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The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level. |
Three months after the study, a survey will be sent to the participants to check if the benefits have persisted. conditions: Stress, Psychological conditions: Burnout, Psychological conditions: Subjective Stress conditions: Occupational Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Box Breathing name: Breathing and Mindfulness Exercise name: Everyday life control measure: Daily perceived stress measure: Daily expectation of perceived stress level on the following day measure: Level of agreement between expected and actually perceived level of stress measure: Compliance with the study protocol: number of participant reported outcomes measure: Compliance with the study protocol: number of performed anti-stress interventions measure: Successful study completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin status: RECRUITING city: Berlin zip: 10117 country: Germany name: Valentin M Vetter, MD role: CONTACT phone: 0049 30 450 566 298 email: [email protected] lat: 52.52437 lon: 13.41053 hasResults: False |
<|newrecord|> nctId: NCT06368778 id: 166591 briefTitle: Real-Time Biofeedback on Partial Weightbearing Training overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-13 date: 2025-04 date: 2025-04 date: 2024-04-16 date: 2024-04-26 name: University of Utah class: OTHER briefSummary: The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback. |
The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions. |
Secondary objectives of the study include: |
Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations. |
Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training. |
By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction. conditions: Physical Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: Verbal Advice name: Bathroom Scale name: Loadsol Biofeedback measure: Average peak force (Newtons, (N)) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Utah Orthopaedic Center city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False |
<|newrecord|> nctId: NCT06368765 id: BL72 briefTitle: Oral Rehydration Solution and Dehydration Recovery overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-16 date: 2024-04-16 name: Abbott Nutrition class: INDUSTRY briefSummary: This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution. conditions: Dehydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Oral Rehydration Solution (ORS) name: Water measure: Plasma Volume measure: Body Mass measure: Hydration Status Urine measure: Blood Biomarker - Plasma Osmolality measure: Blood Biomarker - Plasma Electrolyte Concentration measure: Blood Biomarker - Plasma Glucose Concentration measure: Body Temperature measure: Body Composition measure: Reaction Time measure: Handgrip Strength measure: Urine Volume measure: Hydration Status Saliva measure: Heart Rate measure: Blood Pressure measure: Thirst Sensation Scale measure: Gagge Thermal Scale measure: Urine Color measure: Palatability measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06368752 id: H-22063621 briefTitle: The Role of Endogenous GIP in Glycosis Metabolism During Fasting overallStatus: ENROLLING_BY_INVITATION date: 2023-05-04 date: 2023-12-12 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Frederikke Koefoed-Hansen class: OTHER briefSummary: This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\[3-30\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion. conditions: Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\[3-30\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo). primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP\[3-30\]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: GIP[3-30]NH2 name: Saline measure: Plasma glucagon concentrations measure: Plasma levels of C-peptide measure: Plasma levels of insulin measure: Resting metabolic rate measure: Activity in brown adipose tissue measure: Appetite measure: Blood pressure measure: Puls sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gentofte Hospital city: Hellerup zip: 2900 country: Denmark lat: 55.73204 lon: 12.57093 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-10 uploadDate: 2024-04-11T04:12 filename: Prot_SAP_000.pdf size: 120286 hasResults: False |
<|newrecord|> nctId: NCT06368739 id: STUDY00005622 briefTitle: Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-17 date: 2024-05-01 date: 2024-08-01 date: 2024-04-16 date: 2024-04-16 name: University of Texas at Austin class: OTHER name: Driscoll Health Plan briefSummary: With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data. conditions: Pregnancy Related conditions: Financial Gift conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: From the eligible population, DHP randomly selected a subset of approximately 500 women during the pilot period, from which approximately 200 were in the program, the "exposed group." The women who were covered during the same period but were not selected were not exposed to the program and will compose the "comparison group." primaryPurpose: PREVENTION masking: NONE count: 224 type: ACTUAL name: Nurture program name: Regular benefits measure: Composite outcome 1: Adverse health events during pregnancy measure: Composite outcome 2: Adverse health events at birth and newborn-related measure: Emergency Department visits measure: Cost (outpatient) measure: Cost (inpatient) measure: Cost (pharmacy/medication) measure: Cost (total) measure: Delivery mode (vaginal, C-section) measure: Birthweight sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Driscoll Health Plan city: Corpus Christi state: Texas zip: 78415 country: United States lat: 27.80058 lon: -97.39638 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-24 uploadDate: 2024-02-12T16:26 filename: Prot_SAP_000.pdf size: 630078 hasResults: False |
