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Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, whic... |
<|newrecord|> nctId: NCT06271941 id: HAPC-RCT briefTitle: Prophylactic Double Thermal Ablation and Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-10-01 date: 2028-04-01 date: 202... |
We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. We also hypothesize that performing complete closure of the EMR defect will r... |
<|newrecord|> nctId: NCT06271928 id: TJ-IRB20220634-yijingkeli briefTitle: A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging overallStatus: RECRUITING date: 2021-10-01 date: 2024-01-01 date: 2025-01-01 date: 2024-02-22 date: 2024-02-22 name: Tongji Hospital class: OTHER briefSummary: Ovarian... |
<|newrecord|> nctId: NCT06271915 id: cervical spine mobilization briefTitle: Role of Cervical Spine Mobilization on Lateral Epicondylitis overallStatus: RECRUITING date: 2024-02-15 date: 2024-05-15 date: 2024-06-15 date: 2024-02-22 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The study's primary g... |
<|newrecord|> nctId: NCT06271902 id: IRB-2023-531 briefTitle: Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program Among Youth Volleyball Athletes in Singapore overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-02-22 date: 2024-02-22 name: Nanyang Technological U... |
Hypothesis: The YoSO-IPP will have an effect on shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion and on knowledge scores. conditions: Sport Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL inter... |
<|newrecord|> nctId: NCT06271889 id: B.10.1.TKH.4.34.H.GP.0.01/330 briefTitle: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery overallStatus: RECRUITING date: 2021-11-24 date: 2024-02-24 date: 2024-11-20 date: 2024-02-22 date: 2024-02-22 name: Saglik... |
<|newrecord|> nctId: NCT06271876 id: 0011 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-03-09 date: 2024-03-19 date: 2024-02-22 date: 2... |
According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence muscular strength, exercise capacity and muscle tissue oxygenation. |
In this study, subjects will be divided into three groups: experimental group , activation group and control group. |
Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and vertical jump performance, will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose:... |
<|newrecord|> nctId: NCT06271863 id: Soh-Med-23-11-08MS briefTitle: Outcome of Conservative Management in Cases of Pre Mature Rupture of Membranes (PROM) Between 20 and 28 Weeks of Pregnancy in Sohag City Hospitals overallStatus: ENROLLING_BY_INVITATION date: 2023-06-01 date: 2024-06-01 date: 2024-07-01 date: 2024-02-2... |
<|newrecord|> nctId: NCT06271850 id: P.T.REC/012/004949 briefTitle: Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: Musculos... |
<|newrecord|> nctId: NCT06271837 id: D781AC00001 briefTitle: A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors overallStatus: RECRUITING date: 2024-02-18 date: 2025-10-30 date: 2026-04-17 date: 2024-02-22 date: 2024-04-23 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo Co., Ltd. briefSummary:... |
<|newrecord|> nctId: NCT06271824 id: 23-1519 briefTitle: Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities overallStatus: RECRUITING date: 2024-03-21 date: 2024-06 date: 2024-06 date: 2024-02-22 date: 2024-03-26 name: University of North Carolina, Chapel Hill class: OTHER br... |
1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities? |
2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience? |
Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes sk... |
<|newrecord|> nctId: NCT06271811 id: UJAPFPS briefTitle: Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome acronym: flossing overallStatus: COMPLETED date: 2023-01-09 date: 2023-11-14 date: 2023-11-20 date: 2024-02-22 date: 2024-02-23 name: University of Jaén class: OTHER name: Un... |
* Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone? |
* What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group w... |
<|newrecord|> nctId: NCT06271798 id: P.T.REC/012/004867 briefTitle: Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women overallStatus: RECRUITING date: 2024-02-20 date: 2024-04-05 date: 2024-04-19 date: 2024-02-22 date: 2024-03-05 name: Cairo University class: OTHER briefSum... |
<|newrecord|> nctId: NCT06271785 id: 49RC22_0354 briefTitle: Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery acronym: ISEPEE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-02-22 date: 2024-03-12 name: Unive... |
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues. |
Electrical sources are then fused on structural magnetic resonance imaging (MRI). |
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI. |
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area rese... |
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data. |
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI. |
Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected. |
To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles. |
This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG. |
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome. |
Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigato... |
