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## A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer - NCT ID: NCT06262633 - Study ID: CRE-2023.079 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-06-30 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation ### Outcomes Primary Outcomes - The oncological control of prostate cancer Secondary Outcomes - Cancer detection on biopsy of each ablated MRI visible lesion - Cancer detection on biopsy of each ablated MRI invisible lesion - Gleason 4 or 5 cancer detected on biopsy of ablated area - Out-of-field recurrence: Any cancer outside treated area on systematic biopsy - Common Terminology Criteria for Adverse Events (CTCAE) v5.0 - PSA change - Urinary Symptoms after treatment - Sexual side effects after treatment - Continence side effects after treatment - Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity - Quality of life measured by ED-5Q-5Lquestionnaire - Quality of life in patients with prostate cancer measured by EPIC-26 - Quality of life measured by QLQ-C30, ### Location - Facility: Peter Ka-Fung CHIU, Sha Tin, N/A, N/A, Hong Kong @@
## The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB - NCT ID: NCT06262620 - Study ID: 2022-NHLHCRF-LX-01-0201-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-18 - Completion Date: 2026-02-18 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events. ### Conditions - Lymphadenopathy Hilar - Lymphadenopathy Mediastinal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - EBUS-TBNA - EBUS-TBCB - EBUS-TBFB ### Outcomes Primary Outcomes - Dignostic rate of EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB - Incidence rate of adverse events - the adequacy of sample acquisition - the quality of sample acquisition Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica - NCT ID: NCT06262607 - Study ID: CLE400-NP-201 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2025-01-15 - Lead Sponsor: Clexio Biosciences Ltd. ### Study Description This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP). ### Conditions - Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CLE-400 - Vehicle ### Outcomes Primary Outcomes - Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4. Secondary Outcomes ### Location - Facility: Clinical site 11, Bryant, Arkansas, 72022, United States @@
## Lemborexant Treatment of Insomnia Linked to Epilepsy - NCT ID: NCT06262594 - Study ID: L'ÉTOILE - Status: NOT_YET_RECRUITING - Start Date: 2024-02-08 - Completion Date: 2026-02-08 - Lead Sponsor: University of Manitoba ### Study Description The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. ### Conditions - Epilepsy - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Lemborexant ### Outcomes Primary Outcomes - WASO Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery - NCT ID: NCT06262581 - Study ID: 2021-FXY-471 - Status: RECRUITING - Start Date: 2023-09-23 - Completion Date: 2025-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients. ### Conditions - DMMR Colorectal Cancer - Anti PD-1 - Immunotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tisleizumab(BGB-A317) ### Outcomes Primary Outcomes - pathological complete regression rate Secondary Outcomes - CR rate - Major Pathological Response rate - Disease free survival ### Location - Facility: Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases - NCT ID: NCT06262568 - Study ID: Soh-Med-23-03-18MS - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: Sohag University ### Study Description The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education. ### Conditions - High Risk Pregnancy and Maternal Near Miss Cases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - assess the nurse knowledge and practices. ### Outcomes Primary Outcomes - Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training Secondary Outcomes ### Location - Facility: Sohag University hospitals, Sohag, N/A, N/A, Egypt @@
## Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer - NCT ID: NCT06262555 - Study ID: TYGH111061 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12-31 - Lead Sponsor: Taoyuan General Hospital ### Study Description This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage. ### Conditions - Lung Cancer - Lung Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Transbronchial PDT peripheral lung tumor ablation ### Outcomes Primary Outcomes - Technical Feasibility - Technical Safety Secondary Outcomes - Tumor remission rate ### Location - Facility: Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan City, N/A, 320, Taiwan @@
## Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia - NCT ID: NCT06262542 - Study ID: 111016 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-12-31 - Lead Sponsor: Taichung Armed Forces General Hospital ### Study Description Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia. ### Conditions - Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - moxibustion and Chinese herbal medicine group ### Outcomes Primary Outcomes - Track the number of white blood cells Secondary Outcomes ### Location - Facility: Taichung Armed Force General Hospital, Taichung, Taiping, 411228, Taiwan @@
## Neurocognitive Impairment After Ischemic Stroke - NCT ID: NCT06262529 - Study ID: 22-AOI-06 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2027-02-09 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Cerebral MRI ### Outcomes Primary Outcomes - evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke Secondary Outcomes ### Location - Facility: cannes Hospital, Cannes, N/A, 06600, France @@
## Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma - NCT ID: NCT06262516 - Study ID: CASE2824 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2029-01-01 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:* To determine oncologic outcomes, specifically 2-year recurrence-free survival* To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival* To determine time to recurrence and recurrence patterns* To determine use of adjuvant therapies* To determine perioperative complicationsParticipants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection. ### Conditions - Urothelial Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nephroureterectomy - Lymph Node Dissection ### Outcomes Primary Outcomes - Recurrence-free survival Secondary Outcomes - Treatment-free survival - Cancer-specific survival - Overall Survival - Time to recurrence - Use of adjuvant therapies - Perioperative complications ### Location - Facility: Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland, Ohio, 44195, United States @@
## the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation - NCT ID: NCT06262503 - Study ID: P.T.REC/012/004810 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-03 - Lead Sponsor: Cairo University ### Study Description 1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation . ### Conditions - Phantom Pain Following Amputation of Lower Limb ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual Reality - Transcutaneous Electrical Nerve Stimulation (TENS) - Mirroring Therapy - Phantom Exercises ### Outcomes Primary Outcomes - Pain Intensity Level - Lower Extremity Functional Secondary Outcomes ### Location - Facility: Faculty of Physical therapy, Cairo university, Giza, N/A, 12613, Egypt @@
## Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain - NCT ID: NCT06262490 - Study ID: P.T.REC/012/004765 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-01 - Lead Sponsor: Cairo University ### Study Description The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms . ### Conditions - Chronic Perineal Pain - Pelvic Floor Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional ultrasound therapy - Pelvic floor rehabilitation ### Outcomes Primary Outcomes - Assessment of osteomyoarticular symptoms - Assessment of perineal pain intensity Secondary Outcomes - Assessment of pelvic floor muscle strength - Assessment of pelvic floor muscle tightness - Assessment of lumbar spine mobility ### Location - Facility: Cairo University, Giza, N/A, N/A, Egypt @@
## A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants - NCT ID: NCT06262477 - Study ID: NL-TCZ-12280 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2024-11-30 - Lead Sponsor: Biogen ### Study Description The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BIIB800 - Actemra ### Outcomes Primary Outcomes - Maximum Serum Concentration (Cmax) of Tocilizumab - Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab - Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab Secondary Outcomes - Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab - Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab - Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R) - Maximum Observed Effect (Emax) of sIL-6R - Time to Emax (tEmax) of sIL-6R - AUE of High Sensitive C-Reactive Protein (hsCRP) - Minimum Observed Effect Emin of hsCRP - Time to Emin (tEmin) of hsCRP - Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs) - Number of Participants With ADA Titers ### Location - Facility: Fortrea Clinical Research Unit Inc., Madison, Wisconsin, 53704, United States @@
## An OCD Prevention Programme for at Risk Adults - NCT ID: NCT06262464 - Study ID: 17.361/ 07.12.2023 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2024-04-01 - Lead Sponsor: Babes-Bolyai University ### Study Description The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention. ### Conditions - Obsessive-Compulsive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Prevention ### Outcomes Primary Outcomes - Change from baseline in OCD symptoms on the OCI-R after the intervention - Change from baseline in depressive symptoms on the PHQ-9 after the intervention - Change from baseline in anxiety symptoms on the GAD-7 after the intervention Secondary Outcomes - Change from baseline in experiential avoidance on the EAQ after the intervention - Change from baseline in cognitive distortions on the OBQ-44 after the intervention - Change from baseline in uncertainty intolerance on the IUS after the intervention - Change from baseline in resilience on the RSA after the intervention ### Location - Facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy, Cluj-Napoca, N/A, 400015, Romania @@
## Fecal Microbiota Transplant National Registry - NCT ID: NCT06262451 - Study ID: 20-30182 - Status: RECRUITING - Start Date: 2023-10-20 - Completion Date: 2032-10 - Lead Sponsor: University of California, San Francisco ### Study Description A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits. ### Conditions - Fecal Microbiota Transplant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To assess short-term and long-term safety of FMT and other gut-related-microbiota products Secondary Outcomes - To characterize effectiveness of FMT and other gut-related-microbiota products. - To gather information on FMT practice in North America - To promote scientific investigation. - To aid practitioners and sponsors in satisfying regulatory requirements ### Location - Facility: University of California, San Francisco, San Francisco, California, 94115, United States @@
## CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients - NCT ID: NCT06262438 - Study ID: MH22CAQ - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2032-06 - Lead Sponsor: Princess Maxima Center for Pediatric Oncology ### Study Description The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type. ### Conditions - Acute Myeloid Leukemia in Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Quizartinib - Etoposide - Dexrazoxane - Mitoxantrone - Cytarabine - Methotrexate - Daunorubicin - Fludarabine - allo-SCT ### Outcomes Primary Outcomes - Primary objective (efficacy) - Primary