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<|newrecord|> nctId: NCT06342687 id: JagiellonianU 1 briefTitle: Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment overallStatus: COMPLETED date: 2018-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Jagiellonian University class: OTHER briefSummary: The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection. conditions: Colorectal Cancer conditions: ERAS studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 468 type: ACTUAL name: High compliance with ERAS protocol measure: Post operative 5 year survival rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Medical College city: Kraków state: Małopolskie zip: 31-008 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False
<|newrecord|> nctId: NCT06342674 id: Nejla CANBULAT ŞAHİNER briefTitle: Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients acronym: The overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-01 date: 2025-07-31 date: 2024-04-02 date: 2024-04-02 name: Sakarya University class: OTHER briefSummary: The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.
no effect on the infant's growth parameters and nutrient absorption levels by the infant.
Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.
Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.
Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.
Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk. conditions: Breast Feeding conditions: Breast Milk Collection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single (participant) blinding was used in the study. For this purpose, it was not stated which group the participating mothers were in the research, but they were informed about the procedure to be performed. Therefore, a separate informed consent form was prepared for each group. Statistician blinding will also be applied. While coding the research data, the research group will be coded as A and B, and the statistician will be prevented from knowing which letter represents which group. whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Giving breast milk to the newborn according to the circadian rhythm name: Usual care measure: Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups measure: Evaluation of the baby's height measurements in the study and control groups measure: Evaluation of the baby's head circumference in the study and control groups measure: Evaluation of nutritional absorption of infants in the study and control groups sex: ALL minimumAge: 32 Weeks maximumAge: 34 Weeks stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06342661 id: 2022IIT205 briefTitle: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment overallStatus: RECRUITING date: 2023-03-01 date: 2028-11 date: 2028-11 date: 2024-04-02 date: 2024-04-02 name: First Affiliated Hospital of Harbin Medical University class: OTHER briefSummary: 1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years. conditions: Cerebrovascular Disease Small Vessel studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Neuropsychological testing measure: Patient characteristics measure: VISTA expression in PBMCs in the VCI and control groups sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang zip: 150010 country: China name: LiJun Chi role: CONTACT phone: 13895783757 email: [email protected] lat: 45.75 lon: 126.65 hasResults: False
<|newrecord|> nctId: NCT06342648 id: Cutaneous water in renal colic briefTitle: Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Suez Canal University class: OTHER briefSummary: Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared. conditions: Renal Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 570 type: ESTIMATED name: Sterile Water Injection name: Diclofenac Sodium injection measure: Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342635 id: HYD/DENMARK-001/2023 briefTitle: Hydra Single-centre Experience - Copenhagen, Denmark overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2026-10-31 date: 2024-04-02 date: 2024-04-02 name: Sahajanand Medical Technologies Limited class: INDUSTRY name: Qmed Consulting A/S briefSummary: The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series. conditions: Aortic Valve Stenosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Hydra Transcatheter Aortic Valve (THV) Series measure: Primary safety endpoint measure: Primary performance endpoint measure: Technical success measure: Cardiovascular mortality measure: All-cause mortality measure: All stroke measure: Disabling stroke measure: Myocardial infarction measure: Major vascular complication measure: Acute kidney injury measure: New permanent pacemaker implantation due to procedure related conduction abnormalities measure: New-onset atrial fibrillation measure: Coronary artery obstruction requiring intervention measure: Re-hospitalization for procedure- or valve-related causes measure: Mean aortic valve gradient measure: Effective Orifice Area (EOA) measure: Paravalvular leak measure: New York Heart Association (NYHA) functional class measure: Quality-of-life evaluation measure: Bioprosthetic Valve Failure (BVF) measure: Bioprosthetic valve dysfunction (BVD) measure: Stroke or peripheral embolism measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns measure: Rates of Hypoattenuated Leaflet Thickening (HALT) measure: Rates of Reduced leaflet motion (RLM) measure: Commissural alignment sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital, Rigshospitalet city: Copenhagen country: Denmark name: Dr. Ole De Backer role: CONTACT name: Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False
