, to validate the static and dynamic versions against each other, and to provide estimates of QoL across European countries.\n\nThe EUonQoL-Kit will be administered to a sample of patients from 45 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).\n\nEach centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,500 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:\n\n* FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity.\n* Live-CAT version, to validate the static and dynamic versions against each other.\n* EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.",[224,225,226],"Cancer","Survivorship","Palliative Care",[228,229,230,231,232,233,234],"Quality of life","cancer","questionnaire","validation","survivorship","palliative care","Patient Reported Outcomes","NOT_YET_RECRUITING","2024-08-19",{"date":238,"type":37},"2024-08-20",{"date":240,"type":20},"2024-08-31",{"date":242,"type":20},"2024-10-31",{"name":244,"class":104},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",45,""]