objective (safety) Secondary Outcomes - Secondary objectives (efficacy_1) - Secondary objectives (efficacy_2) - Secondary objectives (efficacy_3) - Secondary objectives (efficacy_4) - Secondary objectives (efficacy_5) - Secondary objectives (efficacy_6) - Secondary objectives (efficacy_7) - Secondary objectives (efficacy_8) - Secondary objectives (efficacy_9) - Secondary objectives (safety) - Adverse Events, Laboratory Abnormalities and cumulative incidence of non-relapse mortality - Pharmacokinetics (PK_1) - Pharmacokinetics (PK_2) - Pharmacokinetics (PK_3) - Pharmacokinetics (PK_4) - Palatability of quizartinib formulations ### Location - Facility: Princess Máxima Center for pediatric oncology, Utrecht, N/A, 3584 CS, Netherlands @@
## rTMS Over S1 Enhance Motor Learning in Healthy People - NCT ID: NCT06262425 - Study ID: ALC001NR004 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2025-09-15 - Lead Sponsor: Neuron, Spain ### Study Description The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple. ### Conditions - Transcranial Magnetic Stimulation - Motor Learning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex - repetitive Transcranial Magnetic Stimulation over primary motor cortex - sham repetitive Transcranial Magnetic Stimulation ### Outcomes Primary Outcomes - Change in accuracy Secondary Outcomes - Change in reaction time speed - Change in pegs placed in 30 seconds ### Location - Facility: Neuron, Madrid, N/A, 28045, Spain @@
## Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder - NCT ID: NCT06262412 - Study ID: 2023-02193-01 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2026-10-31 - Lead Sponsor: Karolinska Institutet ### Study Description The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the 6-month durability of a therapist-guided, Internet-delivered cognitive-behavior therapy programme for children and adolescents with body dysmorphic disorder. ### Conditions - Body Dysmorphic Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Internet-delivered cognitive-behaviour therapy (ICBT) - Internet-delivered relaxation treatment (IRT) ### Outcomes Primary Outcomes - Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A) Secondary Outcomes - Treatment response and full or partial remission - Clinical Global Impression - Severity (CGI-S) - Clinical Global Impression - Improvement (CGI-I) - Children's Global Assessment Scale (CGAS) - Appearance Anxiety Index (AAI) - Short Mood and Feeling Questionnaire - child version and parent version (SMFQ) + additional suicide item (only child/adolescent) - Generalized Anxiety Disorder - 7 item scale (GAD-7) - Deliberate Self-Harm Inventory - Youth version (DSHI-Y-7) - CRAFFT (acronym for the key words Car, Relax, Alone, Forget, Friends and Trouble) - Work and Social Adjustment Scale - youth (WSAS-Y) and parent version (WSAS-P) - Child Health Utility 9D (CHU9D) - Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Working Alliance Inventory - child (WAI-C) and parent version (WAI-P) - Client Satisfaction Questionnaire (CSQ-8) - Treatment Credibility and Expectancy Scale (TCES) - Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS) - Treatment preference ### Location - Facility: BUP OCD och relaterade tillstånd, Stockholm, N/A, 113 30, Sweden @@
## Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 - NCT ID: NCT06262399 - Study ID: ITL-2002-CL-999 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2040-04 - Lead Sponsor: Intellia Therapeutics ### Study Description This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy. ### Conditions - Hereditary Angioedema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol Secondary Outcomes - To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects - Change from baseline in consumption of on-demand HAE medications for reported HAE attacks - Change from baseline in healthcare utilization for HAE attacks - Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument. - Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument. - Change from baseline in QoL parameters as measured by the WPAI:GH instrument. ### Location - Facility: Centre National de Reference - Grenoble, Grenoble, N/A, N/A, France @@
## Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial - NCT ID: NCT06262386 - Study ID: 202202172B0 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2028-07-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases. ### Conditions - Lung Cancer - Relapse/Recurrence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Cisplatin based chemottherapy ### Outcomes Primary Outcomes - Accuracy of proposed relapse prediction model - early relapse rate Secondary Outcomes - Overall surveival ### Location - Facility: Ching-Yang Wu, Taoyuan City, N/A, 333, Taiwan @@
## Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes - NCT ID: NCT06262373 - Study ID: 221321 - Status: COMPLETED - Start Date: 2017-10-01 - Completion Date: 2019-10-01 - Lead Sponsor: King's College Hospital NHS Trust ### Study Description The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery. ### Conditions - Miscarriage in First Trimester ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Primary Secondary Outcomes - Secondary - Secondary ### Location - Facility: King's College Hospital, London, N/A, SE5 9RS, United Kingdom @@
## Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia - NCT ID: NCT06262360 - Study ID: P2023457 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-09-30 - Lead Sponsor: Queen Fabiola Children's University Hospital ### Study Description The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).Patients will be allocated to three different group in a ration of 1:1:1.* Group 1: spontaneous mask ventilation (20 patients).* Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).* Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).* Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).Electrical impedance tomography measurements:The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.The EIT measurements will be taken of 4 different moments:T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.T4: Before the discharge of the PACU. ### Conditions - Anesthesia, Pediatric ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - General anesthesia with mask ventilation - General anesthesia and spontaneous laryngeal mask ventilation - General anesthesia with spontaneous laryngeal mask ventilation with pressure support ### Outcomes Primary Outcomes - Variation of poorly ventilated pulmonary zones Secondary Outcomes ### Location - Facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola, Brussels, N/A, 1020, Belgium @@
## Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD - NCT ID: NCT06262347 - Study ID: 2024-0115 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-20 - Lead Sponsor: T. John Winhusen, PhD ### Study Description The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons. ### Conditions - Opioid Use Disorder - Pregnancy Related - Substance Use - Drug Abuse - Drug Abuse in Pregnancy - Drug Addiction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) - Control ### Outcomes Primary Outcomes - Medication for Opioid Use Disorder (MOUD) knowledge score - Opioid Overdose knowledge score Secondary Outcomes - Medication for Opioid Use Disorder (MOUD) Internalized Stigma - Drug Self-efficacy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men - NCT ID: NCT06262334 - Study ID: Pro00133917 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-06-15 - Lead Sponsor: University of South Carolina ### Study Description The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. ### Conditions - Health Related Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - The Fade to Fitness Program ### Outcomes Primary Outcomes - Number of men who are eligible/eligible. - Length of time needed to enroll 15 men - Facilitator-assessed attendance in intervention - Number of men who express interest in the study - Attrition in intervention - Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention Secondary Outcomes - Change in weight - Change in body mass index - Change in moderate-to-vigorous physical activity - Global Health - Mental 2a - Global Health - Physical 2a - Perceived Stress Scale - Emotional Distress - Depression - Short Form 4a - Healthy Eating Subscale of the Health Promotion Lifestyle Profile II - Instrumental Support- Short Form 4a - Informational Support - Short Form 4a - Emotional Support - Short Form 4a - Companionship - Short Form 4a - Motivation and Attitudes Towards Changing Health (MATCH) - NIH Self-Efficacy Measure - Subjective Social Norms of Health Behavior - Valuing Questionnaire - Diet ### Location - Facility: University of South Carolina, Columbia, South Carolina, 29208, United States @@
## Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax - NCT ID: NCT06262321 - Study ID: URLUN23099 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-02-01 - Lead Sponsor: University of Rochester ### Study Description Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy. ### Conditions - Stage 4 NSCLC - Radiotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Prophylactic Palliative Radiotherapy ### Outcomes Primary Outcomes - Freedom from symptomatic progression of irradiated thoracic target(s) Secondary Outcomes - OS (Kaplan-Meier) (Kaplan-Meier) - Freedom from local recurrence of irradiated thoracic target lesion(s) - PFS (freedom from local and distant progression; Kaplan-Meier) - Duration of time that patient is maintenance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Emotional Support for Women Experiencing PPROM - NCT ID: NCT06262308 - Study ID: 334235 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: King's College London ### Study Description Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women. ### Conditions - Fetal Membranes, Premature Rupture - Preterm Birth Complication ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Psychological intervention along Cognitive Behavioural Therapy principles ### Outcomes Primary Outcomes - Mood Score 1 - Mood Score 2 - Participant Feedback Secondary Outcomes ### Location - Facility: St Thomas' Hospital, King's College London, London, Greater London, SE1 7EH, United Kingdom @@
