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<\|newrecord\|> nctId: NCT06293183 id: EGE-HEM-STO-01 briefTitle: The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-09-30 date: 2024-12-30 date: 2024-03-05 date: 2024-03-05 name: Ege University class: OTHER briefSummary: The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients\' quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized.
This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management. conditions: Cronich Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 76 type: ESTIMATED name: Mobile app measure: Fluid intake compliance measure: Change of individual management sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293170 id: 2024-DETECTIVENEUROLOGYUKD0001 briefTitle: Automated Screening for Clinically Ascertained Loss of Cerebral Functions acronym: DETECT-IVE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-11-01 date: 2024-03-05 date: 2024-03-05 name: Technische Universität Dresden class: OTHER briefSummary: Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.
Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.
Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial
Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.
Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.
Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.
Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT. conditions: Irreversible Loss of Brain Function (ILBF) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 4800 type: ESTIMATED name: DETECT name: Conventional care measure: Number of patients with diagnosis of ILBF measure: Number of patients who undergo deceased organ donation measure: Number of patients in whom diagnosis of ILBF was missed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden city: Dresden zip: 01307 country: Germany name: Kristian Barlinn, MD role: CONTACT phone: +49 (0)351 458 3565 email: kristian.barlinn@ukdd.de lat: 51.05089 lon: 13.73832 hasResults: False
<\|newrecord\|> nctId: NCT06293157 id: 2023/ABM/01/00013 briefTitle: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease overallStatus: RECRUITING date: 2023-12-01 date: 2028-12-31 date: 2033-12-31 date: 2024-03-05 date: 2024-03-05 name: Copernicus Memorial Hospital class: OTHER name: Medical Research Agency, Poland briefSummary: Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.
Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.
Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.
Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible. conditions: Metastatic Spinal Cord Compression conditions: Metastasis Spine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: Transpedicular spinal stabilization - carbon fibers-based implants name: Transpedicular spinal stabilization - titanium implants name: Stereotactic body radiotherapy measure: The assessment of time to local recurrence after treatment with SBRT. measure: The assessment of frequency of local recurrence after treatment with SBRT. measure: DICE convergence factor evaluation between groups of patients. measure: The subjective difficulty of planning radiotherapy treatment. measure: The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC). measure: Failure rate of stabilizing systems. measure: Pain assessment on the VAS scale between groups. measure: Frequency of postoperative infections. measure: Differences in dosimetric parameter Dmin PTV/CTV. measure: Differences in dosimetric parameter D95. measure: Differences in dosimetric parameter D98. measure: Differences in dosimetric parameter D100. measure: Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copernicus Memorial Hospital in Lodz status: RECRUITING city: Łódź state: Łódzkie zip: 93-513 country: Poland name: Krystkiewicz role: CONTACT lat: 51.75 lon: 19.46667 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-05-16 uploadDate: 2024-02-25T03:37 filename: ICF_000.pdf size: 249036 hasResults: False
<\|newrecord\|> nctId: NCT06293144 id: yuewei20231129 briefTitle: the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People overallStatus: RECRUITING date: 2023-11-29 date: 2024-05 date: 2024-05 date: 2024-03-05 date: 2024-03-05 name: Second Hospital of Shanxi Medical University class: OTHER briefSummary: Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM) conditions: Sedation conditions: ED95 conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 70 type: ESTIMATED name: Ciprofol measure: Modified Alertness Sedation Score (MOAA/S) measure: Bispectral index (BIS) measure: systolic blood pressure （SBP） measure: diastolic blood pressure（DBP） measure: heart rate (HR) measure: pulse oxygen saturation（SpO2） measure: Occurrence of Sedation-related adverse events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi zip: 030001 country: China name: Zheng Guo, M.B.,Ph.D. role: CONTACT phone: +863513365790 email: guozheng713@yahoo.com lat: 37.86944 lon: 112.56028 hasResults: False
<\|newrecord\|> nctId: NCT06293131 id: yuewei20230705 briefTitle: Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty overallStatus: COMPLETED date: 2023-05-29 date: 2023-09-28 date: 2023-09-28 date: 2024-03-05 date: 2024-03-05 name: Second Hospital of Shanxi Medical University class: OTHER briefSummary: Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia conditions: Sedation conditions: ED50 conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 70 type: ACTUAL name: Ciprofol measure: Modified Alertness Sedation Score (MOAA/S) measure: Bispectral index (BIS) measure: systolic blood pressure （SBP） measure: diastolic blood pressure（DBP） measure: heart rate (HR) measure: pulse oxygen saturation（SpO2） measure: Occurrence of Sedation-related adverse events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Second Hospital of Shanxi Medical University city: Taiyuan state: Shanxi zip: 030001 country: China lat: 37.86944 lon: 112.56028 hasResults: False
<\|newrecord\|> nctId: NCT06293118 id: 71055423.3.0000.0071 briefTitle: The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2028-01-15 date: 2024-03-05 date: 2024-03-05 name: Hospital Israelita Albert Einstein class: OTHER briefSummary: Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. The objective of the present study is to evaluate the chronic effect of IC on the motor function and cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as mobility, quality of life, and immunological responses. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. Ischemic conditioning group
2. control group (Sham) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients were unaware of the allocation. whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: Ischemic conditioning group name: Sham group measure: Motor function measure: Cognitive performance measure: PDQ-39 measure: Timed up and go (TUG) measure: Assessment of cellular and soluble immune response measure: Quantifications of systemic soluble mediators measure: PBMC acquisition and flow cytometry sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293105 id: MR/T040688/1 briefTitle: Social Responses to Stigma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-05 date: 2024-03-05 name: King's College London class: OTHER name: Groundswell name: Lambeth Service Users Council name: Museum of Homelessness name: Inclusive Insight briefSummary: The Social Responses to Stigma study will explore experiences of stigma and discrimination amongst people who are homeless in south London, and then seek to understand how this stigma is created, mediated or mitigated within health, social, housing and legal care and support systems and social contexts.
The methodology is an ethnographic case study of the south London care and support system and its social context. The study will use a range of methods for data collection: interviews with people who are homeless, delivery stakeholders, and policy makers; a survey of peoples' experiences; observation within selected care sites; and gathering of documentary sources.
The study will be implemented through two parallel studies. The first, with KCL-REMAS approval, will operate in non-NHS sites. The second, with NHS-IRAS approval, will operate in NHS sites. The protocols are aligned with adaptations for each type of site.
A linked method to develop theory is cross-case comparison between South London and Vancouver, Canada, through secondary data analysis to linked studies ongoing there. The study will be ongoing from 2022 until January 2025. The project is funded in two phases, with potential to extend the study by a further three years, to January 2028.
