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Inclusion criteria:
1. age ≥ 18 years of age
2. indication for radiation treatment of a malignant disease
3. Karnofsky Performance score (KPS) ≥ 70%
4. Life expectancy ≥ 3 months
Exclusion criteria:
1. Inability to provide informed consent
2. Inability to attend study visits and fulfill data collection requirements
3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapy
Secondary outcomes:
* Socio-Economic factors at baseline
* Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months
* Depression (PHQ-9) at baseline and 3 months
* Coping mechanisms to address financial burden
Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.
Secondary Endpoints:
* Changes in the COST-Score over time
* Changes in PHQ-9 over time
* Changes in EORTC QLQ-C30 over time
This is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.
To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120 conditions: Financial Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Questionnaire measure: Financial Toxicity measure: Factors that may influence the occurrence or extent of financial burden measure: Factors that may influence the occurrence or extent of financial burden measure: Factors that may influence the occurrence or extent of financial burden measure: Factors that may influence the occurrence or extent of financial burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Göttingen status: RECRUITING city: Göttingen state: Niedersachsen zip: 37075 country: Germany name: Rami El Shafie, Prof. Dr. role: CONTACT phone: +4955164505 email: rami.elshafie@med.uni-goettingen.de lat: 51.53443 lon: 9.93228 hasResults: False
<|newrecord|> nctId: NCT06278818 id: MNESYS-PE0000006 briefTitle: Effects of Telerehabilitation on Brain Network Connectivity overallStatus: RECRUITING date: 2023-12-07 date: 2024-06-07 date: 2026-03-01 date: 2024-02-26 date: 2024-02-26 name: University of Pavia class: OTHER name: University of Parma name: University of Bologna name: University of Rome Tor Vergata briefSummary: The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers.
This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions.
The study aims to:
* Identify correlations between improvement in cognitive performance and functional brain data.
* Use acquired knowledge to develop neurologically guided TR approaches for broader use.
The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up.
The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The neurophysiologist and neuroradiologist will be blinded to the type of rehabilitation treatment (experimental group vs. control). whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Cognitive Telerehabilitation name: Control Condition measure: Changes in resting-state brain networks functional connectivity after NBTC treatment measure: Changes in resting-state EEG coherence after NBTC treatment measure: Changes in resting-state EEG coherence after HomeCore treatment measure: Changes in resting-state brain networks functional connectivity after SMRT treatment measure: Changes in neuropsychological and caregiver burden measures after TR sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Mondino Foundation status: RECRUITING city: Pavia zip: 27100 country: Italy name: Cristina Tassorelli, MD role: CONTACT phone: 0382380419 phoneExt: 0039 email: cristina.tassorelli@unipv.it name: Silvia Paola P Caminiti, PhD role: CONTACT phone: 0382380419 phoneExt: 0039 email: silviapaola.caminiti@unipv.it lat: 45.19205 lon: 9.15917 hasResults: False
<|newrecord|> nctId: NCT06278805 id: ayk22 briefTitle: Adaptation and Validation of the LUNS for Use in Turkey. overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-02-01 date: 2024-02-26 date: 2024-04-11 name: Uşak University class: OTHER name: Ankara University name: Istanbul University briefSummary: According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.
Our hypothesis in this study is:
- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population. conditions: Stroke conditions: Disability Physical conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 110 type: ESTIMATED name: The reliability and validity study of the T-LUNS measure: The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) measure: The Stroke Impact Scale 3.0 (SIS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Usak status: RECRUITING city: Uşak zip: 64200 country: Turkey name: Ali Y Karahan role: CONTACT phone: +905386921934 email: ali.karahan@usak.edu.tr lat: 38.67351 lon: 29.4058 hasResults: False
<|newrecord|> nctId: NCT06278792 id: Z-2021104 briefTitle: Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure acronym: EASY-HF overallStatus: COMPLETED date: 2022-03-07 date: 2023-07-12 date: 2024-01-05 date: 2024-02-26 date: 2024-02-26 name: Ziekenhuis Oost-Limburg class: OTHER name: Fund for Scientific Research, Flanders, Belgium briefSummary: The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:
* difference in natriuresis and diuresis
* feasibility of the protocol.