## National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS) - NCT ID: NCT06262295 - Study ID: 2023-A02475-40 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2027-09 - Lead Sponsor: French Cardiology Society ### Study Description Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use. ### Conditions - Pacemaker ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To confirm the safety of the AVEIR VR LP device - To confirm the effectiveness of the AVEIR VR LP device - To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP device Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria - NCT ID: NCT06262282 - Study ID: NTM-OB-17 (PART C) - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-05 - Completion Date: 2028-12 - Lead Sponsor: National Jewish Health ### Study Description About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year. ### Conditions - Cystic Fibrosis - Nontuberculous Mycobacterial Lung Disease - Nontuberculous Mycobacterium Infection - Mycobacterium Infections - Mycobacterium; Pulmonary ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - mycobacteriophage ### Outcomes Primary Outcomes - Adherence to therapy Secondary Outcomes - Phage susceptibility - Culture conversion - Tolerance of treatment - Clinical Response (pulmonary function testing) - Microbiologic response to phage - Clinical response (BMI) - Clinical response (CFQR) - Clinical Response (antibiotic courses for non- NTM exacerbations) ### Location - Facility: University of Alabama, Birmingham, Alabama, 35233, United States @@
## Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents - NCT ID: NCT06262269 - Study ID: Sportscol - Status: RECRUITING - Start Date: 2022-09-21 - Completion Date: 2025-12 - Lead Sponsor: Association des Paralysees de France (APF) ### Study Description This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows:* Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS.* A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis. ### Conditions - Adolescent Idiopathic Scoliosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Home-based adapted physical activity program supervised by an APA teacher via individual video conference. - First period of the home-based adapted physical activity program with an exercise booklet. - Second period of the home-based adapted physical activity program with an exercise booklet. ### Outcomes Primary Outcomes - Evaluation to overall physical performance on an ergometer-rowing machine Secondary Outcomes - Evaluation of overall physical performance on an ergometer-rowing machine - Evaluation of perivertebral muscle performance (Plank) - Evaluation of perivertebral muscle performance (Rowing) - Indirect assessment of VO2 max - The Ratings Perceveid Exertion for Children during exercise (RPE-C) - Assessment of motivation to change - Evaluation of attendance at adapted physical activity sessions - Anthropometric evaluation (Height) - Anthropometric evaluation (weight) - Anthropometric evaluation (BMI) - Anthropometric evaluation by bioimpedance measurement - Analysis of the static vertical posture on a force platform SATEL® - Evaluation of the EOS radiograph of the total spine in front (Type) - Evaluation of the EOS radiograph of the total spine in front and in profile (Angle) - Evaluation of the EOS radiograph of the total spine in front (Frontal deviation) - Evaluation of the EOS radiograph of the total spine in front (Risser) - Photogrammetric morphostatic evaluation by surface topography - Measurement of the main gibbosity - Assessment of quality of life by the Scoliosis Research Society (SRS) scale : SRS-18 - Satisfaction questionnaires ### Location - Facility: SSR Marc Sautelet, Villeneuve-d'Ascq, N/A, 59650, France @@
## Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients - NCT ID: NCT06262256 - Study ID: HIIT-GLS-METS - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-12-22 - Lead Sponsor: University of Castilla-La Mancha ### Study Description the effects of high-intensity interval training on myocardial function will be studied in a group of patients under medical treatment for the components of metabolic syndrome. ### Conditions - High-Intensity Interval Training - Metabolic Syndrome - Myocardial Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-intensity interval training ### Outcomes Primary Outcomes - Changes in global longitudinal strain Secondary Outcomes - changes in cardiorespiratory fitness - changes in metabolic syndrome z-score - changes in visceral fat - changes in left ventricle passive filling (E wave) - changes in early diastolic mitral annulus velocity (e' wave) - changes in estimated left ventricle filling pressures (E/e') ### Location - Facility: University of Castilla-La Mancha, Toledo, Castilla-La Mancha, 45071, Spain @@
## The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum - NCT ID: NCT06262243 - Study ID: ORDUU-HEM-TÇ-01 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-09-01 - Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ ### Study Description It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success. ### Conditions - Cesarean Section ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - electric blankets ### Outcomes Primary Outcomes - Postpartum comfort scale - A Tool to Evaluate the Amount of Breast Milk the Baby Receives Secondary Outcomes - Bristol Breastfeeding Assessment Tool - Insufficient Milk Perception Scale ### Location - Facility: Samsun Training and Research Hospital, Samsun, İ̇lkadim, 55080, Turkey @@
## Feasibility and Effectiveness of OPCI on ASD Children - NCT ID: NCT06262230 - Study ID: OPCI on ASD Children - Status: COMPLETED - Start Date: 2022-11-20 - Completion Date: 2023-10-31 - Lead Sponsor: Peking University ### Study Description The goal of this interventional study was to explore the feasibility and effectiveness of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are:1. What is the acceptability and adherence of OPCI;2. Whether OPCI is effective on the social abilities and mental health of ASD children;3. What impact does OPCI have on ordinary children and parents of both children? ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Online Inclusive Companionship Intervention ### Outcomes Primary Outcomes - Social Behavior of ASD Children - Mental Health of ASD Children - Intervention Process Screen Recording Coding - Symptom Severity Secondary Outcomes - Mental Health of Ordinary Children - Social Ability of Ordinary Children - Mental Health of Parents ### Location - Facility: Peking University, Beijing, Beijing, 100871, China @@
## Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke - NCT ID: NCT06262217 - Study ID: INGN21ST510 - Status: RECRUITING - Start Date: 2023-11-11 - Completion Date: 2024-08-01 - Lead Sponsor: NHS Greater Glasgow and Clyde ### Study Description This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered. ### Conditions - Stroke, Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mobile MRI scanner ### Outcomes Primary Outcomes - Diagnostic sensitivity and specificity of mobile MRI scanner Secondary Outcomes - Comparison of MRI abnormalities - Final Clinical Diagnosis - Final Clinical Diagnosis - Time from arrival at the Emergency Department to scan - Use of treatments - Patient Outcomes - Level of confidence in final diagnosis ### Location - Facility: Queen Elizabeth University Hospital, Glasgow, N/A, N/A, United Kingdom @@
## Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw). - NCT ID: NCT06262204 - Study ID: Hallux Shark Screw(R) - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-02-28 - Lead Sponsor: Orthopedic Hospital Vienna Speising ### Study Description The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.The main questions it aims to answer are:Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized. ### Conditions - Hallux Valgus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hallux Valgus Treatment with Shark Screw® - Hallux Valgus Treatment with metal screw ### Outcomes Primary Outcomes - clinical result of Hallux Valgus treatment Secondary Outcomes - radiological (bony union)result of Hallux Valgus treatment - change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS) - Hallux-Valgus angle (HVA) change - gait analysis - Intermetatarsal angle (IMA) change ### Location - Facility: Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising, Vienna, N/A, 1130, Austria @@
## Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy - NCT ID: NCT06262191 - Study ID: 2137249 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: Northern Arizona University ### Study Description This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Differential and adjustable stiffness AFO (DAS-AFO) ### Outcomes Primary Outcomes - Muscle activity - Metabolic cost of transport Secondary Outcomes - Pictorial Children's Effort Rating Table (PCERT) - System Usability Score (SUS) questionnaire ### Location - Facility: Northern Arizona University, Flagstaff, Arizona, 86011, United States @@
## Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children - NCT ID: NCT06262178 - Study ID: 23-1393 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: New York University ### Study Description The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy). ### Conditions - PTSD - Depression - Parent-Child Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Parenting-STAIR - Treatment as Usual ### Outcomes Primary Outcomes - Post-traumatic stress disorder (PTSD) Checklist 5 - Patient Health Questionnaire-9 (PHQ-9) - Parenting Sense of Competence Scale (PSOC) Secondary Outcomes - Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Diagnosis - Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Symptom Severity - Structured Clinical Interview for DSM 5 (SCID) - Parenting Stress Index 4-Short Form (PSI4-SF) - Difficulties in Emotion Regulation Scale (DERS) - Brief Cope - Dyadic Parent-Child Interaction Coding System-IV (DPICS) - Treatment Acceptability and Expectations (TAE) - Strengths and Difficulties Questionnaire (SDQ) - Eyberg Child Behavior Inventory (ECBI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis - NCT ID: NCT06262165 - Study ID: RC23_0497 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2032-12-15 - Lead Sponsor: Nantes University Hospital ### Study Description The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis. ### Conditions - Anorexia Nervosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients with Anorexia Nervosa ### Outcomes Primary Outcomes - Identification of new blood biomarkers and hepatic cytolysis Secondary Outcomes ### Location - Facility: Nantes University Hospital, Nantes, Loire-Atlantique, 44093, France @@
## Sleep Profile of Patients With Septo-optic Dysplasia - NCT ID: NCT06262152 - Study ID: 49187/2023 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2025-05-20 - Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation ### Study Description The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies.Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days. ### Conditions - Septo-Optic Dysplasia - Agenesis of Corpus Callosum - Blindness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Actigraphy, blood and salivary sample, and sleep evaluation ### Outcomes Primary Outcomes - Sleep profile ( Sleep quality, sleep efficiency) of patients with SOD Secondary Outcomes - melatonin profile of patients with SOD - Sleep EEG description of patients with SOD ### Location - Facility: IRCCS Casimiro Mondino Foundation, Pavia, PV, 27100, Italy @@
## Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients - NCT ID: NCT06262139 - Study ID: MT218-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-09 - Lead Sponsor: Molecular Theranostics LLC ### Study Description This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy. ### Conditions - MRI Scan ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - MT218 injection ### Outcomes Primary Outcomes - Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT Secondary Outcomes ### Location - Facility: Emory University, Atlanta, Georgia, 30322, United States @@