The results of the study will inform the design of a novel intervention strategy to address the social dimensions of stigma. Subject to additional funding applications, the intervention strategy will be piloted and evaluated from 2025 onwards. The study results will be disseminated through scientific publications, public reports and a range of public and policy engagement activities. conditions: Stigma, Social conditions: Drug Use studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 200 type: ESTIMATED name: Qualitative interview, participant observation measure: Experiences of stigma and discrimination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: to Be Determined city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06293092 id: P.T.REC/012/004008 briefTitle: Effect of Intradialytic Exercises in Chronic Kidney Disease Patients overallStatus: COMPLETED date: 2022-04-30 date: 2023-10-30 date: 2024-01-30 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease. conditions: Chronic Kidney Disease stage3 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: control group receive medical treatment only ,first study group receive medical treatment and intradialytic aerobic exercise , second study group receive medical treatment and intradialytic resistive exercise primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: leg pedaling cycling device name: sand bags name: hemodialysis sessions measure: Concentration of immunoglobulin g measure: Total leukocyte count measure: lymphocyte count measure: neutrophil count measure: Concentration of HbA1c measure: hemoglobin concentration measure: thrombocytes count measure: diastolic blood pressure measure: Systolic blood pressure measure: six minute walk test measure: (KDQOL-SFTM) questionnaire sex: MALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Fayoum hospital city: Fayoum country: Egypt lat: 29.30995 lon: 30.8418 hasResults: False
<\|newrecord\|> nctId: NCT06293079 id: BiruniUnive id: Researcher type: OTHER domain: Biruni University briefTitle: The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2023-08-30 date: 2024-02-12 date: 2024-08-30 date: 2024-03-05 date: 2024-03-05 name: Biruni University class: OTHER briefSummary: The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Exercise Program measure: Gait Speed measure: Functional Capacity measure: EMG muscle activation measure: EMG muscle activation measure: Modified Fatigue Impact Scale measure: Global Rating of Change Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biruni University status: RECRUITING city: İstanbul country: Turkey name: Güzin Kaya Aytutuldu role: CONTACT phone: 05366265884 email: guzinkaya14@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06293066 id: KCH23-257 briefTitle: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-03-01 date: 2024-03-01 date: 2024-03-05 date: 2024-03-05 name: King's College Hospital NHS Trust class: OTHER briefSummary: Primary Objective:
To assess whether there is a higher incidence of uninformative ultrasound in black vs white women conditions: Postmenopausal Bleeding conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 330 type: ACTUAL name: Ultrasound measure: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suite 8, King's College Hospital city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06293053 id: PKM17836 id: U1111-1287-7255 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2027-10-28 date: 2027-11-03 date: 2024-03-05 date: 2024-03-05 name: Sanofi class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.
The study consists of 3 periods:
* Screening period: 2 to 4 weeks.
* Treatment period: 24 weeks.
* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).
The total number of planned study visits for each participant will be 6. conditions: Prurigo Nodularis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Dupilumab measure: Concentration of dupilumab in serum measure: Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) measure: Incidence of anti-drug antibodies (ADA) to dupilumab over time sex: ALL minimumAge: 6 Months maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06293040 id: IRB00434441 id: R01DA052295 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA052295 briefTitle: Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-12 date: 2024-03-05 date: 2024-03-05 name: Johns Hopkins University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states). conditions: Cannabis Intoxication conditions: Alcohol Intoxication studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will complete all dose conditions (study arms) in a randomized order primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Cannabis name: Alcohol name: Placebo Cannabis name: Placebo Alcohol measure: DRUID application global impairment score measure: Correct Trials on Paced Auditory Serial Addition Task (PASAT) measure: Correct Trials on the Digit Symbol Substitution Task (DSST) measure: Cumulative score on Field Sobriety Tests measure: Drug Effect Questionnaire (DEQ) - Feel Drug Effect measure: Drug Effect Questionnaire (DEQ) - Feel High measure: Drug Effect Questionnaire (DEQ) - Confidence to Drive measure: Drug Effect Questionnaire (DEQ) - Willingness to Drive measure: Biphasic alcohol effects scale (BAES) - Sedative Score measure: Biphasic alcohol effects scale (BAES) - Stimulant Score measure: Subjective high assessment scale (SHAS) measure: Driving performance as assessed by standard deviation of lateral position (SDLP) measure: Driving performance as assessed by composite drive score measure: Driving performance as assessed by standard deviation of speed (SDSP) measure: Driving performance (mean speed) measure: Driving performance (number of speed exceedances) measure: Driving performance (number of accidents) measure: Driving performance (total rule violations) measure: Driving performance (distance to lead vehicles) measure: Attempted Trials on the Digit Symbol Substitution Task (DSST) measure: Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST) measure: Reaction time on Paced Auditory Serial Addition Task measure: Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test measure: Field Sobriety Test - Score on Walk and Turn test measure: Field Sobriety Test - Score on One Leg Stand measure: Field Sobriety Test - Score on Modified Romberg Balance measure: Drug Effect Questionnaire - Like Drug Effect measure: Drug Effect Questionnaire - Want more measure: Drug Effect Questionnaire - Dislike Drug Effect measure: Pharmacokinetics - CMax for THC and THC metabolites measure: Pharmacokinetics - AUC for THC and THC metabolites measure: Pharmacokinetics - Breath Alcohol Concentration (BAC) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Behavioral Pharmacology Research Unit city: Baltimore state: Maryland zip: 21224 country: United States name: Madyson Slutzky role: CONTACT email: mslutzk1@jh.edu lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06293027 id: IMAGINER FXS briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Fragile X Syndrome overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-15 date: 2025-12-15 date: 2024-03-05 date: 2024-03-05 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: The objective of this project is to explore the potential of functional near- infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Fragile X Syndrome (FXS) that is still without cure. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With clinical trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. The investigators seek to address this gap by assessing the prognostic reliability of both resting and task- evoked fNIRS. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with FXS; 2. to collect pilot data on individuals with FXS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. conditions: Fragile X Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Resting-state functional connectivity measure: Amplitude of sensory-evoked hemodynamic responses measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale. sex: MALE minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Marina di Pisa-Tirrenia-Calambrone state: Toscana zip: 56128 country: Italy name: Roberta Battini, MD role: CONTACT phone: +39 050886282 email: roberta.battini@fsm.unipi.it name: Laura Baroncelli, PhD role: CONTACT phone: +39 050886233 email: laura.baroncelli@fsm.unipi.it name: Elena Scaffei, MD role: SUB_INVESTIGATOR lat: 43.62719 lon: 10.29204 hasResults: False
<\|newrecord\|> nctId: NCT06293014 id: QLMA-CRC-IIT-001 briefTitle: TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer overallStatus: RECRUITING date: 2024-02-23 date: 2025-10-15 date: 2026-11-28 date: 2024-03-05 date: 2024-03-05 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 224 type: ESTIMATED name: TAS-102+bevacizumab name: Standard chemotherapy+bevacizumab measure: Time to treatment failure (TTF) measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Duration of Response (DoR) measure: Progression-free survival (PFS) measure: Overall survival（OS） measure: Adverse Events measure: European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university status: RECRUITING city: ZhengZhou state: Henan zip: 450008 country: China name: Ying Liu, MD role: CONTACT phone: +86-13783604602 email: Yaya7207@126.com lat: 34.75778 lon: 113.64861 hasResults: False
<\|newrecord\|> nctId: NCT06293001 id: SBA 23/349 briefTitle: Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the ADAP Shoulder Scale overallStatus: RECRUITING date: 2023-11-28 date: 2024-04-26 date: 2024-04-26 date: 2024-03-05 date: 2024-04-29 name: Hacettepe University class: OTHER briefSummary: Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement.
Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied.
The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale). conditions: Questionnaire conditions: Shoulder Pain conditions: Validity conditions: Reliability studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 162 type: ESTIMATED name: No intervention measure: Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Elif Turgut status: RECRUITING city: Ankara zip: 06300 country: Turkey name: Elif Turgut, Assoc. Prof. role: CONTACT phone: +90 (544) 264 56 00 email: elifcamci@gmail.com name: Pınar KUYULU HAKSAL, Master role: SUB_INVESTIGATOR name: Kübra CAYLAN GURSES, Master role: SUB_INVESTIGATOR name: Birgül DINGIRDAN, Master role: SUB_INVESTIGATOR name: Büşra PAKOZ, Master role: SUB_INVESTIGATOR name: Irem DUZGUN, Proffessor role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06292988 id: MYELO briefTitle: Predictive Factors for Medullary Thyroid Cancer Aggressiveness acronym: MYELO overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-15 date: 2024-04-15 date: 2024-03-05 date: 2024-03-05 name: Aristotle University Of Thessaloniki class: OTHER briefSummary: This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival. conditions: Medullary Thyroid Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: Total Thyroidectomy measure: Central lymph node metastasis measure: Lateral lymph node metastasis measure: Distant metastasis measure: Nuclear atypia as histological predictor of aggressiveness measure: Amyloid as histological predictor of aggressiveness measure: Immunohistochemistry as histological predictor of aggressiveness measure: Desmoplasia as histological predictor of aggressiveness measure: CEA as Biochemical predictor of aggressiveness measure: Calcitonin as Biochemical predictor of aggressiveness measure: White blood cell as Biochemical predictor of aggressiveness measure: Platelet count as Biochemical predictor of aggressiveness measure: CEA drop as Biochemical cure marker measure: Calcitonin drop as Biochemical cure marker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health & Science University, Oregon city: Oregon City state: Oregon zip: 97239 country: United States name: James Lim role: CONTACT email: ljam@ohsu.edu lat: 45.35734 lon: -122.60676 facility: Department of Surgery, Saint John of God Hospital, Salzburg, Austria city: Salzburg country: Austria name: Michael De Cilia role: CONTACT email: Michael.DeCillia@bbsalz.at lat: 47.79941 lon: 13.04399 facility: Saint Luc, University Clouvain, Belgium city: Bruxelles country: Belgium name: Antoine Buemi, Prof role: CONTACT email: antoine.buemi@saintluc.uclouvain.be lat: 50.85045 lon: 4.34878 facility: Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil city: Santa Cruz Do Sul country: Brazil name: Fabio Muradas Girardi role: CONTACT email: fabiomgirardi@gmail.com lat: -29.7175 lon: -52.42583 facility: University Clinic of Surgery, University Hospital "Lozenec" city: Sofia country: Bulgaria name: Rumen Pandev role: CONTACT email: pandevrumen@gmail.com lat: 42.69751 lon: 23.32415 facility: Chinese University of Hong Kong city: Hong Kong country: China name: Shirley Liu role: CONTACT email: liuyw@surgery.cuhk.edu.hk lat: 22.39407 lon: 114.13737 facility: Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia city: Manizales country: Colombia name: Andres Chalas role: CONTACT email: andreschalag@hotmail.com lat: 5.06889 lon: -75.51738 facility: the University Hospital Center Sestre milosrdnice, Zagreb, Croatia, Department of Otorhinolaryngology and Head and Neck Surgery city: Zagreb country: Croatia name: Andro Kosec, Prof role: CONTACT email: andro.kosec@yahoo.com lat: 45.81444 lon: 15.97798 facility: Head and Neck Surgery, Brest University Hospital, Brest, France city: Brest country: France name: 27. Jean-Christophe Leclere role: CONTACT email: leclere.jean-christophe@hotmail.fr lat: 48.3903 lon: -4.48628 facility: The University Hospital of Poitiers, France city: Poitiers country: France lat: 46.58333 lon: 0.33333 facility: Thyroid Surgery Clinic IKE, Athens, Greece city: Athens country: Greece name: Stavros Karakozis role: CONTACT email: modernsurgery@gmail.com name: Lampros Karakozis role: SUB_INVESTIGATOR lat: 37.97945 lon: 23.71622 facility: ENT Department University Hospital of Larissa city: Larissa country: Greece name: Jiannis Hajiioannou role: CONTACT email: jhajiioannou@gmail.com lat: 39.63689 lon: 22.41761 facility: Department of Surgery, General University Hospital of Patras city: Patra country: Greece name: Franko Mulita role: CONTACT email: oknarfmulita@hotmail.com lat: 38.24444 lon: 21.73444 facility: Aristotle University of Thessaloniki city: Thessaloníki country: Greece lat: 40.64361 lon: 22.93086 facility: Gennimatas General Hospital city: Thessaloníki country: Greece name: Ioannis Koutelidakis role: CONTACT email: iokoutel@gmail.com name: Nikolaos Voloudakis role: SUB_INVESTIGATOR lat: 40.64361 lon: 22.93086 facility: Department of ENT-Head and Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar city: Bhubaneswar country: India name: Kumar Parida Pradipta role: CONTACT email: drpradipta04@gmail.com lat: 20.27241 lon: 85.83385 facility: KMCH and KMCH Comprehensive Cancer Center city: Coimbatore country: India name: Manoj Dhiwakar role: CONTACT email: dhiwamahi@yahoo.com lat: 11.00555 lon: 76.96612 facility: Department of Endocrine and Breast Surgery at Sanjay Gandhi Post Graduate Institute of Medical Sciences city: Madurai country: India name: Sabaretnam Mayilvaganan role: CONTACT email: drretnam@gmail.com lat: 9.91769 lon: 78.11898 facility: Department of Surgery, Maulana Azad Medical College & Lok Nayak Hospital city: New Delhi country: India name: Lovenish Bains role: CONTACT email: lovenishbains@gmail.com lat: 28.63576 lon: 77.22445 facility: Endocrine and Metabolic Surgery, Bhargav Endocrine Hospital, Vijayawada, India city: Vijayawada country: India name: Ramakanth Bhargav Panchangam role: CONTACT email: endoanswers@gmail.com lat: 16.50745 lon: 80.6466 facility: University of Sulaimani \| UNIVSUL ,Department of Surgery, Kurdistan city: Erbil country: Iraq name: Fahmi Hussein role: CONTACT email: fahmi.hussein@univsul.edu.iq lat: 36.19257 lon: 44.01062 facility: ASL VCO - San Biagio Hospital - Domodossola (VB) - Italy city: Domodossola country: Italy name: Luigi Oragano role: CONTACT email: luigioragano@luigioragano.com lat: 46.1165 lon: 8.29313 facility: Dipartimento di Scienze Chirurgiche (DISC), University of Genoa, Italy city: Genoa country: Italy name: Michele Minuto role: CONTACT email: micheleminuto72@gmail.com lat: 44.40478 lon: 8.94438 facility: Asst Santi Paolo e Carlo - Ospedale Polo Universitario San Paolo, Milan, Italy city: Milan country: Italy name: Loredana De Pasquale role: CONTACT email: loredana.depasquale@asst-santipaolocarlo.it lat: 45.46427 lon: 9.18951 facility: UOC Chirurgia Endocrina e Metabolica, Fondazione Policlinico Universitario A Gemelli IRCCS city: Roma country: Italy name: Marco Raffaelli role: CONTACT email: Marco.Raffaelli@unicatt.it name: Francesco Pennestri role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Department of Medical and Surgical Sciences, University of Trieste, Cattinara Teaching Hospital, Trieste, Italy city: Trieste country: Italy name: Chiara Dobrinja role: CONTACT email: ch_dobrinja@yahoo.it lat: 45.64953 lon: 13.77679 facility: Department of Surgery and Oncology, Endocrine Surgery Unit, Verona University Hospital city: Verona country: Italy name: Giacomo DiFilippo role: CONTACT email: giacomo.difilippo@aovr.veneto.it lat: 45.4299 lon: 10.98444 facility: Hashemite University of Zarqa city: Zarqa country: Jordan name: Sohail Bakkar, Prof role: CONTACT email: sohail.bakkar@gmail.com lat: 32.07275 lon: 36.08796 facility: Hepatobiliairy and endocrine surgery, Ibn Sina Hospital, Medical School of Medecine Rabat, Mohamed Vth University of Rabat Morocco city: Marrakech country: Morocco name: Omar El Malki Hadj, Prof role: CONTACT email: oelmalki@hotmail.com lat: 31.63416 lon: -7.99994 facility: Division of General, Endocrine and Transplant Surgery, Medical University of Gdańsk city: Gdańsk country: Poland name: Andrzej Hellman, Prof role: CONTACT email: hellmannandrzej@gumed.edu.pl lat: 54.35205 lon: 18.64637 facility: Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Medical School, University of Belgrade city: Belgrad country: Serbia name: Nada Santrac role: CONTACT email: santrac.nada@gmail.com lat: 44.80401 lon: 20.46513 facility: Comenius University in Bratislava, Department of Paediatric Surgery, National Institute of Children's Diseases city: Bratislava country: Slovakia name: Petra Zahradníková, Prof role: CONTACT email: petra.zahradnikova@nudch.eu lat: 48.14816 lon: 17.10674 facility: Department of oncological surgery, St. Elisabeth cancer Institute city: Bratislava country: Slovakia name: Robert Kralik role: CONTACT email: robert.kralik@ousa.sk lat: 48.14816 lon: 17.10674 facility: Hospital Clinic (Barcelona, Spain) city: Barcelona country: Spain name: Aida Orois role: CONTACT email: aidaorois@hotmail.com name: Òscar Vidal Perez role: SUB_INVESTIGATOR name: Marti Manyalich role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Universitaria de Cordoba city: Córdoba country: Spain name: Constanza Ramacciotti role: CONTACT email: cramacciotti@hotmail.com lat: 37.89155 lon: -4.77275 facility: Hospital Regional de Málaga city: Málaga country: Spain name: Viyey Kishore Doulatram role: CONTACT email: viyu90@hotmail.es name: Marta Iturregui Guevara role: SUB_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: Department of General and Digestive Surgery, Division of Endocrine Surgery, Complexo Hospitalario Universitario de Vigo, Vigo, Spain city: Vigo country: Spain name: Angel Rivo Vazaquez role: CONTACT email: anxorivo@yahoo.es lat: 42.23282 lon: -8.72264 facility: Bern University Hospital city: Bern country: Switzerland name: Reto Kaderli, Prof role: CONTACT email: Reto.Kaderli@insel.ch name: Nesti Cedric role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 facility: Geneva University Hospital city: Geneva country: Switzerland lat: 46.20222 lon: 6.14569 facility: Division of Endocrinology and Metabolism Department of Medicine Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok, Thailand city: Bangkok country: Thailand name: Sriphrapradang Chutintorn role: CONTACT email: chutins@gmail.com lat: 13.75398 lon: 100.50144 facility: Ankara University Faculty of Medicine, Department of Endocrine Surgery city: Ankara country: Turkey name: Volkan Cenc role: CONTACT email: volkangenc77@yahoo.com lat: 39.91987 lon: 32.85427 facility: Acibadem MAA University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 facility: Cerrahpasa medical faculty endocrine surgery department city: Istanbul country: Turkey name: Selen Soylu role: CONTACT email: selen_soylu@yahoo.com lat: 41.01384 lon: 28.94966 facility: Department of Endocrin Pathology Unit, University of Health Sciences, Faculty of Medicine, Bakırköy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey city: Istanbul country: Turkey name: Altinay Serdar role: CONTACT email: drserdara@yahoo.com lat: 41.01384 lon: 28.94966 facility: Endocrine surgeon-consultant, International medical center "CITIDOCTOR" city: Kyiv country: Ukraine name: Sergii Cherenko role: CONTACT email: sergmakar5@gmail.com lat: 50.45466 lon: 30.5238 facility: Department of Radiology, Thien Hanh Hospital, Buon Ma Thuot, Vietnam city: Việt Trì country: Vietnam name: Hoang Van Trung role: CONTACT email: dr.hoangvantrungradiology@gmail.com lat: 21.32274 lon: 105.40198 hasResults: False
<\|newrecord\|> nctId: NCT06292975 id: RS210 - 326709 briefTitle: Exercise for Improving Radiotherapy Efficacy in Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02 date: 2026-02 date: 2024-03-05 date: 2024-04-24 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: This is a single arm feasibility study of exercise for improving short- course neoadjuvant radiotherapy efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patient's will be provided with a 7 weeks course of structured aerobic exercises and resistance training in the periods before, during and after their radiotherapy treatment. The patients will be followed up for 6 months post short course neoadjuvant radiotherapy, with a total of 3 assessment periods. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Supervised Vigorous intensity aerobic interval exercise measure: Recruitment rate measure: Attendance rate measure: withdrawal rate measure: Serum Carcinoembryonic antigen levels measure: Quality of life assessment measure: Quality of life assessment measure: Physical activity levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06292962 id: SH-34988389 briefTitle: Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain acronym: VNSDPN overallStatus: COMPLETED date: 2023-10-01 date: 2024-03-01 date: 2024-03-03 date: 2024-03-05 date: 2024-04-22 name: Saima Abass Tahammal class: OTHER name: Al Ain University briefSummary: The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes. conditions: Diabetes Mellitus conditions: Diabetic Neuropathies conditions: Type2diabetes conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: a randomized, double-blinded, sham-controlled, parallel group clinical trial whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 165 type: ACTUAL name: non-invasive transcutaneous vagal nerve stimulation (tVNS) name: Sham device measure: Neuropathic pain scores measure: Quality of life score sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shifa Hospital city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06292949 id: TJ-IRB20230956 briefTitle: Clinical Study of Resistant Starch in Improving Constipation overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-25 date: 2024-09-25 date: 2024-03-05 date: 2024-03-05 name: Huaping Xie class: OTHER briefSummary: Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Resistant starch measure: Changes in constipation symptoms measure: Changes in the diversity of intestinal flora measure: Changes in the relative abundance of species of intestinal flora measure: Changes in the number of intestinal flora measure: Changes in the metabolic function of intestinal flora sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: ping h Xie role: CONTACT phone: 86+13437187007 email: hpxie@tjh.tjmu.edu.cn name: qiang Ding role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-21 uploadDate: 2024-02-29T21:24 filename: Prot_SAP_000.pdf size: 358565 hasResults: False
<\|newrecord\|> nctId: NCT06292936 id: 30692 briefTitle: RemI for Post-Bariatric Surgery Weight Regain overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2028-04-01 date: 2024-03-05 date: 2024-03-05 name: Temple University class: OTHER name: Rush University briefSummary: The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).
The main research aims are:
1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.
2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.
3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior. conditions: Obesity conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Acceptance-Based Behavioral Intervention measure: Weight measure: Caloric Intake measure: Eating Behavior - Cognitive Constraint measure: Eating Behavior - Disinhibition measure: Eating Behavior - Hunger measure: Physical Activity measure: Weight-Related Medical Comorbidities - Number of participants with hypertension measure: Weight-Related Medical Comorbidities - Number of participants with diabetes measure: Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia measure: Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia measure: Mechanisms of Action (Exploratory) - Acceptance of food-related internal experiences measure: Mechanisms of Action (Exploratory) - Mindfulness measure: Mechanisms of Action (Exploratory) - Defusion measure: Mechanisms of Action (Exploratory) - Values clarity measure: Mechanisms of Action (Exploratory) - Depressive symptoms measure: Mechanisms of Action (Exploratory) - Anxiety measure: Mechanisms of Action (Exploratory) - Internal states measure: Mechanisms of Action (Exploratory) - Maladaptive eating behaviors sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University city: Chicago state: Illinois zip: 60612 country: United States name: Lauren Bradley, PhD role: CONTACT phone: 312-942-2714 email: lauren_e_bradley@rush.edu lat: 41.85003 lon: -87.65005 facility: Temple University city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: David B Sarwer, PhD role: CONTACT phone: 215-707-8632 email: dsarwer@temple.edu name: Sarah R Fischbach, MPH role: CONTACT phone: 215-707-8633 email: sarah.fischbach@temple.edu lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06292923 id: TILS-021 briefTitle: A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients overallStatus: RECRUITING date: 2023-11-15 date: 2024-11 date: 2024-11 date: 2024-03-05 date: 2024-03-19 name: Tiziana Life Sciences LTD class: INDUSTRY briefSummary: Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases.
The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS).
The primary objectives that this study aims to answer are:
1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo
2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment. conditions: Secondary Progressive Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The treating physician, study staff, and patients will be blinded to treatment. The research pharmacy at each site will have the treatment code assignments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Foralumab name: Placebo measure: The number of patients with adverse event (AE) reports. measure: Changes in the Total Nasal Symptom Score (TNSS). measure: Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment. measure: Changes in the Expanded Disability Status Scale (EDSS). measure: Changes in the Multiple Sclerosis Functional Composite-4 (MSFC-4). measure: Changes in the Modified Fatigue Impact Scale (MFIS). measure: Changes in the mean number of gadolinium-enhancing lesions per T1-weighted MRI scan, as measured by 3T MRI. measure: Changes in percent brain volume change by 3T MRI analysis pipeline between the Screening Visit (Baseline) and after 3 months of treatment, as measured by 3T MRI. measure: Paramagnetic rim lesions by quantitative susceptibility mapping sequences on MRI, as measured by 3T MRI (if center is able). sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Niveditha Gopalakrishnan role: CONTACT phone: 617-732-5588 email: foralumab@mgb.org name: Tanuja Chitnis, M.D role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06292910 id: REC 64-299-1-1 briefTitle: Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery acronym: VACO2 overallStatus: COMPLETED date: 2021-08-08 date: 2023-12-21 date: 2023-12-26 date: 2024-03-05 date: 2024-03-05 name: Prince of Songkla University class: OTHER briefSummary: The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.
The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research conditions: Congenital Heart Disease conditions: Perioperative/Postoperative Complications conditions: Lactate Blood Increase studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 136 type: ACTUAL name: arterial and central venous blood gas analysis, lactate measure: number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation measure: ventilator days measure: inotrope days measure: length of stay in ICU sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine, Prince of Songkla University city: Hat Yai state: Songkhla zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-05 uploadDate: 2024-02-09T09:23 filename: Prot_SAP_000.pdf size: 745529 hasResults: False
<\|newrecord\|> nctId: NCT06292897 id: 3312 briefTitle: Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression acronym: OBESITA'&PCa overallStatus: RECRUITING date: 2023-03-20 date: 2026-09-15 date: 2027-01-15 date: 2024-03-05 date: 2024-03-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: National Research Council briefSummary: Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.
ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.
iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways. conditions: Prostate Cancer conditions: Prostate Adenocarcinoma conditions: Prostate Neoplasm conditions: Prostatic Neoplasm conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 25 type: ESTIMATED name: observational study measure: Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano status: RECRUITING city: Milan country: Italy name: giancarlo albo, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06292884 id: IMAGINER CREATINE briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Creatine Deficiency Syndromes overallStatus: RECRUITING date: 2023-10-06 date: 2025-06-15 date: 2025-12-15 date: 2024-03-05 date: 2024-03-05 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: The objective of this project is to explore the potential of functional near-infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Creatine Deficiency Syndromes (CDS), a group of rare neurodevelopmental disorders. Among these disorders, effective treatments are lacking for two. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With gene therapy trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. This project seeks to address this gap by assessing the prognostic reliability of both resting and task-evoked fNIRS. Arousal of participants will be also assessed through the measure of spontaneous heart rate (HR) fluctuations. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with CDS; 2. to collect pilot data on individuals with CDS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. conditions: Creatine Deficiency, X-linked conditions: Creatine Deficiency Syndrome Due to Gamt Deficiency studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Resting-state functional connectivity measure: Amplitude of sensory-evoked hemodynamic responses measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale. sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Pisa zip: 56128 country: Italy name: Roberta Battini, MD role: CONTACT phone: +39 050886282 email: roberta.battini@fsm.unipi.it name: Laura Baroncelli, PhD role: CONTACT phone: +39 050886233 email: laura.baroncelli@fsm.unipi.it name: Elena Scaffei, MD role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06292871 id: 2023/2712 briefTitle: The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2025-05 date: 2024-03-05 date: 2024-03-05 name: KK Women's and Children's Hospital class: OTHER_GOV name: Singapore Institute of Technology briefSummary: To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,
i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform.
ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire.
iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM.
iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM. conditions: Gestational Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will employ a randomized controlled trial design, with GDM patients from KKH randomly assigned to either the intervention or control group. Randomization will be conducted via the electronic randomization list. primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Additional GDM management through social media name: Usual care measure: Acceptance levels measure: Satisfaction levels measure: Engagement levels measure: Appropriateness levels measure: Feasibility levels measure: Emotional wellbeing measure: Blood glucose levels measure: Proportion of participants with optimal blood glucose control measure: Confidence levels measure: Meal skipping measure: Proportion of participants with cigarette smoking measure: Proportion of participants with alcohol intake measure: Gestational weight gain rate measure: Proportion of participants with inappropriate weight gain measure: Motivational levels measure: Proportion of participants with induced labour measure: Proportion of participants with caesarean delivery measure: Birth weight measure: Birth length measure: Head circumference measure: Birth size-for-gestational age measure: Gestational length at birth measure: Proportion of participants with preterm delivery measure: Neonatal apgar score measure: Proportion of participants delivering healthy live birth sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06292858 id: IMB071703-101 briefTitle: Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2023-02-24 date: 2025-04 date: 2025-08 date: 2024-03-05 date: 2024-03-05 name: Beijng Immunoah Pharma Tech Co., Ltd. class: INDUSTRY briefSummary: A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors conditions: Recurrent or Metastatic, Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: IMB071703 injection measure: Incidence of adverse events/serious adverse event related with IMB071703 injection measure: Dose-limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection measure: Maximum measured plasma concentration (Cmax) of IMB071703 injection. measure: Time to maximum plasma concentration (Tmax) of IMB071703 injection. measure: Half-life (T1/2) of IMB071703 injection. measure: Immunogenicity profile of IMB071703 injection. measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oncology, Shanghai East Hospital, Tongji University status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Ye Guo, Doctor role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06292845 id: 11272 briefTitle: Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents acronym: SprayDye overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-01 date: 2027-12-01 date: 2024-03-05 date: 2024-03-05 name: Erasmus Medical Center class: OTHER briefSummary: This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Topical application of a fluorescent imaging agent measure: Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices. measure: Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology measure: Difference in tumor-to-background ratio (TBR) between different imaging time windows measure: The concordance between the presence of tumor cells and fluorescence signal measure: Depth of the fluorescence signal on 4-μm tissue slides sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus University Medical Center city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06292832 id: MSR/AZAST/AIP029/22/222/8/2023 briefTitle: Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-09-10 date: 2024-09-10 date: 2024-03-05 date: 2024-03-05 name: Al-Azhar University class: OTHER briefSummary: The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Ultrasound-guided pain block name: Ultrasound Machine measure: postoperative time to rescue analgesia requirement sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Al-Azhar University city: Assiut country: Egypt name: Warda Ali role: CONTACT phone: 010300020456 email: warda2001@hotmail.com lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06292819 id: CMUH112-REC2-214 briefTitle: Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-05 date: 2024-03-05 name: China Medical University Hospital class: OTHER briefSummary: The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events. conditions: Photobiomodulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Bright light name: Near-infrared light name: Bright light+ near-infrared light measure: Actigraphy-derived sleep indicators measure: Dim-light melatonin onset measure: Sleep quality measure: Emotional state measure: Daytime sleepiness sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06292806 id: 001-2024 briefTitle: Inhibin B/AFC Ratio for Ovarian Response overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-20 date: 2025-12-31 date: 2024-03-05 date: 2024-03-05 name: Insemine Humen Reproduction Centre class: NETWORK briefSummary: Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.
A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality. conditions: IVF conditions: Infertility, Female conditions: Ovulation Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 144 type: ESTIMATED name: FSH-R measure: serum Inhibin B levels measure: serum Anti Mullerian Hormone levels sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06292793 id: STUDY00004696 briefTitle: Cyclical Sighing for Pain overallStatus: COMPLETED date: 2023-12-13 date: 2024-02-26 date: 2024-02-26 date: 2024-03-05 date: 2024-03-05 name: Florida State University class: OTHER briefSummary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 81 type: ACTUAL name: Pain Coping Information name: Cyclical Sighing measure: Change in Pain Unpleasantness Numeric Rating Scale measure: Change in Pain Intensity Numeric Rating Scale measure: Change in Anxiety Numeric Rating Scale measure: Change in Depression Numeric Rating Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tallahassee Orthopedic Clinic (TOC) city: Tallahassee state: Florida zip: 32308 country: United States lat: 30.43826 lon: -84.28073 hasResults: False
<\|newrecord\|> nctId: NCT06292780 id: R5458-ONC-2274 id: 2023-507809-34-00 type: OTHER domain: EUCT Number briefTitle: A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) acronym: LINKER-AL2 overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-08-26 date: 2035-02-26 date: 2024-03-05 date: 2024-03-05 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called linvoseltamab ("study drug").
This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.
The study consists of 2 phases (Phase 1 and Phase 2):
* In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.
* In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.
