hackint0sh/New-Dataset huggingface dataset:
Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.
Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.
The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later. conditions: Insomnia Chronic conditions: Insomnia Due to Medical Condition conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We randomize patients to receive either the Sleep-Well intervention or to the TAU condition (active waiting-list group). After 3 months, the TAU patients cross over and receive the Sleep-Well intervention; hence, the design is semi-crossover. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: Sleep-Well despite persistent pain name: TAU (treatment-as-usual) measure: Insomnia symptoms measure: Insomnia diagnosis measure: Actigraphy insomnia indicators (SOL, WASO and EMA in minutes) measure: Actigraphy insomnia indicators (SE %) measure: Sleep diary insomnia indicators (SOL, WASO and EMA in minutes) measure: Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST) measure: Anxiety and depression (HADS) measure: Quality of Life (EQ-5Q-5L) measure: Fatigue (Chalder Fatigue Scale) measure: Pain intensity, interference and locations (BPI) measure: Tolerance and Acceptance of chronic pain (CPAQ-R) measure: Mediator: Sleep hygiene (SHI) measure: Hyperactivity (HAS) measure: Mediator: Dysfunctional beliefs and attitudes about sleep (DBAS) measure: Mediator: Metacognitions about insomnia (MCQ-i) measure: Mediator: Insomnia catastrophizing Scale (ISC) measure: Mediator: Pain Catastrophizing Scale (PCS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UiT The Arctic University of Norway city: Tromsø state: Troms County zip: 9037 country: Norway name: Oddgeir Friborg, ph.d. role: CONTACT phone: 4777646772 email: oddgeir.friborg@uit.no name: Svein Bergvik, ph.d. role: CONTACT phone: 4777646323 email: svein.bergvik@uit.no name: Oddgeir Friborg, ph.d. role: PRINCIPAL_INVESTIGATOR name: Jan H Rosenvinge, ph.d. role: SUB_INVESTIGATOR name: Svein Bergvik, PhD role: SUB_INVESTIGATOR lat: 69.6489 lon: 18.95508 hasResults: False
nctId: NCT06351826 id: 22070876 briefTitle: Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department overallStatus: RECRUITING date: 2024-01-03 date: 2024-04 date: 2024-05 date: 2024-04-08 date: 2024-04-08 name: Indonesia University class: OTHER briefSummary: This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:
Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention. conditions: Polytrauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: ELLASI name: Standard measure: Response time measure: Deterioration score measure: Acidic Level (pH) measure: Base Excess (BE) measure: Bicarbonate level (HCO3) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSCM status: RECRUITING city: Jakarta Pusat state: Jawa Barat zip: 10430 country: Indonesia name: RSCM role: CONTACT phone: 062211500135 email: info@rscm.co.id lat: -6.1818 lon: 106.8223 hasResults: False
nctId: NCT06351813 id: B2024-029R briefTitle: Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Shanghai Zhongshan Hospital class: OTHER name: Zhongshan Hospital (Xiamen), Fudan University name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University briefSummary: The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes. conditions: Acute Kidney Injury conditions: Critical Illness conditions: Kidney Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 358 type: ESTIMATED measure: AKI nonresolving subphenotype measure: Major adverse kidney events at 30 days measure: Major adverse kidney events at 90 days measure: Major adverse kidney events at 365 days measure: Mortality measure: Receipt of renal replacement treatment measure: Moderate and severe AKI measure: AKI progression measure: Composite Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Zhongshan Hospital city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06351800 id: PE-0280-2018 briefTitle: The PredictPlusPrevent Study overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-12-31 date: 2026-04-30 date: 2024-04-08 date: 2024-04-08 name: The Mediterranean Institute for the Advance of Biotechnology and Health Research class: OTHER briefSummary: Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).
Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12). conditions: Depression conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 9000 type: ESTIMATED name: Predictplusprevent intervention name: Psychoeducational intervention measure: Incidence of depression and/or anxiety disorders. measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7). measure: Probability of depression measured by the Spanish predictD risk algorithm. measure: Probability of anxiety measured by the Spanish predictA risk algorithm. measure: Quality of life measured by the 12-item Short Form (SF-12). sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
nctId: NCT06351787 id: 22-X-97 briefTitle: Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis overallStatus: COMPLETED date: 2022-10-31 date: 2023-06-28 date: 2023-06-28 date: 2024-04-08 date: 2024-04-08 name: Ohio University class: OTHER briefSummary: In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.
Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).
Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan-\>yoga intervention sequence compared to the yoga-\>body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being. conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience. primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Resting and movement-based focused awareness meditations measure: Cortical activity measure: Interoceptive awareness measure: Mindful awareness measure: Pressure pain threshold and tolerance measure: Healthy emotionality measure: Well-being sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False
nctId: NCT06351774 id: 21-F-45 briefTitle: Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain acronym: AdaPT overallStatus: COMPLETED date: 2022-05-24 date: 2024-02-08 date: 2024-03-25 date: 2024-04-08 date: 2024-04-08 name: Ohio University class: OTHER name: University of Wisconsin, Madison briefSummary: In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP). conditions: Back Pain Lower Back Chronic conditions: Disability Physical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 2 armed sequential, multiple-assignment randomized trial design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigator was masked to the initial treatment assignment. The outcome assessor was not masked to treatment assignment and monitored treatment response at the mid-intervention in order to recommend continuation of current treatment or to augment treatment with the Healthy Mind Innovations training program for individuals who did not favorably respond to standalone PT. whoMasked: INVESTIGATOR count: 13 type: ACTUAL name: Physical therapy measure: Oswestry Disability Index measure: PROMIS Pain Interference measure: Actigraphy measure: 3D Motion Capture measure: Pain acceptance measure: Committed action measure: Healthy emotionality measure: Exercise behavior measure: Back pain screening tool 1 measure: Back pain screening tool 1 measure: Kinesiophobia measure: Attitudes towards complementary and alternative medicine measure: Treatment expectancy measure: Lumbar pressure pain threshold measure: Thermal method of limits sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False
nctId: NCT06351761 id: SCT02-ECG briefTitle: WIBOFA - Validation of SCT02 With ECG-App for Detection of AF acronym: WIBOFA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-03 date: 2024-04-08 date: 2024-04-08 name: Withings class: INDUSTRY briefSummary: The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 270 type: ESTIMATED name: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording name: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording measure: Co-primary outcome 1 - Sensitivity of Investigational Device measure: Co-primary outcome 2 - Specificity of Investigational Device measure: Rhythm classification by ranges of heart rate measure: Quality of plots measured by the IMD - ECG Waveform Visibility measure: Quality of plots measured by the IMD - ECG Waveforms Polarity measure: Quality of plots measured by the IMD - ECG Waveforms Intervals measure: Quality of plots measured by the IMD - Heart Rate calculation sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FWD Clinical Research city: Boca Raton state: Florida zip: 33486 country: United States lat: 26.3669 lon: -80.13033 facility: Diverse Clinical Research city: Miami state: Florida zip: 33175 country: United States lat: 25.77427 lon: -80.19366 facility: Henri Mondor University Hospital city: Créteil state: Val De Marne zip: 94000 country: France lat: 48.78333 lon: 2.46667 hasResults: False
nctId: NCT06351748 id: NN9535-7877 id: U1111-1296-3151 type: OTHER domain: World Health Organization (WHO) briefTitle: Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR) acronym: SCHOLAR overallStatus: ENROLLING_BY_INVITATION date: 2024-04-05 date: 2024-06-30 date: 2024-06-30 date: 2024-04-08 date: 2024-04-08 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \[NRDL\] in China\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period. conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 27000 type: ESTIMATED name: Semaglutide measure: Change in Haemoglobin A1c (HbA1c) level measure: Change in HbA1c level measure: Proportion of participants achieving HbA1c less than (<) 7.0% measure: Change in HbA1c level measure: Change in HbA1c level measure: Proportion of participants achieving HbA1c <7.0% measure: Change in body weight measure: Change in body weight measure: Description of participants with different demographic characteristics measure: Description of participants with different clinical characteristics measure: Proportion of participants with different antidiabetic medications measure: Proportion of participants with different non-antidiabetic medications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Chu Hsien-I Memorial Hospital city: Tianjin country: China lat: 39.14222 lon: 117.17667 hasResults: False
nctId: NCT06351735 id: 2024-0336 briefTitle: Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-08 date: 2024-04-08 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression. conditions: Evaluation of the Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in Patients With Amyotrophic Lateral Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 3 type: ESTIMATED name: Deep cervical lymph node-vein bypass surgery measure: ALSFRS-R scale measure: Cognitive and Behavioral Scale (CAS) measure: Baseline of slow vital capacity (SVC) measure: Evaluation of glymphatic and meningeal lymphatic drainage measure: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351722 id: smokingnlrp3inflasome briefTitle: Non-surgical Periodontal Treatment in Smokers on SIRT-1, NLRP3 Inflammasome and LncRNAs overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-03-15 date: 2024-04-08 date: 2024-04-08 name: Necmettin Erbakan University class: OTHER briefSummary: The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate potential confounders that may mediate this relationship.
question 1: Is there a relationship between the biomarkers mentioned above and periodontitis and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers? conditions: Periodontitis, Adult studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Before non-surgical periodontal treatment name: non-surgical periodontal treatment name: 3rd month after non-surgical periodontal treatment measure: Pre-treatment clinical and laboratory evaluation measure: Comparison of clinical measurements and laboratory measurements at 3 months post-treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351709 id: UmutPaksoy briefTitle: Acute Effects of Heat, Cold and Stretching on Knee Proprioception and Vertical Jump overallStatus: COMPLETED date: 2020-11-02 date: 2021-02-20 date: 2021-02-20 date: 2024-04-08 date: 2024-04-08 name: Istanbul Bilgi University class: OTHER briefSummary: The aim of our study is to investigate the effects of heat, cold and stretching on knee proprioception and vertical jump. 60 healthy individuals were randomized into hot, cold, stretching and control groups of 15 each. Pre-test and post-test measurements were made immediately after the application. Knee proprioception was measured with a digital goniometer using the EPD (joint position sense) test. Vertical jump heights were measured with contact mat by countermovement (CMJ) and squat splash (SQS) tests. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Stretching name: Hot pack application name: Cold pack application measure: Vertical Jump Distance Measurement measure: Joint Position Sense Measurement sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: İstanbul Medipan Tıp Merkezi city: Istanbul zip: 34218 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06351696 id: 43008563 briefTitle: The Effects of Bromelain Supplement in Patients With Ulcerative Colitis overallStatus: RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-08-10 date: 2024-04-08 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.