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## Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer - NCT ID: NCT06369259 - Study ID: 2023-0997 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2028-02-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer. ### Conditions - Advanced Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Defactinib - Cetuximab - Avutometinib ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77807, United States @@
## PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer - NCT ID: NCT06369246 - Study ID: 2023-0893 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2027-09-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer. ### Conditions - Advanced Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Stereotactic Body Radiation Therapy ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery - NCT ID: NCT06369233 - Study ID: LNC-MS-002 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-02-28 - Lead Sponsor: L&C Bio ### Study Description This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied. ### Conditions - Herniation, Disc ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MegaShield®-SP - Guardix-SP Plus ### Outcomes Primary Outcomes - MRI scar score Secondary Outcomes - Oswestry Disability Index(ODI) score - Visual Analog Scale(VAS) Back & Leg Pain Score ### Location - Facility: Eunpyeong ST. Mary's Hospital, Seoul, N/A, 03312, Korea, Republic of @@
## A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections - NCT ID: NCT06369220 - Study ID: LIA-STI-542 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2024-10-31 - Lead Sponsor: Hoffmann-La Roche ### Study Description This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG). ### Conditions - Chlamydia Trachomatis Infection - Neisseria Gonorrhoeae Infection - Mycoplasma Genitalium Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - cobas® liat CT/NG/MG nucleic acid test - Standard of Care (SOC): Clinician's Standard Practice ### Outcomes Primary Outcomes - Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) Secondary Outcomes - Percentage of Participants Given Inappropriate Treatment for CT Infection - Percentage of Participants Given Inappropriate Treatment for NG Infection - Percentage of Participants Given Inappropriate Treatment for MG Infection - Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire - Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux - NCT ID: NCT06369207 - Study ID: 113454 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-12 - Completion Date: 2024-09 - Lead Sponsor: Golestan University of Medical sciences ### Study Description Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. . ### Conditions - Venous Insufficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determination of reflux transmission pathways in CVI patients with SFJ incompetency Secondary Outcomes - Anatomic variations of GSV in CVI patients with SFJ incompetency - Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency - Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency ### Location - Facility: Pezhman Kharazm, MD, Gorgan, Golestan, 4917956808, Iran, Islamic Republic of @@
## POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol - NCT ID: NCT06369194 - Study ID: POWER5 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-14 - Completion Date: 2024-04-15 - Lead Sponsor: Grupo Español de Rehabilitación Multimodal ### Study Description The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \<0.05 (two tails). ### Conditions - Colorectal Surgery - Critical Pathways - Enhanced Recovery After Surgery - Retrospective Studies - Chemotherapy, Adjuvant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Colorectal Surgery ### Outcomes Primary Outcomes - Overall Survival - Disease-free survival - Time to disease recurrence - Time to return to intended oncologic treatment (RIOT) Secondary Outcomes ### Location - Facility: Hospital Virgen de los Lirios de Alcoy, Alcoy, Alicante, N/A, Spain @@
## Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC - NCT ID: NCT06369181 - Study ID: NET 2020 - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2028-12-31 - Lead Sponsor: Fudan University ### Study Description Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).In a previous study \[Pubmed ID: 35609408\], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53/Rb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1/TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1/TP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1/TP53 dual inactivation might have elevated risk for NET.In this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1/TP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression. ### Conditions - Neuroendocrine Carcinoma - Non-small Cell Lung Cancer - Histology Transformation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - neuroendocrine transformation rate Secondary Outcomes ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy - NCT ID: NCT06369168 - Study ID: Kliniken Essen-Mitte - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2025-11-20 - Lead Sponsor: Kliniken Essen-Mitte ### Study Description With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer.Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed. ### Conditions - Hot Flashes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - auricular acupuncture ### Outcomes Primary Outcomes - subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS) Secondary Outcomes - Menopause Rating Scale (MRS) total score - Psychological symptoms and urogenital symptoms subscales of the MRS - functional assessment of cancer therapy - breast (FACT-B) - perceived stress questionnaire (PSQ) - insomnia severity index (ISI) - big five inventory (BFI) - Expected effect of the respective intervention on a 100mm visual analogue scale - intensity and degree of impairment due to hot flashes on a 100mm visual analogue scale - adverse events (AEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Azenosertib in Uterine Serous Carcinoma: Biomarker Study - NCT ID: NCT06369155 - Study ID: 24-061 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-01-31 - Lead Sponsor: Joyce Liu, MD ### Study Description This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma.The name of the study drug involved in this study is:-Azenosertib (a type of Wee1 inhibitor) ### Conditions - Uterine Serous Carcinoma - Uterine Carcinoma - Uterine Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Azenosertib ### Outcomes Primary Outcomes - Percentage Change in Replication Fork Speed in Overall Response - Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6) Secondary Outcomes - Overall Response Rate (ORR) - 6-month Progression-Free Survival (PFS6) - Clinical Benefit Rate (CBR) - Median Duration of Overall Response (DOR) - Median Progression-Free Survival (PFS) - Grade 3-5 Treatment-related Toxicity Rate ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States @@
## Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy - NCT ID: NCT06369142 - Study ID: GE IDE No. L00123 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-07-31 - Lead Sponsor: Deutsches Herzzentrum Muenchen ### Study Description The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intravascular lithotripsy (IVL) - Standard non-IVL methods ### Outcomes Primary Outcomes - Combined endpoint of major cardiac and cerebrovascular events Secondary Outcomes - Mortality - Cardiac mortality - Non-fatal myocardial infarction - Non-fatal stroke - Clinically indicated target vessel revascularization - Definite stent thrombosis - Clinically indicated non-target vessel revascularization - Hospitalization due to acute coronary syndrome - Symptoms of coronary heart disease (CHD): physical health status - Symptoms of CHD: mental health status - Bleeding during index hospitalization or ≤30 days (BARC 3-5) - Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure) - Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome) ### Location - Facility: Deutsches Herzzentrum München, Munich, Bavaria, 80636, Germany @@
## Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction - NCT ID: NCT06369129 - Study ID: CEBD-CU-2024-06-16 - Status: RECRUITING - Start Date: 2024-04-06 - Completion Date: 2025-08 - Lead Sponsor: Cairo University ### Study Description Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures . ### Conditions - Blow-Out Fractures - Orbital Fractures - Orbital Floor Fracture - Orbital Trauma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Orbital floor reconstruction with Patient Specific Zirconia Implant - Orbital floor reconstruction with Patient Specific Titanium Implant ### Outcomes Primary Outcomes - Orbital Volume Secondary Outcomes - Accuracy of the patient specific implant in the orbital floor reconstruction - Cost effectiveness - Patient satisfaction ### Location - Facility: Cairo University, Cairo, N/A, 11511, Egypt @@
## Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users - NCT ID: NCT06369116 - Study ID: CLS-017B - Status: RECRUITING - Start Date: 2023-10-12 - Completion Date: 2024-04-22 - Lead Sponsor: bioLytical Laboratories ### Study Description This is a controlled study intended to evaluate the usability, label comprehension and performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick blood, with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess "lay" users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use. Comprehension will be assessed without product familiarization (demonstration/training) by a healthcare professional. ### Conditions - Hepatitis C ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - INSTI HCV Self Test ### Outcomes Primary Outcomes - Clinical sensitivity and specificity of INSTI HCV Self Test Secondary Outcomes - To assess the usability and label comprehension of the INSTI HCV Self Test ### Location - Facility: Ezintsha, a division of Wits Health Consortium (Pty) Ltd, Parktown, N/A, 2193, South Africa @@