<|newrecord|> nctId: NCT06342622 id: Weiguo Dong briefTitle: Young-onset Colorectal Cancer Screening Based on Artificial Intelligence overallStatus: COMPLETED date: 2023-12-01 date: 2024-01-10 date: 2024-01-25 date: 2024-04-02 date: 2024-04-02 name: Renmin Hospital of Wuhan University class: OTHER briefSummary: In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 11000 type: ACTUAL name: Using routine clinical data and machine learning models. measure: The performance of machine learning screening models sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06342609 id: 32857-01-EKSTROM briefTitle: Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease acronym: EKSTROM overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-15 date: 2024-09-07 date: 2024-09-07 date: 2024-04-02 date: 2024-04-02 name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center class: OTHER briefSummary: This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind Placebo controlled primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ACTUAL name: Colchicine 0.5 MG measure: Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography measure: Effect of Colchicine on markers of inflammation using laboratory tests measure: Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA measure: Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA measure: Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD) sex: ALL minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 hasResults: False
<|newrecord|> nctId: NCT06342596 id: 18597 id: J2O-MC-EKBD type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-05 date: 2024-04 date: 2024-04 date: 2024-04-02 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: [14C]-LY3473329 name: [14C]-LY3473329 name: LY3473329 measure: Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered measure: Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered measure: Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity measure: Part 1: PK: Maximum Concentration (Cmax) of LY3473329 measure: Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity measure: Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) measure: Part 1: Total Number of Metabolites of LY3473329 measure: Part 2: PK: AUC (0-∞) of LY3473329 measure: Part 2: PK: AUC (0-∞) of [14C]-LY3473329 measure: Part 2: PK: AUC (0-∞) of Total Radioactivity measure: Part 2: PK: Cmax of LY3473329 measure: Part 2: PK: Cmax of [14C]-LY3473329 measure: Part 2: PK: Cmax of Total Radioactivity measure: Part 2: Total Radioactivity Recovered in Urine and Feces sex: MALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit city: Holbeck state: Leeds zip: LS11 9EH country: United Kingdom lat: 53.25 lon: -1.18333 hasResults: False
<|newrecord|> nctId: NCT06342583 id: CNR-IRIB-PRO-2024-004 briefTitle: Advanced Social Relations Training overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-17 date: 2026-02-10 date: 2024-04-02 date: 2024-04-02 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.
The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them. conditions: Autism conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Advanced social relations training with technical device name: Advanced social relations training without technical device measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) measure: Eye contact measure: Smile in relation to group members' expressions measure: Greeting measure: Asking a question measure: Proposing an idea or activity to be carried out measure: Answering a question measure: Taking verbal initiative measure: Approval/sharing gestures sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: [email protected] name: Maria Valeria Maiorana role: CONTACT phone: +393285856656 email: [email protected] name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Cinzia Grasso role: SUB_INVESTIGATOR name: Mariaelena Franchina role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False
<|newrecord|> nctId: NCT06342570 id: 3-2023-0462 briefTitle: Quantitative Analysis of EEG Changes in Response to Nociception overallStatus: RECRUITING date: 2024-04-18 date: 2026-12-30 date: 2026-12-30 date: 2024-04-02 date: 2024-04-17 name: Gangnam Severance Hospital class: OTHER briefSummary: This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception. conditions: Patients Undergoing Laparoscopic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 109 type: ESTIMATED name: There is no Intervention name to describe. measure: Correlation between changes in ANI and EEG band power in response to surgical stimulation. measure: Correlation between changes in ANI and EEG band power in response to tracheal intubation measure: Correlation between changes in ANI and EEG connectivity in response to surgical stimulation measure: Correlation between changes in ANI and EEG connectivity in response to tracheal intubation measure: Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration measure: Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI measure: Differences in EEG connectivity during surgery between groups with large and small changes in ANI measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI measure: Differences in EEG connectivity during recovery between groups with large and small changes in ANI measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic measure: Differences in EEG connectivity depending on the type of inhaled anesthetic measure: Differences in ANI depending on the type of inhaled anesthetic sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GangnamSeverance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Myung Il Bae role: CONTACT phone: 82-2-2019-6611 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06342557 id: FROM briefTitle: Transitional ePRO Diary Liver acronym: MACROLIVER overallStatus: RECRUITING date: 2024-03-28 date: 2034-02-21 date: 2034-02-21 date: 2024-04-02 date: 2024-04-16 name: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS class: OTHER briefSummary: The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients. conditions: Liver Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: four-item Morisky Medication Adherence Scale (MGLS) sex: ALL minimumAge: 14 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: ASST-Papa Giovanni XXIII status: RECRUITING city: Bergamo state: Milano zip: 24127 country: Italy name: Stefano Fagiuoli, MD role: CONTACT phone: 035.2674259 email: [email protected] lat: 45.69601 lon: 9.66721 hasResults: False
<|newrecord|> nctId: NCT06342544 id: AGN_2023_14 briefTitle: Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial. acronym: IMCOMG overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2029-06 date: 2024-04-02 date: 2024-04-02 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness.