<|newrecord|> nctId: NCT06271772 id: 18-26045-RII briefTitle: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II acronym: REAGIR II overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-31 date: 2025-07-31 date: 2024-02-22 date: 2024-02-22 name: University of California, San F... |
Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity ... |
* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT |
* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT conditions: Bacterial Keratitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMaske... |
<|newrecord|> nctId: NCT06271759 id: PSYFRAG briefTitle: Psychological Effects of a Set of Functional Fragrances acronym: PSYFRAG overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-08-15 date: 2024-02-22 date: 2024-04-09 name: University of Bucharest class: OTHER name: IFF (International Flavors & F... |
Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart. conditions: Stress conditions: Anxiety conditions: Well-Being, Psychological condit... |
<|newrecord|> nctId: NCT06271746 id: TCH101 briefTitle: Treatment of Fibromyalgia With the FibroNova Neuromodulation Device overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-01 date: 2025-06-01 date: 2024-02-22 date: 2024-04-11 name: Theranica class: INDUSTRY briefSummary: Fibromyalgia (FM) is a chronic disorder... |
Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniqu... |
Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown tha... |
The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignme... |
<|newrecord|> nctId: NCT06271733 id: 21110503 briefTitle: TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD overallStatus: ENROLLING_BY_INVITATION date: 2022-01-11 date: 2026-01-31 date: 2027-01-31 date: 2024-02-22 date: 2024-02-29 name: Rush University Medical Center class: OTHER briefSummary: ... |
<|newrecord|> nctId: NCT06271720 id: faculty of physical therapy briefTitle: Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-22 date: 2024-02-22 name: Noha Else... |
<|newrecord|> nctId: NCT06271707 id: ANES-2024-32720 briefTitle: Stellate Ganglion Block overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2026-09-30 date: 2024-02-22 date: 2024-04-23 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if the additi... |
<|newrecord|> nctId: NCT06271694 id: STUDY22020027 id: 1K23DC020215-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DC020215-01 briefTitle: Activity and Participation in Vestibular Disorders acronym: APV overallStatus: RECRUITING date: 2024-01-01 date: 2024-11-29 date: 2025-01-31 date: 2024-02-22 date: 2024... |
<|newrecord|> nctId: NCT06271681 id: 2120135-1 briefTitle: Evaluation of PCV15 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2025-02-01 date: 2024-02-22 date: 2024-02-22 name: VA Sierra Nevada Health Care System class: ... |
<|newrecord|> nctId: NCT06271668 id: 23-2356 id: R61DA057610 type: NIH link: https://reporter.nih.gov/quickSearch/R61DA057610 briefTitle: Clinical Decision Support to Improve System Naloxone Co-prescribing overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-09 date: 2024-02-22 date: 2024-02-29 name... |
<|newrecord|> nctId: NCT06271655 id: BFD-RST-23-004 briefTitle: Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE) acronym: RADIATE overallStatus: RECRUITING date: 2024-03-12 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2... |
<|newrecord|> nctId: NCT06271642 id: 73822 briefTitle: Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-02-22 date: 2024-02-22 name: Stanford University class: OTHE... |
<|newrecord|> nctId: NCT06271629 id: 2204-042-1314 briefTitle: Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients overallStatus: COMPLETED date: 2022-02-26 date: 2023-11-30 date: 2024-02-29 date: 2024-02-22 date: 2024-03-26 name: Seou... |
However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel move... |
Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them. condition... |
<|newrecord|> nctId: NCT06271616 id: MC1873 id: NCI-2024-01061 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-008754 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Tran... |
<|newrecord|> nctId: NCT06271603 id: 23.02645.000357-MS01 id: CPP Ile de France III type: OTHER domain: 23.02645.000357-MS01 briefTitle: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas acronym: ECOBAS... |
<|newrecord|> nctId: NCT06271590 id: CM-US-R03 briefTitle: MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels acronym: MAGICAL-SV overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2031-04 date: 2024-02-22 date: 2024-02-22 name: Concept Medical Inc. class: IND... |
A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees. conditions: Coronary Artery Disease conditions: Native Coronary Arter... |
<|newrecord|> nctId: NCT06271577 id: PRO-0013 briefTitle: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II acronym: STLEUISII overallStatus: RECRUITING date: 2024-03-12 date: 2024-11 date: 2024-12 date: 2024-02-22 date: 2024-03-19 name: AliveCor class: INDUSTRY briefSummary: AliveCor (www.ali... |
Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it ... |
<|newrecord|> nctId: NCT06271564 id: FDASU-Rec IM012415 briefTitle: Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions overallStatus: RECRUITING date: 2024-02-29 date: 2024-07 date: 2024-12 date: 2024-02-22 date: 2024-03-05 name: Ain Shams Unive... |
<|newrecord|> nctId: NCT06271551 id: ESTRACISE briefTitle: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy acronym: ESTRACISE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-12 date: 2029-12 date: 2024-02-21 date: 2024-02-... |