## Virtual Reality for Non-cardiac Chest Pain - NCT ID: NCT06262126 - Study ID: 23-012673 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2025-01 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP). ### Conditions - Gastrointestinal Diseases - Chest Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality ### Outcomes Primary Outcomes - Measure changes in GERD symptoms using the GERDQ questionnare - Measure changes in GERD quality of life using the GERD-HRQL questionnaire - Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire - Measure changes in GI symptom severity using the PAGI-SYM questionnaire - Measure changes in GI related patient assessment of quality of life using PAGI-QOL Secondary Outcomes - Measure changes in anxiety and depression using the HADs scale - Measure changes in resilience using the brief resilience scale ### Location - Facility: Mayo Clinic Florida, Jacksonville, Florida, 32224, United States @@
## A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1 - NCT ID: NCT06262113 - Study ID: 2024P000392 - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2026-08 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study. ### Conditions - Neurofibromatosis 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Letters about NF1 Care (Content Type 1) - Letters about NF1 Care (Content Type 2) ### Outcomes Primary Outcomes - Receipt of Recommended NF1 Health Screenings Secondary Outcomes - Patient Activation Measure® - Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Rating of the Visit - Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): How Well Providers Communicate With Patients Subscale - Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Providers' Use of Information to Coordinate Patient Care Subscale ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye - NCT ID: NCT06262100 - Study ID: EYL_23_01 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-12-15 - Lead Sponsor: Marinomed Biotech AG ### Study Description Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed. ### Conditions - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Carragelose ### Outcomes Primary Outcomes - Change in dry eye symptoms Secondary Outcomes - Responder analysis ### Location - Facility: IOBA,Ocular Surface Research Group, University of Valladolid, Valladolid, N/A, 47011, Spain @@
## The Combined FIFA 11+ and Change of Direction Training - NCT ID: NCT06262087 - Study ID: MU-CIRB 2023/044.2203 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12 - Lead Sponsor: Mahidol University ### Study Description The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+. ### Conditions - Rehabilitation - Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Change of direction training - FIFA 11+ program ### Outcomes Primary Outcomes - Peak knee valgus angle Secondary Outcomes ### Location - Facility: FFC league in Cambodia, Phnom Penh, N/A, N/A, Cambodia @@
## Effect of Structured Training Program in Diabetic Patients - NCT ID: NCT06262074 - Study ID: IEC-2418 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2024-03-31 - Lead Sponsor: Maharishi Markendeswar University (Deemed to be University) ### Study Description Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals. ### Conditions - Diabetic Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Structured Exercise Program - Non structured exercise program ### Outcomes Primary Outcomes - Michigan neuropathy screening instrument (MNSI) - Biothesiometer - NeuroQoL Secondary Outcomes - NPRS ### Location - Facility: MMIPR, Ambala, Haryana, 133207, India @@
## Propranolol for the Treatment of Traumatic Brain Injury - NCT ID: NCT06262061 - Study ID: PRO-TBI-FS - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09 - Lead Sponsor: London Health Sciences Centre ### Study Description Traumatic brain injury (TBI) is a leading cause of global disease and directly affects over 1.5 million Canadians, with 165 000 TBIs occurring yearly in Canada. Despite the burden of TBIs, there are limited treatment options available and current treatments generally focus on supportive care. The aim of TBI treatment is reduce inflammation and damage occurring after the TBI (secondary injury).Beta- blockers (BBs) are medications commonly used to block the actions of endogenous catecholamines- hormones that are thought to contribute to secondary injury within brain tissue. This reduces metabolic demand in the vulnerable, injured brain. BBs have been studied in several retrospective trials and one single-center, non- blinded randomized controlled study. These results point towards a benefit to the use of BBs in TBI but need to be confirmed in a rigorous manner before they are widely adopted.The current study aims to assess the feasibility of a single centre randomized controlled trial of BBs versus placebo to treat moderate to severe TBI. This feasibility trial will inform the planning of a large multi-center study powered to detect a difference in cognitive outcomes and mortality. It also will allow the investigators to gather biologic samples for measuring serum catecholamines and inflammatory mediators to better understand the basic science mechanisms of BBs in this patient population; and to assess the feasibility of using the Cambridge Battery to assess cognitive outcomes of trial participants. ### Conditions - TBI (Traumatic Brain Injury) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Propranolol - Placebo ### Outcomes Primary Outcomes - Hospital Mortality - Cognitive function Secondary Outcomes - Catecholamines/Inflammatory markers ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial - NCT ID: NCT06262048 - Study ID: PrePOURTS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-31 - Lead Sponsor: Lawson Health Research Institute ### Study Description The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing pulmonary surgery. ### Conditions - Urinary Retention Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tamsulosin Hydrochloride - Placebo ### Outcomes Primary Outcomes - Rate of post operative urinary retention Secondary Outcomes - Rate of Straight Catheterizations - Rate of Indwelling Catheterizations - Time to first catheterization - Treatment Related Adverse Events - Catheter related complications - Length of stay ### Location - Facility: London Health Sciences Centre, London, Ontario, N6A 5W9, Canada @@
## Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases - NCT ID: NCT06262035 - Study ID: 2023-02987-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2030-12-31 - Lead Sponsor: Karolinska Institutet ### Study Description 1. To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.2. To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated. ### Conditions - Peri-implantitis - Periodontitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Periodontitis and Peri-implantitis ### Outcomes Primary Outcomes - Protein levels in peri-implantitis and periodontitis - Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method. - Gene expression profile in peri-implantitis and periodontitis. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Cold Application on Pain Level, Edema and Drainage Amount - NCT ID: NCT06262022 - Study ID: KaramanogluMehmetbeyUFGok - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-04-30 - Lead Sponsor: Karamanoğlu Mehmetbey University ### Study Description In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question\[s\]it aims to answer are:* Is there a difference between the pain levels of patients in the control and cold application arms?* Is there a difference between the knee edema of patients in the control and cold application arms?* Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT). ### Conditions - Cold Therapy - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - cold therapy ### Outcomes Primary Outcomes - pain level Secondary Outcomes - edema - amount of drainage ### Location - Facility: Karamanoğlu Mehmet bey Üniversitesi, Merkez, Karaman, 70100, Turkey @@
## Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment - NCT ID: NCT06262009 - Study ID: APHP220101 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO ### Conditions - Antibiotic Resistant Strain - Transmission, Close-Contact ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - human faecal collection - ancillary study ### Outcomes Primary Outcomes - generation of a list of priorities for future prevention and control strategies to mitigate antimicrobial resistance (AMR) transmission between companion animals and humans Secondary Outcomes - Rates of AMR acquisitions in one or several housekeepers - A list in nature of changes in dog microbiota - A list in magnitude of changes in dog microbiota - A list in nature of changes in housekeepers microbiota - A list in magnitude of changes in housekeepers microbiota - explore unknown parameters of AMR colonization in dogs under various antibiotic exposures - the generation of a list of sociological factors and potential at-risk practices relevant in the transmission of AMR from dogs to housekeepers ### Location - Facility: the National Veterinary School Alfort, Maisons-Alfort, N/A, 94700, France @@
## Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation. - NCT ID: NCT06261996 - Study ID: henanFSH - Status: NOT_YET_RECRUITING - Start Date: 2024-02-12 - Completion Date: 2025-01-15 - Lead Sponsor: Henan Provincial People's Hospital ### Study Description The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation. ### Conditions - Invasive Mechanical Ventilation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fospropofol ### Outcomes Primary Outcomes - The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions Secondary Outcomes - Incidence of adverse reactions during the follow-up period - Extubation time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma. - NCT ID: NCT06261983 - Study ID: 2019111032 - Status: RECRUITING - Start Date: 2018-10-01 - Completion Date: 2024-12-31 - Lead Sponsor: Hospital Donostia ### Study Description Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique. ### Conditions - Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sentinel node biopsy guided by magnetic probe ### Outcomes Primary Outcomes - The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV). Secondary Outcomes ### Location - Facility: Josué Hernando Vázquez, Donostia, Guipuzkoa, 20011, Spain @@
## Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: The Connect Project - NCT ID: NCT06261970 - Study ID: 999002684 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-22 - Completion Date: 2025-12 - Lead Sponsor: George Washington University ### Study Description While a growing body of programs have shown promise to increase use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing postpartum Family Planning (PPFP) adoption among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial. ### Conditions - Contraceptive Usage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Connect ### Outcomes Primary Outcomes - Adoption of of Postpartum Family Planning (PPFP): - Currently Using PPFP Secondary Outcomes - Adopted or Intention to adopt PPFP - Average Satisfaction with PPFP methods - Contraceptive Preferences - Quality of Family Planning Counseling - Communication and Agency - PPFP Attitudes - PPFP Knowledge ### Location - Facility: EDI, Bahi, Dodoma, N/A, Tanzania @@