## The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery - NCT ID: NCT06369103 - Study ID: FMBSUREC/03032024/Fakhry - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: Beni-Suef University ### Study Description The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events. ### Conditions - Patient - Satisfaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine - Propofol ### Outcomes Primary Outcomes - Patient satisfaction Secondary Outcomes - Visual analogue scale ### Location - Facility: Beni Suef University Hospital, Banī Suwayf, Beni Suef, 62814, Egypt @@
## Effect of Breast Size on the Electrical Impedance Tomography Measurement - NCT ID: NCT06369090 - Study ID: JP/1/2013 - Status: COMPLETED - Start Date: 2013-11-01 - Completion Date: 2014-05-31 - Lead Sponsor: Czech Technical University in Prague ### Study Description Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated. ### Conditions - Effect of Breast Tissue on EIT Lung Monitoring ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Electrical impedance tomography (EIT) ### Outcomes Primary Outcomes - Regional ventilation changes possibly caused by the breast tissue Secondary Outcomes - Female subjects enrollment in EIT studies and clinical applications ### Location - Facility: Faculty of Biomedical Engineering, Czech Technical University in Prague, Kladno, N/A, 27201, Czechia @@
## How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure? - NCT ID: NCT06369077 - Study ID: CTGlaucoma1 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: CT Glaucoma Associates ### Study Description IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed. ### Conditions - Glaucoma, Open-Angle - Glaucoma; Drugs ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - dorzolamide/timolol ### Outcomes Primary Outcomes - intraocular pressure Secondary Outcomes - dry eye ### Location - Facility: CT Glaucoma Associates, Norwalk, Connecticut, 06851, United States @@
## Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient - NCT ID: NCT06369064 - Study ID: 2023A02707-38 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2026-08-15 - Lead Sponsor: Centre Hospitalier Universitaire de Nīmes ### Study Description In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT. ### Conditions - Acute Kidney Injury - Continuous Renal Replacement Therapy - Intensive Care Unit ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CVVHD Dialysis parameters - CVVHDF Dialysis parameters ### Outcomes Primary Outcomes - urea reduction rate (URR) Secondary Outcomes - Creatinine clearance at H24 - Urea clearance at H24 - Urea clearance at H48 - ICU Mortality - Mortality at Day 28 - Organ failure-free days at Day 28 - Hypokalemia at Day 28 - Hypophosphatemia at Day 28 - Hypomagnesemia at Day 28 - Hyperkalemia at Day 28 - Medical Cost ### Location - Facility: CHU de Nimes, Nîmes, N/A, 30029, France @@
## Supporting Self-employment in Young Adults With Stroke - NCT ID: NCT06369051 - Study ID: YSEmploy - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Self-employment support intervention ### Outcomes Primary Outcomes - Self-employment rate Secondary Outcomes - Self-efficacy - Life satisfaction - Emotional well-being - Community reintegration ### Location - Facility: Non-government organisations, Hong Kong, N/A, N/A, Hong Kong @@
## Children's Drawing as a Projective Tool to Assess Dental Anxiety - NCT ID: NCT06369038 - Study ID: CUP3222024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-30 - Lead Sponsor: Cairo University ### Study Description The aim in this study is to compare the results of anxiety measurement of the child using the CD:H scale with the long-used Face,Legs,Activity,Cry and Consolability scale (FLACC scale) and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's behaviour before the dental procedure. ### Conditions - Dental Anxiety ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observation of level of dental anxiety in children ### Outcomes Primary Outcomes - FLAAC behavioral scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz) - NCT ID: NCT06369025 - Study ID: PreVio - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-07-30 - Lead Sponsor: Bielefeld University ### Study Description More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania. ### Conditions - Violence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Interaction Competencies with Children ### Outcomes Primary Outcomes - Reduction of children's exposure to emotional and physical violence by parents and teachers - Reduction of parents' or teachers' use of emotional and physical violence Secondary Outcomes - Change of parents' and teachers' attitudes towards emotional and physical violence - Improvement of children's mental health - Increase of children's quality of life - Improvement of school climate ### Location - Facility: Daressalaam University College of Education, Daressalam, N/A, N/A, Tanzania @@
## Management of Abnormal Uterine Bleeding - NCT ID: NCT06369012 - Study ID: Rania Gamal - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-30 - Lead Sponsor: Egymedicalpedia ### Study Description Abnormal uterine bleeding "AUB" describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation, problems related to pregnancy, infections, vaginal and cervical abnormalities, uterine pathologies including benign and malignant tumors, coagulopathies, endocrine disorders, trauma, foreign bodies, systemic diseases and iatrogenic causes. AUB may be clinically presented by menorrhagia, metrorrhagia or menometrorrhagia. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists ### Conditions - Abnormal Uterine Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Mefenamic acid 500 mg ### Outcomes Primary Outcomes - Bleeding Control Secondary Outcomes ### Location - Facility: Ain Shams University Hospitals, Cairo, N/A, N/A, Egypt @@
## Neurophysiological and Neuropsychological Evalution in Healthcare Workers - NCT ID: NCT06368999 - Study ID: EEGCOV - Status: COMPLETED - Start Date: 2020-05-27 - Completion Date: 2021-01-09 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers. ### Conditions - Stress Disorders, Post-Traumatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - EEG ### Outcomes Primary Outcomes - EEG activity Secondary Outcomes ### Location - Facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants - NCT ID: NCT06368986 - Study ID: 222420 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-06-12 - Lead Sponsor: ViiV Healthcare ### Study Description The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VH4011499 ### Outcomes Primary Outcomes - Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499 - Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499 - Maximum observed plasma drug concentration (Cmax) of VH4011499 - Time to maximum observed plasma concentration (Tmax) of VH4011499 Secondary Outcomes - Number of participants with AEs (Adverse Events), by severity - Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters - Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter) - Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit - NCT ID: NCT06368973 - Study ID: RC16-4-2023 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Benha University ### Study Description The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications. ### Conditions - Mechanical Ventilation Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Adverse events associated with mechanical ventilation Secondary Outcomes ### Location - Facility: Benha University Hospital, Cairo, N/A, 13511, Egypt @@
## BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors - NCT ID: NCT06368960 - Study ID: BM201-1001 - Status: RECRUITING - Start Date: 2022-11-07 - Completion Date: 2024-12-31 - Lead Sponsor: InnoBM Pharmaceuticals Co., Ltd. ### Study Description This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiotherapy - BM201 injection ### Outcomes Primary Outcomes - DLT and MTD - Pharmacokinetic (PK) parameters - Number of patients with adverse events (AEs) Secondary Outcomes - ORR - Peripheral blood cytokine profiling in study participants. - The variation in peripheral blood tumor biomarker concentrations. - Other exploring outcomes ### Location - Facility: Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China @@
## Therapeutic Play on Pain Tolerance and Emotion Regulation in Children - NCT ID: NCT06368947 - Study ID: B.30.2.ATA.0.01.00/172 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2026-12-29 - Lead Sponsor: Ataturk University ### Study Description The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Therapeutic Play ### Outcomes Primary Outcomes - Pain Tolerance Scale for Children with Cancer - Emotion Regulation Scale for Children and Adolescents Secondary Outcomes ### Location - Facility: Ataturk University Nursing of Faculty, Erzurum, N/A, 25240, Turkey @@
## Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma - NCT ID: NCT06368934 - Study ID: KY2024-011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2027-06 - Lead Sponsor: Huashan Hospital ### Study Description Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease. ### Conditions - Glioma - Glioblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - sub-lobectomy - imaging total resection ### Outcomes Primary Outcomes - Progression-free Survival Secondary Outcomes - Overall Survival ### Location - Facility: Hushan Hospital, Fudan University, Shanghai, Shanghai, 200040, China @@
## A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors - NCT ID: NCT06368921 - Study ID: VRT106-C01 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd. ### Study Description To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - VRT106 ### Outcomes Primary Outcomes - Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. - Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. Secondary Outcomes - Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106. - Assess the immunogenicity of intratumoral injection of VRT106. - Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators. - Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators. ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, N/A, China @@
## Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill - NCT ID: NCT06368908 - Study ID: 6I/2023/3 - Status: RECRUITING - Start Date: 2023-12-08 - Completion Date: 2024-12-30 - Lead Sponsor: General and Teaching Hospital Celje ### Study Description ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge.Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans.In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers.In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy.To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals.The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW. ### Conditions - Critical Illness Myopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Functional Magnetic Muscle Stimulation ### Outcomes Primary Outcomes - Measurement of Thickness of Thigh Muscles Secondary Outcomes - Measurement of Thigh Circumference - Assessment of Muscle Strength and Communication Ability - Body composition measurement by bioimpedance- Extracellular water - Body composition measurement by bioimpedance- Intracellular water - Body composition measurement by bioimpedance- skeletal muscle mass ### Location - Facility: General Hospital Celje, Celje, N/A, 300, Slovenia @@
## Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment - NCT ID: NCT06368895 - Study ID: 2188 - Status: RECRUITING - Start Date: 2021-04-07 - Completion Date: 2025-06 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.The aims of the study are:To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement. ### Conditions - Hepatic Encephalopathy - Dysbiosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fecal microbiota transplantation delivery through colonoscopy - Fecal microbiota transplantation delivery through oral capsules ### Outcomes Primary Outcomes - Evaluation of safety of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy - Evaluation of efficacy of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy Secondary Outcomes - Evaluation of changes in the gut microbiota composition following the fecal microbiota transplantation - Evaluation of changes in the systemic inflammatory following the fecal microbiota transplantation - Evaluation of changes in the intestinal inflammatory following the fecal microbiota transplantation - Comparison between protein metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation - Comparison between lipid metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation - Comparison between carbohydrates metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation ### Location - Facility: Fondazione Policlinico Agostino Gemelli IRCCS, Rome, N/A, 00168, Italy @@
## Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT） - NCT ID: NCT06368882 - Study ID: Yongping _Chen - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-12-31 - Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University ### Study Description This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.The security assessment includes adverse events, vital signs, and imaging. ### Conditions - Nonalcoholic Fatty Liver Disease - Chronic Hepatitis b ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Peg-Interferon α ### Outcomes Primary Outcomes - HBsAg clearance Secondary Outcomes - HBsAg clearance at 96 weeks - Cumulative HBsAg clearance rate - Liver Function Tests - The incidence of liver cirrhosis and liver cancer ### Location - Facility: Ningbo No.2 Hospital, Ningbo, N/A, N/A, China @@
## The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers - NCT ID: NCT06368869 - Study ID: #1/2022 - Status: COMPLETED - Start Date: 2023-01-10 - Completion Date: 2024-01-20 - Lead Sponsor: amr elshimy ### Study Description Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements. ### Conditions - Color; Change Teeth, Posteruptive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Livento press veneers luted with dual cured resin cement - Livento press veneers luted with light cured resin cement - Celtra duo veneers luted with dual cured resin cement - Celtra duo veneers luted with light cured resin cement ### Outcomes Primary Outcomes - Color stability assessment Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Alexandria University, Alexandria, N/A, N/A, Egypt @@
## Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study - NCT ID: NCT06368856 - Study ID: 20CH024 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-03 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril.Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy. ### Conditions - Healthy - Staphylococcus Aureus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Mupirocin (50 mg) - Mupirocin (500 mg) - blood samples after Single dose part - nasal swab after Single dose part - Collection of urine after Single dose part - nasal swab during Repeated dose part - Collection of urine during Repeated dose part - nasal swab after Repeated dose part ### Outcomes Primary Outcomes - plasma concentrations of mupirocin - plasma concentrations of mupirocin - plasma concentrations of mupirocin - intranasal concentrations of mupirocin - intranasal concentrations of mupirocin - intranasal concentrations of mupirocin - intranasal concentrations of mupirocin - intranasal concentrations of mupirocin - intranasal concentrations of mupirocin Secondary Outcomes - presence of Staphylococcus aureus - presence of Staphylococcus aureus - presence of Staphylococcus aureus - presence of Staphylococcus aureus - urinary concentrations of monic acid - urinary concentrations of monic acid - urinary concentrations of monic acid - urinary concentrations of monic acid ### Location - Facility: CHU de SAINT-ETIENNE, Saint-Étienne, N/A, N/A, France @@
## the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat - NCT ID: NCT06368843 - Study ID: Ketamine for POST - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-09-20 - Lead Sponsor: Al-Azhar University ### Study Description Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction. ### Conditions - Postoperative Sore Throat ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gargle with ketamine ### Outcomes Primary Outcomes - Sore throat Secondary Outcomes - Cough - Hoarseness of voice ### Location - Facility: Ministry of Health, Baghdad, Thi-Qar, 00964, Iraq @@
## Oral and Swallowing Function in Older Adults - NCT ID: NCT06368830 - Study ID: 2024-0337 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions. ### Conditions - Oropharyngeal Dysphagia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 3-ounce water swallow test - Kayser-Jones Brief Oral Health Status Examination (BOHSE) - Tongue pressure - Test of Masticating and Swallowing Solids (TOMASS) - Respiratory function tests ### Outcomes Primary Outcomes - Positive oropharyngeal dysphagia screen prevalence Secondary Outcomes - Mean brief oral health status examination (BOHSE) score - Oral dryness prevalence - Decreased tongue pressure prevalence - Decreased masticatory function prevalence - pH of saliva sample - Extensional viscosity of saliva sample - Salivary Substance P Concentration - Oral microbiome - Cell barrier function - Protein composition - Gene expression - Immunofluorescent staining - Immune cell trafficking ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas - NCT ID: NCT06368817 - Study ID: ACNS2321 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-04 - Completion Date: 2033-11-04 - Lead Sponsor: Children's Oncology Group ### Study Description A phase II trial that is attempting to build upon the excellent results of ACNS1123 stratum 2 by reducing the Radiotherapy (RT) dose for patients in a Complete Response (CR) after chemotherapy. The trial will be testing a further reduction in the whole ventricular irradiation (WVI) dose. Additionally, patients with metastatic disease and basal ganglia and thalamic germinoma will be included, and they will be treated with craniospinal irradiation (CSI) or whole brain irradiation (WBI) respectively. ### Conditions - Intracranial Germ Cell Tumor - Childhood Central Nervous System Germinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 3-Dimensional Conformal Radiation Therapy - Carboplatin - Etoposide - Intensity-Modulated Radiation Therapy ### Outcomes Primary Outcomes - Event-free survival (EFS) Secondary Outcomes - Estimate the EFS distribution for eligible and evaluable patients in Stratum 2 - To estimate the EFS distribution for eligible and evaluable patients in Stratum 3 - Overall Survival (OS) - Determine the impact of tumor location, treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas. - Prospectively evaluate processing speed of children and young adults with CNS germinoma through the Children's Oncology Group (COG) Standardized assessment battery. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis - NCT ID: NCT06368804 - Study ID: ANTEIPA - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-01 - Lead Sponsor: Centre Hospitalier Intercommunal Creteil ### Study Description Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact. ### Conditions - Bronchiectasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Antibiotic monotherapy treatment and follow-up - Antibiotic bitherapy treatment and follow-up ### Outcomes Primary Outcomes - PA-eradication rate Secondary Outcomes - Time to first exacerbation - 1 year-exacerbation rate - Quality-of-life using questionnaires - Quality-of-life using questionnaires - Treatment burden assessment using questionnaires - Quality-of-life using questionnaires - Detection of PA at 3-month and 1 year - Time to first PA-recurrence - Emergence of FQ-resistant strains of (PA or other bacteria) - Adverse event (AE) and serious AE at 12 months follow-up - Number of premature ending of one of the treatment in study due to any AE - Number of premature ending of one of the treatment in study - Proportion of non-administered doses of nebulized colistin - Cost and incremental cost effectiveness ratio at 1 year - Cost and incremental cost effectiveness ratio at 1 year - Cost and incremental cost effectiveness ratio at 1 year ### Location - Facility: CHU Amiens-Picardie, Amiens, N/A, N/A, France @@
## Anti-Stress Intervention Among Physicians Study - NCT ID: NCT06368791 - Study ID: 30001479 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-10-30 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.Three months after the study, a survey will be sent to the participants to check if the benefits have persisted. ### Conditions - Stress, Psychological - Burnout, Psychological - Subjective Stress - Occupational Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Box Breathing - Breathing and Mindfulness Exercise - Everyday life control ### Outcomes Primary Outcomes - Daily perceived stress - Daily expectation of perceived stress level on the following day Secondary Outcomes - Level of agreement between expected and actually perceived level of stress - Compliance with the study protocol: number of participant reported outcomes - Compliance with the study protocol: number of performed anti-stress interventions - Successful study completion ### Location - Facility: Charité - Universitätsmedizin Berlin, Berlin, N/A, 10117, Germany @@
## Real-Time Biofeedback on Partial Weightbearing Training - NCT ID: NCT06368778 - Study ID: 166591 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-13 - Completion Date: 2025-04 - Lead Sponsor: University of Utah ### Study Description The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback.The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions.Secondary objectives of the study include:Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations.Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training.By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction. ### Conditions - Physical Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Verbal Advice - Bathroom Scale - Loadsol Biofeedback ### Outcomes Primary Outcomes - Average peak force (Newtons, (N)) Secondary Outcomes ### Location - Facility: University of Utah Orthopaedic Center, Salt Lake City, Utah, 84108, United States @@
## Oral Rehydration Solution and Dehydration Recovery - NCT ID: NCT06368765 - Study ID: BL72 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: Abbott Nutrition ### Study Description This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution. ### Conditions - Dehydration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Oral Rehydration Solution (ORS) - Water ### Outcomes Primary Outcomes - Plasma Volume Secondary Outcomes - Body Mass - Hydration Status Urine - Blood Biomarker - Plasma Osmolality - Blood Biomarker - Plasma Electrolyte Concentration - Blood Biomarker - Plasma Glucose Concentration - Body Temperature ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Role of Endogenous GIP in Glycosis Metabolism During Fasting - NCT ID: NCT06368752 - Study ID: H-22063621 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-05-04 - Completion Date: 2025-12-31 - Lead Sponsor: Frederikke Koefoed-Hansen ### Study Description This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\[3-30\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - GIP[3-30]NH2 - Saline ### Outcomes Primary Outcomes - Plasma glucagon concentrations Secondary Outcomes - Plasma levels of C-peptide - Plasma levels of insulin - Resting metabolic rate - Activity in brown adipose tissue - Appetite - Blood pressure - Puls ### Location - Facility: Gentofte Hospital, Hellerup, N/A, 2900, Denmark @@
## Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women - NCT ID: NCT06368739 - Study ID: STUDY00005622 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-10-17 - Completion Date: 2024-08-01 - Lead Sponsor: University of Texas at Austin ### Study Description With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data. ### Conditions - Pregnancy Related - Financial Gift - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nurture program - Regular benefits ### Outcomes Primary Outcomes - Composite outcome 1: Adverse health events during pregnancy - Composite outcome 2: Adverse health events at birth and newborn-related Secondary Outcomes ### Location - Facility: Driscoll Health Plan, Corpus Christi, Texas, 78415, United States @@
## Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders - NCT ID: NCT06368726 - Study ID: SFND04042024 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-01 - Completion Date: 2025-07-01 - Lead Sponsor: Spanish Foundation for Neurometrics Development ### Study Description Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS ### Conditions - Attention - Visual Perceptual Weakness - Social Behavior - Fluency Disorder - EEG With Periodic Abnormalities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tDCS or Transcranial Direct Current Stimulation - Risperidone ### Outcomes Primary Outcomes - FFT - Power Density Spectrum Changes or PSD - ERP MMN changes - ERP MMN Changes Secondary Outcomes - Attention - Social Skills - Language - Visual Contact ### Location - Facility: New Remedies Ltd, Liverpool, Merseyside, L1 0AH, United Kingdom @@
## Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients - NCT ID: NCT06368713 - Study ID: PD-GIEX - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Sichuan Academy of Medical Sciences ### Study Description This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients. ### Conditions - Peritoneal Dialysis - Exercise - Gastrointestinal Function - Quality of Life - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Change in GIQLI Secondary Outcomes - Change in GSRS - Change in PAC-SYM - Change in 6-MWT - Change in SGA - Change in measured Gastrointestinal Hormones ### Location - Facility: Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610000, China @@
## The Hyalex Early Feasibility Study (EFS) - NCT ID: NCT06368700 - Study ID: CL-00001 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2026-10 - Lead Sponsor: Hyalex Orthopaedics, Inc. ### Study Description The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant. ### Conditions - Cartilage Injury - Cartilage Damage ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Hyalex Knee Cartilage System ### Outcomes Primary Outcomes - Freedom from implant rejection and infection. - Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months. Secondary Outcomes ### Location - Facility: Hospital for Special Surgery, New York, New York, 10021, United States @@
## TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum - NCT ID: NCT06368687 - Study ID: 2023-06112-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-12-31 - Lead Sponsor: Göteborg University ### Study Description In a pilot study, we will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery. ### Conditions - Anorexia Nervosa - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Anorexia nervosa plus autism ### Outcomes Primary Outcomes - BMI change between baseline and discharge 12 weeks later Secondary Outcomes - Change of level of anxiety between baseline and discharge 12 weeks later - Change of Quality of life between baseline and discharge 12 weeks later ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bridging the Gap: Creating a Continuum of Care - NCT ID: NCT06368674 - Study ID: 2023-00363 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2027-02-01 - Lead Sponsor: Göteborg University ### Study Description Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care. ### Conditions - Frailty - Dependence - Integrated Care ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intervention group Case Manager (CM) - Control Group ### Outcomes Primary Outcomes - Dependency in Activities of Daily Living (ADL) Secondary Outcomes - Self-rated health - Life satisfaction - Satisfaction with quality of care - Health economics ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1) - NCT ID: NCT06368661 - Study ID: 23.79 Colo-MAR 1 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-12-31 - Lead Sponsor: Fundación Vithas ### Study Description This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention. ### Conditions - Nutrition Related Neoplasm/Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Dietary habits registry from participants: the dietary intake - Biomarkers in colon mucosa, precancerous lesions and colorectal cancer - Gut microbiota profile Secondary Outcomes ### Location - Facility: Ciro Cabezas Checchi, Vigo, Pontevedra, 36206, Spain @@
## CoMind Early Feasibility Study - NCT ID: NCT06368648 - Study ID: CP-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-04 - Lead Sponsor: CoMind Technologies Limited ### Study Description The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP. ### Conditions - Intracranial Pressure - Intracranial Pressure Changes - Traumatic Brain Injury - Intracerebral Hemorrhage - Encephalitis - Encephalopathy - Hydrocephalus - Stroke - Autoregulation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP - Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP. Secondary Outcomes - Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population. - Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg). - Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform. - Demonstration of an non-invasive ICP model that can predict trends in ICP ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study - NCT ID: NCT06368635 - Study ID: 2022-GSP-QN-8 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-03-31 - Lead Sponsor: Weijing Wang ### Study Description Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD). ### Conditions - Microcirculation - Coronary Artery Disease - Cerebrovascular Circulation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Coronary angiography ### Outcomes Primary Outcomes - MACE - MACE Secondary Outcomes - Cerebral microcirculation - Cerebral microcirculation ### Location - Facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, 100000, China @@
## Evolve China PMCF Study - NCT ID: NCT06368622 - Study ID: CDM10001814 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2031-08 - Lead Sponsor: Stryker Neurovascular ### Study Description A prospective, multi-center, single-arm, open-label, observational post-market real-world registry. The expected duration of the study is 8 years (including up to 5-years' follow-up).Each subject will be followed in accordance with the standard of care (SOC) at each participating hospital. ### Conditions - Intracranial Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surpass Evolve Flow Diverter System ### Outcomes Primary Outcomes - Neurological death or disabling stroke - 100% occlusion without significant parent artery stenosis Secondary Outcomes - Procedure- and device-related serious adverse events - Key neurological events - Procedural success - Device success - Re-sheathing success ### Location - Facility: Xuanwu Hospital Capital Medical University, Beijing, Beijing, N/A, China @@
## Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection - NCT ID: NCT06368609 - Study ID: 2024-09 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-05 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description Single center, no profit experimental study on sera available in the Tropica Biobank. ### Conditions - Strongyloides Stercoralis Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - IgG RDT - IgG4 RDT ### Outcomes Primary Outcomes - RDTs IgG results: positive or negative - RDTs IgG4 results: positive or negative Secondary Outcomes - Agreement between readers ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis - NCT ID: NCT06368596 - Study ID: 2024-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.A control group would however be recruited for secondary objective 1 and 2.The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice. ### Conditions - Endometriosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Fusobacterium detection ### Outcomes Primary Outcomes - Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis Secondary Outcomes - Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis - Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled - Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis . - Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present - Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis - Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis ### Location - Facility: IRCCS Sacro Cuore Don Calabria di Negrar, Negrar, Verona, N/A, Italy @@
## The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia - NCT ID: NCT06368583 - Study ID: 24-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery. ### Conditions - Well-Being, Psychological ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interview ### Outcomes Primary Outcomes - Patient questionnaire - Patient interview Secondary Outcomes ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada @@
## The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery - NCT ID: NCT06368570 - Study ID: 24-04 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-12 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD. ### Conditions - Well-Being, Psychological ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interview ### Outcomes Primary Outcomes - Patient questionnaire - Patient interview Secondary Outcomes ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada @@
## Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders - NCT ID: NCT06368557 - Study ID: 22/59602 - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2025-06 - Lead Sponsor: Region of Southern Denmark ### Study Description The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to theDiagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.2. What effect different degrees of therapist support have on the treatment.Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment. ### Conditions - Anxiety Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - CoolMinds: Internet-based cognitive behavioral therapy (iCBT) ### Outcomes Primary Outcomes - The Youth Online Diagnostic Assessment - Child and Parent Versions - Spence Children's Anxiety Scale- Child and Parent Versions Secondary Outcomes - Child Anxiety Life Interference Scale- Child and Parent Version - The Mood and Feelings Questionnaire- Child and Parent Version - Working Alliance Inventory - Short Form - Working Alliance Inventory for Online Interventions ### Location - Facility: Centre for Digital Psychiatry, Odense, Region Of Southern Denmark, 5000, Denmark @@
## Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06368544 - Study ID: M2023816 - Status: RECRUITING - Start Date: 2024-01-07 - Completion Date: 2030-02-07 - Lead Sponsor: Peking University Third Hospital ### Study Description A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation. ### Conditions - Anterior Cruciate Ligament Injuries - Cartilage Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - lower-body positive-pressure ### Outcomes Primary Outcomes - Gait biomechanical data - Gait biomechanical data - Gait biomechanical data - Gait biomechanical data - Gait biomechanical data - Biochemical characteristics of knee cartilage - Biochemical characteristics of knee cartilage Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, N/A, N/A, China @@
## Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain - NCT ID: NCT06368531 - Study ID: 2314270 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-08-15 - Lead Sponsor: Odense University Hospital ### Study Description Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights. ### Conditions - Chronic Pain - Insomnia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - sleep period time (SPT) from Ear EEG - Qualitative sleep parameters obtained from sleep diary. - Pain intensity rating - Time from sleep onset until final awakening (TST) from Ear EEG - Sleep efficiency (SE) from Ear EEG - Sleep onset latency (SOL) from Ear EEG - Wake after sleep onset (WASO) from Ear EEG - REM sleep latency from Ear EEG - Time from sleep onset until first epoch of REM stage sleep from Ear EEG - Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG - Number of awakenings within TST from Ear EEG - Arousal index which is number of arousals per hour from Ear EEG Secondary Outcomes - Ease-of-use and Comfort with ear EEG - Adverse device effects - Polysomnography ### Location - Facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense, Odense, N/A, 5000, Denmark @@
## Austrian HCM Registry - NCT ID: NCT06368518 - Study ID: ID01/2024/MZHCM-Reg/NV - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2034-03 - Lead Sponsor: Medical University of Graz ### Study Description The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee. ### Conditions - Hypertrophic Cardiomyopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All cause mortality - Cardiovascular events Secondary Outcomes ### Location - Facility: Medical University of Graz, Graz, Styria, 8036, Austria @@
## Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome - NCT ID: NCT06368505 - Study ID: R.24.02.2506.R1 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2024-07-16 - Lead Sponsor: Osama Ahmed Elshafei ### Study Description The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:* Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome* Asses safety profile of both methodsParticipants will:* Randomized to one of the two arms* Visit the clinic 1 and 3 months after intervention* Assessed for efficacy and safety of the intervention ### Conditions - Carpal Tunnel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ultrasound guided PRP injection - ultrasound guided hydrodissection ### Outcomes Primary Outcomes - Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) - The visual analog scale (VAS) Secondary Outcomes - The cross-sectional area (CSA) of the Median nerve ### Location - Facility: Mansoura University, Mansoura, N/A, 35511, Egypt @@
## The Impact of Psilocybin on Pain in Fibromyalgia Patients - NCT ID: NCT06368492 - Study ID: P137 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Maastricht University ### Study Description Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects. ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Psilocybin - Hypnosis script ### Outcomes Primary Outcomes - Ischemic Pain perception - Pressure-evoked Pain perception - Self-reported pain Secondary Outcomes - Subjective effects: psychedelic phenomenology - Subjective effects: mood - Subjective effects: intensity of effects - Subjective effects: Ego dissolution - Subjective effects: Dissociation - Psychiatric symptoms - Cognitive performance - Vigilance - Empathy - Creativity - Creativity - Autobiographical memory - Autobiographical memory - Treatment expectancy - Treatment expectancy - Fibromyalgia-related pain - Personality - Absorption - Interpersonal Reactivity - Depression ### Location - Facility: Maastricht University, Maastricht, Limburg, 6226AK, Netherlands @@
## A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings - NCT ID: NCT06368479 - Study ID: CLS-016B - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-01 - Lead Sponsor: bioLytical Laboratories ### Study Description A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care. ### Conditions - Hepatitis B - Hepatitis B Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - iStatis HBsAg Test ### Outcomes Primary Outcomes - iStatis Performance Secondary Outcomes ### Location - Facility: Epicentre Health Research, Hillcrest, Kwazulu Natal, 3650, South Africa @@
## A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites - NCT ID: NCT06368466 - Study ID: CLS-016A - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-09-01 - Lead Sponsor: bioLytical Laboratories ### Study Description A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions. ### Conditions - Hepatitis B - Hepatitis B Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - iStatis HBsAg Test ### Outcomes Primary Outcomes - Performance - Sensitivity and Specificity Secondary Outcomes ### Location - Facility: St. Vincent's Hospital, Melbourne, Melbourne, Fitzroy Victoria, 3065, Australia @@
## A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test - NCT ID: NCT06368453 - Study ID: CLS-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: bioLytical Laboratories ### Study Description The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.The study aims to:To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test. ### Conditions - Human Immunodeficiency Virus I Infection - Human Immunodeficiency Virus II Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - INSTI® HIV Self-Test ### Outcomes Primary Outcomes - Clinical sensitivity and specificity of the INSTI® HIV Self-Test Secondary Outcomes - The INSTI® HIV Self-Test usability and result interpretation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants - NCT ID: NCT06368440 - Study ID: D7860C00003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-10-04 - Lead Sponsor: AstraZeneca ### Study Description The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - AZD6793 - AZD6793 - Placebo ### Outcomes Primary