<|newrecord|> nctId: NCT06368726 id: SFND04042024 briefTitle: Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders acronym: tDCS&ASD overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-16 date: 2024-04-16 name: Spanish Foundation for Neurometrics Development class: OTHER name: Fundacion para la Salud Materno Infantil briefSummary: Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS conditions: Attention conditions: Visual Perceptual Weakness conditions: Social Behavior conditions: Fluency Disorder conditions: EEG With Periodic Abnormalities studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation. whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: tDCS or Transcranial Direct Current Stimulation name: Risperidone measure: FFT measure: Power Density Spectrum Changes or PSD measure: ERP MMN changes measure: ERP MMN Changes measure: Attention measure: Social Skills measure: Language measure: Visual Contact sex: ALL minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD facility: New Remedies Ltd city: Liverpool state: Merseyside zip: L1 0AH country: United Kingdom lat: 53.41058 lon: -2.97794 hasResults: False |
<|newrecord|> nctId: NCT06368713 id: PD-GIEX briefTitle: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Sichuan Academy of Medical Sciences class: OTHER briefSummary: This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients. conditions: Peritoneal Dialysis conditions: Exercise conditions: Gastrointestinal Function conditions: Quality of Life conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Exercise measure: Change in GIQLI measure: Change in GSRS measure: Change in PAC-SYM measure: Change in 6-MWT measure: Change in SGA measure: Change in measured Gastrointestinal Hormones sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Jin Chen, Doctor role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06368700 id: CL-00001 briefTitle: The Hyalex Early Feasibility Study (EFS) overallStatus: RECRUITING date: 2024-04-04 date: 2025-10 date: 2026-10 date: 2024-04-16 date: 2024-04-16 name: Hyalex Orthopaedics, Inc. class: INDUSTRY briefSummary: The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant. conditions: Cartilage Injury conditions: Cartilage Damage studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Hyalex Knee Cartilage System measure: Freedom from implant rejection and infection. measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery status: RECRUITING city: New York state: New York zip: 10021 country: United States name: Ava Neijna role: CONTACT phone: 917-260-3677 email: [email protected] name: Morgan Rizy role: CONTACT name: Sabrina Strickland, M.D. role: PRINCIPAL_INVESTIGATOR name: Andreas Gomoll, M.D. role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Oregon Health & Science University status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Jessica Ballin role: CONTACT phone: 503-418-9580 email: [email protected] name: Dennis Crawford, M.D. role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False |
<|newrecord|> nctId: NCT06368687 id: 2023-06112-01 briefTitle: TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum acronym: TRANPAS overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Göteborg University class: OTHER briefSummary: In a pilot study, we will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery. conditions: Anorexia Nervosa conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot study. Ten consecutive patients with anorexia nervosa (AN) plus autism will be admitted to the autism care location at an inpatient ward for eating disorders. The planned period of care for each patient is 12 weeks. The patient will be assessed (including weight, height, self-report questionnaires and interviews) before admission, at discharge and 6 months later. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Anorexia nervosa plus autism measure: BMI change between baseline and discharge 12 weeks later measure: Change of level of anxiety between baseline and discharge 12 weeks later measure: Change of Quality of life between baseline and discharge 12 weeks later sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368674 id: 2023-00363 briefTitle: Bridging the Gap: Creating a Continuum of Care overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-12-31 date: 2027-02-01 date: 2024-04-16 date: 2024-04-22 name: Göteborg University class: OTHER name: Vastra Gotaland Region name: Narhalsan Reasearch and Development primary care Region Vastra Gotaland name: Sahlgrenska University Hospital, Sweden name: Forte briefSummary: Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward. |