The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen depriv... |
Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supe... |
Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized in a 1:... |
<|newrecord|> nctId: NCT06271538 id: EP-USM-122023-001 briefTitle: Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-11-30 date: 2025-03-30 date: 2024-02-21 date: 2024-04-26 name: EP Plus Group Sdn Bhd class: INDUSTRY briefSum... |
<|newrecord|> nctId: NCT06271525 id: P.T.REC/012/002532 briefTitle: Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis acronym: CT overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-05-20 date: 2024-05-20 date: 2024-02-21 date: 2024-02-21 name: Shady Abdelsattar Refaat clas... |
<|newrecord|> nctId: NCT06271512 id: REG-501 briefTitle: A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel overallStatus: RECRUITING date: 2024-01-23 date: 2043-12 date: 2043-12 date: 2024-02-21 date: 2024-02-21 name: bluebird bio class: INDUSTRY name: Center for International Blood and M... |
<|newrecord|> nctId: NCT06271499 id: AnkaraU-Smart-cannulation briefTitle: The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization overallStatus: COMPLETED date: 2022-08-01 date: 2022-12-28 date: 2023-02-14 date: 2024-02-21 date: 2024-02-21 name: Ankara University class: OTHER name... |
<|newrecord|> nctId: NCT06271486 id: RC. 40.5.2023 briefTitle: Pregabalin in Treatment of Postdural Puncture Headache overallStatus: RECRUITING date: 2024-02-28 date: 2024-08-15 date: 2024-08-15 date: 2024-02-21 date: 2024-03-15 name: Al-Azhar University class: OTHER name: Benha University briefSummary: Lumbar puncture... |
<|newrecord|> nctId: NCT06271473 id: AinShamsU3 briefTitle: Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME overallStatus: RECRUITING date: 2023-08-30 date: 2024-12-30 date: 2025-06-30 date: 2024-02-21 date: 2024-02-21 name: Ain Shams University class: ... |
* Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only |
* Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. measure: ch... |
<|newrecord|> nctId: NCT06271460 id: 2023-21-728 briefTitle: Disability in Patients With Non-specific Chronic Low Back Pain overallStatus: RECRUITING date: 2024-03-04 date: 2024-08 date: 2024-10 date: 2024-02-21 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: To investigate the reliability and sen... |
<|newrecord|> nctId: NCT06271447 id: 2023-21-705 briefTitle: Answerability and Minimal Clinical Significance of the Pain Questionnaires overallStatus: RECRUITING date: 2024-03-04 date: 2024-06 date: 2024-08 date: 2024-02-21 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: To investigate the reliabi... |
<|newrecord|> nctId: NCT06271434 id: Olej z kryla/jelita briefTitle: Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers. overallStatus: NOT_YET_RECRUITING date: 2024-03-23 date: 2024-06-24 date: 2024-06-24 date: 2024-02-21 date: 2024-03-18 name: Poznan University of Physical Education class: OTHER bri... |
Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses. |
Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results ... |
Hypotesis: |
The krill oil will infleunce the gut barier integrity. conditions: Endothelial Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All competitors will be randomly divided into two groups (double-blind): |
A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. |
B. control (n = 15) receiving placebo. The supplementation period will be six weeks. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Triple whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: THYROX (Atlantic krill oil name: Placebo measure: I-FA... |
<|newrecord|> nctId: NCT06271421 id: 01/24 briefTitle: NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme acronym: ANCHIALE overallStatus: RECRUITING date: 2024-01-01 date: 2027-02-01 date: 2027-09-01 date: 2024-02-21 date: 2024-02-26 name: Poznan University of Medical Sciences class: OTHER name: MagForce USA bri... |
The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM. |
The main questions it aims to answer are: |
1. how NanoTherm therapy influences overall survival, and progression free survival; |
2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life. |
Participants will undergo: |
* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life; |
* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field; |
* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation; |
* after the first activation (10th day), the catheter will be removed; |
* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day; |
* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed; |
* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted. |
Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects. conditions: Glioblastoma Multiforme studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective longitudinal study will b... |
1. are included for NanoTherm therapy (group A), |
2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B) primaryPurpose: TREATMENT masking: NONE maskingDescription: ANCHIALE is open-label study count: 100 type: ESTIMATED name: NanoTherm therapy name: Glioma Resection name: radiotherapy according to Stupp protocol name: chemotherapy accordin... |
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