Participants will be asked to gather two 24 h urine collections.
Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ACTUAL name: Diuretic protocol name: Standard of Care measure: Urinary sodium excretion after 48 hours measure: Urinary output after 48 hours measure: Urinary sodium excretion on daily base measure: Urinary output on daily base measure: Achievement of decongestion measure: Diuretic dose measure: User-friendliness device and protocol measure: Weight measure: Number of participants with need for heart failure rehospitalization measure: Rate of all-cause mortality measure: Length of hospital stay measure: Number of participants with severe hypotension measure: Number of participants with abnormal blood parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg AV city: Genk state: Limburg zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 hasResults: False
<|newrecord|> nctId: NCT06278779 id: X23-0311 briefTitle: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression acronym: TREK overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-02-26 date: 2024-03-13 name: The George Institute class: OTHER name: The University of New South Wales briefSummary: The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:
* How the two formulations compare in terms of their effectiveness in treating TRD.
* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.
Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes. conditions: Treatment Resistant Depression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, prospective, parallel group, comparative effectiveness trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Primary outcome raters will be blinded to treatment allocation. whoMasked: OUTCOMES_ASSESSOR count: 162 type: ESTIMATED name: Esketamine group name: Racemic ketamine measure: Montgomery-Asberg Depression Rating Scale (MADRS) measure: Montgomery-Asberg Depression Rating Scale (MADRS) score measure: Response - Montgomery-Asberg Depression Rating Scale (MADRS) measure: Remission - Montgomery-Asberg Depression Rating Scale (MADRS) measure: DASS-21 measure: Clinical Global Impression-Improvement (CGI-I) measure: Clinical Global Impression-Severity (CGI-S) measure: Columbia Suicide Severity Rating Scale (C-SSRS) measure: Speed of response - Clinical Global Impression-Improvement (CGI-I) measure: Psychotomimetic symptoms measure: Suicide attempts or gestures measure: Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) measure: Cognitive Failure Questionnaire scores (CFQ) measure: Ketamine liking/craving score measure: Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET) measure: Acceptability Questionnaire measure: All-cause dropouts measure: Recovering Quality of Life Questionnaire (REQOL-10) measure: WHO Disability Assessment Scale (WHODAS-12) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Assessment of Quality of Life Questionnaire (AQoL-8D) measure: Resource Use Questionnaire (RUQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Prince Alfred Hospital city: Camperdown state: New South Wales zip: 2050 country: Australia name: Hadley Lindsay role: CONTACT email: SLHD-RPA-KetamineClinic@health.nsw.gov.au name: Nicholas Glozier role: PRINCIPAL_INVESTIGATOR lat: -33.88965 lon: 151.17642 facility: Black Dog Institute city: Randwick state: New South Wales zip: 2031 country: Australia name: Stella Antoniou role: CONTACT email: depressionclinic@blackdog.org.au name: Adam Bayes role: PRINCIPAL_INVESTIGATOR lat: -33.91439 lon: 151.24895 facility: Ramsay Clinic Northside city: St Leonards state: New South Wales zip: 2065 country: Australia name: Mayra Ouriques role: CONTACT email: neuroinfo.nsc@ramsayhealth.com.au name: Colleen Loo role: PRINCIPAL_INVESTIGATOR lat: -33.82344 lon: 151.19836 facility: Ramsay Clinic Lakeside city: Warners Bay state: New South Wales zip: 2282 country: Australia name: Sally Sally Wilkinson role: CONTACT email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au name: Natasha Cairns role: CONTACT email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au name: Michael Bull role: PRINCIPAL_INVESTIGATOR lat: -32.97251 lon: 151.65268 facility: Gold Coast University Hospital city: Southport state: Queensland zip: 4215 country: Australia name: Catherine Donald role: CONTACT email: specialistmooddisorderclinic@health.qld.gov.au name: Shanthi Sarma role: PRINCIPAL_INVESTIGATOR lat: -27.96724 lon: 153.39796 facility: Ramsay Clinic Albert Road city: Melbourne state: Victoria zip: 3004 country: Australia name: Melanie Hurley role: CONTACT email: research.arc@ramsayhealth.com.au name: Malcolm Hopwood role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False
