hackint0sh/New-Dataset huggingface dataset:
Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures. conditions: Bronchoalveolar Lavage Fluid conditions: Sensitivity and Specificity conditions: Critical Illness conditions: Respiration Failure conditions: Respiratory Fungal Infection conditions: Exhaled Breath Condensate conditions: Aspergillosis, Invasive Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ACTUAL name: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF measure: Diagnostic accuracy of EBC-GM vs. BALF-GM measure: EBC-GM levels: measure: Correlation between EBC-GM and BALF-GM levels sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 86610072 country: China lat: 30.66667 lon: 104.06667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-04-12 uploadDate: 2024-03-22T15:01 filename: Prot_SAP_000.pdf size: 81579 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-12 uploadDate: 2024-03-22T15:02 filename: ICF_001.pdf size: 133154 hasResults: False
nctId: NCT06333366 id: 202301590A0C501 id: Application No.2402020052 type: OTHER domain: Chang Gung Memorial Hospital briefTitle: First-In-Human Study of PDT to Detect IAH overallStatus: RECRUITING date: 2024-02-18 date: 2024-07-16 date: 2025-09-20 date: 2024-03-27 date: 2024-03-27 name: Chang Gung Memorial Hospital class: OTHER name: DOTSPACE briefSummary: PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends. conditions: Intra-Abdominal Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: Intra-gastrointestinal monitoring device (PDT) measure: Incidence of device-related or sensor insertion/removal procedure-related adverse events measure: Rate of foreign body reaction due intra-gastrointestinal insertion measure: Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus measure: Incidence of sensor failure measure: Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire measure: Duration of PDT insertion and explantation procedure measure: Incidence of side effects in Post explantation follow-up measure: Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days measure: Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm measure: Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Dong-Ru Ho status: RECRUITING city: Chiayi City zip: 60061 country: Taiwan name: Dong-Ru Ho, MD, PhD role: CONTACT phone: 886-975353211 email: redoxdrh@gmail.com role: CONTACT phoneExt: Ho email: redoxdrh@gmail.com name: Dong-Ru Ho, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 23.47917 lon: 120.44889 hasResults: False
nctId: NCT06333353 id: H-06-23-9278 briefTitle: Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain overallStatus: RECRUITING date: 2024-04-12 date: 2027-05-20 date: 2027-06-20 date: 2024-03-27 date: 2024-04-15 name: University of Ottawa class: OTHER briefSummary: The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.
5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP. conditions: Endometriosis conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All participants, care providers, investigators and outcome assessors will remain blinded to real/sham intervention. The outcomes assessor and the investigator will remain blinded to intervention duration. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 152 type: ESTIMATED name: Real RepetitiveTranscranial Magnetic Stimulation 5 sessions name: Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions name: Real RepetitiveTranscranial Magnetic Stimulation 10 sessions name: Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions measure: Numeric rating scale (NRS) used to record daily pain over 30 days measure: Numeric rating scale(NRS) used to record daily pain over 30 days measure: Patient Global Impression of Change (PGIC) in pain measure: Patient Global Impression of Change (PGIC) in pain measure: Patient Global Impression of Change (PGIC) in pain measure: The Beck Depression Inventory (BDI-II) measure: The Beck Depression Inventory (BDI-II) measure: The Beck Depression Inventory (BDI-II) measure: The State-Trait Anxiety Inventory (STAI) measure: The Pain Catastrophizing Scale measure: The Central sensitization index measure: Female Sexual Distress Scale (FSDS) measure: Adherence