## A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants 12 Years of Age and Older With Asthma - NCT ID: NCT06261957 - Study ID: 220735 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-04-25 - Lead Sponsor: GlaxoSmithKline ### Study Description The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged 12 years and above with asthma. ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Salbutamol HFA-134a - Salbutamol HFA-152a ### Outcomes Primary Outcomes - Number of participants with Adverse Events (AEs) Secondary Outcomes - Number of participants with Serious Adverse Events (SAEs) - Absolute Values of Minimum serum potassium (milliequivalents per litre (mEq/L) - Absolute values of serum potassium (milligrams per decilitre) - Change from baseline in serum potassium (milligrams per decilitre) - Absolute value of haematology parameter: Platelet count (cells per microliter) - Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) - Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) - Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) - Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes) - Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) - Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre) - Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood) - Absolute values of Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre) - Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alanine aminotransferase,Creatine phosphokinase (International Units per litre) - Absolute value of routine urinalysis: potential of hydrogen (pH) - Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase - Change from baseline in haematology parameter: Platelet count (cells per microliter) - Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) - Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) - Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) - Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes) - Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) - Change from baseline in haematology parameters: haemoglobin (Hgb) (grams per decilitre) - Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood) - Change from baseline in Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre) - Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alanine aminotransferase,Creatine phosphokinase (International Units per litre) - Change from baseline in routine urinalysis: pH - Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg) - Absolute values for vital signs: pulse rate [beats per min (bpm) - Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg) - Change from baseline in vital signs: pulse rate [beats per min (bpm) - Absolute values for 12 Lead ECGs in QTc (milliseconds) - Absolute values for heart rate [beats per min (bpm) - Change from baseline for 12 Lead ECGs in QTc (milliseconds) - Change from baseline for heart rate [beats per min (bpm) ### Location - Facility: GSK Investigational Site, Aventura, Florida, 33180, United States @@
## A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package - NCT ID: NCT06261944 - Study ID: NIRDM-SXCIP03 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-08-08 - Lead Sponsor: Glyconics Ltd ### Study Description The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology. ### Conditions - Pre-diabetes - Undiagnosed Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Near-infrared (NIR) ### Outcomes Primary Outcomes - Dichotomised diabetes risk status Secondary Outcomes - Sensitivity and specificity ### Location - Facility: Sant Pau Hospital, Barcelona, N/A, N/A, Spain @@
## Severity Over Time of Early Forms of Spondyloarthritis - NCT ID: NCT06261931 - Study ID: 6313 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-12 - Completion Date: 2044-02-28 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission. ### Conditions - Spondyloarthritis - Spondyloarthritis, Axial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic assessment - Diagnostic assessment ### Outcomes Primary Outcomes - spondyloarthritis severity Secondary Outcomes ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome - NCT ID: NCT06261918 - Study ID: 6269 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-07-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells. ### Conditions - Breast Cancer - Metabolic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Influence of metabolic syndrome on the achievement of pathological complete response ### Outcomes Primary Outcomes - Acheivement of pathological complete response Secondary Outcomes - Event-free survival (EFS) ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS, Roma, N/A, N/A, Italy @@
## Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System - NCT ID: NCT06261905 - Study ID: 2000036908 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-06 - Lead Sponsor: Yale University ### Study Description The research team is investigating Opioid Use Disorder (OUD), a disorder characterized by dysregulated dopaminergic tone, to evaluate the mechanisms of adjunctive treatment with calcitriol. The investigators will recruit 12 subjects with OUD and 12 healthy subjects to participate in a double-blind, randomized study design where subjects will complete up to 2 Positron Emission Tomography (PET) scans using \[11C\]-PHNO. The investigators will compare subjects in differences between their own study days and in differences between healthy control subjects and subjects with OUD. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - [11C]-PHNO - Calcitriol - Placebo Control - PET Scan ### Outcomes Primary Outcomes - Non-displaceable Tracer Binding Potentials (BPND) - Non-displaceable Tracer Binding Potentials (BPND) Secondary Outcomes - Spontaneous Blink Rate (SBR) - Continuous Performance Task - Identical Pairs (CPT-IP) - Probabilistic Reversal Learning Task (PRLT) ### Location - Facility: Yale School of Medicine, New Haven, Connecticut, 06510, United States @@
## Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine - NCT ID: NCT06261892 - Study ID: 2023-002 - Status: RECRUITING - Start Date: 2023-07-20 - Completion Date: 2025-06 - Lead Sponsor: WomenX Biotech Limited ### Study Description The goal of this clinical trial is1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.2. If HPV DNA is not a promising biomarker, other biomarkers will be explored.3. To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.The main question it aims to answer is:To validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancerParticipants will1. Join the briefing session of the study2. Sign the consent form and health questionnaire3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test4. Collect the urine sampleIf there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer ### Conditions - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Collect HPV DNA from urine ### Outcomes Primary Outcomes - HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer Secondary Outcomes ### Location - Facility: WomenX Biotech Limited, Hong Kong, N/A, N/A, Hong Kong @@
## Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood - NCT ID: NCT06261879 - Study ID: 2023-001 - Status: RECRUITING - Start Date: 2023-07-20 - Completion Date: 2025-06 - Lead Sponsor: WomenX Biotech Limited ### Study Description The goal of this clinical trial is1. To test the sensitivity and specificity of using ACTN4 from menstrual blood for the detection of pre-cervical or/and cervical cancer.2. If ACTN4 is not a promising biomarker, other biomarkers will be explored.3. To develop an effective and non-invasive detection method for pre-cervical or/and cervical cancer.in Women with menstruation.The main question it aims to answer is:To validate whether menstrual blood could be used as a non-invasive means for the detection of pre-cervical or cervical cancerParticipants will1. Join the briefing session of the study2. Sign the consent form and health questionnaire3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test4. Collect the menstrual blood sampleIf there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if ACTN4 from menstrual blood is a promising biomarker for the detection of pre-cervical or cervical cancer ### Conditions - Cervical Cancer - CIN ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Special sanitary pad ### Outcomes Primary Outcomes - ACTN4 is a promising biomarkers for the detection of pre-cervical/ cervical cancer Secondary Outcomes ### Location - Facility: WomenX Biotech Limited, Hong Kong, N/A, N/A, Hong Kong @@
## Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome - NCT ID: NCT06261866 - Study ID: MultiInter-CCS - Status: RECRUITING - Start Date: 2011-04-07 - Completion Date: 2028-12-31 - Lead Sponsor: Medical University of Warsaw ### Study Description The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis. ### Conditions - Chronic Coronary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis - Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis Secondary Outcomes - Major adverse cardiovascular events ### Location - Facility: Medical University of Warsaw, Warsaw, N/A, N/A, Poland @@
## The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery - NCT ID: NCT06261853 - Study ID: 2-081-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-05 - Lead Sponsor: University of Aberdeen ### Study Description The investigators aim to investigate if the additional information available from a 3D scan of the wisdom tooth can reduce the risk of nerve injury during wisdom tooth surgery compared to conventional 2D images.Wisdom tooth surgery is a common surgical procedures that a significant proportion of the population will undergo. As with any other surgical procedure, there are potential complications, of which, injury to the nerve supplying feeling to the lip, chin, and tongue is the most significant. This can lead to persistent pain, tingling, or numbness that may impact a patient's ability to eat and function.The risk of nerve injury during wisdom tooth surgery is assessed using X-ray images, which show the position of the nerve and tooth in the jawbone. 2D and 3D scans are used, which have their own advantages and disadvantages such as reduced cost and radiation dose with 2D or more information from 3D images, but it remains unclear which is better at reducing the risk of nerve injuries. ### Conditions - Inferior Alveolar Nerve Injuries - Impacted Third Molar Tooth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 3D-CBCT - 2D-OPG ### Outcomes Primary Outcomes - The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery Secondary Outcomes - Surgical time - Planned surgical approach - Intraoperative complications - Postoperative Complications - Wisdom tooth impaction classification ### Location - Facility: King'S College Hospital Nhs Foundation Trust, London, England, SE5 9RS, United Kingdom @@
## Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole - NCT ID: NCT06261840 - Study ID: 2024-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2029-07-31 - Lead Sponsor: Tulane University ### Study Description This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men. ### Conditions - Trichomonas Vaginitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metronidazole 500 mg - Secnidazole 2000 MG ### Outcomes Primary Outcomes - Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB - NCT ID: NCT06261827 - Study ID: RECORD - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-04-01 - Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences ### Study Description The primary aim of this single-center, prospective, randomized, controlled, study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery under CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB. ### Conditions - Nosocomial Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sham treatment - 200-ppm NO ### Outcomes Primary Outcomes - Incidence of nosocomial pneumonia (percent) Secondary Outcomes - Total leukocyte counts (109/L) - Immature cell counts (percentage) - C-reactive protein (CRP) level (mg/L) - PCT (procalcitonin) test (ng/mL) - Presepsin levels (pg/mL) - Ferritin levels (ng/mL) - LDH (lactate dehydrogenase) levels (IU/L) - Interleukin-6 (IL-6) levels (pg/mL) - Interleukin-8 (IL-8) levels (pg/mL) - Surfactant protein SP-D plasma levels (ng/mL) - sRAGE levels (pg/mL) - endothelin-1 levels (pg/mL) - Asymmetric dimethylarginine (ADMA) levels (ng/mL) - Vascular endothelial growth factor A (VEGF-A) levels (pg/mL) - Angiopoietin-1 levels (ng/mL) - Angiopoietin-2 levels (ng/mL) - S/F index (ratio) - Incidence of adverse lung ultrasound findings (percentage) - Six-minute walk test (6MWT) distance (meters) - Lung vital capacity (L) - Forced vital capacity (L) - Forced expiratory volume (L/s) - Peak expiratory flow (L/s) - VE-minute ventilation (L/min) - VT-tidal volume (L) - VE/VO2 - ventilatory equivalents for oxygen (ratio) - VE/VСO2 - ventilatory equivalent for carbon dioxide - PetO2 - partial pressure of oxygen in exhaled air (mm Hg) - PetCO2 - partial pressure of carbon dioxide in exhaled air (mmHg) - Exhaled NO levels (ppm) - Systolic blood pressure (SBP) levels (mmHg) - Diastolic blood pressure (DBP) levels (mmHg) - Heart rate (HR) (bpm) - Respiratory rate (RR) (brpm) - Saturation of peripheral oxygen (SpO2) levels (percentage) ### Location - Facility*: Cardiology Research Institute Tomsk national Research Medical Center, Tomsk, N/A, N/A, Russian Federation @@
## Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors - NCT ID: NCT06261814 - Study ID: iRISID-2023-2142 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2028-01-01 - Lead Sponsor: john eisenbrey ### Study Description This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods. ### Conditions - Liver Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Sulfur Hexafluoride Lipid Microspheres - Contrast-Enhanced Ultrasound - Transarterial Chemoembolization - Medical Chart Review ### Outcomes Primary Outcomes - Recurrence - Specificity - Positive predictive value - Negative predictive value - False discovery rate Secondary Outcomes - Residual tumor vacularity - Diagnostic performance for each imaging mode - Ability of the model to predict binary treatment response ### Location - Facility: Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States @@
## Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol - NCT ID: NCT06261801 - Study ID: GZY-ZJ-KJ-23088 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2025-12-20 - Lead Sponsor: The Third People's Hospital of Hangzhou ### Study Description Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin. ### Conditions - Trigeminal Herpetic Neuralgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Medication Group - EA Group - EA+Medication Group ### Outcomes Primary Outcomes - Visual Analog Score change Secondary Outcomes - McGill Pain Questionnaire Short Form (SF-MPQ) - Brief Pain Inventory Scale (BPI-SF) - Medical Outcomes Study Sleep Scale (MOS-SS) - Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA) - Hamilton Depression Rating Scale (HAMD) - Short Form 36 Health Survey (SF-36) ### Location - Facility: The Hangzhou Third People's Hospital, Hangzhou, Zhejiang, 310009, China @@
## Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter - NCT ID: NCT06261788 - Study ID: EASY II Trial - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-09-26 - Lead Sponsor: Swift Sync, Inc. ### Study Description This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support. ### Conditions - Heart Block - Valve Heart Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Temporary pacing ### Outcomes Primary Outcomes - With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure) - Procedure related complications Secondary Outcomes ### Location - Facility: Centro de Intervenciones Endovasculares y Cirugia Cardiovascular, Asunción, N/A, N/A, Paraguay @@
## Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline - NCT ID: NCT06261775 - Study ID: IRB-2401011-EXM - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-30 - Completion Date: 2026-01-02 - Lead Sponsor: South Dakota State University ### Study Description Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a dietary guideline-based diet will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same. ### Conditions - Healthy Lifestyle ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Red meat-based meal - Lacto-ovo-vegetarian meal ### Outcomes Primary Outcomes - Concentration of phosphatidylcholine in blood Secondary Outcomes ### Location - Facility: South Dakota State University, Wagner Hall 416, Brookings, South Dakota, 57007, United States @@
## Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone - NCT ID: NCT06261762 - Study ID: SDC-24-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2026-06-30 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:* Is significant alveolar ridge resorption observed at center sites after consecutive extractions* Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption* Is a thick or thin wall phenotype associated with the amount of bone resorption* Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone* Is the interdental papilla height significantly affected after extractions.Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks. ### Conditions - Wound Heal ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Bone level change from baseline - Soft tissue change from baseline Secondary Outcomes - Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Analysis of Scapular Musculature Activation During Targeted Abdominal Contraction With Scapular Stabilization Exercises - NCT ID: NCT06261749 - Study ID: EmgSCAPULA - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-08 - Lead Sponsor: Hacettepe University ### Study Description Muscle activation of the upper trapezius, lower trapezius and serratus anterior muscles will be measured during prone scapular retraction exercises. Then the same exercises will be performed with abdominal contraction using a stabilizer and muscle activity of the same muscles will be measured. A comparison will be made between the two conditions. ### Conditions - Scapula; Increased ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Voluntary Abdominal Contractions - Exercise ### Outcomes Primary Outcomes - Electromyography Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, N/A, 06100, Turkey @@
## The Effectiveness of Prophylactic Antibiotics for Urethral Bulking - NCT ID: NCT06261736 - Study ID: 2107044-1 - Status: RECRUITING - Start Date: 2023-10-24 - Completion Date: 2025-05 - Lead Sponsor: Atlantic Health System ### Study Description The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections. ### Conditions - Stress Urinary Incontinence - Postoperative Urinary Tract Infection - Urethral Bulking ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Prophylactic antibiotics - No antibiotics ### Outcomes Primary Outcomes - Rate of urinary tract infection (UTI) Secondary Outcomes - Rate of postoperative urinary retention - Rates of other postoperative complications ### Location - Facility: Atlantic Health, Morristown, New Jersey, 07960, United States @@
## Effect of Non-chirurgical Periodontal Treatment on the Immune System From a Gender Perspective - NCT ID: NCT06261723 - Study ID: PI22/1009 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-12-31 - Lead Sponsor: Milagros Rocha Barajas ### Study Description The goal of this observational study is to evaluate non-surgical periodontal treatment in women and men with periodontitis with and without obesity. The main questions it aims to answer are:* If non-surgical periodontal treatment of patients with chronic periodontitis can modulate the innate and adaptive immune response taking into account patient gender and the coexistence of obesity* If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets.Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences. ### Conditions - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - non-chirurgical periodontal treatment ### Outcomes Primary Outcomes - Changes in inflammasome complex activation grade in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment. - Changes in endothelial function in the study population. - Changes in endothelial function at molecular level in the study population. - Changes in the systemic inflammation status in the study population. - Changes in the expression of genes related to inflammatory pathways in PBMC in the study population. - Changes in the expression of genes related to oxidative stress levels in PBMC in the study population. - Changes in the expression of genes related to cellular respiration in PBMC in the study population. - Sequence miRNAs in biological fluids in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment. - Evaluate the distribution and phenotype of different T lymphocyte and monocyte subpopulations in the study population. Secondary Outcomes - Changes in the protein expression of autophagy markers in PBMC in the study population. - Evaluate autophagy flux in the study population. - Evaluate autophagosome formation in the study population. ### Location - Facility: University Hospital Dr Peset, Valencia, N/A, 46017, Spain @@
## Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations - NCT ID: NCT06261710 - Study ID: EA2_253_23 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2030-02-01 - Lead Sponsor: Larry Hinkson ### Study Description This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes. ### Conditions - Labor Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sonography in labour ### Outcomes Primary Outcomes - Maternal Fever Incidence - Maternal Tachycardia Incidence - Maternal Leucocytosis - Uterine tenderness - Fetal Tachycardia - Foul-smelling amniotic fluid Secondary Outcomes - Average age - Maternal weight - Maternal height - Completed weeks of pregnancy - Previous pregnancy - Incidence of Vaginal Examinations - Incidence of Caesarean section - Incidence of Instrumental Delivery - Incidence of estimated blood loss >1000 ml - Incidence of antibiotics usage - Incidence of Neonatal Admission - Neonatal weight - Maternal Satisfaction Scores ### Location - Facility: Charité University Hospital, Berlin, N/A, N/A, Germany @@
## Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt. - NCT ID: NCT06261697 - Study ID: P.T.REC/012/004876 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-06 - Lead Sponsor: Cairo University ### Study Description Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires. ### Conditions - Temporomandibular Disorders - Smartphone Addiction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - A web based survey ### Outcomes Primary Outcomes - Fonseca Anamnestic Index (FAI) questionnaire - Smartphone Addiction Scale-Short version (SAS-SV) questionnaire - Patient Health Questionnaire (PHQ) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial. - NCT ID: NCT06261684 - Study ID: MS-259-2023 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-10-01 - Lead Sponsor: Cairo University ### Study Description The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:1. Is Intralesional acyclovir safe for plantar warts?2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy? ### Conditions - Plantar Wart ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intralesional Acyclovir - Cryotherapy ### Outcomes Primary Outcomes - Cure rate - Recurrence rate - Patient satisfaction score Secondary Outcomes - Correlation of treatment with number of ipsilateral warts - Correlation of treatment with age - Correlation of treatment with gender - Correlation of treatment with size of the wart ### Location - Facility: Cairo University Hospital, Cairo, N/A, N/A, Egypt @@
## Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates. - NCT ID: NCT06261671 - Study ID: 2312-ABU-028-VF - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: ART Fertility Clinics LLC ### Study Description One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes. ### Conditions - Infertility - In Vitro Fertilization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - antioxidants-enriched culture medium (Gx) ### Outcomes Primary Outcomes - Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic Secondary Outcomes - Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma - NCT ID: NCT06261658 - Study ID: TESOVA2022 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2033-12-29 - Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna ### Study Description The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue. ### Conditions - Cryopreservation - Ovary Injury - Infertility, Female - Menopause Ovarian Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cryopreserved Ovarian Tissue Reimplantation ### Outcomes Primary Outcomes - Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma Secondary Outcomes - Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma ### Location - Facility: Diego Raimondo, Bologna, BO, 40138, Italy @@
## Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function - NCT ID: NCT06261645 - Study ID: ROTOFUNK_2_2023 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2026-12 - Lead Sponsor: Sahlgrenska University Hospital, Sweden ### Study Description The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition. ### Conditions - Shoulder Dislocation or Subluxation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Early Physiotherapist selected active exercises - Delayed Physiotherapist selected active exercises ### Outcomes Primary Outcomes - Neuromuscular control Secondary Outcomes - Clinical assessment - Active and passive range of motion - Pain at rest - Pain during motion - Apprehension of instability during motion - Patient reported quality-of-life in relation to shoulder function - Patient's satisfaction ### Location - Facility: Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt, Gothenburg, Mölndal, SE 43180, Sweden @@
## Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee Arthropathy - NCT ID: NCT06261632 - Study ID: Hemo-Blood - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-11-01 - Lead Sponsor: Investigación en Hemofilia y Fisioterapia ### Study Description Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.Study design. Randomized, multicenter, single-blind clinical study. Method. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy. ### Conditions - Hemophilia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blood flow restriction ### Outcomes Primary Outcomes - Change from baseline hemarthrosis after treatment and at four weeks Secondary Outcomes - Change from baseline pressure pain threshold after treatment and at four weeks - Change from baseline muscle strength after treatment and at four weeks - Change from baseline electrical activity of the muscles after treatment and at four weeks - Change from baseline range of motion after treatment and at four weeks - Change from baseline joint status after treatment and at four weeks - Change from baseline functionality after treatment and at four weeks ### Location - Facility: University of Oviedo, Oviedo, Asturias, 33006, Spain @@
## Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone - NCT ID: NCT06261619 - Study ID: 2079951 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-06-01 - Lead Sponsor: Rhode Island Hospital ### Study Description Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone. ### Conditions - Airway Management - Respiration, Artificial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Adult Sotair Device ### Outcomes Primary Outcomes - Peak airway pressure Secondary Outcomes - Tidal volume - Airflow ### Location - Facility: Rhode Island Hospital, Providence, Rhode Island, 02903, United States @@
## Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution - NCT ID: NCT06261606 - Study ID: 4020286 - Status: RECRUITING - Start Date: 2024-01-28 - Completion Date: 2024-03 - Lead Sponsor: Parham Sadeghipour ### Study Description The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients. ### Conditions - Atherosclerosis - Coronary Artery Disease - Peripheral Arterial Disease - Ischemic Stroke - Carotid Artery Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Hybrid strategy ### Outcomes Primary Outcomes - Feasibility of conducting the trial Secondary Outcomes - Adherence to the individual components of the hybrid strategy - Patient satisfaction with the hybrid strategy - Any potential adverse events in intervention and control groups during the 30-day follow-up ### Location - Facility: Rajaie Cardiovascular Medical and Research Center, Tehran, N/A, 1995614331, Iran, Islamic Republic of @@
## Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy - NCT ID: NCT06261593 - Study ID: Ankle-Blood - Status: RECRUITING - Start Date: 2024-04-06 - Completion Date: 2024-09-20 - Lead Sponsor: Investigación en Hemofilia y Fisioterapia ### Study Description Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and stability (The Single Leg Stance Test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy. ### Conditions - Hemophilia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blood flow restriction ### Outcomes Primary Outcomes - Change from baseline hemarthrosis after treatment and at 4 weeks Secondary Outcomes - Change from baseline pressure pain threshold after treatment and at 4 weeks - Change from baseline muscle strength after treatment and at 4 weeks - Change from baseline electrical activity of the muscles after treatment and at 4 weeks - Change from baseline joint status after treatment and at 4 weeks - Change from baseline range of motion after treatment and at four weeks - Change from baseline balance after treatment and at four weeks ### Location - Facility: University of Oviedo, Oviedo, Asturias, 33006, Spain @@
## Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers - NCT ID: NCT06261580 - Study ID: TP-CLN-100502 - Status: COMPLETED - Start Date: 2021-07-28 - Completion Date: 2021-10-25 - Lead Sponsor: Haemonetics Corporation ### Study Description This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.Written consent to participate in the study will be obtained prior to volunteer screening per site procedures. ### Conditions - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TEG 6s Citrated K, KH, RTH, and FFH Cartridge - Clauss Fibrinogen ### Outcomes Primary Outcomes - CK-MA TEG Parameter - CK-R TEG Parameter - CKH-MA TEG Parameter - CKH-R TEG Parameter - CKH-LY30 TEG Parameter - CRTH-MA TEG Parameter - CFFH-MA TEG Parameter Secondary Outcomes ### Location - Facility: Machaon Diagnostics, Oakland, California, 94609, United States @@
## A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service - NCT ID: NCT06261567 - Study ID: D2287R00189 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-09-27 - Lead Sponsor: AstraZeneca ### Study Description Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biologic treatment ### Outcomes Primary Outcomes - Proportion of patients in clinical remission - Number and proportion achieving specific criteria for clinical remission - Number and proportion of super-responders - Number and proportion of responders - Number and proportion of non-responders Secondary Outcomes - Age at index - Sex - Ethnicity - Smoking status - BMI - IMD quintile - Comorbidities - COVID-19 vaccination status - Fractional Exhaled Nitric Oxide (FeNO) - Blood eosinophil count (EOS) - IgE - ACQ-6 - AQLQ - lung function (FEV1) - Rate of exacerbation in prior 12 months - Asthma treatments at 6 months - Asthma treatments at 12 months - Annualised exacerbation rate (AER) - mOCS use (proportion with 0 mg/day) - ACQ-6 score - AQLQ score - Lung function (FEV-1) - Respiratory infections - Annualised exacerbation rate (AER) - mOCS use (proportion with 0 mg/day) - ACQ-6 score - AQLQ score - Lung function (FEV-1) - Respiratory infections ### Location - Facility: Research Site, Birmingham, N/A, N/A, United Kingdom @@
## Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients - NCT ID: NCT06261554 - Study ID: Low-dose sesame OIT - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03-01 - Lead Sponsor: Medical University of Warsaw ### Study Description It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy. ### Conditions - Food Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary Supplement: Low dose OIT ### Outcomes Primary Outcomes - Tolerance of sesame Secondary Outcomes - Adverse event - Laboratory data - Basophil activation test - Skin prick test (SPT) - Desensitization dose ### Location - Facility: Medical University of Warsaw, Warsaw, Mazowieckie, 02-091, Poland @@
## Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting - NCT ID: NCT06261541 - Study ID: ABLEexoMS - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-08-01 - Lead Sponsor: ABLE Human Motion S.L. ### Study Description The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ABLE Exoskeleton ### Outcomes Primary Outcomes - Number and type of device-related Adverse Events - Level of Assistance (LoA) to don/doff the device - Time taken to don/doff the device - Level of Assistance (LoA) to complete therapy activity tasks - Time spent upright and time spent walking - Number of steps walked - Distance walked Secondary Outcomes - Timed 25-Feet Walk test (T25FW) - Ambulation Index (AI) - 6-Minute Walk Test (6MWT) - Timed Up-and-Go test (TUG) - Trunk Impairment Scale (TIS) - Lower extremity muscle strenght - Modified Ashworth Scale (MAS) - Borg Rating of Perceived Exertion - Barthel Index (BI) score - Modified Fatigue Impact Scale (MFIS) score - Multiple Sclerosis Quality of Life-54 (MSQoL-54) - Psychosocial Impact of Assistive Devices Scale (PIADS) score - Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score ### Location - Facility: Fundación Esclerosis Múltiple Madrid (FEMM), Madrid, N/A, N/A, Spain @@
## Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis - NCT ID: NCT06261528 - Study ID: STU-2023-1289 - Status: RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-12-01 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team. ### Conditions - Progressive Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Light therapy ### Outcomes Primary Outcomes - Treatment Emergent Adverse Events (TEAEs) Secondary Outcomes ### Location - Facility: UT Southwestern Medical Center, Dallas, Texas, 75247, United States @@
## Multi-omics Analysis of Oral-gut Microbial Profiles - NCT ID: NCT06261515 - Study ID: Perio-gut PRIN - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-02-15 - Lead Sponsor: University of Turin, Italy ### Study Description Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Active periodontal treatment ### Outcomes Primary Outcomes - Changes in gut microbial profile measured in stool samples - Changes in oral microbial profile measured in saliva samples - Changes in oral microbial profile measured in subgingival plaque samples Secondary Outcomes - Changes in oral-gut metabolome measured in stool samples - Changes in oral-gut miRNAome measured in stool samples - Metabolic plasma changes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome - NCT ID: NCT06261502 - Study ID: 2023-4527 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-08-01 - Lead Sponsor: Université de Sherbrooke ### Study Description This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a critical therapeutic target for the disorder. Using transcranial magnetic stimulation (TMS) in FXS patients, our team provided the first direct evidence of Gamma-aminobutyric acid (GABA) receptor a (GABAa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (PMID: 31748507). Concurrent lines of evidence suggest that stimulation of the endocannabinoid (eCB) system with the administration of Cannabidiol (CBD) could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. CBD has been shown to increase GABA concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in FXS. Thus, this trial aims to define the therapeutic potential of the eCB system for FXS, by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients, and the severity of the clinical phenotype. ### Conditions - Fragile X Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - CBD Oral Solution - Placebo ### Outcomes Primary Outcomes - Impact of Oral CBD Solution anxiety. - Impact of Oral CBD Solution on disruptive behavior - Impact of Oral CBD Solution on Behavioral Inhibition Secondary Outcomes - Impact of Oral CBD Solution on intracortical inhibition - Impact of Oral CBD Solution on intracortical facilitation - Impact of Oral CBD Solution on ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cannabis (THC vs. CBD) in Multiple Sclerosis - NCT ID: NCT06261489 - Study ID: REB23-1128 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: University of Calgary ### Study Description The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - THC - CBD ### Outcomes Primary Outcomes - Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT). - NLUTD outcome: The Differential Effect, if any, of THC and CBD on Neurogenic lower urinary tract dysfunction (NLUTD) symptoms will be measured by Neurogenic Bladder Symptom Score (NBSS). Secondary Outcomes - Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety of Ashwagandha (Withania Somnifera) Root Extract - NCT ID: NCT06261476 - Study ID: DYP-Pharm-RP-23 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-05 - Lead Sponsor: SF Research Institute, Inc. ### Study Description The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Ashwagandha (Withnia somnifera) ### Outcomes Primary Outcomes - Hemoglobin Test - Total Erythrocyte Count - Total Leukocyte Count - Platelet Count - Hematocrit Test - Total Cholesterol Test - LDL Test - HDL Test - Triglycerides Test - Serum Alkaline Transaminase Test - Aspartate Transaminase Test - Alkaline Phosphatase Test - Bilirubin Test - Serum Creatinine Test - Blood Urea Nitrogen Test - T4 - T3 - Serum TSH - Fasting Blood Sugar - HbA1c Secondary Outcomes - Adverse Events - Quality of Life (SF-36 QoL) ### Location - Facility: SF Research Institute, San Francisco, California, 94127, United States @@
## Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families - NCT ID: NCT06261463 - Study ID: 2023-0326 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07 - Lead Sponsor: University of Illinois at Chicago ### Study Description The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions. ### Conditions - Depression - Anxiety - PTSD - Family Dynamics - Social Functioning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - CAFES2 ### Outcomes Primary Outcomes - Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory) - Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory) - Changes in youth depression and anxiety via the Hospital Anxiety and Depression Scale (HADS, youth, exploratory) - Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory) Secondary Outcomes - Changes in social support via the Medical Outcomes Study Social Support Survey - Changes in social interaction via the Duke Social Support Index, social interaction subscale - Changes in parenting via the Alabama Parenting Questionnaire (adult and youth) - Changes in family communication via the Family Problem Solving Communication Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of CBD on the Brain - NCT ID: NCT06261450 - Study ID: 2020-3424 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-08-15 - Lead Sponsor: Université de Sherbrooke ### Study Description This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients. ### Conditions - Fragile X Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - CBD Oral Solution (eCBD system Target) - Placebo ### Outcomes Primary Outcomes - Short Intracortical Inhibition Secondary Outcomes - Intracortical Facilitation - Gaba concentration levels ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise - NCT ID: NCT06261437 - Study ID: M-11053 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-03-04 - Lead Sponsor: United States Army Research Institute of Environmental Medicine ### Study Description The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.The main questions it aims to answer are:* Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?* Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?* Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - CCAR - FSR ### Outcomes Primary Outcomes - Energy intake - Energy expenditure - Energy balance Secondary Outcomes - Physical performance (vertical jump) - Physical performance (peak power) - Physical performance (Anaerobic capacity) - Physical performance (lower-body strength) - Food acceptance scale - Gastrointestinal Quality of Life Index - Hunger and Satiety Visual Analog Scales ### Location - Facility: U.S. Army Research Institute of Environmental Medicine, Natick, Massachusetts, 01760, United States @@
## Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias - NCT ID: NCT06261424 - Study ID: 2024-1426 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2027-03 - Lead Sponsor: Université du Québec à Chicoutimi ### Study Description Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT \[rehabIlitation prograM for sPAstiC aTaxias\]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide. ### Conditions - ARSACS - SPG7 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - IMPACT - rehabIlitation prograM for sPAstiC aTaxias ### Outcomes Primary Outcomes - Severity of ataxia Secondary Outcomes - Medication change - Weight - height - Physical activities - Walking speed. - Standing balance - Balance confidence - Sitting balance - Activities of Daily Living - Muscle tone - Life habits - Community mobility - Plasma - DNA - Serum - RNA - Urine - Saliva - Mobility Life-space - Ataxia impact scale - Lower limb coordination - Peak respiratory flow and cough - Fatigue - Falls. - Patient-reported impression of change. - Anxiety and Depression - Pain characteristics - Functional lower extremity strength - Focus group with intervention group participants - Focus groups with stakeholders - Lower limb muscle activation - Quality of life - CBA analyses and Willingness to pay - Gait's temporal parameters - Stance balance - Postural balance ### Location - Facility: CIUSSS de la Capitale-Nationale, Hôpital de Baie-Saint-Paul, Baie-Saint-Paul, Quebec, G3Z 0K3, Canada @@
## Lung Ultrasound as Alternative to Radiation in Thoracic Surgery - NCT ID: NCT06261411 - Study ID: 999430 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-12 - Completion Date: 2025-04-30 - Lead Sponsor: Uppsala University Hospital ### Study Description This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs. ### Conditions - Thoracic Surgery - Ultrasonography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Lung Ultrasound ### Outcomes Primary Outcomes - Reduction in chest x-ray Secondary Outcomes - Re-insertion of chest tube - Delayed removal of chest tube - Time to chest tube removal - Patient Satisfaction ### Location - Facility: Uppsala Akademiska sjukhuset, Uppsala, Uppland, 751 85, Sweden @@
## Better Birth Outcomes Through Technology, Education, and Reporting - NCT ID: NCT06261398 - Study ID: 2023H0065 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2028-03 - Lead Sponsor: Ohio State University ### Study Description This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data. ### Conditions - Pregnancy - Maternal Anemia - Pre-Term Birth - Hypertensive Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - BETTER: motivational interviewing and text messaging - Standard of care ### Outcomes Primary Outcomes - Incidence of maternal anemia Secondary Outcomes - Incidence of Pre-term birth - Incidence of Hypertensive disorders of pregnancy - Incidence of infection - Incidence of Cesarean Delivery - Incidence of Postpartum hemorrhage - Incidence Severe maternal morbidity - Incidence of maternal mortality - Incidence of Small for gestational age birth - Incidence of Large for gestational age - Incidence of NICU admission - Incidence of Perinatal mortality - Incidence of Prenatal care visits - Incidence of Antepartum admission - Length of stay (days) - Postpartum re-admission ### Location - Facility: The Ohio State University Outpatient Care East, Columbus, Ohio, 43203, United States @@
## Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial - NCT ID: NCT06261385 - Study ID: typology - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2025-01-31 - Lead Sponsor: The University of Hong Kong ### Study Description This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio\>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted. ### Conditions - Smoking Cessation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - typology-based intervention ### Outcomes Primary Outcomes - self-reported abstinence in the past 30 days at 2-month follow-up - iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence - the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group. Secondary Outcomes - Time required for the counselling - Compliance rate of the SC counsellors in following the intervention protocol - Proportion of screened clients who participate in the RCT - Dropout rate of the participants who consent to the RCT - Satisfaction on the SC counsellors - Satisfaction on the e-messages - Frequency of reading the e-messages - Perceived effectiveness on the intervention - Satisfaction on the enrolment procedures - Intention to recommend the intervention to other smokers - Satisfaction about the intervention from SC counsellor - Perceived appropriateness of the intervention length from SC counsellor - Satisfaction on the enrolment procedures from SC counsellor - Perceived effectiveness of the screening tool from SC counsellor - Perceived clients' acceptance of the intervention from SC counsellor - Intention to apply this intervention in other clients from SC counsellor ### Location - Facility: LKS Faculty of Medicine, Hong Kong, N/A, 00, Hong Kong @@
## Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia - NCT ID: NCT06261372 - Study ID: KY2023PJ204 - Status: COMPLETED - Start Date: 2023-08-15 - Completion Date: 2023-11-15 - Lead Sponsor: Ningbo Medical Center Lihuili Hospital ### Study Description To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time. ### Conditions - Hemodialysis Patients With Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The mindfulness meditation combined with progressive muscle relaxation training . ### Outcomes Primary Outcomes - 10 sit-to-stand test in seconds - Grip strength in kilograms - 6-meter walk test in metre per second - KDQOLTM(Kidney Disease Quality of Life short Form) score - interleukin-6 (IL-6) - high-sensitivity C-reactive protein (hsCRP) - albumin(ALB) - prealbumin (PA） Secondary Outcomes ### Location - Facility: Li Huili Hospital, Ningbo Medical Center, Ningbo, Zhejiang, 315046, China @@
## A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma - NCT ID: NCT06261359 - Study ID: CEND1-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-10 - Lead Sponsor: Qilu Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma. ### Conditions - Pancreatic Ductal Adenocarcinoma (PDAC) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CEND-1 - Gemcitabine - Nab paclitaxel ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall Survival (OS) - Progression Free Survival(PFS) - 6-month PFS rate - Duration Of Response (DOR) - Disease Control Rate (DCR) - Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs) ### Location - Facility: Chinese People's Liberation Army (PLA) General Hospital, Beijing, Beijing, 100000, China @@
## Plasma Rich in Growth Factors in Corneal Endothelial Transplantation - NCT ID: NCT06261346 - Study ID: 20230420 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-06-30 - Lead Sponsor: Price Vision Group ### Study Description The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss. Subjects scheduled for endothelial keratoplasty will be enrolled and randomized to have the graft incubated in PRGF or not prior to graft implantation. The main outcome is the percentage central corneal endothelial cell loss 6 months after surgery. ### Conditions - Fuchs' Endothelial Dystrophy - Corneal Edema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PRGF ### Outcomes Primary Outcomes - Endothelial cell loss at 6 months Secondary Outcomes - Corneal endothelial cell density - Endothelial cell loss - Best corrected visual acuity - Re-bubble rate ### Location - Facility: Bascom Palmer Eye Institute, Miami, Florida, 33136, United States @@