hackint0sh/New-Dataset huggingface dataset:
3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation. conditions: Sjogren's Syndrome conditions: Dry Eye conditions: Neurotrophic Keratitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Eye Exam measure: Corneal Epithelium health measure: Corneal Nerve health measure: Correlations Between Corneal Staining Score measure: Correlations Between Patient Symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital Wilmer Eye Institute city: Baltimore state: Maryland zip: 21287 country: United States name: Esen K Akpek, MD role: CONTACT phone: 410-955-5490 email: esakpek@jhmi.edu name: Lee W Guo, OD role: SUB_INVESTIGATOR name: Michelle M Hessen, OD role: SUB_INVESTIGATOR name: Esen K Akpek, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
nctId: NCT06364644 id: IRB00336599 id: 1P50MD017348-01 type: NIH link: https://reporter.nih.gov/quickSearch/1P50MD017348-01 briefTitle: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure acronym: UNLOAD-HF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09-30 date: 2027-06-30 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility. conditions: Type2diabetes conditions: Heart Failure conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design of the study is a randomized 2:1 parallel-arm clinical trial. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm . whoMasked: OUTCOMES_ASSESSOR count: 402 type: ESTIMATED name: Community Champions name: Homegrown Heroes measure: Change in cardiorespiratory fitness measure: Change in cardiac biomarker, hs-cTnT measure: Change in hemoglobin A1c measure: Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales. measure: Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA) measure: Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test measure: Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ) measure: Change in weight (kgs) measure: Change in BMI measure: Change in hip and waist circumference (centimeters) measure: Change in Metabolic Syndrome Severity Z score measure: Change in self-management as assessed by the Patient Activation Measure (PAM-13). measure: Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 measure: Change in blood pressure (systolic and diastolic (mmHg)) measure: Change in cardiac biomarker, gal-3 measure: Change in cardiac biomarkers, NT-proBNP sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06364631 id: 2023-503317-29-00 id: 2023/3764 type: OTHER domain: CSET number briefTitle: CARE1 Pragmatic Clinical Trial acronym: CARE1 overallStatus: RECRUITING date: 2024-04-12 date: 2032-05-05 date: 2032-05-05 date: 2024-04-15 date: 2024-04-19 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: European Commission name: CRIS Cancer Foundation name: National Cancer Institute, France name: Rennes University Hospital name: University Hospital, Essen name: Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron name: The Netherlands Cancer Institute name: Servicio Madrileño de Salud, Madrid, Spain name: Hospital Universitario 12 de Octubre name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano name: Medical University of Vienna name: FAKULTNI NEMOCNICE OLOMOUC name: International Kidney Cancer Coalition name: Association pour la Recherche sur les Tumeurs du Rein name: Resilience name: PRIMAA name: Queen Mary University of London briefSummary: Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical /biomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients.
Study design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients. conditions: Metastatic Kidney Cancer conditions: Metastatic Kidney Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: International, multicenter, open-label, randomized, controlled Phase 3 trial - 2 arms (A and B) primaryPurpose: TREATMENT masking: NONE count: 1250 type: ESTIMATED name: Nivolumab name: Ipilimumab name: Pembrolizumab name: Cabozantinib name: Axitinib name: Lenvatinib measure: Overall Survival (OS). measure: Progression-free survival according to RECIST 1.1 measure: Objective Response Rate (ORR) according to RECIST 1.1 measure: Quality of Life via questionnaire EQ-5D-5L measure: Quality of Life via questionnaire NNCCN/FACT Kidney Cancer Symptom Index (NFKSI) measure: Quality of Life via questionnaire Kidney Symptom Index (KSI) measure: Duration of Treatment measure: Time to treatment discontinuation (TTD) measure: Treatment-free survival (TFS) measure: Time to subsequent systemic anticancer therapy (TTSST) measure: Incidence of AE's measure: Health Economic evaluation: healthcare costs [France & Netherlands only] measure: Health Economic evaluation: cost-utility [France & Netherlands only] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy status: RECRUITING city: Villejuif zip: 94805 country: France name: Laurence ALBIGES, MD, PhD role: CONTACT phone: +33 (0)1 42 11 66 90 email: laurence.albiges@gustaveroussy.fr lat: 48.7939 lon: 2.35992 hasResults: False
nctId: NCT06364618 id: G-24-07 briefTitle: Use of Wearables to Detect Infections in Kidney Transplant Recipients acronym: RENALERT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-31 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: Institute for Clinical and Experimental Medicine class: OTHER_GOV briefSummary: The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.
Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection. conditions: Kidney Transplant Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Accuracy of the algorithm at detecting infections at presymptomatic stage measure: Rate of in-patient admissions measure: Incidence of decrease/increase of Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical and Experimental Medicine city: Prague zip: 14021 country: Czechia name: Tereza Metelcova, PhD role: CONTACT phone: +420261262125 email: tereza.metelcova@ikem.cz name: Ivan Zahradka, MD role: PRINCIPAL_INVESTIGATOR name: Vojtech Petr, MD role: SUB_INVESTIGATOR name: Katarina Jakubov, MD role: SUB_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False
nctId: NCT06364605 id: IIT_UVIP_MySpace briefTitle: MySpace: the Role of Vision in Representing Space overallStatus: ENROLLING_BY_INVITATION date: 2021-05-03 date: 2021-06-26 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: Istituto Italiano di Tecnologia class: OTHER briefSummary: My Space aims to identify the ontogenesis of spatial representation through cross-sectional and longitudinal studies in infants, children, and adolescents with typical and atypical development (visual impairments). The results will serve for the design and development of a novel multisensory device for sensorimotor rehabilitation in blind children from the early stages of life. conditions: Blindness conditions: Visual Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 720 type: ESTIMATED name: Rehabilitation with the iReach novel multisensory medical device measure: Perceptual responses to multisensory stimuli measure: Stimuli velocity perception measure: Distance stimuli perception measure: Eye movements measure: Saccade Analysis measure: ERP evaluation and analysis measure: Power of the cortical activity sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit For Visually Impaired People city: Genova zip: 16152 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False
nctId: NCT06364592 id: 2024-011-KY briefTitle: Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-05 date: 2024-04-15 date: 2024-04-15 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis. conditions: Dysmenorrhea conditions: Adenomyosis conditions: Electroacupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Electroacupuncture name: Sham Electroacupuncture measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain measure: The change from baseline in the numerical rating scale (NRS) score on the average pain measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain. measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain. measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain. measure: The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score. measure: The change from baseline in the the Cox Menstrual Symptom Scale (CMSS). measure: The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5). measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS). measure: Proportion of participants with positive expectance assessment measure: Blinding assessment measure: Adherence assessment measure: The change from baseline in the dose of rescue medicine. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: zhishunjournal@163.com name: Min Yang role: CONTACT phone: +8618810268077 email: yangmin2019@yeah.net lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06364579 id: 6533 briefTitle: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT). acronym: PROACT overallStatus: RECRUITING date: 2024-03-28 date: 2027-01-31 date: 2031-01-31 date: 2024-04-15 date: 2024-04-15 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires. conditions: Anal Cancer Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 120 type: ESTIMATED measure: QOL analysis measure: Overall survival (OS) measure: Colostomy Free Survival (CFS) measure: Loco-Regional Recurrence (LRR) measure: Disease-Free Survival (DFS) measure: Acute toxicity measure: Late toxicity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy name: Stefania Manfrida, MD role: CONTACT phone: +3900630154434 email: stefania.manfrida@policlinicogemelli.it name: Stefania Mandrida role: CONTACT phone: +390630155701 name: Stefania Manfrida, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
nctId: NCT06364566 id: time-exploring briefTitle: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma overallStatus: COMPLETED date: 2010-10-15 date: 2016-10-15 date: 2019-10-15 date: 2024-04-15 date: 2024-04-15 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use conditions: Time studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 303 type: ACTUAL name: Neoadjuvant chemradiotherapy name: Minimally invasive esophagectomy measure: The overall survival of the overall population measure: The Disease-Free survival of the overall population measure: The overall survival of the non-PCR population measure: The Disease-Free survival of the non-PCR population measure: The overall survival of the PCR population measure: The Disease-Free survival of the PCR population sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital Affiliated to Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2021-10-15 uploadDate: 2024-04-10T05:47 filename: SAP_000.pdf size: 119312 hasResults: False
nctId: NCT06364553 id: NL86416.078.24 briefTitle: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study acronym: ENTRANCE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-15 name: Erasmus Medical Center class: OTHER briefSummary: A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia. conditions: Oesophageal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Esophageal self-expandable metal stent measure: Complication: incidence of perforation measure: Complication: incidence of hemorrhage measure: Complication: incidence of fistula formation measure: Complication: incidence of gastroesophageal reflux measure: Complication: incidence of stent migration measure: Efficacy: clinical outcome measure: Efficacy: incidence of patients receiving technical successful stent placement measure: Incidence of recurrent dysphagia measure: Pain related to esophageal stent (placement) measure: Overall survival measure: Patient characteristic: age measure: Patient characteristic: gender measure: Patient characteristic: tumor location measure: Patient characteristic: tumor histology measure: Stent characteristic: length of the stent measure: Stent characteristic: diameter of the stent measure: Patient characteristic: prior radiotherapy measure: Patient characteristic: prior chemotherapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06364540 id: 2023-08-14 briefTitle: Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED acronym: KETAFEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: Antonios Likourezos class: OTHER briefSummary: In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus.
Our research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed.
Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions. conditions: Pain, Acute studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Ketamine name: Fentanyl measure: Reduction of pain scores on the numeric rating pain scale (NRS) measure: Need for Rescue Analgesia measure: Severity of Adverse Events measure: Evaluation of Severity of agitation and/or sedation sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-18 uploadDate: 2024-04-05T12:16 filename: Prot_SAP_000.pdf size: 208117 hasResults: False
nctId: NCT06364527 id: ADH-BSA-02-23 briefTitle: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-15 date: 2024-04-15 name: CoheroHealth class: INDUSTRY name: Aptar Digital Health name: Lindus Health briefSummary: The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.
The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines. conditions: Asthma Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 118 type: ESTIMATED name: Aptar Digital Health respiratory disease management platform measure: Asthma Control Questionnaire - 5 scores measure: Mini-Asthma Quality of Life Questionnaire measure: Rescue medication usage measure: Inhaled corticosteroid steroid daily adherence measure: Step-up from inhaled corticosteroids to biologics measure: Asthma related oral corticosteroids utilization and associated cost measure: Asthma related accident and emergency department visits and associated cost measure: Asthma related unscheduled outpatient clinic visits and associated cost measure: Asthma related inpatient hospitalization, associated length of stay, and associated cost measure: Computer System Usability Questionnaire measure: Semi-structured interviews using the 2019 Rudin et al study sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False