to the intervention protocol measure: Pressure pain threshold (PPThresh) measure: Pressure pain threshold (PPThresh) measure: Pressure Pain Tolerance (PPTol) measure: Pressure Pain Tolerance (PPTol) measure: Perceived pain intensity (PPI) measure: Perceived pain intensity (PPI) measure: Temporal summation (TS) of pain measure: Temporal summation (TS) of pain measure: Pain rating during the tampon test measure: Pain rating during the tampon test measure: Conditioned pain modulation (CPM) measure: Conditioned pain modulation (CPM) measure: The Brief Pain Inventory measure: The Brief Pain Inventory measure: The Brief Pain Inventory measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: Patient satisfaction with treatment (PST) measure: Patient satisfaction with treatment (PST) measure: Patient satisfaction with treatment (PST) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: McLean Function Measurement Lab status: RECRUITING city: Ottawa state: Ontario zip: K1S1S2 country: Canada name: Anne-Marie MacDonald, MSc role: CONTACT phone: 613-562-5800 phoneExt: 4102 email: mfmlab@uottawa.ca name: Linda McLean, PhD role: CONTACT phone: 613-562-5800 phoneExt: 4102 email: lmclea2@uottawa.ca name: Linda McLean, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 hasResults: False
nctId: NCT06333340 id: 24-03 briefTitle: Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors. conditions: Post Partum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Oxytocin name: Carbetocin measure: Proportion of parturients requiring additional uterotonic agents intraoperatively measure: Uterine Tone 3 minutes measure: Uterine Tone 5 minutes measure: Uterine Tone 10 minutes measure: Calculated blood loss (CBL) measure: Semi-quantitative blood loss (SQBL) measure: Presence of blood transfusion measure: Number of patients with ICU admission measure: Number of patients with conservative surgical methods to manage post partum hemorrhage measure: Number of patients with radiological methods used to manage post partum hemorrhage measure: Number of patients with surgical post partum hemorrhage management measures measure: Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline measure: Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline measure: Number of patients with tachycardia defined as heart rate greater than 130% of baseline measure: Number of patients with bradycardia defined as heart rate less than 70% of baseline measure: Presence of ventricular tachycardia: ECG measure: Presence of atrial fibrillation: ECG measure: Presence of atrial flutter: ECG measure: Presence of nausea: questionnaire measure: Presence of vomiting: questionnaire measure: Number of patients with chest pain: questionnaire measure: Number of patients with shortness of breath: questionnaire measure: Number of patients with headache: questionnaire measure: Number of patients with flushing: questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Narinder Singh, MD role: SUB_INVESTIGATOR name: Ronald George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
nctId: NCT06333327 id: 1432022000278 briefTitle: Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter acronym: COLLABORATE overallStatus: RECRUITING date: 2021-01-01 date: 2030-01-01 date: 2030-12-01 date: 2024-03-27 date: 2024-03-27 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter measure: Atrial arrhythmia recurrence after ablation measure: Procedural safety sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Brussel Heart Rhythm Management Center status: RECRUITING city: Brussels zip: 1090 country: Belgium name: Carlo de Asmundis, MD, PhD role: CONTACT phone: +32024763704 email: hrmc@uzbrussel.be lat: 50.85045 lon: 4.34878 hasResults: False
nctId: NCT06333314 id: UC-IMM-2302 briefTitle: Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI acronym: Pan-MSI-ACSE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-10 date: 2030-09 date: 2024-03-27 date: 2024-03-29 name: UNICANCER class: OTHER name: National Cancer Institute, France name: GlaxoSmithKline briefSummary: The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.
Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).