The study is looking at several other research questions, including:
* How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long
* How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long
* What the right dosing regimen is for linvoseltamab
* What side effects may happen from taking linvoseltamab
* How much linvoseltamab is in your blood at different times
* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects) conditions: Relapsed/Refractory Systemic Light Chain Amyloidosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Note: Participants enrolled in Phase 2 will be randomized 1:1 primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: Linvoseltamab measure: Incidence of dose-limiting toxicity (DLTs) measure: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) measure: Achievement of hematologic CR, as determined by the IRC measure: Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC measure: Achievement of overall hematologic response (PR or better), as determined by the IRC measure: Time to initial hematologic response measure: Time to best hematologic response measure: Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC measure: Hematologic progression-free survival (PFS) measure: Incidence of death measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Incidence of serious adverse events (SAEs) measure: Severity of SAEs measure: Incidence of adverse events of special interest (AESIs) measure: Severity of AESIs measure: Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2 measure: Incidence of TEAEs in dose regimen 1 vs 2 measure: Severity of TEAEs in dose regimen 1 vs 2 measure: Incidence of SAEs in dose regimen 1 vs 2 measure: Severity of SAEs in dose regimen 1 vs 2 measure: Incidence of AESIs in dose regimen 1 vs 2 measure: Severity of AESIs in dose regimen 1 vs 2 measure: Time from treatment initiation to hematologic disease progression as determined by the IRC measure: Time from treatment initiation to cardiac deterioration, as determined by the IRC measure: Time from treatment initiation to kidney deterioration as determined by the IRC measure: Time from treatment initiation to death as determined by the IRC measure: Time from initiation of treatment to date of death from any cause measure: Achievement of renal response in participants with renal involvement at baseline, as determined by IRC measure: Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC measure: Time to first renal response in participants with renal involvement at baseline measure: Time to first cardiac response in participants with cardiac involvement at baseline measure: Linvoseltamab concentration in serum over time measure: Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time measure: Titers of ADAs to linvoseltamab over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06292767 id: 2023/462 briefTitle: Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-01-15 date: 2025-04-25 date: 2024-03-05 date: 2024-03-05 name: TC Erciyes University class: OTHER briefSummary: During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications. conditions: Postoperative Pulmonary Atelectasis conditions: Pneumothorax conditions: Pneumonia conditions: Ards conditions: Respiratory Failure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: mechanical power calculation measure: mechanical power measure: mechanical power sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06292754 id: 2023.211 briefTitle: Rotator Cuff Repair With Magnesium Pin overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Chinese University of Hong Kong class: OTHER briefSummary: Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes. conditions: Arthroscopic Rotator Cuff Repair studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: magnesium pin in additional to the suture anchor name: routine suture anchor measure: Imaging Examinations measure: Cofield classification measure: Sugaya Score measure: Goutallier Classification measure: Height measurement measure: Weight measurement measure: BMI measurement measure: Shoulder flexibility (range of motion) measure: Shoulder muscle strength measure: Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index measure: Constant-Murley Score measure: Visual Analogue Scale (VAS) measure: Adverse events measure: C-reactive protein measurement measure: Calcium (Ca) measurement measure: Magnesium (Mg) measurement measure: Phosphorous (P) measurement measure: Creatinine (Cr) measurement measure: Urea measurement measure: Alanine transaminase (ALT) measurement measure: Aspartate aminotransferase (AST) measurement measure: Total protein (TP) measurement measure: Albumin (ALB) measurement measure: Globulin (GLB) measurement sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06292741 id: 4956 briefTitle: Autonomic Involvement in Patient With Cognitive Decline overallStatus: RECRUITING date: 2023-01-11 date: 2024-07 date: 2026-01 date: 2024-03-05 date: 2024-04-04 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline conditions: Dementia, Mild conditions: Dementia of Alzheimer Type studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: Sudoscan measure: evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia measure: correlation between the extent of autonomic involvement and the severity of cognitive decline measure: evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction. sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS status: RECRUITING city: Roma state: Lazio zip: 00168 country: Italy name: Camillo Marra, MD role: CONTACT phone: 0630154333 email: camillo.marra@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06292728 id: ENDOPLY1 briefTitle: ENDOPLY System in Humans: a Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-07 date: 2024-03-05 date: 2024-03-05 name: ENDOPLY class: OTHER name: Just 4 Device s.r.o. briefSummary: Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: ENDOPLY System measure: Time of duration of the ENDOPLY System study procedure measure: Number of ligatures placed by ENDOPLY System study procedure measure: Gastric perforation events measure: Gastrointestinal bleeding events measure: Initial weight-loss sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Institut klinické a experimentální medicíny (IKEM), Klinika hepatogastroenterologie city: Prague zip: 14021 country: Czechia name: Evžen Machytka, MD, Ph.D. role: CONTACT email: evmac@seznam.cz name: Evžen Machytka, MD, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06292715 id: Microwave Ablation01 briefTitle: Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism overallStatus: RECRUITING date: 2024-01-20 date: 2025-12-31 date: 2026-12-31 date: 2024-03-05 date: 2024-03-05 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism. conditions: Secondary Hypersplenism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: microwave ablation of the spleen name: Splenic artery balloon implantation measure: Portal venous pressure measure: Hepatic artery blood flow velocity measure: Routine blood test measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute & Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300060 country: China name: Huikai Li role: CONTACT phone: +862223340123 phoneExt: 3091 email: lihuikai@tjmuch.com lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06292702 id: Modified Burch Colposuspension briefTitle: Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension. overallStatus: COMPLETED date: 2022-01-01 date: 2023-10-01 date: 2024-02-01 date: 2024-03-05 date: 2024-03-05 name: Damascus University class: OTHER briefSummary: The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Traditional Burch colposuspension name: Modified Burch colposuspension measure: Subjective voiding dysfunction after surgery, first evaluation measure: Urinary peak flow rate after surgery, first evaluation measure: Residual urine after surgery, first evaluation measure: Urinary retention after surgery, first evaluation measure: Subjective voiding dysfunction after surgery, second evaluation measure: Urinary peak flow rate after surgery, second evaluation measure: Residual urine after surgery, second evaluation measure: Urinary retention after surgery, second evaluation measure: Subjective voiding dysfunction after surgery, third evaluation measure: Urinary peak flow rate after surgery, third evaluation measure: Residual urine after surgery, third evaluation measure: Urinary retention after surgery, third evaluation measure: Subjective recovery from urinary incontinence, first evaluation measure: Objective recovery from urinary incontinence, first evaluation measure: Subjective recovery from urinary incontinence, second evaluation measure: Objective recovery from urinary incontinence, second evaluation measure: Subjective recovery from urinary incontinence, third evaluation measure: Objective recovery from urinary incontinence, third evaluation sex: FEMALE minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus university city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False
<\|newrecord\|> nctId: NCT06292689 id: IRB-2024-5(IIT) briefTitle: A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2026-03-22 date: 2027-03-22 date: 2024-03-05 date: 2024-03-05 name: Zhejiang Cancer Hospital class: OTHER name: Akeso name: Innovent Biologics, Inc. briefSummary: To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment. conditions: Vulvar and Vaginal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cardunolizumab measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Adverse events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Hanmei Lou, MD. role: CONTACT phone: +8619817462599 email: louhm@zjcc.org.cn name: Hanmei Lou, MD. role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06292676 id: ObGynEASC004 briefTitle: Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning acronym: ERdeliv overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-20 date: 2024-06-30 date: 2024-03-05 date: 2024-03-05 name: G. d'Annunzio University class: OTHER briefSummary: Mannequin training for emergency home delivery on medical doctors and nurses conditions: Home Birth Delivery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: skills retained for home birth delivery in emergency measure: Kirkpatrick levels improvement sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Claudio Celentano status: RECRUITING city: Pescara state: Italia zip: 65100 country: Italy name: Claudio Celentano, MD role: CONTACT phone: 3285577305 email: celentanoclaudio70@gmail.com lat: 42.4584 lon: 14.20283 hasResults: False
<\|newrecord\|> nctId: NCT06292663 id: EMN-2023-08767 briefTitle: Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? overallStatus: RECRUITING date: 2024-03-05 date: 2024-11 date: 2024-11 date: 2024-03-05 date: 2024-03-12 name: Zealand University Hospital class: OTHER briefSummary: The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:
* Can preoperative information through a VR headset lower the patients preoperative anxiety?