This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need. |
The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care. conditions: Frailty conditions: Dependence conditions: Integrated Care studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinical control study primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Intervention group Case Manager (CM) name: Control Group measure: Dependency in Activities of Daily Living (ADL) measure: Self-rated health measure: Life satisfaction measure: Satisfaction with quality of care measure: Health economics sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368661 id: 23.79 Colo-MAR 1 briefTitle: Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1) overallStatus: RECRUITING date: 2023-09-01 date: 2024-10-01 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Fundación Vithas class: OTHER name: CEU San Pablo University briefSummary: This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention. conditions: Nutrition Related Neoplasm/Cancer studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: Dietary habits registry from participants: the dietary intake measure: Biomarkers in colon mucosa, precancerous lesions and colorectal cancer measure: Gut microbiota profile sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ciro Cabezas Checchi status: RECRUITING city: Vigo state: Pontevedra zip: 36206 country: Spain name: Ciro Cabezas Checchi, MD role: CONTACT phone: +34 986 82 11 00 email: [email protected] lat: 42.23282 lon: -8.72264 hasResults: False |
<|newrecord|> nctId: NCT06368648 id: CP-1 briefTitle: CoMind Early Feasibility Study acronym: CoMind EFS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-04 date: 2024-04-16 date: 2024-04-16 name: CoMind Technologies Limited class: INDUSTRY name: Lindus Health briefSummary: The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. |
Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. |
Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP. conditions: Intracranial Pressure conditions: Intracranial Pressure Changes conditions: Traumatic Brain Injury conditions: Intracerebral Hemorrhage conditions: Encephalitis conditions: Encephalopathy conditions: Hydrocephalus conditions: Stroke conditions: Autoregulation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 581 type: ESTIMATED measure: A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP measure: Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP. measure: Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population. measure: Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg). measure: Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform. measure: Demonstration of an non-invasive ICP model that can predict trends in ICP measure: A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368635 id: 2022-GSP-QN-8 briefTitle: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study acronym: CCMD overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-16 date: 2024-04-18 name: Weijing Wang class: OTHER_GOV name: Chinese Academy of Medical Sciences, Fuwai Hospital briefSummary: Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds. |
Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown. |
The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD). conditions: Microcirculation conditions: Coronary Artery Disease conditions: Cerebrovascular Circulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Coronary angiography measure: MACE measure: MACE measure: Cerebral microcirculation measure: Cerebral microcirculation sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Weijing Wang, PhD role: CONTACT phone: +8601088326200 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06368622 id: CDM10001814 briefTitle: Evolve China PMCF Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-11 date: 2031-08 date: 2024-04-16 date: 2024-04-16 name: Stryker Neurovascular class: INDUSTRY name: Stryker (Beijing) Healthcare Products Co., Ltd briefSummary: A prospective, multi-center, single-arm, open-label, observational post-market real-world registry. The expected duration of the study is 8 years (including up to 5-years' follow-up). |
Each subject will be followed in accordance with the standard of care (SOC) at each participating hospital. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Surpass Evolve Flow Diverter System measure: Neurological death or disabling stroke measure: 100% occlusion without significant parent artery stenosis measure: Procedure- and device-related serious adverse events measure: Key neurological events measure: Procedural success measure: Device success measure: Re-sheathing success sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06368609 id: 2024-09 briefTitle: Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection acronym: PROTOSS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-16 date: 2024-04-18 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: Single center, no profit experimental study on sera available in the Tropica Biobank. conditions: Strongyloides Stercoralis Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: IgG RDT name: IgG4 RDT measure: RDTs IgG results: positive or negative measure: RDTs IgG4 results: positive or negative measure: Agreement between readers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital city: Negrar state: Verona zip: 37024 country: Italy name: Dora Buonfrate role: CONTACT email: [email protected] name: Dora Buonfrate role: PRINCIPAL_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False |