Outcomes - Part 1 (SAD): Number of Participants with Adverse Events - Part 2 (MAD): Number of Participants with Adverse Events Secondary Outcomes - Part 1 (SAD) : Maximum Observed Plasma Drug Concentration - Part 1 (SAD): Time to Reach Peak Concentration (tmax) - Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) - Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) - Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]) - Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) - Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) - Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) - Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) - Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) - Part 1 (SAD): Dose Normalized AUClast - Part 1 (SAD): Dose Normalized AUCinf - Part 1 (SAD): Dose Normalized Cmax - Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax) - Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough) - Part 2 (MAD): Temporal Change Parameter (TCP) - Part 2 (MAD): Time to Reach Peak Concentration (tmax) - Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) - Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) - Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) - Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) - Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) - Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau) - Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) - Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) - Part 2 (MAD): Dose Normalized AUClast - Part 2 (MAD): Dose Normalized AUCtau - Part 2 (MAD): Dose Normalized Cmax - Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC) - Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax) - Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]) - Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf) - Part 2 (MAD): Renal Clearance (CLR) ### Location - Facility: Research Site, Glendale, California, 91206, United States @@
## Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD - NCT ID: NCT06368427 - Study ID: D5980R00100 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-09-30 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis. ### Conditions - Chronic Obstructive Pulmonary Disease (COPD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - budesonide / glycopyrronium / formoterol ### Outcomes Primary Outcomes - Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score Secondary Outcomes - Change from baseline to 6 months in the CAT score - Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment - Percent responders of the CAT [MID=2] after 12 weeks of treatment - Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation - Drivers for initiation or switch to BGF MDI via physician questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia - NCT ID: NCT06368414 - Study ID: KCMLWP-2021-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2028-08-31 - Lead Sponsor: Korean Society of Hematology ### Study Description To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI ### Conditions - Chronic Myeloid Leukemia, Chronic Phase ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Asciminib ### Outcomes Primary Outcomes - MR3.0 or less by 1 year Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A First in Human Study for the Versa Device for Tricuspid Regurgitation - NCT ID: NCT06368401 - Study ID: TP_01428 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: Versa Vascular, Inc ### Study Description This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates. ### Conditions - Tricuspid Regurgitation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Versa Implant ### Outcomes Primary Outcomes - Acute Procedural Success - Incidence of major adverse events (MAE) Secondary Outcomes - Tricuspid Regurgitation Severity Change ### Location - Facility: Auckland City Hospital, Auckland, N/A, N/A, New Zealand @@
## Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force - NCT ID: NCT06368388 - Study ID: S64854 - Status: RECRUITING - Start Date: 2021-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration. ### Conditions - Musculoskeletal Infection - Chronic Rhinosinusitis (Diagnosis) - Sepsis - Pulmonary Infection - Hidradenitis Suppurativa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prospective data collection - Prospective data collection ### Outcomes Primary Outcomes - Disease free period - Bacterial eradication Secondary Outcomes - PROMIS global health (patient-reported outcome measurement information system) - PROMIS (patient-reported outcome measurement information system) physical function - PROMIS (patient-reported outcome measurement information system) pain interference - Sino-nasal outcome test (SNOT)-22 - Visual Analogue Scale (VAS) score - Cystic fibrosis questionnaire (CF-Q-R) - Dermatology Life Quality Index (DLQI) - Hidradenitis Suppurativa Quality of Life (HiSQoL) ### Location - Facility: University Hospitals Leuven, Leuven, N/A, 3000, Belgium @@
## Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa - NCT ID: NCT06368375 - Study ID: PRPF31-3102022BO2 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-06-30 - Lead Sponsor: University Hospital Tuebingen ### Study Description Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s) ### Conditions - Retinitis Pigmentosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Best Corrected Visual Acuity (BCVA) - Visual Field (VF) - Fundus Photography (FP) - Optos - Autofluorescence (AF) - Optical Coherence Tomography (OCT) - Full-Field Electroretinogram (ff-ERG) Secondary Outcomes ### Location - Facility: University Hospital Tuebingen, Tuebingen, Baden-Wuerttemberg, 72076, Germany @@
## Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain - NCT ID: NCT06368362 - Study ID: CBM-I001 - Status: COMPLETED - Start Date: 2020-11-17 - Completion Date: 2021-05-01 - Lead Sponsor: University of Southampton ### Study Description Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals. ### Conditions - Chronic Pain - Musculoskeletal Pain Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Benign cognitive bias modification for interpretation - Pain-related cognitive bias modification for interpretation ### Outcomes Primary Outcomes - Emotional response to exercise induced pain - Emotional response to pain-related images Secondary Outcomes - Fear of Pain - Anxiety - Depression - Emotional response to average clinical pain - Pain severity - Pain interference - Pain-related interpretation bias index ### Location - Facility: University of Southampton, Southampton, Hampshire, SO17 1BJ, United Kingdom @@
## Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma - NCT ID: NCT06368349 - Study ID: 202101771B0 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-06-30 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry. ### Conditions - Lymphopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Persistent lymphopenia predict poor overall survival - T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient - Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use Secondary Outcomes ### Location - Facility: Department of Surgery, Kaohsiung, N/A, 833, Taiwan @@
## Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study. - NCT ID: NCT06368336 - Study ID: 994894 - Status: COMPLETED - Start Date: 2008-01-01 - Completion Date: 2022-12-31 - Lead Sponsor: Uppsala University Hospital ### Study Description The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU). ### Conditions - Sepsis - Septic Shock - Sepsis, Severe ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis Secondary Outcomes - Ability to work before and after ICU (intensive care unit) treatment for Sepsis - The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia - NCT ID: NCT06368323 - Study ID: H-01-24-9931 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-12-31 - Lead Sponsor: University of Ottawa ### Study Description The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.The main question it aims to answer is:Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?Participants will have:12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h) ### Conditions - Aphasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Choir singing - Usual care ### Outcomes Primary Outcomes - Communication Index Secondary Outcomes - Level of confidence in communication - Aphasia severity index - Speech and language in functional communication - Apraxia of speech severity - Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) - Emotional wellbeing - Social participation - Generic measure of health - Appetence to music - Singing voice abilities ### Location - Facility: University of South Florida, Tampa, Florida, 33620, United States @@