nctId: NCT06333301 id: TIME-ZZZ briefTitle: Translational Initiative to Map Epigenetics in Sleep acronym: TIME-ZZZ overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2034-04 date: 2034-04 date: 2024-03-27 date: 2024-03-27 name: Elysium Health class: INDUSTRY name: University of Oxford briefSummary: The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging. conditions: Biological Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: Surveys measure: Effect of being "out of phase" with chronotype on biological age measure: Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging measure: Identification of DNA methylation markers associated with chronotype measure: Identification of DNA methylation markers associated with depression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06333288 id: 2024-0268 briefTitle: Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-30 date: 2025-03-30 date: 2024-03-27 date: 2024-03-27 name: University of Illinois at Chicago class: OTHER briefSummary: The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT). primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: PST-APPLE Watch group name: Education-only control group measure: Alcohol abstinence measure: Change in AUD severity at 3 months. measure: Change in AUD frequency status. measure: Change in Alcohol-related negative consequences at 3 months. measure: Change in Alcohol use at 3 months. measure: Change in Reasons for drinking at 3 months. measure: Change in negative affect at 3 months. measure: Change in positive affect at 3 months. measure: Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months. measure: Change in the quality of life at 3 months. measure: Percent heavy drinking days at 3 months. measure: Percent binge drinking days at 3 months. measure: Percent days abstinence at 3 months. measure: Intervention Acceptability measure: Intervention Fidelity measure: Participant Retention measure: Protocol Acceptability sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60608 country: United States name: Hagar Hallihan role: CONTACT lat: 41.85003 lon: -87.65005 hasResults: False
nctId: NCT06333275 id: DLF-Nr: 5564 id: BASEC-Nr: 2023-01141 type: OTHER domain: BASEC (Business Administration System for Ethics Committees) - Switzerland briefTitle: Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy acronym: IMCAR overallStatus: RECRUITING date: 2023-11-14 date: 2025-12 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:
* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy conditions: Vaccine Immunity in CAR-T Cell Therapy Recipients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles measure: CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens measure: Rate of seroprotection against tetanus 6 months after CAR-T cell therapy measure: Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy measure: Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy measure: Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy measure: Rate of seroprotection against measles virus 12 months after CAR-T cell therapy measure: Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy measure: Clinical predictors of vaccine elicited immune response measure: Immunological predictors of vaccine elicited immune response measure: Persistence of vaccine elicited seroprotection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bern status: RECRUITING city: Bern zip: 3010 country: Switzerland name: Lukas N Baumann, MD role: CONTACT phone: +41 31 66 4 30 69 email: lukas.baumann2@insel.ch name: Cédric Hirzel, PD, MD role: CONTACT phone: +41 31 66 4 01 17 email: cedric.hirzel@insel.ch name: Christine Thurnheer Zürcher, PD, MD role: PRINCIPAL_INVESTIGATOR name: Cédric Hirzel, PD, MD role: PRINCIPAL_INVESTIGATOR name: Lukas N Baumann, MD role: SUB_INVESTIGATOR name: Urban Novak, Professor role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False
nctId: NCT06333262 id: 24-017 briefTitle: Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia overallStatus: RECRUITING date: 2024-04 date: 2027-02-01 date: 2029-02-01 date: 2024-03-27 date: 2024-04-23 name: Inhye Ahn class: OTHER name: Loxo Oncology, Inc. briefSummary: This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL). conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pirtobrutinib name: Obinutuzumab measure: Rate of complete response after initial therapy measure: Overall response rate measure: Rate of partial response measure: Time to next line of therapy measure: Event-free survival measure: Progression-free survival measure: Overall survival measure: Rate of re-treatment with pirtobrutinib sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Jon Arnason, MD role: CONTACT name: Jon Arnason, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham & Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Inhye Ahn role: CONTACT name: Inhye Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Megan Forsyth role: CONTACT phone: 857-215-1405 email: megan_forsyth@dfci.harvard.edu name: Inhye Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
nctId: NCT06333249 id: AGTC-RPGR-001 SKYLINE briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-04-13 date: 2023-04-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: Beacon Therapeutics class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations. conditions: X-Linked Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The purpose of the Phase 2 study is to evaluate the efficacy, safety, and tolerability of two doses of AGTC-501 in male subjects between 8 - 50 years of age (inclusive) with XLRP genetically confirmed by at least one pathogenic variant in the RPGR gene.
nctId: NCT06333236 id: OCU_KRON briefTitle: Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-09-30 date: 2024-11-30 date: 2024-03-27 date: 2024-03-27 name: ASST Santi Paolo e Carlo class: OTHER briefSummary: Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Food for Special Medical Purposes: Kron® measure: Electrofunctional evaluation measure: VF and SD-OCT sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False