<|newrecord|> nctId: NCT06368596 id: 2024-04 briefTitle: ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis acronym: ENDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-16 date: 2024-04-16 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation. |
A control group would however be recruited for secondary objective 1 and 2. |
The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 845 type: ESTIMATED name: Fusobacterium detection measure: Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis measure: Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis measure: Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis . measure: Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria di Negrar city: Negrar state: Verona country: Italy name: Marcello Ceccaroni, Doctor role: CONTACT email: [email protected] role: CONTACT phone: 0456013111 name: Marcello Ceccaroni role: PRINCIPAL_INVESTIGATOR name: Dora Buonfrate role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False |
<|newrecord|> nctId: NCT06368583 id: 24-05 briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia acronym: PAS-EDU-NLA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-23 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery. |
Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery. conditions: Well-Being, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Interview measure: Patient questionnaire measure: Patient interview sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Sabine Nabecker, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: [email protected] name: Ron George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR name: Sunti Barahi, MD role: SUB_INVESTIGATOR name: Ratesh Bassi, MD role: SUB_INVESTIGATOR name: Afsheen Nasir, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06368570 id: 24-04 briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery acronym: PAS-EDU-RCD overallStatus: RECRUITING date: 2024-04-25 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-26 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD. |
Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD. conditions: Well-Being, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Interview measure: Patient questionnaire measure: Patient interview sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Sabine Nabecker, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: [email protected] name: Ron George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR name: Fernanda Septimio Lanza Oliveira, MD role: SUB_INVESTIGATOR name: Lada Kordich, MD role: SUB_INVESTIGATOR name: Afsheen Nasir, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06368557 id: 22/59602 briefTitle: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders overallStatus: RECRUITING date: 2023-10-10 date: 2025-03 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Region of Southern Denmark class: OTHER name: University of Aarhus briefSummary: The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the |
Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are: |
1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist. |
2. What effect different degrees of therapist support have on the treatment. |
Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment. |
Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment. conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The RCT is designed as a superiority RCT with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months. primaryPurpose: TREATMENT masking: NONE maskingDescription: As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design. count: 168 type: ESTIMATED name: CoolMinds: Internet-based cognitive behavioral therapy (iCBT) measure: The Youth Online Diagnostic Assessment - Child and Parent Versions measure: Spence Children's Anxiety Scale- Child and Parent Versions measure: Child Anxiety Life Interference Scale- Child and Parent Version measure: The Mood and Feelings Questionnaire- Child and Parent Version measure: Working Alliance Inventory - Short Form measure: Working Alliance Inventory for Online Interventions measure: Children´s Anxiety Scale measure: The Short Mood and Feelings questionnaire measure: EuroQol-5 Dimension Youth measure: Client Satisfaction Questionnaire-8 measure: Systems Usability Scale measure: Negative Effects Questionnaire measure: Sociodemographic measures measure: Engagement measure: Cost-effectiveness measure: Cost-effectiveness measure: The Anxiety Disorders Interview Schedule for Children sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Centre for Digital Psychiatry status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Helene Skaarnes, MSc (psych)) role: CONTACT phone: +4529649702 email: [email protected] name: Kim Mathiasen, Ph.d. role: CONTACT phone: +4561677747 email: [email protected] lat: 55.39594 lon: 10.38831 hasResults: False |