<|newrecord|> nctId: NCT06278766 id: M24-416 briefTitle: A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration overallStatus: COMPLETED date: 2024-02-21 date: 2024-04-19 date: 2024-04-19 date: 2024-02-26 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 8 type: ACTUAL name: ABBV-552 measure: Number of Participants with Adverse Events (AEs) measure: Maximum observed concentration (Cmax) of ABBV-552 measure: Time to Cmax (peak time, Tmax) of ABBV-552 measure: Terminal phase elimination rate constant (λz) of ABBV-552 measure: Terminal phase elimination half-life (t1/2) of ABBV-552 measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552 measure: Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552 measure: Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) measure: Percent of ABBV-552 excreted in the urine measure: Renal clearance ABBV-552 (CLr) measure: Amount of ABBV-552 excreted in the feces over the sampling period (Aef) measure: Percent radioactivity excreted in the feces sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Inc /ID# 262684 city: Madison state: Wisconsin zip: 53704 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
<|newrecord|> nctId: NCT06278753 id: 2025/05/02 briefTitle: Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy overallStatus: RECRUITING date: 2021-07-01 date: 2024-03-01 date: 2024-04-01 date: 2024-02-26 date: 2024-02-26 name: Tepecik Training and Research Hospital class: OTHER briefSummary: For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared. conditions: Bladder Injury conditions: Ureter Injury conditions: Surgical Injury conditions: Complication of Surgical Procedure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: carbon dioxide cystoscopy measure: It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy. measure: It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses. sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tepecik Training and Research Hospital status: RECRUITING city: İzmir state: Eurasia zip: 35090 country: Turkey name: Ali Turgut role: CONTACT phone: 02324696969 email: iyikliniktepecikeah@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06278740 id: SCIUSG24 briefTitle: Upper Extremity Pathologies in Spinal Cord Injuries overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2025-02-26 date: 2025-03-26 date: 2024-02-26 date: 2024-02-26 name: Afyonkarahisar Health Sciences University class: OTHER briefSummary: This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries. conditions: Spinal Cord Injuries conditions: Upper Extremity Problem conditions: Musculoskeletal Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 174 type: ESTIMATED name: Musculoskeletal Ultrasound measure: Comparison of US findings among participants measure: Visual Analog Scale (VAS) measure: The Physical Examination of the Shoulder Scale (PESS) measure: The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) measure: American Spinal Injury Association (ASIA) Impairment Scale measure: The Spinal Cord Independence Measure (SCIM-III) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Afyonkarahisar Health Sciences University city: Afyonkarahisar zip: 03100 country: Turkey name: Mahmut Sami DOĞANLAR, MD role: CONTACT phone: +905512579828 email: mahmutdoganlar96@gmail.com name: Nuran EYVAZ, MD role: CONTACT phone: +905334262442 email: eyvaznuran@gmail.com lat: 38.75667 lon: 30.54333 hasResults: False
<|newrecord|> nctId: NCT06278727 id: SYSKY-2023-1173-01 briefTitle: Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy overallStatus: RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached. conditions: Mitral Regurgitation conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 270 type: ESTIMATED name: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor name: The development of the prediction model measure: FMR regression rate measure: FMR regression rate measure: composite endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun-Yatsen Memorial Hospital status: RECRUITING city: Canton state: Guangdong country: China name: Maohuan Lin role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06278714 id: 0012 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-03-11 date: 2024-03-20 date: 2024-02-26 date: 2024-02-26 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.
According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function.
In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.
Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Heart rate variability sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06278701 id: 2024-003-01 briefTitle: The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-01 date: 2025-01-31 date: 2025-07-30 date: 2024-02-26 date: 2024-02-26 name: DU Yao class: OTHER briefSummary: Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism.
The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma;
* the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients;
* the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma;
* the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma;
* the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma.