## FIH Clinical Investigation of Graphene Electrodes for Brain Mapping - NCT ID: NCT06368310 - Study ID: R124807 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-28 - Completion Date: 2025-01-31 - Lead Sponsor: University of Manchester ### Study Description The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:* To understand the safety of these new electrodes when used during brain tumor surgery (primary objective);* To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery. ### Conditions - Brain Tumor - Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - INBRAIN Graphene Cortical Interface ### Outcomes Primary Outcomes - To evaluate the preliminary safety of the investigational device for its intended use Secondary Outcomes - Assess the ability of the device to record signals from the brain - Evaluate the ability of the device to provide functional stimulation of the brain - Assess stability of sensing and stimulating electrodes - Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery ### Location - Facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, Greater Manchester, M6 8HD, United Kingdom @@
## The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults - NCT ID: NCT06368297 - Study ID: BSERE22-APP007-FED - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: University of Macau ### Study Description This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses. ### Conditions - Overweight and Obesity - Cognitive Change - Psychophysiologic Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Ketone Monoester Supplementation - Ketogenic diet ### Outcomes Primary Outcomes - Brain Plasticity - Grey Matter Volume - Cortical Thickness - Blood-Oxygen-Level-Dependent (BOLD) Signal Changes Secondary Outcomes - Blood Glucose - Blood Beta-Hydroxybutyrate - Blood Insulin - Leptin - Ghrelin - Brain-Derived Neurotrophic Factor - Reaction Time of Attention Network Test - Accuracy of Attention Network Test - Reaction Time of Stroop Task - Accuracy of Stroop Task - Reaction Time of N-back Task - Accuracy of N-back Task - Cerebral Hemoglobin Concentration - Height in Kilograms - Weight in Meters - Body Fat Percentage - Fat Mass - Muscle Mass - Body Water - Body Mass Index - Skinfold Thickness - Maximal Oxygen Uptake ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results - NCT ID: NCT06368284 - Study ID: IRB-MTP_2022_09_202201170 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: University Hospital, Montpellier ### Study Description French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice. ### Conditions - Perineum; Tear, Traumatic - Anal Tear - Anal Incontinence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident ### Outcomes Primary Outcomes - Rate of fecal incontinence Secondary Outcomes - Rate of permanent stoma - Rate of acontractile bladder - Rate of sexual dysfunction - Rate of impact on quality of life ### Location - Facility: Chu Montpellier, Montpellier, N/A, 34295, France @@
## Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile - NCT ID: NCT06368271 - Study ID: Lipidomix - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2024-02-28 - Lead Sponsor: University of Copenhagen ### Study Description In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover. ### Conditions - Healthy Nutrition - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Lipidomics ### Outcomes Primary Outcomes - Meal test including medium-chain fatty acids Secondary Outcomes - Resting metabolic rate ### Location - Facility: University of Copenhagen, Copenhagen, N/A, 2100, Denmark @@
## Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia - NCT ID: NCT06368258 - Study ID: Curr-RYR2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-05-02 - Lead Sponsor: University of Bologna ### Study Description The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated. ### Conditions - Hypercholesterolemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Red yeast rice - Placebo ### Outcomes Primary Outcomes - Treatment-dependent change in LDL-C Secondary Outcomes - Treatment-dependent change in Total Cholesterol - Treatment-dependent change in Non-HDL-C - Treatment-dependent change in liver parameters - Treatment-dependent change in CPK plasma levels - Treatment-dependent change in plasma proteomic pattern ### Location - Facility: AOU Policlinico S.Orsola-Malpighi, Bologna, N/A, N/A, Italy @@
## Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions - NCT ID: NCT06368245 - Study ID: SMART - Status: NOT_YET_RECRUITING - Start Date: 2024-10-15 - Completion Date: 2029-07-31 - Lead Sponsor: AO Foundation, AO Spine ### Study Description This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites. ### Conditions - Spinal Fusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - long-segment posterior TL instrumented fusion ### Outcomes Primary Outcomes - Rod fracture (RF) Secondary Outcomes - Time to rod fracture - Time to rod fracture - Configurations of supplementary rod constructs - Treatment for rod fracture - Recurrent RFs - Other mechanical failures - Surgical complications ### Location - Facility: University of Minnesota Medical Center, Minneapolis, Minnesota, 55454, United States @@
## Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study - NCT ID: NCT06368232 - Study ID: 19.036.123.125 - Status: COMPLETED - Start Date: 2022-02-15 - Completion Date: 2023-04-15 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess. ### Conditions - Bariatric Surgery Candidate - Gastrostomy - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - püPatients undergoing bariatric surgery ### Outcomes Primary Outcomes - Body Weight - BMI (Body Mass Index) - Lean Mass - Fat Mass - Fasting Blood Glucose - HbA1c - Iron levels - Vitamin D level - Lipid Profile (Triglycerides, LDL, HDL) Secondary Outcomes ### Location - Facility: Ankara Yıldırım Beyazıt University, Ankara, N/A, 06760, Turkey @@
## Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting - NCT ID: NCT06368219 - Study ID: 0108161 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Alexandria University ### Study Description This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events ### Conditions - Procedural Sedation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ketamine- midazolam versus ketamine- propofol ### Outcomes Primary Outcomes - Induction and recovery time for both combinations Secondary Outcomes - incidence and severity of adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2 - NCT ID: NCT06368206 - Study ID: OBPM_Calfree2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-31 - Lead Sponsor: Aktiia SA ### Study Description The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Investigational device Aktiia G2C - Marketed device used as reference for blood pressure monitoring: double auscultation cuff - Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 - Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff - Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff - Marketed device used as reference for pulse rate monitoring: pulse finger oximeter ### Outcomes Primary Outcomes - Blood pressure mean value of differences - Blood pressure standard deviation of differences Secondary Outcomes - Pulse rate root-mean-square error ### Location - Facility: CHUV, Lausanne, N/A, 1011, Switzerland @@
## The Neuralert Stroke Monitor Pilot Trial - NCT ID: NCT06368193 - Study ID: Neuralert 001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Neuralert Technologies LLC ### Study Description This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, clinical usability, and tolerability. ### Conditions - Stroke - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Neuralert Monitor ### Outcomes Primary Outcomes - Data Aggregation Secondary Outcomes - Time to alarm reception - Time to alarm reponse - Stroke detection ### Location - Facility: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## The Efficacy of a RAGT & BWSTT on Children With CP - NCT ID: NCT06368180 - Study ID: 439106274 - Status: COMPLETED - Start Date: 2020-08-30 - Completion Date: 2021-03-08 - Lead Sponsor: King Saud University ### Study Description This study compared the effects of RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Robotic assisted gait training ### Outcomes Primary Outcomes - Gait spatio-temporal parameters Secondary Outcomes - Six-minute walk test (6MWT) ### Location - Facility: King Abdu Aziz Medical City, Riyadh, N/A, N/A, Saudi Arabia @@
## A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma - NCT ID: NCT06368167 - Study ID: SHR2554-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma ### Conditions - Follicular Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SHR2554 ### Outcomes Primary Outcomes - Objective response rate (ORR) assessed by independent review committee (IRC) Secondary Outcomes - ORR assessed by investigator - Progression free survival - Time to Response - Duration of response - Overall survival ### Location - Facility: Peking University Cancer Hospital, Beijing, Beijing, 100142, China @@
## Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity - NCT ID: NCT06368154 - Study ID: HCHLL-2019-08 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Hunan Children's Hospital ### Study Description Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs. ### Conditions - Exosomes - Newborn - Bone Diseases, Metabolic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - exosomes Secondary Outcomes ### Location - Facility: Hunan Children's Hospital, Changsha, Hunan, 410007, China @@
## Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer - NCT ID: NCT06368141 - Study ID: 2023294 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: Ruijin Hospital ### Study Description The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are:* Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer?* Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer?Participants will receive:* a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen.* a sequential CAPEOX plus Serplulimab regimen.* a standard complete mesocolic excision (CME) operation. ### Conditions - Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Serplulimab - Capecitabine - Oxaliplatin ### Outcomes Primary Outcomes - pathologic complete response Secondary Outcomes ### Location - Facility: Ruijin Hospital, Shanghai, Shanghai, 200025, China @@
## Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study - NCT ID: NCT06368128 - Study ID: HS-24_51 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12-31 - Lead Sponsor: Northern Michigan University ### Study Description The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention). ### Conditions - Lifestyle Factors - Physical Inactivity - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Indoor Rock Climbing Exercise Training Program ### Outcomes Primary Outcomes - Fasting lipids - Fasting glucose - Hemoglobin a1c Secondary Outcomes - Physical activity and sedentary behavior - Sedentary behavior bouts (30 min, 60 min, >60 min) - Cardiorespiratory fitness - Muscular fitness - Handgrip strength asymmetry - Lower-body dynamic balance - Health-related quality of life using CDC Health-Related Quality of Life Scale - Exercise self-efficacy measured via Self-efficacy for exercise scale - Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale - Perceived stress - Blood pressure - Body composition - Bone density ### Location - Facility: Northern Michigan University, Marquette, Michigan, 49855, United States @@