<|newrecord|> nctId: NCT06368544 id: M2023816 briefTitle: Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction overallStatus: RECRUITING date: 2024-01-07 date: 2030-02-07 date: 2030-02-07 date: 2024-04-16 date: 2024-04-16 name: Peking University Third Hospital class: OTHER briefSummary: A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation. conditions: Anterior Cruciate Ligament Injuries conditions: Cartilage Degeneration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: lower-body positive-pressure measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Biochemical characteristics of knee cartilage measure: Biochemical characteristics of knee cartilage sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing country: China name: ren shuang role: CONTACT phone: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06368531 id: 2314270 briefTitle: Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain overallStatus: RECRUITING date: 2024-04-04 date: 2025-02-15 date: 2025-08-15 date: 2024-04-16 date: 2024-04-16 name: Odense University Hospital class: OTHER name: University of Aarhus name: T&W Engineering A/S briefSummary: Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights. conditions: Chronic Pain conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED measure: sleep period time (SPT) from Ear EEG measure: Qualitative sleep parameters obtained from sleep diary. measure: Pain intensity rating measure: Time from sleep onset until final awakening (TST) from Ear EEG measure: Sleep efficiency (SE) from Ear EEG measure: Sleep onset latency (SOL) from Ear EEG measure: Wake after sleep onset (WASO) from Ear EEG measure: REM sleep latency from Ear EEG measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG measure: Number of awakenings within TST from Ear EEG measure: Arousal index which is number of arousals per hour from Ear EEG measure: Ease-of-use and Comfort with ear EEG measure: Adverse device effects measure: Polysomnography measure: Sleep quality measure: Insomnia measure: The Graded Chronic Pain Scale Revised measure: Age measure: Sex measure: Ethnicity measure: Height measure: Weight measure: Level of education measure: Obstructive sleep apnea sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense status: RECRUITING city: Odense zip: 5000 country: Denmark name: Henrik B Vaegter, PhD role: CONTACT phone: 004565413869 lat: 55.39594 lon: 10.38831 hasResults: False |
<|newrecord|> nctId: NCT06368518 id: ID01/2024/MZHCM-Reg/NV briefTitle: Austrian HCM Registry overallStatus: RECRUITING date: 2024-03-08 date: 2034-03 date: 2034-03 date: 2024-04-16 date: 2024-04-16 name: Medical University of Graz class: OTHER briefSummary: The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: All cause mortality measure: Cardiovascular events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Nicolas Verheyen, MD, PHD role: CONTACT phone: 004331638530173 email: [email protected] name: Viktoria Santner, MD role: CONTACT email: [email protected] name: Nicolas Verheyen, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False |
<|newrecord|> nctId: NCT06368505 id: R.24.02.2506.R1 briefTitle: Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome overallStatus: RECRUITING date: 2024-01-16 date: 2024-06-16 date: 2024-07-16 date: 2024-04-16 date: 2024-04-16 name: Osama Ahmed Elshafei class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are: |
* Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome |
* Asses safety profile of both methods |
Participants will: |
* Randomized to one of the two arms |
* Visit the clinic 1 and 3 months after intervention |
* Assessed for efficacy and safety of the intervention conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: ultrasound guided PRP injection name: ultrasound guided hydrodissection measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) measure: The visual analog scale (VAS) measure: The cross-sectional area (CSA) of the Median nerve sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University status: RECRUITING city: Mansoura zip: 35511 country: Egypt name: osama elshafei, MD PHD role: CONTACT email: [email protected] name: Dena El-Ghzzawy role: CONTACT email: [email protected] name: Dena El-Ghzzawy, MD role: SUB_INVESTIGATOR name: OSAMA ELSHAFEI, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 31.03637 lon: 31.38069 hasResults: False |
<|newrecord|> nctId: NCT06368492 id: P137 id: 2021-002909-10 type: EUDRACT_NUMBER id: NL78008.068.21 type: OTHER domain: METC azM/Maastricht University briefTitle: The Impact of Psilocybin on Pain in Fibromyalgia Patients acronym: PsiloFM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Maastricht University class: OTHER name: Leiden University Medical Center briefSummary: Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. |
Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. |
Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. |
Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: double-blind, randomized, within-subjects, placebo-controlled design. primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinding will be handled by one of the study pharmacies and order and allocation of the treatment to each participant will be completely randomized. This setup ensures that neither the participant nor the experimenter running the test day will be aware of the contents of the capsule. count: 35 type: ESTIMATED name: Psilocybin name: Hypnosis script measure: Ischemic Pain perception measure: Pressure-evoked Pain perception measure: Self-reported pain measure: Subjective effects: psychedelic phenomenology measure: Subjective effects: mood measure: Subjective effects: intensity of effects measure: Subjective effects: Ego dissolution measure: Subjective effects: Dissociation measure: Psychiatric symptoms measure: Cognitive performance measure: Vigilance measure: Empathy measure: Creativity measure: Creativity measure: Autobiographical memory measure: Autobiographical memory measure: Treatment expectancy measure: Treatment expectancy measure: Fibromyalgia-related pain measure: Personality measure: Absorption measure: Interpersonal Reactivity measure: Depression sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University city: Maastricht state: Limburg zip: 6226AK country: Netherlands name: Mauro Cavarra, MSc role: CONTACT phone: +313494438261 email: [email protected] lat: 50.84833 lon: 5.68889 facility: Leiden University Medical Center city: Leiden state: South Holland zip: 2333 country: Netherlands name: Monique van Velzen, PhD role: CONTACT email: [email protected] lat: 52.15833 lon: 4.49306 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-08 uploadDate: 2023-10-30T07:36 filename: Prot_SAP_000.pdf size: 673739 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-10 uploadDate: 2023-10-30T07:38 filename: ICF_001.pdf size: 451492 hasResults: False |
<|newrecord|> nctId: NCT06368479 id: CLS-016B briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-01 date: 2024-07-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care. conditions: Hepatitis B conditions: Hepatitis B Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 4400 type: ESTIMATED name: iStatis HBsAg Test measure: iStatis Performance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research status: RECRUITING city: Hillcrest state: Kwazulu Natal zip: 3650 country: South Africa name: Cherie Cawood role: CONTACT phone: +27828202955 email: [email protected] hasResults: False |
<|newrecord|> nctId: NCT06368466 id: CLS-016A briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-30 date: 2024-09-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY name: St Vincent's Hospital Melbourne briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions. conditions: Hepatitis B conditions: Hepatitis B Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 350 type: ESTIMATED name: iStatis HBsAg Test measure: Performance measure: Sensitivity and Specificity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Vincent's Hospital, Melbourne city: Melbourne state: Fitzroy Victoria zip: 3065 country: Australia name: Alex Thompson role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False |
<|newrecord|> nctId: NCT06368453 id: CLS-003 briefTitle: A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing. |
The study aims to: |
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population. |
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results). |
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test. conditions: Human Immunodeficiency Virus I Infection conditions: Human Immunodeficiency Virus II Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: SINGLE whoMasked: CARE_PROVIDER count: 1700 type: ESTIMATED name: INSTI® HIV Self-Test measure: Clinical sensitivity and specificity of the INSTI® HIV Self-Test measure: The INSTI® HIV Self-Test usability and result interpretation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368440 id: D7860C00003 briefTitle: A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-10-04 date: 2024-10-04 date: 2024-04-16 date: 2024-04-16 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: AZD6793 name: AZD6793 name: Placebo measure: Part 1 (SAD): Number of Participants with Adverse Events measure: Part 2 (MAD): Number of Participants with Adverse Events measure: Part 1 (SAD) : Maximum Observed Plasma Drug Concentration measure: Part 1 (SAD): Time to Reach Peak Concentration (tmax) measure: Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) measure: Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]) measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) measure: Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) measure: Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) measure: Part 1 (SAD): Dose Normalized AUClast measure: Part 1 (SAD): Dose Normalized AUCinf measure: Part 1 (SAD): Dose Normalized Cmax measure: Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax) measure: Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough) measure: Part 2 (MAD): Temporal Change Parameter (TCP) measure: Part 2 (MAD): Time to Reach Peak Concentration (tmax) measure: Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) measure: Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) measure: Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) measure: Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) measure: Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau) measure: Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) measure: Part 2 (MAD): Dose Normalized AUClast measure: Part 2 (MAD): Dose Normalized AUCtau measure: Part 2 (MAD): Dose Normalized Cmax measure: Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC) measure: Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax) measure: Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]) measure: Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf) measure: Part 2 (MAD): Renal Clearance (CLR) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Research Site city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 hasResults: False |