In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease.
Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants.
There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens.
On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile.
We propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis.
Patients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant.
The aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off. conditions: Ocular Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: immediate treatment with corticosteroids name: addition of rituximab if recurrence measure: proportion of patients who progressed to generalized myasthenia within 2 years of follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342531 id: 210324 briefTitle: More Effective Violence Risk Management - eDASA+APP FI acronym: eDASA+APP FI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: University of Turku class: OTHER name: Helsinki University Central Hospital briefSummary: The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care. conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A pre-post design (quasi-experimental), a cluster design primaryPurpose: SCREENING masking: NONE count: 26 type: ESTIMATED name: eDASA+APP FI measure: Workplace violence measure: Coercive measures measure: Job satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342518 id: MU ESWT briefTitle: ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation overallStatus: COMPLETED date: 2020-12-01 date: 2021-09-01 date: 2021-12-01 date: 2024-04-02 date: 2024-04-02 name: Istanbul Medeniyet University class: OTHER briefSummary: This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound. conditions: Lateral Epicondylitis conditions: Tennis Elbow studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: Extracorporeal Shock Wave Therapy (ESWT) name: Sham ESWT name: Resting Splint , Exercises and ice measure: Hand Grip Strength measure: Pain severity measure: Functionality measure: Quality of life score measure: deep muscular tissue sensitivity measure: thickness of the common extensor tendon (CET) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department city: Istanbul zip: 34732 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06342505 id: MEC-2022-0037 briefTitle: Tacrolimus in CD3+ T Lymphocytes acronym: INTACT overallStatus: COMPLETED date: 2022-05-30 date: 2022-10-10 date: 2022-11-10 date: 2024-04-02 date: 2024-04-02 name: Erasmus Medical Center class: OTHER briefSummary: The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are:
(i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug?
Participants will:
* Receive standard clinical care;
* Undergo two extra venipunctures for the collection of blood. conditions: Immunosuppression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 28 type: ACTUAL name: Venipunctures measure: The intracellular tacrolimus concentration in CD3+ T lymphocytes measure: Intracellular cytokine production sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
<|newrecord|> nctId: NCT06342492 id: KCHRRF_CS Lead Failure_0025 briefTitle: Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: Kansas City Heart Rhythm Research Foundation class: OTHER briefSummary: This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Coronary Sinus Lead Revision measure: Need for lead revision measure: Electrocardiography characteristics - QRS Interval sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center city: Overland Park state: Kansas zip: 66209 country: United States lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic city: Overland Park state: Kansas zip: 66211 country: United States lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center city: Overland Park state: Kansas zip: 66215 country: United States lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic city: Independence state: Missouri zip: 64057 country: United States lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center city: Independence state: Missouri zip: 64057 country: United States lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic city: Kansas City state: Missouri zip: 64032 country: United States lat: 39.09973 lon: -94.57857 facility: Research Medical Center city: Kansas City state: Missouri zip: 64032 country: United States lat: 39.09973 lon: -94.57857 hasResults: False