* Can VR information make the patients more ready for surgery. Painscore will also be collected.
Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.
If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain conditions: Anxiety conditions: Surgery conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subjects are being randomized to one of two groups. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The primary investigator will stay blinded in this study and an assistant to the investigator is screening and including the patients and collecting data. whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: Virtual Reality measure: Preoperative anxiety measure: Cumulative sedative consumption measure: Opioid consumption measure: Patient preoperatively expectations measure: Patient preoperatively readiness measure: Adverse events measure: Level of pain measure: The need for information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zealand University Hospital status: RECRUITING city: Køge state: Zealand zip: 4600 country: Denmark name: Karsten Lomholt Lassen, CRNA role: CONTACT phone: 26131350 email: karlas@regionsjaelland.dk name: Nanna Wagner Christiansen, B.Eng role: CONTACT phone: 40306799 email: nanchr@regionsjaelland.dk name: Karsten Lomholt Lassen, Ph.D Student, CRNA role: PRINCIPAL_INVESTIGATOR lat: 55.45802 lon: 12.18214 hasResults: False
<\|newrecord\|> nctId: NCT06292650 id: ZM-02 briefTitle: Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients acronym: ZM-02 overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-12-25 date: 2028-12-25 date: 2024-03-05 date: 2024-03-05 name: Zhongmou Therapeutics class: INDUSTRY briefSummary: This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye. conditions: Retinitis Pigmentosa studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 12 type: ESTIMATED name: ZM-02-L name: ZM-02-H name: ZM-02-S measure: Incidence of adverse events and serious adverse events measure: Changes in intraocular pressure (IOP) in Subjects measure: Change of FST outcome measure: Change of MLMT level measure: Change of Quality of Life measure: Change in best corrected visual acuity (BCVA) measure: Change in visual field (VF) measure: Change in Fundus Autofluorescence (FAF) measure: Change in central foveal thickness (CFT) using Optical Coherence Tomography (OCT) measure: Change in central macular thickness (CMT) using Optical Coherence Tomography (OCT) measure: Changes in the fundus using fundus color photography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital of Capital Medical University city: Beijing state: Beijing country: China name: Pei Cao role: CONTACT phone: +86 18707134160 email: zmt@simbaeye.com name: Yin Shen role: CONTACT name: Wenbin Wei, PhD role: PRINCIPAL_INVESTIGATOR name: Laichun Lu, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06292637 id: 2020-1484 id: A545000 type: OTHER domain: UW Madison id: NUR/FACULTY AFFAIRS/ADMIN type: OTHER domain: UW Madison id: Protocol Version 4/4/2024 type: OTHER domain: UW Madison id: 1R01HS029477-01 type: AHRQ link: https://reporter.nih.gov/quickSearch/1R01HS029477-01 briefTitle: Cognitive Behavioral and Faith Fellowship to Improve Thy Health acronym: CB-FAITH overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09 date: 2026-09 date: 2024-03-05 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized stepped wedge design (R-SWD), a type of cluster randomized controlled trial, will be used to randomize a cluster (church groups with a group of 10 participants), not individual subjects.
At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the CB-FAITH treatment, with all clusters eventually crossing over to receive the treatment. The sample will be comprised of 12 groups, each with 10 individuals (N=120). primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) measure: Patient Health Questionnaire measure: Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR) measure: Multidimensional Measure of Religious Involvement (MMRI) score measure: Client Satisfaction Inventory (CSI) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Baptist Church city: Madison state: Wisconsin zip: 53711-3800 country: United States name: Anthony Wade role: CONTACT phone: 608-278-1430 email: a.wade4@hotmail.com name: Anthony Wade role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 facility: The Board of Regents of the UW System city: Madison state: Wisconsin zip: 53715-1218 country: United States name: Earlise Ward, PhD role: CONTACT lat: 43.07305 lon: -89.40123 hasResults: False
<\|newrecord\|> nctId: NCT06292624 id: HSEARS20230417002 briefTitle: Effectiveness of Intermittent Vacuum Therapy Combined With Aerobic Exercise in Individuals With Diabetes Mellitus overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2024-04-30 date: 2024-04-30 date: 2024-03-05 date: 2024-03-06 name: The Hong Kong Polytechnic University class: OTHER name: Yan Chai Hospital Social Services briefSummary: Consequences of the compromised vascular system in diabetes mellitus (DM) are among the most devastating complications. Reduction in blood flow and oxygen uptake of skeletal muscle leads to muscle fatigue and impaired skeletal muscle post-exercise adaptation. Recent studies showed that intermittent vacuum therapy (IVT) augments the blood flow of the foot in people with DM. This pilot study investigates the effects of combined IVT and aerobic exercise in improving lower limb muscle oxygenation and distal circulation in individuals with DM. Positive results of the study shed light on strategy that enhances the effectiveness of aerobic exercise in people with DM. conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinical trials with a single arm, receiving IVT combined with cycling exercise primaryPurpose: TREATMENT masking: NONE count: 12 type: ACTUAL name: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) name: Cycling exercise measure: Muscle oxygenation measure: Muscle oxygenation measure: Surface Electromyography measure: Surface Electromyography measure: Foot Sensation measure: Foot Sensation measure: Functional muscle strength measure: Functional muscle strength measure: Functional mobility measure: Functional mobility sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06292611 id: ST-23-U35 briefTitle: Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush overallStatus: COMPLETED date: 2023-11-27 date: 2023-12-12 date: 2024-01-25 date: 2024-03-05 date: 2024-03-05 name: Church & Dwight Company, Inc. class: INDUSTRY briefSummary: To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing. conditions: Dental Devices, Home Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 102 type: ACTUAL name: Battery operated toothbrush name: Manual toothbrush measure: Extrinsic Stain sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Salus Research, Inc. city: Fort Wayne state: Indiana zip: 46825 country: United States lat: 41.1306 lon: -85.12886 hasResults: False

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