<|newrecord|> nctId: NCT06368427 id: D5980R00100 briefTitle: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD acronym: COnCORD overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-09-30 date: 2025-09-30 date: 2024-04-16 date: 2024-04-16 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 250 type: ESTIMATED name: budesonide / glycopyrronium / formoterol measure: Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score measure: Change from baseline to 6 months in the CAT score measure: Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment measure: Percent responders of the CAT [MID=2] after 12 weeks of treatment measure: Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation measure: Drivers for initiation or switch to BGF MDI via physician questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368414 id: KCMLWP-2021-04 briefTitle: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia acronym: AsterA overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-08-31 date: 2028-08-31 date: 2024-04-16 date: 2024-04-16 name: Korean Society of Hematology class: NETWORK briefSummary: To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI conditions: Chronic Myeloid Leukemia, Chronic Phase studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 69 type: ESTIMATED name: Asciminib measure: MR3.0 or less by 1 year sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-21 uploadDate: 2024-04-11T22:40 filename: Prot_000.pdf size: 903002 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-21 uploadDate: 2024-04-11T22:40 filename: Prot_001.pdf size: 903226 hasResults: False |
<|newrecord|> nctId: NCT06368401 id: TP_01428 briefTitle: A First in Human Study for the Versa Device for Tricuspid Regurgitation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Versa Vascular, Inc class: INDUSTRY briefSummary: This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates. conditions: Tricuspid Regurgitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Versa Implant measure: Acute Procedural Success measure: Incidence of major adverse events (MAE) measure: Tricuspid Regurgitation Severity Change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Auckland City Hospital city: Auckland country: New Zealand name: Mark Webster, MD role: CONTACT lat: -36.84853 lon: 174.76349 hasResults: False |
<|newrecord|> nctId: NCT06368388 id: S64854 briefTitle: Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force acronym: PHAGEFORCE overallStatus: RECRUITING date: 2021-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-16 date: 2024-04-16 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: KU Leuven briefSummary: PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration. conditions: Musculoskeletal Infection conditions: Chronic Rhinosinusitis (Diagnosis) conditions: Sepsis conditions: Pulmonary Infection conditions: Hidradenitis Suppurativa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Prospective data collection name: Prospective data collection measure: Disease free period measure: Bacterial eradication measure: PROMIS global health (patient-reported outcome measurement information system) measure: PROMIS (patient-reported outcome measurement information system) physical function measure: PROMIS (patient-reported outcome measurement information system) pain interference measure: Sino-nasal outcome test (SNOT)-22 measure: Visual Analogue Scale (VAS) score measure: Cystic fibrosis questionnaire (CF-Q-R) measure: Dermatology Life Quality Index (DLQI) measure: Hidradenitis Suppurativa Quality of Life (HiSQoL) measure: Rate of exacerbations measure: Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR) measure: Lund-Mackay CT score measure: Lund Kennedy endoscopy score measure: Modified Davos score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Jolien Onsea, PhD role: CONTACT phone: 003216342041 email: [email protected] name: Willem-Jan Metsemakers, MD, PhD role: CONTACT phone: 003216344277 email: [email protected] name: Willem-Jan Metsemakers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06368375 id: PRPF31-3102022BO2 briefTitle: Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-16 date: 2024-04-16 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s) conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 87 type: ACTUAL measure: Best Corrected Visual Acuity (BCVA) measure: Visual Field (VF) measure: Fundus Photography (FP) measure: Optos measure: Autofluorescence (AF) measure: Optical Coherence Tomography (OCT) measure: Full-Field Electroretinogram (ff-ERG) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen city: Tuebingen state: Baden-Wuerttemberg zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False |
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