<|newrecord|> nctId: NCT06342479 id: NM: 04.20.ND:30.03.2023 briefTitle: Discharge Training for Patients With Intertrochanteric Fracture overallStatus: RECRUITING date: 2023-09-01 date: 2024-06-01 date: 2024-07-01 date: 2024-04-02 date: 2024-04-02 name: Erzurum Technical University class: OTHER briefSummary: This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically. conditions: Surgical Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Discharge Education measure: Toronto Wound Symptom Assessment System measure: Discharge readiness scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erzurum Technical University Faculty of Health Sciences status: RECRUITING city: Erzurum zip: 25000 country: Turkey name: Yasemin Erden role: CONTACT phone: 05303461516 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False
<|newrecord|> nctId: NCT06342466 id: 2023-358-02 briefTitle: Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis overallStatus: RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: Jin Lu, MD class: OTHER briefSummary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months. conditions: Systemic Amyloidosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Bortezomib, pomalidomide, dexamethasone primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bortezomib name: Pomalidomide name: Dexamethasone measure: Hematologic VGPR + CR rate at 6 months measure: Overall Hematologic response rate at 6 months measure: At least one organ response at 6 months measure: TTNT at 2 years measure: Estimated PFS at 2 years measure: Estimated OS at 2 years measure: TRAE sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China name: Yang Liu role: CONTACT phone: +8613716926210 email: [email protected] name: Jin Lu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06342453 id: STUDY00026814 id: NCI-2024-01534 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00026814 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Examining Arts as Therapy in Children With Cancer, CREATe Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-30 date: 2026-03-30 date: 2024-04-02 date: 2024-04-02 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: Art Therapy name: Discussion name: Media Intervention name: Survey Administration measure: Number of participants that complete all interventions and data collection time points measure: Number of eligible participants that enroll in the study (feasibility threshold of 60%) measure: Number of participants that complete all interventions and all surveys in the study. measure: Number of intervenor fidelity surveys that obtain at least 95% score. measure: Comparison of scores on the PRO-CTCAE between intervention arms measure: Comparison of scores on the PROMIS between intervention arms measure: Comparison of scores on the Faces between intervention arms sex: ALL minimumAge: 8 Years maximumAge: 13 Years stdAges: CHILD facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Jennifer L. Raybin role: CONTACT phone: 503-418-5150 email: [email protected] name: Jennifer L. Raybin role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
<|newrecord|> nctId: NCT06342440 id: 23228/AACRC briefTitle: Early Detection of Advanced Adenomas and Colorectal Cancer acronym: AACRC overallStatus: RECRUITING date: 2020-03-15 date: 2025-12-15 date: 2025-12-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses. conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Polyp conditions: Colorectal Adenocarcinoma conditions: Colorectal Disorders conditions: Colorectal Dysplasia conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Cancer Stage IV conditions: Colorectal Neoplasms Malignant conditions: Colorectal Serrated Adenocarcinoma conditions: Colorectal Adenoma With Severe Dysplasia conditions: Colorectal Adenoma With Mild Dysplasia conditions: Colorectal Adenoma With Moderate Dysplasia conditions: Colorectal Adenoma and Carcinoma 1 conditions: Colorectal Adenomatous Polyp conditions: Colorectal Adenocarcinoma Metastatic in the Liver studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: DENEB measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Monrovia state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR name: James Lin role: SUB_INVESTIGATOR name: Gregory Idos role: SUB_INVESTIGATOR name: Trilokesh Kadambi role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: University of California San Diego status: RECRUITING city: San Diego state: California zip: 92093 country: United States name: C Richard Boland, MD, PhD role: CONTACT name: C Richard Boland, MD, PhD role: SUB_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian country: China name: Jing Zhang role: CONTACT name: Jing Zhang role: SUB_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: IRCCS San Raffaele status: RECRUITING city: Milan country: Italy name: Giulia Martina Cavestro, MD, PhD role: CONTACT email: [email protected] name: Giulia Martina Cavestro role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Mie University status: RECRUITING city: Mie country: Japan name: Yuji Toiyama role: CONTACT name: Yuji Toiyama role: SUB_INVESTIGATOR name: Yoshinaga Okugawa role: SUB_INVESTIGATOR name: Tadanobu Shimura role: SUB_INVESTIGATOR facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: [email protected] name: Francesc Balaguer role: SUB_INVESTIGATOR name: Miguel Pera role: SUB_INVESTIGATOR name: Lorena Moreno role: SUB_INVESTIGATOR name: Luis Bujanda role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<|newrecord|> nctId: NCT06342427 id: 23228/DESTINEX briefTitle: Stomach Cancer Exosome-based Detection acronym: DESTINEX overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer. conditions: Gastric Cancer conditions: Gastric Adenocarcinoma conditions: Gastric Cancer Stage conditions: Gastric Neoplasm conditions: Gastric Lesion conditions: Gastric Cancer in Situ conditions: Gastric Cancer Stage IV conditions: Gastric Cancer Stage IIIB conditions: Gastric Cancer Stage III conditions: Gastric Cancer Stage IB conditions: Gastric Cancer Stage IA conditions: Gastric Cancer, Stage 0 conditions: Gastric Cancer Stage IIIA conditions: Gastric Cancer Stage II conditions: Gastric Cancer TNM Staging conditions: Gastric Cancer Metastatic to Lung conditions: Gastric Cancer Metastatic to Liver conditions: Gastric Cancer Stage I conditions: Gastric Cancer TNM Staging Primary Tumor (T) T2B studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 800 type: ESTIMATED name: DESTINEX measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Silei Sui role: PRINCIPAL_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Nagoya University status: RECRUITING city: Nagoya country: Japan name: Yasuhiro Kodera role: CONTACT name: Yasuhiro Kodera role: SUB_INVESTIGATOR name: Mitsuo Kanda role: SUB_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Mie University status: RECRUITING city: Tsu country: Japan name: Yuji Toiyama role: CONTACT name: Yuji Toiyama role: SUB_INVESTIGATOR name: Yoshinaga Okugawa role: SUB_INVESTIGATOR lat: 34.73333 lon: 136.51667 hasResults: False
<|newrecord|> nctId: NCT06342414 id: 23228/ELUCIDATE briefTitle: An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer acronym: ELUCIDATE overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery. conditions: Hepatocellular Carcinoma conditions: Intrahepatic Cholangiocarcinoma conditions: Cholangiocarcinoma conditions: Primary Liver Cancer conditions: Primary Liver Carcinoma conditions: Hepatic Cancer conditions: Hepatic Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: ELUCIDATE measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Caiming Xu, MD, PhD role: SUB_INVESTIGATOR name: Yoh Asahi, MD role: PRINCIPAL_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Graduate School of Medical Sciences, Kyushu University status: RECRUITING city: Fukuoka country: Japan name: Tomoharu Yoshizumi role: CONTACT name: Tomoharu Yoshizumi role: SUB_INVESTIGATOR name: Takeo Toshima role: SUB_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Graduate School of Medical Sciences, Kumamoto University status: RECRUITING city: Kumamoto country: Japan name: Hideo Baba role: CONTACT name: Hideo Baba role: SUB_INVESTIGATOR lat: 32.80589 lon: 130.69182 facility: Hokkaido University Graduate School of Medicine status: RECRUITING city: Sapporo country: Japan name: Akinobu Taketomi role: CONTACT name: Akinobu Taketomi role: PRINCIPAL_INVESTIGATOR name: Yoh Asahi role: PRINCIPAL_INVESTIGATOR name: Tatsuhiko Kakisaka role: SUB_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Tokushima University status: RECRUITING city: Tokushima country: Japan name: Mitsuo Shimada role: CONTACT name: Mitsuo Shimada role: SUB_INVESTIGATOR name: Katsuki Miyazaki role: SUB_INVESTIGATOR lat: 34.06667 lon: 134.56667 hasResults: False
<|newrecord|> nctId: NCT06342401 id: 23228/ENCODE briefTitle: Early Onset Colorectal Cancer Detection acronym: ENCODE overallStatus: RECRUITING date: 2023-04-15 date: 2025-04-15 date: 2025-10-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.