After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to :
* eat 1h before bedtime;
* follow the doctor's instructions during their stay in the hospital;
* have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing. conditions: Liver Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study utilizes a grouping method based on patient preference. You will learn about the 2 dietary modalities, the late-evening snacks and the regular diet, and then you will be placed in the different groups according to your preference. Patients who volunteer for the 1h bedtime meal will be in the test group and those who volunteer for the regular diet will be in the control group. Dietary counseling and follow-up visits will be conducted in both groups, the difference being the presence or absence of the 1h bedtime meal pattern. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 106 type: ESTIMATED name: late-evening snacks measure: Albumin rising measure: Prealbumin rising measure: Decrease in Alanine Aminotransferase measure: Decrease in Aspartate Aminotransferase measure: Decrease in Cholinesterase measure: Decrease in Total bilirubin measure: Lower total hospitalization costs measure: Relapse-Free Survival measure: Improved quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Drum Tower Hospital, Medical School of Nanjing University city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-22 uploadDate: 2024-02-02T09:22 filename: Prot_SAP_000.pdf size: 743937 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-22 uploadDate: 2024-02-04T04:41 filename: ICF_001.pdf size: 292546 hasResults: False
<|newrecord|> nctId: NCT06278688 id: 112R10438Y briefTitle: Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-07-31 date: 2027-07-31 date: 2024-02-26 date: 2024-02-26 name: National Yang Ming University class: OTHER name: National Science and Technology Council name: Far Eastern Memorial Hospital briefSummary: The overarching goal of this randomized-controlled trial is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI. The main questions it aims to answer are:
Aim 1: To investigate the association between gut microbiota, MCI and AD biomarkers. Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data. Also, the relationship between gut microbiota and AD biomarkers, such as amyloid PET and plasma tau, will be explored in MCI and cognitively normal adults.
Aim 2: To determine the efficacy of precision probiotic supplementation on cognitive decline (primary outcome) and functional brain changes (secondary outcome) in individuals with MCI due to AD using a randomized, double-blind, placebo-controlled trial. Investigators plan to recruit 120 individuals with MCI due to AD, i.e., MCI with positive amyloid biomarkers. Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo. The primary outcome measure will be the changes in cognitive functions over 6 months (primary endpoint) and 12 months. The secondary outcome measure will be resting-state functional brain changes.
Aim 3: To investigate potential mediators underlying the effect of probiotic supplementation. The most apparent mediator will be a shift or changes in gut microbiota. Other potential mediators will be related to decreased lipopolysaccharide, proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-6 and IL-10, and increased brain- derived neurotrophic factor, short-chain fatty acid, etc. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Precision probiotics measure: The changes in attention measure: The changes in memory measure: The changes in executive function measure: The changes in global cognition at the 12th month from baseline. measure: The changes in brain imaging at the 12th month from baseline. sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06278675 id: SEOVA briefTitle: Multiple Study of Electroaccpuncture in ARDS overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-04-23 name: Nanjing University of Traditional Chinese Medicine class: OTHER briefSummary: In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS. conditions: Acute Respiratory Distress Syndrome conditions: Sepsis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 264 type: ESTIMATED name: Acupuncture needles measure: Respiratory mechanics indicators 1 measure: Respiratory mechanics indicators 2 measure: Respiratory mechanics indicators 3 measure: Respiratory mechanics indicators 4 measure: Respiratory mechanics indicators 5 measure: Respiratory mechanics indicators 6 measure: Respiratory mechanics indicators 7 measure: Sedation and analgesia measure: Sedative drug use measure: Analgesic drug use measure: Inflammatory factors measure: CD4、CD8、CD4/CD8 measure: Vasoactive drugs applications measure: CRRT applications measure: ECMO applications measure: All-cause mortality to day 28 measure: All-cause mortality to day 60 measure: ICU-free days measure: Hospital-free days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine city: Nanjing state: Jiangsu zip: 210029 country: China name: Jun Lu, Doctor role: CONTACT phone: +86 13813865758 email: lujun@njucm.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False
<|newrecord|> nctId: NCT06278662 id: CIRCUS cmRCT briefTitle: Cohort Multiple Randomized Controlled Trial in Pediatric Asthma acronym: CIRCUS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2034-04-01 date: 2034-04-01 date: 2024-02-26 date: 2024-02-26 name: Mattienne van der Kamp class: OTHER briefSummary: The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).
Primary Objectives within cmRCT cohort:
* Provide a framework for multiple randomized (eHealth) interventions for asthmatic children