## A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2 - NCT ID: NCT06368115 - Study ID: 00023453 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Educational Materials ### Outcomes Primary Outcomes - Absence of Inappropriate Medication Prescription Dispensing Secondary Outcomes - Dose Change - Polypharmacy - Rates of Health Care and Emergency Care Utilization - Mortality - Switching within Classes ### Location - Facility: UMass Chan Medical School, Worcester, Massachusetts, 01605, United States @@
## Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery - NCT ID: NCT06368102 - Study ID: R6-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08 - Lead Sponsor: Uji Takeda Hospital ### Study Description The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration. ### Conditions - Surgical Site Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ampicillin ### Outcomes Primary Outcomes - Occurrence of surgical site infection Secondary Outcomes - Occurrence of alveolar osteitis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients - NCT ID: NCT06368089 - Study ID: REC.66-474-30-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: Prince of Songkla University ### Study Description Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program. ### Conditions - Ventilator Dependent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inspiratory muscle training (IMT) group - Early mobilization (EM) group ### Outcomes Primary Outcomes - Maximum inspiratory pressure (MIP) - Dynamic lung compliance (Cdyn) Secondary Outcomes - Weaning time - Weaning outcome - Grip strength - chest wall expansion ### Location - Facility: Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital, Songkhla, N/A, 90110, Thailand @@
## High-intensity Interval Training in Patients With Spinal Muscular Atrophy - NCT ID: NCT06368076 - Study ID: H-23065096 - Status: RECRUITING - Start Date: 2024-01-09 - Completion Date: 2025-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy. ### Conditions - Spinal Muscular Atrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Questionnaire on fatigue - Questionnaire on pain. - Questionnaire on constipation - Questionnaire on quality of life - Questionnaire on sleep quality Secondary Outcomes - Blood sample - Blood sample - Blood sample - Blood sample - Blood sample - Blood sample - Blood sample - Blood sample - Blood sample - Blood sample - MRI scan liver size - MR-elastography - MRI scan liver steatosis - Ultrasound scan - MRI scan - MRI scan - Exercise test - Motorscore ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer - NCT ID: NCT06368063 - Study ID: HE-202301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-03 - Lead Sponsor: Health Science Center of Xi'an Jiaotong University ### Study Description The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer ### Conditions - Pancreatic Cancer Resectable ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Huaier granule - chemotherapy drugs ### Outcomes Primary Outcomes - Disease-free survival Secondary Outcomes - Overall survival - Progression-free survival - The incidence and severity of adverse events (AE) and severe adverse events (SAE) - The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football - NCT ID: NCT06368050 - Study ID: IRB00067187.2 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2024-11 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein. ### Conditions - Head Injury - Sport Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - practice structure intervention ### Outcomes Primary Outcomes - Number of practice head impacts - Number of practice head acceleration events - Practice head impact rate - Practice head acceleration even rate - Median linear acceleration - Median rotational acceleration - Median rotational velocity - 95th percentile linear acceleration - 95th percentile rotational acceleration - 95th percentile rotational velocity Secondary Outcomes - Feasibility of Intervention Measure (FIM) Values - Acceptability of Intervention Measure (AIM) Values - Number of practices the intervention was implemented as prescribed - Average minutes per practice of live time ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy - NCT ID: NCT06368037 - Study ID: DragonFire-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-06 - Lead Sponsor: Hangzhou Valgen Medtech Co., Ltd ### Study Description This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively. ### Conditions - Obstructive Hypertrophic Cardiomyopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DragonFire Transcatheter Myocardial Radiofrequency Ablation System ### Outcomes Primary Outcomes - The rate of freedom from major adverse events at 30 days postoperatively - The success rate of treatment at 6 months postoperatively Secondary Outcomes ### Location - Facility: Northern Theater Command General Hospital of the Chinese People's Liberation Army, Shenyang, N/A, N/A, China @@
## Establishment of Delphi-MD Safety Performance and Reliability - NCT ID: NCT06368024 - Study ID: CL-12-600 - Status: COMPLETED - Start Date: 2023-11-28 - Completion Date: 2023-11-28 - Lead Sponsor: QuantalX Neuroscience ### Study Description A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements. ### Conditions - Neurologic Disorder - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - This is a retrospective analysis study of data collected with a diagnostic medical device ### Outcomes Primary Outcomes - Cortical Excitability - Specific Peak Amplitudes - GMFP Secondary Outcomes ### Location - Facility: QuantalX Neuroscience Ltd., Kfar Saba, Center, 4453001, Israel @@
## The Impact of Acceptance and Commitment Therapy on Stigmatization - NCT ID: NCT06368011 - Study ID: MustafaKU-CINCINOGLU-001 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-04-15 - Completion Date: 2024-06-30 - Lead Sponsor: Mustafa Kemal University ### Study Description The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients.Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group.Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara.Intervention: Before the psychoeducation process started, personal information form and scales were applied to the relatives of the patients in the experimental and control groups. An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental group. each session lasted approximately 90 minutes. The control group did not receive any intervention. After the psychoeducation, the scales were reapplied to the experimental and control groups. In addition, the experimental group was asked to fill out the psychoeducation evaluation form. The scales were reapplied to the experimental group after the 1-month follow-up study and evaluated. ### Conditions - Stigmatization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - acceptance and commitment therapy ### Outcomes Primary Outcomes - Stigma Scale for Relatives of Patients with Schizophrenia - Stigma Scale for Relatives of Patients with Schizophrenia - Stigma Scale for Relatives of Patients with Schizophrenia Secondary Outcomes - Stigmatization Scale - Stigmatization Scale - Stigmatization Scale ### Location - Facility: Hatay Mustafa Kemal Üniversitesi, Hatay, N/A, N/A, Turkey @@
## The Effect of Pregabalin on Shoulder Pain of Patients With Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair - NCT ID: NCT06367998 - Study ID: PC24MISV0017 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: The Catholic University of Korea ### Study Description This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin. ### Conditions - Rotator Cuff Tears - Central Sensitisation - Neuropathic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pregabalin ### Outcomes Primary Outcomes - VAS pain score Secondary Outcomes - Constant shoulder score - American shouler and elbow surgeons (ASES) score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CAPA-IVM Culture With Low Oxygen Tension - NCT ID: NCT06367985 - Study ID: 03/24/DD-BVMD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2025-06-01 - Lead Sponsor: Mỹ Đức Hospital ### Study Description Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology. ### Conditions - In Vitro Fertilization ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Air Oxygen Concentration CAPA-IVM culture - Low Oxygen Concentration CAPA-IVM culture ### Outcomes Primary Outcomes - Maturation rate Secondary Outcomes - Total number of oocytes retrieval - Number of patients with no oocyte retrieved - Number of MII oocytes - Number of GV oocytes - Number of patients with no matured oocyte - Number of 2PN oocytes - Fertilization rate - Abnormal fertilization rate - Number of patients with no day-3 embryo - Number of day-3 embryos - Number of good quality Day-3 embryos - Number of frozen day-3 embryos - Number of blastocyst (day 5 or day 6 embryo) - Number of patients with no blastocyst - Number of good quality blastocysts - Number of frozen blastocysts - Number of embryos transferred - Quality of embryos transferred (Grade 1, Grade 2, Grade 3) - Positive pregnancy test rate - Implantation rate - Clinical pregnancy rate - Ectopic pregnancy rate - Ongoing pregnancy rate - Miscarriage <12 weeks rate (Early miscarriage) - Miscarriage <22 weeks rate (late miscarriage) - Live birth rate - Multiple pregnancy rate - Multiple delivery rate - Mode of delivery - Gestational age at birth - Birth weight - Very low birth weight rate - Low birth weight rate - High birth weight rate - Very high birth weight rate - Small for gestational age rate - Large for gestational age rate - Hypertension in pregnancy rate - Gestational diabetes mellitus rate - Still birth rate - Premature birth rate - Antepartum haemorrhage rate - Major congenital abnormalities rate - Neonatal mortality rate - NICU admission rate - Reason for NICU admission ### Location - Facility: My Duc Hospital, Ho Chi Minh City, N/A, N/A, Vietnam @@
## A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP) - NCT ID: NCT06367972 - Study ID: 2024-0070 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2030-10-10 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation \[the removal or destruction of a body part or tissue or its function\], or embolization \[a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel\]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy. ### Conditions - OligoProgressive Metastatic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Local Consolidation Therapy - Next-line Systemic Therapy ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@