This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid) conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage IV conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: ENCODE measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Alessandro Mannucci, MD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: IRCCS San Raffaele status: RECRUITING city: Milan country: Italy name: Giulia Martina Cavestro, MD, PhD role: CONTACT email: [email protected] name: Alessandro Mannucci, MD role: PRINCIPAL_INVESTIGATOR name: Giulia Martina Cavestro, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Kawasaki University status: RECRUITING city: Kawasaki country: Japan lat: 35.52056 lon: 139.71722 facility: Mie University status: RECRUITING city: Mie country: Japan facility: National Cancer Center Hospital status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Tokyo Medical and Dental University status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Yamagata University status: RECRUITING city: Yamagata country: Japan lat: 38.23333 lon: 140.36667 facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: [email protected] lat: 41.38879 lon: 2.15899 facility: University of La Laguna status: RECRUITING city: La Laguna country: Spain lat: 28.4853 lon: -16.32014 facility: Salamanca Biomedical Research Institute status: RECRUITING city: Madrid country: Spain name: Jose Perea, MD role: CONTACT email: [email protected] name: Jose Perea, MD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
<|newrecord|> nctId: NCT06342388 id: 2024-0427 id: A538500 type: OTHER domain: UW- Madison id: Protocol Version 3/20/2024 type: OTHER domain: UW- Madison id: SMPH/POP HEALTH SCI/POP HLTH type: OTHER domain: UW- Madison briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage overallStatus: WITHDRAWN date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-02 date: 2024-04-09 name: University of Wisconsin, Madison class: OTHER name: Covering Wisconsin briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:
1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? conditions: No Medicaid Coverage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 0 type: ACTUAL measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call measure: Duration of coverage gaps measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342375 id: 2024-0434 id: A538500 type: OTHER domain: UW- Madison id: Protocol Version 3/20/2024 type: OTHER domain: UW- Madison id: SMPH/POP HEALTH SCI/POP HLTH type: OTHER domain: UW- Madison briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-02 date: 2024-04-05 name: University of Wisconsin, Madison class: OTHER name: Covering Wisconsin briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:
1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? conditions: No Medicaid Coverage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 425000 type: ESTIMATED name: Outbound phone call measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call measure: Duration of coverage gaps measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342362 id: SICHN/IRB-001/2024 briefTitle: Magnesium Sulfate in Neonatal HIE" overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-10-02 date: 2024-12-02 date: 2024-04-02 date: 2024-04-02 name: Sindh Institute of Child Health and Neonatology class: OTHER briefSummary: The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management. conditions: Neonates With HIE studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Magnesium sulfate name: placebo or standard treatment) measure: Neuroprotective effects sex: ALL minimumAge: 1 Day maximumAge: 30 Days stdAges: CHILD facility: SICHN city: Karachi state: Sindh zip: 74201 country: Pakistan name: Naseem Ahmed, FCPS role: CONTACT phone: 03003145554 email: [email protected] lat: 24.8608 lon: 67.0104 hasResults: False
<|newrecord|> nctId: NCT06342349 id: SIBP-V03-I briefTitle: A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above. overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Shanghai Institute Of Biological Products class: INDUSTRY name: Shaanxi Provincial Center for Disease Control and Prevention briefSummary: To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above. conditions: Influenza studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single center, randomized, double-blind, controlled phase I clinical trial. primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Quadrivalent influenza virus split vaccine (MDCK cells) name: Quadrivalent influenza virus split vaccine (Chicken embryo) name: Phosphate buffer solution measure: Solicited Adverse Events (AEs) measure: Unsolicited Adverse Events measure: Serious Adverse Events (SAE) measure: Seroconversion rate measure: Ratio of ≥1:40 measure: Geometric mean increase (GMI) sex: ALL minimumAge: 6 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342336 id: HS-IT101ST01-I briefTitle: HS-IT101 Injection in the Treatment of Advanced Solid Tumors overallStatus: RECRUITING date: 2024-01-18 date: 2026-03-31 date: 2028-03-31 date: 2024-04-02 date: 2024-04-02 name: Qingdao Sino-Cell Biomedicine Co., Ltd. class: INDUSTRY name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences name: The First Hospital of Jilin University name: West China Hospital briefSummary: Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: HS-IT101 Injection measure: Adverse Events (AE) measure: Serious Adverse Events (SAE) measure: Objective Response Rate (ORR) measure: Time-to-response (TTR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Progression-Free-Survival (PFS) measure: Overall Survival (OS) measure: Lymphocyte subpopulation measure: TCR repertoire sex: ALL minimumAge: 18 Days maximumAge: 75 Days stdAges: CHILD facility: Cancer Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Ning Li, MD role: CONTACT phone: 86-010-87788713 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06342323 id: IRB00006761-M2023235 id: ONFM-SBRT type: OTHER domain: Peking university third hospital briefTitle: The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy acronym: ONFM-SBRT overallStatus: RECRUITING date: 2023-10-08 date: 2024-10-07 date: 2025-10-07 date: 2024-04-02 date: 2024-04-02 name: Peking University Third Hospital class: OTHER briefSummary: This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study:
Study Design: Prospective, single-center, exploratory clinical study.
Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases.
Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved.
Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol.
Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process.
Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment.
SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration.
Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy. conditions: Lung Cancer conditions: Liver Cancer conditions: Pancreatic Cancer conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 57 type: ESTIMATED name: SBRT measure: success rate measure: Treatment error sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Qiu Bin role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06342310 id: RE104-201-PPD briefTitle: RE104 Safety and Efficacy Study in Postpartum Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-02 date: 2024-04-03 name: Reunion Neuroscience Inc class: INDUSTRY briefSummary: The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo. conditions: Postpartum Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: RE104 for Injection measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline) measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10) measure: RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I) measure: RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S) measure: RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) measure: RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06342297 id: OLL-1003043 briefTitle: Dermatoscopy Guided Resection for Skin Cancer overallStatus: RECRUITING date: 2024-01-14 date: 2025-12-15 date: 2026-01-14 date: 2024-04-02 date: 2024-04-02 name: Region Örebro County class: OTHER briefSummary: In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report. conditions: Basal Cell Carcinoma conditions: Cutaneous Squamous Cell Carcinoma conditions: Surgical Margin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Dermatoscopy measure: Pathology resection side margin (radical/not radical) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Örebro University Hospital status: RECRUITING city: Örebro zip: 70375 country: Sweden name: Örebro U Hospital role: CONTACT phone: 0729655663 email: [email protected] lat: 59.27412 lon: 15.2066 hasResults: False
<|newrecord|> nctId: NCT06342284 id: NYPC ERC# 2021-030 briefTitle: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer acronym: PGHD overallStatus: RECRUITING date: 2024-03-22 date: 2026-03-21 date: 2031-03-21 date: 2024-04-02 date: 2024-04-02 name: The New York Proton Center class: OTHER briefSummary: This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards. conditions: Thoracic Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Proton Beam Radiation with or without concurrent chemotherapy measure: Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion. measure: Demonstrate the face validity of physical activity and vital sign data collected in this trial by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics. measure: Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York Proton Center status: RECRUITING city: New York state: New York zip: 10035 country: United States name: Ryan Holder, BS role: CONTACT phone: 646-968-9055 email: [email protected] name: Thomas Mistretta, MS role: CONTACT phone: 646-568-5675 email: [email protected] name: Nitin Ohri, MD role: PRINCIPAL_INVESTIGATOR name: Charles Simone, MD role: SUB_INVESTIGATOR name: Annemarie Shepherd, MD role: SUB_INVESTIGATOR name: Stanislav Lazarev, MD role: SUB_INVESTIGATOR name: Alexandra Hanlon, PhD role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<|newrecord|> nctId: NCT06342271 id: 24-2023 briefTitle: Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-30 date: 2025-06-30 date: 2024-04-02 date: 2024-04-02 name: University of Talca class: OTHER briefSummary: People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait.
Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait.
This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD.
The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life.
People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2). conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Nordic walking training name: Free Walking training measure: Change in the amplitude of arm swing measure: Change in the arm swing asymmetry measure: Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m]. measure: Change in the functional mobility will be measured through the Timed up and go (TUG). measure: Change in the quality of life sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06342258 id: HS-23-00611 briefTitle: COES: Curing Order Effects on Sealants acronym: COES overallStatus: RECRUITING date: 2024-02-23 date: 2026-06-30 date: 2026-06-30 date: 2024-04-02 date: 2024-04-11 name: University of Southern California class: OTHER briefSummary: Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases.