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## Expediting Access to Services for Equity (EASE) - NCT ID: NCT06291246 - Study ID: 23-1823 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-06-30 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 3 after their initial diagnosis of autism.The main questions it aims to answer are:* Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?* Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?* Does Family Navigation improve caregiver well-being?Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Family Navigation - Educational Materials ### Outcomes Primary Outcomes - Time to initiation of autism specific intervention Secondary Outcomes - Caregiver Well-Being Score - Child's Developmental Functioning Score - Child's Adaptive Functioning Score - Appropriateness of Intervention Score - Feasibility of Intervention Score - Acceptability of Intervention Score ### Location - Facility: Carolina Institute for Developmental Disabilities, Carrboro, North Carolina, 27510, United States @@
## A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth - NCT ID: NCT06291233 - Study ID: HUM00236812 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: University of Michigan ### Study Description The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group). ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Virtual Interview Training (VIT) - Services-as-usual ### Outcomes Primary Outcomes - Competitive Employment based on self-report employment surveys - Change in Job Interview Skills from Mock Interview Rating Scale (MIRS) - Change in Job Interview Skills from Measure of Job Interview Skills (MOJO-iSkills) - Time to Employment - Vocational Index Score - Vocational Index Score Secondary Outcomes - Change in Interview Anxiety using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA) - Change in Interview Motivation - Change in Social Responsiveness using the Social Responsiveness Scale 2nd version (SRS-2) - Change in Job Search Behavior using the Job Search Behavior Scale (JSBS) - Change in Work Readiness using the Work Readiness Scale (WRS) - Change in Work Motivation using the Work Motivation Scale (WMS) - Change in Social Cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) - Change in Interview Knowledge ### Location - Facility: The San Diego State University, San Diego, California, 92182, United States @@
## A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) - NCT ID: NCT06291220 - Study ID: M24-291 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-02 - Completion Date: 2029-07-21 - Lead Sponsor: AbbVie ### Study Description Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world.Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects. ### Conditions - Chronic Lymphocytic Leukemia - Small Lymphocytic Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Obinutuzumab - ABBV-453 ### Outcomes Primary Outcomes - Part A and B: Percentage of Participants With Adverse Events (AEs) - Part A: Maximum Administered Dose (MAD) of ABBV-453 - Part A: Maximum Tolerated Dose (MTD) of ABBV-453 Secondary Outcomes - Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453 - Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453 - Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453 - Part A and B: Overall Response Rate (ORR) - Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better - Part A and B: Complete response rate (CRR) - Part A and B: Duration of Complete Response (DOCR) - Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi - Part A and B: Progression-free survival (PFS) - Part A and B: Overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate the Efficacy and Safety of AD-224 - NCT ID: NCT06291207 - Study ID: AD-224P3 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Addpharma Inc. ### Study Description The purpose of this study is to evaluate the efficacy and safety of AD-224 ### Conditions - Hypertension,Essential ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AD-224A - AD-224B - AD-224C - Placebo of AD-224A - Placebo of AD-224B - Placebo of AD-224C ### Outcomes Primary Outcomes - Change rate of MSSBP Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients - NCT ID: NCT06291194 - Study ID: 22DE30902 - Status: RECRUITING - Start Date: 2023-11-10 - Completion Date: 2024-05 - Lead Sponsor: AJU Pharm Co., Ltd. ### Study Description This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease. ### Conditions - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AJU-S56 5% - Placebo Group(Vehicle) ### Outcomes Primary Outcomes - Total corneal staining score (TCSS) Secondary Outcomes - LGCSS - TFBUT ### Location - Facility: AJU Pharm Co., Ltd., Seoul, N/A, N/A, Korea, Republic of @@
## Studying the Distribution of Accessory Gene Regulator (Agr) Quorum Sensing System and the Prevalence of Linezolid and Mupirocin Resistance in Biofilm Producer/Non Producer Staphylococcus Aureus in Sohag University Hospitals - NCT ID: NCT06291181 - Study ID: Soh-Med-24-01-05MD - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-06-30 - Lead Sponsor: Sohag University ### Study Description Staphylococcus aureus is an important pathogen causing a wide spectrum of infections . The organism usually colonizes the skin and mucous of humans and several animal species. Multiple body sites can be colonized in humans, however, the anterior nares of the nose are the most frequent carriage site for S. aureus. Other sites for carriage include the skin, perineum, and pharynx . It has been shown that there is an increased prevalence of staphylococcus infections, which may be attributed to its carriage in anterior nares and hands of health care workers and patients .The pathogenic mechanisms enabling S. aureus to cause serious infections could include: biofilm which protects organisms from host immune response; opsonophagocytosis and antimicrobial agents, thus leading to chronic and persistent infections.Antibiotic resistance associated with S.aureus infections is a great concern for the clinicians to prevent spread of infections. Methicillin was commonly used for these infections before the emergence of MRSA which is developed due to irrational use of antibiotics, prolonged hospital stay, nasal and hand carriage in health care staff. Also vancomycin, linezolid and mupirocin are used in treating infections,as well as decolonization of carriers .Mupirocin act by inhibiting the protein synthesis of bacteria by binding specifically to isoleucyl-tRNAsynthetase enzyme. The irrational use of Mupirocin among patients and its carriage in health care staff has led to the emergence of resistance to this antibiotic. .MupA, plasmid mediated gene, has a great role in mupirocinresistence as it had a supplementary modified isoleucyltRNAsynthetase which leads to the high level resistance to Mupirocin. The mupA gene has the ability to facilitate and disseminate the resistance mechanism in different patterns .Linezolid,theﬁrstoxazolidinonedrug,waslaunchedin2001andis still displaying excellent in vitro activity against Staphylococcus epidermidis on a global scale,although outbreaks of linezolidresistant S. epidermidis (LRSE) are occasionally reported..Linezolid resistance is mediated by, mutations in the 23S rRNA gene, altering the drug-binding site, and/or the 50S ribosomal proteins L3, L4 and L22, impairing linezolid binding;,Oracquisition of the primarily plasmid-encoded genes cfr, encoding a methyltransferase, or optrA, encoding an ABC transporter, or the cfr homologues cfr(B) and cfr(C).While cfr can mediate the PhLOPSA phenotype (resistance to phenicols, lincosamides,oxazolidinones, pleuromutilins and streptogramin A compounds), optrA confers oxazolidinone and phenicolresistance only..Pathogenecity of S. aureus is regulated by various factors ,one of them is the accessory gene regulatory (agr) system. It consists of 2 divergently transcribed loci (3 kb) controlled by means of 2 promoters P2 and P3. Most of clinical isolates of acute infections have a functional agr system and all, like strains, produce RNAIII in vitro and in vivo.Agr deficiency has been related to increased biofilm formation because RNAIII reduces the expression of surface adhesins and increases the production of capsule, toxins, and proteases. The agr system is supposed to regulate over 70 genes, 23 of which are renowned virulence factors.There are 2 classes of virulence factors regulated by agr. The first class includes virulence factors implicated in attachment to the host and immune evasion, whereas the second class contains genes engaged in the production of exoproteins related to invasion and toxin production . The activation of the agr system switches the bacterium from an adhesive, colonizing commensal into an invasive and aggressive pathogen(Roux A et al; 2009).Major virulence factors in S. aureus, exfoliative toxins (ETs), toxic shock syndrome toxin (TSST-1), and staphylococcal enterotoxins (SEs) are involved in host colonization, invasion of damaged skin and mucus, gastrointestinal infection, and prevarication of host defense mechanisms. Indeed, agr operon including agrA, agrB, agrC, and agrD genes regulate over 70 genes in S. aureus 23 of which control its pathogenicity and invasive infections .Moreover, S. aureus can be stratified into 4 different groups (agr I, agr II, agr III, and agr IV) according to the sequences of agrC (auto inducing peptide) and agrD (cyclic AIP) genes. It is stated that agr types are different in their properties and prevalence in various geographical areas thus, identification of predominant types in each region may well be functional . ### Conditions - Staphylococcus Aureus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - antibiotic sensitivity test ### Outcomes Primary Outcomes - resistence of staphylococci to mupirocin and linezolid antibiotics Secondary Outcomes ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain - NCT ID: NCT06291168 - Study ID: CMT002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-01 - Lead Sponsor: SEFA HAKTAN HATIK ### Study Description The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain. ### Conditions - Low Back Pain - Spinal Manipulation - Yoga ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Chiropractic Manipulation (HVLA - High Velocity Low Amplitude) - Yoga-Based Exercise Program - Conventional Exercises ### Outcomes Primary Outcomes - Numeric Rating Scale (NRS) - Roland-Morris Disability Questionnaire - Hospital Anxiety and Depression Scale (HADS) - Range of Motion (ROM) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Renal Mechanism of SGLT2 Inhibition - NCT ID: NCT06291155 - Study ID: HUM00222335 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-06-30 - Lead Sponsor: University of Michigan ### Study Description The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:Consent and Screening:* Laboratory tests to determine baseline health* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneysMonth 0:* Study entry kidney MRI (day 0)* Study entry kidney biopsy (within 30 days of MRI)* Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supplyMonth 3:* Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication* Review of systemsMonth 6:* Follow-up kidney MRI* Follow-up kidney biopsyStudy participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples. ### Conditions - Type 2 Diabetes - Diabetic Kidney Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - SGLT2 inhibitor ### Outcomes Primary Outcomes - Glomerular basement membrane (GBM) width and mesangial expansion Secondary Outcomes - Kidney Transcript Changes ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot - NCT ID: NCT06291142 - Study ID: R129030 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-22 - Completion Date: 2025-03 - Lead Sponsor: University of Manchester ### Study Description The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:* Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?* Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report* Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report. ### Conditions - Systemic Sclerosis - Raynaud Phenomenon ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation - Nailfold capillaroscopy ### Outcomes Primary Outcomes - Pilot Image Acquisition Secondary Outcomes - Qualitative Feedback - Skin tone sub-study data set ### Location - Facility: Northern Care Alliance NHS Foundation Trust, Salford, N/A, M6 8HD, United Kingdom @@
## Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents - NCT ID: NCT06291129 - Study ID: CAAE: 61347422.4.0000.5626 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-10-30 - Completion Date: 2024-10-30 - Lead Sponsor: Universidade Federal Fluminense ### Study Description Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test. ### Conditions - Gingivitis - Periodontal Diseases - Diabetes - Diabetes Mellitus, Type 1 - Malocclusion - Malocclusion in Children ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Periodontal therapy ### Outcomes Primary Outcomes - Bleeding on probing Secondary Outcomes ### Location - Facility: Universidade Federal Fluminense, Nova Friburgo, Rio De Janeiro, 28625650, Brazil @@
## Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease - NCT ID: NCT06291116 - Study ID: 2022/0345/HP - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2029-05-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions.Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h).Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels.This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact. ### Conditions - Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - standard care + rotigotine at 4 mg/24h for 24 months. - standard care for 24 months. ### Outcomes Primary Outcomes - Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) - NCT ID: NCT06291103 - Study ID: 2022/0342/HP - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2031-03-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and/or proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, we published a retrospective multicenter study within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, we did not observe any effect of standard of care treatment in active sABMR. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. They concluded the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, we propose to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.The monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. We will evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way. ### Conditions - Kidney Transplant Rejection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conversion to Belatacep - Standard of care treatment (SOC regimen) with Tacrolimus ### Outcomes Primary Outcomes - The efficacy of belatacept combined with standard of care, compared to calcineurin inhibitors (CNI) combined with standard of care, among kidney transplant recipients with sABMR Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision - NCT ID: NCT06291090 - Study ID: 22-0789 - Status: RECRUITING - Start Date: 2023-01-18 - Completion Date: 2025-05-01 - Lead Sponsor: University of Colorado, Denver ### Study Description The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - OUD treatment intervention ### Outcomes Primary Outcomes - Change in buprenorphine prescribing at hospital discharge Secondary Outcomes - Change in rates of methadone prescribing during hospitalization ### Location - Facility: University of Colorado Anschutz Medicl Campus, Aurora, Colorado, 80045, United States @@
## Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO> - NCT ID: NCT06291077 - Study ID: 2021/0391/HP - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2028-01-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Kidney transplantation is the standard treatment for patients with end-stage renal failure.However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage. ### Conditions - Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Belatacept - anticalcineurins ### Outcomes Primary Outcomes - Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer - NCT ID: NCT06291064 - Study ID: IRB23-0678 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2032-06 - Lead Sponsor: University of Chicago ### Study Description The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis. ### Conditions - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cyclophosphamide - Epirubicin - Docetaxel - Carboplatin - Breast Surgery - Capecitabine ### Outcomes Primary Outcomes - Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast) - Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes) - Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage) Secondary Outcomes - Side Effects of the Study Pre-surgery Chemotherapy Regimen - Clinical Response - Progressive Disease - Invasive Disease Free Survival (iDFS) - Duration of Response - Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia - NCT ID: NCT06291051 - Study ID: 2021/0382/HP - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2028-01-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Electrical spinal cord stimulation ### Outcomes Primary Outcomes - Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability - NCT ID: NCT06291038 - Study ID: 2021/0381/HP - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2029-03-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).Our working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation. ### Conditions - Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks - • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. ### Outcomes Primary Outcomes - Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura: Multicentric Non-inferiority Single-arm Study - NCT ID: NCT06291025 - Study ID: 2021/0374/HP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-08-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and we could reduce the median number of PEX sessions from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP \[5\]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, we consider that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, we wish here to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab. ### Conditions - Thrombotic Microangiopathies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PEX-FREE ### Outcomes Primary Outcomes - To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stopping Pneumonia Antibiotherapy Regimen Early - NCT ID: NCT06291012 - Study ID: RECHMPL22_0399 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-09-01 - Lead Sponsor: University Hospital, Montpellier ### Study Description The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days. ### Conditions - Community-acquired Pneumonia - Child, Only ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Quick response: Amoxicillin for 3 days - Delayed response: Amoxicillin for 5 days - Quick response: Amoxicillin for 5 days - Delayed response: Amoxicillin for 7 days ### Outcomes Primary Outcomes - Therapeutic failure rate D7 Secondary Outcomes - Therapeutic failure rate on D30 - Adverse effects - Compliance - Duration of antibiotic therapy ### Location - Facility: CHU de Montpellier, Montpellier, N/A, 34295, France @@
## Study of Multifrequential Impedancemetry in Pulsatile Tinnitus - NCT ID: NCT06290999 - Study ID: CHUBX 2023/80 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-12-15 - Lead Sponsor: University Hospital, Bordeaux ### Study Description This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus. ### Conditions - Pulsatile Tinnitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - multifrequential admittancemetry ### Outcomes Primary Outcomes - Multifrequency admittancemetry Secondary Outcomes - compression maneuvers - Evaluation of the effect of interventional radiology - success of radiointerventional treatment ### Location - Facility: Bordeaux University Hospital, Bordeaux, N/A, 33000, France @@
## Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis - NCT ID: NCT06290986 - Study ID: Pyrocardan® RCT - Status: RECRUITING - Start Date: 2022-09-26 - Completion Date: 2025-09-30 - Lead Sponsor: Herlev and Gentofte Hospital ### Study Description This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years. ### Conditions - CMC-1 Osteoarthritis - Trapeziometacarpal Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pyrocardan® implant - Ligament reconstruction and tendon interposition (LRTI) ### Outcomes Primary Outcomes - Patient-reported outcome: QuickDASH Secondary Outcomes - Patient-reported outcome - Strength measurements - Radiographs - Return to occupation ### Location - Facility: Herlev and Gentofte Hospital, Hellerup, N/A, 2900, Denmark @@
## Quality of Life and Health Perception After Surgery of Varicose Veins - NCT ID: NCT06290973 - Study ID: PI-23-3017 - Status: COMPLETED - Start Date: 2023-01-02 - Completion Date: 2023-11-14 - Lead Sponsor: Hospital Clínico Universitario de Valladolid ### Study Description The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary. ### Conditions - Quality of Life - Varicose Veins ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - surgery of varicose veins ### Outcomes Primary Outcomes - changes in qol questionarie SF-12 after surgery of varicose veins - changes in qol questionarie Veines QoL/Sym after surgery of Secondary Outcomes - changes in VCSS after surgery of varicose veins ### Location - Facility: Hospital CLínico Universitario de Valladolid, Valladolid, N/A, N/A, Spain @@
## BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes - NCT ID: NCT06290947 - Study ID: BFR-AE-DT2-2023-01 - Status: COMPLETED - Start Date: 2022-03-06 - Completion Date: 2024-01-08 - Lead Sponsor: Arab American University (Palestine) ### Study Description This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively. ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - BFR Cuffs for Intervention Group - Standard Walking Training Program ### Outcomes Primary Outcomes - Improvement in Insulin Sensitivity - Improvement in Aerobic Capacity Secondary Outcomes - Change in Body Mass Index (BMI) ### Location - Facility: Arab American University - Palestine, Jenin, N/A, P.O Box 24, Palestinian Territory, occupied @@
## Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis - NCT ID: NCT06290934 - Study ID: GS-US-409-5704 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2028-03 - Lead Sponsor: Gilead Sciences ### Study Description The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).The primary objectives of this study are:Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12 ### Conditions - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - GS-1427 - Ustekinumab - Placebo-to-match GS-1427 ### Outcomes Primary Outcomes - Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12 Secondary Outcomes - Part 2: Proportion of Participants Achieving Clinical Response at Week 24 - Parts 1 and 2: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths. - Parts 1 and 2: Incidence of Treatment-emergent Lab Abnormalities - Parts 1 and 2: Proportion of Participants Achieving Clinical Remission at Week 12 - Part 1: Proportion of Participants Achieving Clinical Remission at Week 52 - Part 2: Proportion of Participants Achieving Clinical Remission at Week 24 - Part 2: Proportion of Participants Achieving Partial Modified Mayo Score Remission at Week 52 - Parts 1 and 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12 - Part 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 24 - Parts 1 and 2: Proportion of Participants Achieving Mucosal Healing at Week 12 - Part 2: Proportion of Participants Achieving Mucosal Healing at Week 24 - Parts 1 and 2: Proportion of Participants Achieving Endoscopic Improvement at Week 12 - Part 2: Proportion of Participants Achieving Endoscopic Improvement at Week 24 ### Location - Facility: Om Research LLC, Camarillo, California, 93010, United States @@
## Ovulation Triggering 2 vs 3 Follicles - NCT ID: NCT06290921 - Study ID: 3472 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2025-02-20 - Lead Sponsor: Clinique Ovo ### Study Description Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles. ### Conditions - Infertility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ovulation triggering ### Outcomes Primary Outcomes - Clinical Pregnancy Rate Secondary Outcomes ### Location - Facility: Clinique Ovo, Montréal, Quebec, H4P 2S4, Canada @@
## RPE-P/TLIF for Lumbar Spinal Stenosis With Instability - NCT ID: NCT06290908 - Study ID: TF2018-001-01 - Status: COMPLETED - Start Date: 2018-09-04 - Completion Date: 2024-02-01 - Lead Sponsor: Wen-xi Sun ### Study Description Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films. ### Conditions - Spinal Stenosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - RPE-P/TLIF ### Outcomes Primary Outcomes - Pain visual analog scale (VAS) Secondary Outcomes - Oswestry disability index (ODI) - MacNab criteria - intervertebral space height - lumbar physiological curvature - fusion rate - pedicle screw accuracy ### Location - Facility: Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, N/A, N/A, China @@
## Artificial Oocyte Activation - NCT ID: NCT06290895 - Study ID: 3465 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2025-02-19 - Lead Sponsor: Clinique Ovo ### Study Description Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization. ### Conditions - Infertility - Ovarian Insufficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - women having had a second IVF cycle with AOA ### Outcomes Primary Outcomes - Blastocyst rate Secondary Outcomes ### Location - Facility: Clinique Ovo, Montréal, Quebec, H4P 2S4, Canada @@
## Endoscopic Versus Robotic Myotomy for Treatment of Achalasia - NCT ID: NCT06290882 - Study ID: ERMA trial - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-01-01 - Lead Sponsor: Germans Trias i Pujol Hospital ### Study Description Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. According to these data, it seems that the two procedures offer the same clinical results in the medium term. On the other hand, in recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy with a lower complication rate. Based on the evidence, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures.The purpose of the study is to evaluate the clinical and quality of life results of the RHM and compare them with the results of POEM in treatment of achalasia. ### Conditions - Achalasia Cardia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Robotic Heller Myotomy - Peroral Endoscopic Myotomy ### Outcomes Primary Outcomes - Eckhard symptom scores Secondary Outcomes - GERD-Q score ### Location - Facility: Elisenda Garsot Savall, Badalona, Barcelona, 08016, Spain @@
## Tobacco Education and Lung Health Study (TEAL) - NCT ID: NCT06290869 - Study ID: STUDY00006070 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2026-04 - Lead Sponsor: Georgetown University ### Study Description Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective. ### Conditions - Smoking Cessation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention - E-Referral to the Tobacco Quitline ### Outcomes Primary Outcomes - Biochemically verified smoking abstinence- MHS vs. QL-E arms - Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care Secondary Outcomes - self-reported smoking status - cigarettes per day - readiness to quit - Patient reach and patient engagement - Costs per arm from the health system perspective ### Location - Facility: Georgetown University Medical Center, Washington, District of Columbia, 20007, United States @@
## Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy - NCT ID: NCT06290856 - Study ID: 651397 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2025-12-15 - Lead Sponsor: Oslo University Hospital ### Study Description Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making. ### Conditions - Metastatic Colorectal Cancer - Pancreas Adenocarcinoma - Cholangiocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Multiplex PCR-test for circulating tumor DNA ### Outcomes Primary Outcomes - Clinical validity of ctDNA tests Secondary Outcomes - Resources needed for ctDNA assays in routine diagnostics ### Location - Facility: Oslo university Hospital, Oslo, N/A, N/A, Norway @@
## Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis - NCT ID: NCT06290843 - Study ID: AWFiS/2024_1_PE - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-05-30 - Lead Sponsor: Gdansk University of Physical Education and Sport ### Study Description The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group. ### Conditions - Idiopathic Scoliosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Schroth method ### Outcomes Primary Outcomes - Analysis of body balance on the AMTI force platform - Analysis of body balance on the AMTI force platform - Analysis of body balance on the AMTI force platform - Analysis of body balance on the AMTI force platform - Photographic analysis of body posture - Analysis of x-ray in the frontal plane - Analysis of x-ray in the frontal plane - Analysis of x-ray in the frontal plane - Analysis of x-ray in the frontal plane - Analysis of x-ray in the sagittal plane - Analysis of x-ray in the sagittal plane Secondary Outcomes ### Location - Facility: Gdansk University of Physical Education and Sport, Gdańsk, Pomorskie, 80-336, Poland @@
## Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students - NCT ID: NCT06290830 - Study ID: OMUŞükranBaşgöl01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-01 - Lead Sponsor: Ondokuz Mayıs University ### Study Description In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data. ### Conditions - Functional Constipation - Constipation - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Abdominal massage group - Kegel Exercises group - Both abdominal massage and kegel exercises to gether ### Outcomes Primary Outcomes - Constipation severity change - Quality of Life change - Bristol stool form score change Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI - NCT ID: NCT06290817 - Study ID: 2023-0724 - Status: RECRUITING - Start Date: 2023-03-30 - Completion Date: 2026-03-20 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen. ### Conditions - Diffuse Large B-cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Orelabrutinib combined with R-CDOP regimen ### Outcomes Primary Outcomes - 2-year central nervous system relapse rate Secondary Outcomes - Complete Response Rate - Overall Response Rate (ORR) - 2-year Overall survival (OS) rate - 1-year Overall survival (OS) rate - 2-year progression-free survival (PFS) rate - 1-year progression-free survival (PFS) rate - Occurrence of hematologic adverse events and non-hematologic adverse events according to CTCAE V4.03 ### Location - Facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang, Zhejiang, N/A, China @@
## Assessing Sustainable Behaviors and Health Impacts of Climate Change - NCT ID: NCT06290804 - Study ID: drezgiyucel0000000193593877 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-07 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description The relationship between climate change, sustainability and child health is complex and important. These three concepts are interacting factors and have significant impacts on children's health. Sustainability measures are vital to protect child health by mitigating the impacts of climate change. At the same time, children's education and awareness is an important factor that will contribute to future generations living in a sustainable world. As a society, tackling climate change and striving for a sustainable future is crucial to ensure that children live healthy and safe lives. The aim of this study is to evaluate the effectiveness of the education program and educational videos to be applied to children in terms of environmentally sustainable behaviors and awareness of the health effects of climate change in 60-72-month-old children studying in Eskişehir Odunpazarı Municipality Day Care Center and Nurseries. In addition, in this study, it was aimed to measure the level of global climate change awareness of parents and to evaluate the relationship with children's environmentally sustainable behaviors. ### Conditions - Climate Change - Child Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - education ### Outcomes Primary Outcomes - increasing sustainable behaviors - raising awareness of the health impacts of climate change - raising awareness of global climate change Secondary Outcomes ### Location - Facility: Ezgi Yücel, Odunpazarı, Eskişehir, 553 723 43 57, Turkey @@
## Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? - NCT ID: NCT06290791 - Study ID: K2020214 - Status: COMPLETED - Start Date: 2020-12-31 - Completion Date: 2024-02-10 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis. ### Conditions - Drain Tube Influence the Postoperative Epidural Haematoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - two level lumbar decompression with BESS procedure received one drain. - two level lumbar decompression with BESS procedure received two drain. ### Outcomes Primary Outcomes - the cross-sectional area of POSEH Secondary Outcomes - the volume of drain output ### Location - Facility: Zhonglin Zhong, Yiwu, Zhejiang, 322000, China @@
## Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees - NCT ID: NCT06290778 - Study ID: Baylor IRB #023-445 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-08 - Lead Sponsor: Baylor Research Institute ### Study Description The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?* Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?Participants will:* Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.* Complete a questionnaire and clinical interview prior to the workshop.* Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms. ### Conditions - PTSD - Alcohol Use Disorder - Depression - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Brief Unified Protocol - Psychoeducation ### Outcomes Primary Outcomes - PTSD Symptoms Secondary Outcomes - Alcohol Use Disorder symptoms - Depression symptoms - Anxiety symptoms - Functional Impairment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera - NCT ID: NCT06290765 - Study ID: A23-401 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-02-28 - Lead Sponsor: PharmaEssentia ### Study Description This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks). ### Conditions - Polycythemia Vera - Myeloproliferative Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ropeginterferon alfa-2b - Phlebotomy ### Outcomes Primary Outcomes - The proportion of patients with treatment response evaluated. Treatment response is defined as the maintenance of the median HCT values <45% over time, without progression of disease, and no need of any extra-protocol cytoreductive drugs. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block - NCT ID: NCT06290752 - Study ID: KY-2024-030 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care. ### Conditions - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - operation time Secondary Outcomes ### Location - Facility: Dongmei Ma, Yiwu, Zhejiang, 322000, China @@
## A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma - NCT ID: NCT06290739 - Study ID: JHuang886 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-03-27 - Lead Sponsor: West China Hospital ### Study Description The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND. ### Conditions - Intrahepatic Cholangiocarcinoma - Machine Learning ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lymph nodes dissection ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Disease free survival ### Location - Facility: Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China @@
## Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients - NCT ID: NCT06290726 - Study ID: 202001927B0 - Status: COMPLETED - Start Date: 2002-02 - Completion Date: 2024-01 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts. The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated. Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival. ### Conditions - Living Donor Liver Transplantations With Anti-HBc (+) Grafts ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vasodilator and Exercise Study for DMD (VASO-REx) - NCT ID: NCT06290713 - Study ID: IRB202301491 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-11 - Lead Sponsor: University of Florida ### Study Description Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment. ### Conditions - Duchenne Muscular Dystrophy - Duchenne Disease - Muscular Dystrophy - Muscular Dystrophy in Children - Vasodilation - Exercise - DMD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tadalafil - Placebo - Exercise Training ### Outcomes Primary Outcomes - Vascular responsiveness after muscle contraction to a single dose of tadalafil. - Cycling time to fatigue Secondary Outcomes - Quadriceps muscle Fat Fraction - Metabolic recovery - cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max) - cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE) - cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2) - cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET) - cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT) - The 100-meter timed test (100m) - the North Star Ambulatory Assessment (NSAA) - The 4-stair climb - The Physical activity questionnaire (PAQ-C) - Pulmonary function testing - vital capacity (FVC) - Pulmonary function testing - forced expiratory volume in 1 second (FEV1) - Neurology Quality of Life (NeuroQoL) pediatric lower extremity function - Patient Reported Outcomes Measurement Information System (PROMIS) pediatric fatigue - PROMIS parent proxy for physical activity - PROMIS pediatric physical activity - Physical Activity Monitoring - Daily Step Rate - Physical Activity Monitoring - Time in Low-Level Activity - Physical Activity Monitoring - Time in Moderate-Level Activity - Physical Activity Monitoring - Time in High-Level Activity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life - NCT ID: NCT06290700 - Study ID: MCBU_2880 - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2024-02-01 - Lead Sponsor: Celal Bayar University ### Study Description This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life. ### Conditions - Life Quality - Functional Status ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Neonatal Care education ### Outcomes Primary Outcomes - severity of maternal function by Barkin Index of Maternal Functioning Secondary Outcomes - Maternal Postpartum Quality of Life Instrument ### Location - Facility: Yonca ÇIÇEK OKUYAN, Manisa, N/A, N/A, Turkey @@
## Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy - NCT ID: NCT06290687 - Study ID: CASE5824 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2027-01-29 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy. ### Conditions - Malignant Neoplasm of Bladder - Muscle Invasive Bladder Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neoadjuvant Chemotherapy - Partial cystectomy with Extended pelvic lymph node dissection - Adjuvant systemic therapy ### Outcomes Primary Outcomes - Recurrence-Free Survival (RFS) Secondary Outcomes - Presence of Post-operative Complications - Median Bladder RFS - Median Muscle-Invasive Bladder RFS - Median Bladder-Intact Survival - Median Cancer-Specific Survival - Changes in Genitourinary-specific HRQoL ### Location - Facility: Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, 44195, United States @@
## Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile - NCT ID: NCT06290674 - Study ID: P.T.REC/012/004043 - Status: COMPLETED - Start Date: 2022-09-11 - Completion Date: 2024-02-01 - Lead Sponsor: Adly A Adam ### Study Description Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women. ### Conditions - Obesity, Abdominal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal Shockwave therapy - Balanced low-calorie diet ### Outcomes Primary Outcomes - Waist/ hip ratio - Skin fold caliper Secondary Outcomes - Lipid profile ### Location - Facility: Helwan General Hospital, Cairo, Helwan, Cairo Governate, 02, Egypt @@
## Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Postherpetic Neuralgia. - NCT ID: NCT06290661 - Study ID: UHCT-IEC-SOP-016-03-01 - Status: RECRUITING - Start Date: 2023-02-09 - Completion Date: 2025-06-30 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia. The main questions it aims to answer are:1. The efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia2. The safety of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with postherpetic neuralgia. ### Conditions - Neuropathic Pain - Postherpetic Neuralgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active electrostimulation - Placebo electrostimulation ### Outcomes Primary Outcomes - Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period - Visual simulation assessment scale collects pain scores after peripheral electrode placement Secondary Outcomes - Proportion of subjects whose pain relief more than 30% - Proportion of subjects of ideal pain state - Sleep-related assessment after electrostimulation - Change of life quality after electrostimulation - Analgesic medications - Stability of external assistant devices - Questionnaire survey equipment satisfaction ### Location - Facility: Union Hospital, Tongji medical college, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China @@
## Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings - NCT ID: NCT06290648 - Study ID: 22-0868 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are:1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure).2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records. ### Conditions - Mental Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Forging New Paths ### Outcomes Primary Outcomes - Change in Levels of Aggression Score from Baseline to Month 3 - Change in Levels of Aggression Score From Baseline to Month 6 - Community Tenure Secondary Outcomes - Change in Overall Criminal Attitudes Score - Change in Overall Impulsivity Score ### Location - Facility: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States @@
## Edmonton Dyspnea Inventory- Validation Study - NCT ID: NCT06290635 - Study ID: Pro00119668 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-11-11 - Completion Date: 2024-12-30 - Lead Sponsor: University of Alberta ### Study Description Breathlessness is a common problem for many patients with Interstitial lung disease (ILD). ILD is a group of lung diseases that cause inflammation (swelling) and scarring in the lung tissue where gas exchange (oxygen and carbon dioxide) occurs. Unfortunately, there is no cure for these conditions and as a result many patients decline over time with worsening breathlessness. This limits their ability to live a good life. Clinicians do not often recognize, assess, or treat breathlessness appropriately. Breathlessness, being a subjective experience, cannot be fully understood through objective measurements such as lung function tests, the arterial blood gas test etc. The objective and subjective measures of breathlessness are frequently disconnected. Clinicians who often rely on these types of objective tests do not directly enquire into its nature and severity of breathlessness from patients themselves. As a result, they remain unaware of this disabling symptom and the extent of its impact on patients. While there are many tools to measure breathlessness, they are not consistently used in routine care or have impacted care in a meaningful way. Many such tools are also complex with intricate response systems with possibility of errors and user fatigue. As a result, easy to use tools like modified MRC or MRC are frequently used even though they do not assess severity of breathlessness. No tool has been effective at helping clinicians identify the problem and prescribe appropriate treatments. This results in needless suffering for patients and their families and prevents them from receiving timely and appropriate therapies. Investigators propose to test an easy-to-use tool that combines the subjective and objective aspects of breathlessness. Investigators hope that the tool will help clinicians quickly identify the patient's breathlessness severity and provide them with an algorithm of what to do next. The tool was developed by clinicians with +15 years of experience in ILD and dyspnea. Early analysis already suggests the tool is useful to patients and helps improve care. ### Conditions - ILD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breathlessness Assessment Tool ### Outcomes Primary Outcomes - Validate Edmonton Dyspnea Inventory (EDI; formerly known as multidimensional dyspnea scale-MDDS) Secondary Outcomes - To perform time-motion observation of care providers or patients using the scale - Calculate MCID for Edmonton Dyspnea Inventory - Feasibility of Questionnaire - To assess day-to-day variability in dyspnea scores ### Location - Facility: Kaye Edmonton Clinic, Edmonton, Alberta, T6G 2G3, Canada @@
## PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL - NCT ID: NCT06290622 - Study ID: IRB300012414 (UAB23136) - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2028-01-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses. ### Conditions - Diffuse Large B Cell Lymphoma - Lymphoma, B-Cell - Lymphoma, Follicular ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Retifanlimab, INCAGN02385, INCAGN02390 ### Outcomes Primary Outcomes - Identify the optimal biological dose (OBD) for Retifanlimab in combination with INCAGN02385 and INCAGN02390 in relapsed/refractory DLBCL. Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury - NCT ID: NCT06290609 - Study ID: 72799 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-15 - Lead Sponsor: Stanford University ### Study Description The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study. ### Conditions - Spasticity, Muscle - Spinal Cord Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vibrotactile Coordinated Reset ### Outcomes Primary Outcomes - Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks. Secondary Outcomes ### Location - Facility: Stanford University, Stanford, California, 94305, United States @@
## Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy - NCT ID: NCT06290596 - Study ID: MSR/AZAST/AIP029/21/222/8/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Al-Azhar University ### Study Description To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions. ### Conditions - Uterine Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Vasopressin - Tranexamic acid - Saline ### Outcomes Primary Outcomes - blood loss Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section - NCT ID: NCT06290583 - Study ID: Prilocaine in cesarean section - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: South Valley University ### Study Description one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes. ### Conditions - Spinal Anesthetics Causing Adverse Effects in Therapeutic Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Bupivacaine - Prilocaine ### Outcomes Primary Outcomes - Maternal arterial blood pressure Secondary Outcomes - Evaluation of duration of motor block - Total dose of ephedrine ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's Heart - NCT ID: NCT06290570 - Study ID: 23-007685 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices. ### Conditions - Hypertrophic Cardiomyopathy - Athlete Heart ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 12-Lead ECG - Apple Smart Watch Single Lead ECG - AliveCor KardiaMobile 6-Lead ECG ### Outcomes Primary Outcomes - Distribution of AI-ECG probabilities in HCM - Comparative diagnostic performance between tracings obtained from different devices Secondary Outcomes - Distribution of AI-ECG probabilities in Athlete's Heart - Correlation with false negative AI ECG result ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133 - NCT ID: NCT06290557 - Study ID: 2023-507737-17-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-07-01 - Lead Sponsor: University Hospital Tuebingen ### Study Description In this clinical trial we will test a new approach for decolonization of S. aureus.As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned. ### Conditions - Staphylococcus Aureus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - HY_133 - Placebo ### Outcomes Primary Outcomes - ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1) - NCT ID: NCT06290544 - Study ID: CCM 1552 - Status: RECRUITING - Start Date: 2021-11-29 - Completion Date: 2026-07 - Lead Sponsor: Centro Cardiologico Monzino ### Study Description This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria. ### Conditions - Diabetes Mellitus, Type 1 - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Standard of care plus additional examinations ### Outcomes Primary Outcomes - Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines. - Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE). - Prevalence of cardiovascular disease in type 1 diabetes patients Secondary Outcomes - Prevalence of diabetic retinopathy - Prevalence of diabetic nephropathy - Prevalence of diabetic neuropathy - CT-derived calcium score - Carotid intima-media thickness - Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method) - Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ) - Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS) - Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires. - Stratify type 1 patient cohort by lipid profile - Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics. ### Location - Facility: IRCCS Centro Cardiologico Monzino, Milan, N/A, 20138, Italy @@
## Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain - NCT ID: NCT06290531 - Study ID: CEBD-CU-2023-11-12 - Status: COMPLETED - Start Date: 2022-01-16 - Completion Date: 2023-09-28 - Lead Sponsor: Cairo University ### Study Description Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients. ### Conditions - Dental Caries in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Buzzy device (cold and vibration) - Buzzy device (vibration only) - precooling - Flavored Benzocaine topical anesthetic gel 20% ### Outcomes Primary Outcomes - Patient reported pain during needle injection Secondary Outcomes - Child behaviour during needle injection - Heart rate - Oxygen saturation - Child and parent satisfaction ### Location - Facility: Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Cairo, N/A, 11559, Egypt @@
## Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713 - NCT ID: NCT06290518 - Study ID: PROBIFERT P051 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2024-01-29 - Lead Sponsor: Biosearch S.A. ### Study Description The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation. ### Conditions - Infertility Unexplained ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Ligilactobacillus salivarius CECT5713 - Placebo ### Outcomes Primary Outcomes - Successful pregnancies Secondary Outcomes - Modification of the vaginal microbiota - Vaginal immunomodulation ### Location - Facility: Biosearch S.A.U., Granada, N/A, 18004, Spain @@
## A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study - NCT ID: NCT06290505 - Study ID: PALEO - Status: RECRUITING - Start Date: 2021-12-08 - Completion Date: 2028-01-31 - Lead Sponsor: Australasian Gastro-Intestinal Trials Group ### Study Description The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised). ### Conditions - Oesophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Durvalumab ### Outcomes Primary Outcomes - Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT Scan and clinical review. Secondary Outcomes - Duration of dysphagia relief - Nutritional status - Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30 - Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18 - Response rate in metastatic lesions - Physician graded toxicity - SAE Rate - Overall survival. ### Location - Facility: Border Medical Oncology, Albury, New South Wales, 2640, Australia @@
## Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia - NCT ID: NCT06290492 - Study ID: AHMU-tDCS-insomnia - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-11-01 - Lead Sponsor: WANG KAI ### Study Description To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients. ### Conditions - Chronic Insomnia - Transcranial Direct Current Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial direct current stimulation - sham transcranial direct current stimulation ### Outcomes Primary Outcomes - subjective sleep quality assessed by the PSQI - subjective sleep quality assessed by the ISI - daytime sleepiness assessed by the FFS - daytime sleepiness assessed by the ESS - objective sleep quality assessed by the PSG Secondary Outcomes - emotional symptoms assessed by the HAMA - emotional symptoms assessed by the HAMD ### Location - Facility: Anhui Medical University, Hefei, Anhui, N/A, China @@
## A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes - NCT ID: NCT06290479 - Study ID: 20358 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-06-30 - Lead Sponsor: air up GmbH ### Study Description A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks. ### Conditions - Water Intake ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Air Up® Peach Pod - Air Up® Orangeade Pod ### Outcomes Primary Outcomes - Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale Secondary Outcomes - Blood Biomarkers ### Location - Facility: Citruslabs, Santa Monica, California, 90404, United States @@
## Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects - NCT ID: NCT06290466 - Study ID: FCN-437c-CP-004 - Status: COMPLETED - Start Date: 2022-11-11 - Completion Date: 2023-02-08 - Lead Sponsor: Ahon Pharmaceutical Co., Ltd. ### Study Description This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation. ### Conditions - Advanced Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low dose group - High dose group ### Outcomes Primary Outcomes - ΔΔQTcF Secondary Outcomes - adverse events - Physical examination - Axillary temperature - blood pressure - pulse - Ecg monitoring and electrocardiogram - laboratory examination - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters - Plasma concentration and pharmacokinetic parameters ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## The Regulatory Role of miRNA 27 Follistatin Like Protein-1 Gene in Multiple Scelerosis - NCT ID: NCT06290453 - Study ID: AOGR - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Assiut University ### Study Description Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - micro RNA 27- FLP1 gene expression - The Expanded Disability Status Scale (EDSS) - Electrophysiological assessment: - MRI examination MRI brain: ### Outcomes Primary Outcomes - • To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients. Secondary Outcomes - To correlate the levels of expression of miR-27 expression and its target gene (FSTL1) relative to the severity of symptoms of MD patients. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## MEdication Counselling Models for Outpatient oRal antIcoaguLation - NCT ID: NCT06290440 - Study ID: 28/NDGD-HDDD - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Gia Dinh People Hospital ### Study Description The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants. ### Conditions - Anticoagulants; Circulating, Hemorrhagic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Telepharmacy-led counselling - Pharmacist-led counselling ### Outcomes Primary Outcomes - Medication adherence Secondary Outcomes - Knowledge of oral anticoagulants - All-cause hospitalisation - VTE-related hospitalisation - Bleeding-related hospitalisation - All-cause mortality - VTE-related mortality - Bleeding-related mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K) - NCT ID: NCT06290427 - Study ID: COMPAR-K - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12 - Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona ### Study Description The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using three currently available platforms:* DaVinci®;* Hugo®;* Versius®.The questions it aims to answer are:Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?Participants will be invited to join one of these three experimental group:1. surgery with the DaVinci platform;2. surgery with the Hugo platform;3. surgery with the Versius platform. ### Conditions - Renal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - DaVinci RAPN - Hugo RAS RAPN - Versius® RAPN ### Outcomes Primary Outcomes - Number of participants with postoperative complications - Number of participants with moderate to major postoperative complications - Number of participants with major postoperative complications Secondary Outcomes - Overall duration of the surgery - Number of intraoperative complications - Type of intraoperative complications - Number of intraoperative technical malfunctions - Type of intraoperative technical malfunctions - Estimated Blood Loss - Postoperative hospitalization - Postoperative pain - Positive Surgical Margins - Serum Creatinine dosage for renal function assessment - Estimated Glomerular Filtration Rate for renal function assessment - Time taken for platform related timings - Procedure-related costs ### Location - Facility: Urology Unit, AOUI Verona, Verona, VR, 37126, Italy @@
## The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status - NCT ID: NCT06290414 - Study ID: FDASU-Rec IM 112318 - Status: RECRUITING - Start Date: 2023-11-30 - Completion Date: 2024-07-30 - Lead Sponsor: Ain Shams University ### Study Description The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated. ### Conditions - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - infrared thermal camera ### Outcomes Primary Outcomes - Determine the agreement of thermographic images for diagnosis of periodontal diseases Secondary Outcomes - The temperature ranges for healthy periodontium, gingivitis and periodontitis ### Location - Facility: Faculty of dentistry Ain Shams University, Cairo, N/A, N/A, Egypt @@
## A Socio-ecological Approach for Improving Self-management in Adolescents With SCD - NCT ID: NCT06290401 - Study ID: 2023-0671 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-06-30 - Lead Sponsor: Children's Hospital Medical Center, Cincinnati ### Study Description The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.The main question\[s\]it aims to answer are:* Does SCThrive improve patient activation?* Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?* Are any improvements maintained 3 months after treatment?Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits. ### Conditions - Anemia, Sickle Cell ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SCThrive - SCHealthED ### Outcomes Primary Outcomes - Patient Activation Secondary Outcomes - Self-Management Behaviors - Daily Functioning - Emergency Room (ER) Visits - Self-Management Skills - Health-related quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of 23ME-01473 in Patients With Advanced Solid Malignancies - NCT ID: NCT06290388 - Study ID: 23ME-01473-CLIN-001 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2026-06-30 - Lead Sponsor: 23andMe, Inc. ### Study Description This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - 23ME-01473 ### Outcomes Primary Outcomes - Phase 1:Incidence and severity of dose-limiting toxicities (DLTs) - Phase 1: Incidence and severity of adverse events (AEs) - Phase 1 Incidence and severity of serious adverse events (SAEs) - ORR based on investigator assessment against RECIST 1.1 criteria Secondary Outcomes - Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473 - Phase 1: Objective response rate (ORR) - Duration of response (DoR) - Disease Control Rate (DCR) - Progression free survival (PFS) - Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473 - Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473 - Last measurable serum concentration (Clast) following a single dose of 23ME-01473 - Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473 - Terminal half-life (T1/2) following a single dose of 23ME-01473 - Maximum serum concentration (Cmax) following multiple doses of 23ME-01473 - Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473 - Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473 - Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473 - Terminal half-life (T1/2) following multiple doses of 23ME-01473 ### Location - Facility: START Center for Cancer Care, San Antonio, Texas, 78229, United States @@
## A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population. - NCT ID: NCT06290375 - Study ID: HSK21542-T-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-08 - Completion Date: 2025-04-11 - Lead Sponsor: Xizang Haisco Pharmaceutical Co., Ltd ### Study Description This is a two- stage study. Stage I is a multicenter, open-label trial；Stage II was a multi-center, randomized, double-blind, placebo-controlled trial. About 250 maintenance peritoneal dialysis patients with moderate or above pruritus are planned to be enrolled. ### Conditions - Pruritus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HSK21542 tablet - Placebo ### Outcomes Primary Outcomes - Proportion of subjects with an improvement of ≥ 4points from baseline in the weekly average of the daily Worst Itch Numeric Rating Scale (WI-NRS) after 12 weeks of treatment. Secondary Outcomes - Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment. - Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) after 12 weeks of treatment. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring Digitalized Interventions for Stress and Problem Solving - NCT ID: NCT06290362 - Study ID: EgeTrial4 - Status: COMPLETED - Start Date: 2021-04-16 - Completion Date: 2021-11-28 - Lead Sponsor: Ege University ### Study Description Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and problem-solving skills among young adults. ### Conditions - Stress - Problem-solving ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - Cognitive Behavioural Theory-based group consultation ### Outcomes Primary Outcomes - Perceived Stress Scale (first evaluation with posttest) - Problem Solving Inventory (first evaluation with posttest) - Perceived Stress Scale (second evaluation with follow up) - Problem Solving Inventory (second evaluation with follow up) Secondary Outcomes ### Location - Facility: Ege University, İzmir, N/A, 35100, Turkey @@
## Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control - NCT ID: NCT06290349 - Study ID: DA5221_DM_III - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-11-30 - Lead Sponsor: Dong-A ST Co., Ltd. ### Study Description This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DA5221-T1 - DA5221-T2 - Placebo - DA5221-B1 - DA5221-B2 ### Outcomes Primary Outcomes - Change from the baseline in HbA1c (%) after 24 weeks Secondary Outcomes - Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks - Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks - Change from the baseline in weight after 24 weeks ### Location - Facility: Severance Hospital, Yonsei University college of Medicine, Seoul, N/A, N/A, Korea, Republic of @@
## Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement - NCT ID: NCT06290336 - Study ID: PROTEKT - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2026-12-30 - Lead Sponsor: Linkoeping University ### Study Description The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.The main questions it aims to answer are:* Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?* Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?* Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?* Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?Participants will be randomized stratified by age (≤ 67 years, \> 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pre-operative exercise therapy and education - Standardized pre-operative information session ### Outcomes Primary Outcomes - Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery - Patient satisfaction at 1 year after surgery - Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery - Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery - Change in active knee range of motion from baseline to 6 weeks after surgery - Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery Secondary Outcomes - Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery - Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery - Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery - Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery - : Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery - Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery - Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery - Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery ### Location - Facility: Linkoping University, Linkoping, Ostergotland, 58183, Sweden @@
## Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms - NCT ID: NCT06290323 - Study ID: 11/05/2022-9/VIII - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-25 - Completion Date: 2024-05-30 - Lead Sponsor: Muğla Sıtkı Koçman University ### Study Description The most common reason for applying to a hospital in the postoperative period due to the double J stent inserted during operations of the uteroscopic lithotripsy is reflected pain (T11-L2). The posterior approximation QL block (QL-P) is known to extend more easily to the thoracic paravertebral cavity or thoracolumbar plane, creating analgesia from T 7' to L 1'. The effects of double J catheter in patients are followed by 'Ureteral Stent Symptom Scoring Survey'. QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective, randomized, controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease. Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block, made under ultrasound guidance, on pain scores that occur after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia. ### Conditions - Lower Urinary Tract Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Quadratus lumborum block - Placebo ### Outcomes Primary Outcomes - Quadratus posterior block Secondary Outcomes - Pain Score ### Location - Facility: Mugla Sitki Kocman Training and Research Hospital, Mugla, N/A, 48000, Turkey @@
## Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography - NCT ID: NCT06290310 - Study ID: PAVELA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2024-09-01 - Lead Sponsor: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged ### Study Description Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony. ### Conditions - Acute Lung Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EIT - patient-ventilator asynchrony assessment ### Outcomes Primary Outcomes - distribution Secondary Outcomes - connecting asysnchrony cycles with electric impedance tomography measurements - identifying unic electric impedance tomography signs of asynchrony ### Location - Facility: Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged, Kiskunhalas, N/A, 6400, Hungary @@
## Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project) - NCT ID: NCT06290297 - Study ID: Progetti di Rete (RIN-IDEA) - Status: RECRUITING - Start Date: 2020-09-30 - Completion Date: 2024-06-30 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description The development and application of new technologies to support functional assessment and rehabilitation pathways for neurodevelopmental disabilities allow the evaluation and enhancement of cognitive, motor, and speech abilities within a more playful and motivating context. In fact telerehabilitation programs foster access to rehabilitative services and permit the delivery of a wide range of neuropsychological, motor, speech and communication interventions, even for patients unable to frequently attend a clinical institution (distance from the hospital, parental work employment, etc.), by overcoming geographic barriers. In this scenario, new technologies guarantee significant time- and cost-saving, shortening hospitalization and delivering the rehabilitative process at home, in a more ecological context (American Telemedicine Association, 2017) therefore enforcing the generalization of the achieved competences. Another great advantage provided by using innovative technologies in clinical practice to foster therapies tailored to patient's needs concerns both the possibility of collecting comprehensive and accurate quantitative data, thus supporting a better intervention monitoring, and of offering multi domain activities, also integrating peripheral devices (i.e. sensors). Using innovative technologies in clinical practice also give the possibility to propose neuropsychological and motor activities in a playful and motivating context, thus enhancing participation and enjoyment, especially for the pediatric population, while maintaining high levels of efficiency. Such telerehabilitation pathways allow to increase dosage and intensity of the intervention and ensure caregivers' involvement in the rehabilitation process. This multicenter study aims to assess the feasibility of using technological systems, primarily validated in the adult population, in children with congenital and acquired disabilities by administering ad-hoc questionnaires. ### Conditions - Neurodevelopmental Cognitive, Motor and Speech-language Disabilities ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation VRRS ### Outcomes Primary Outcomes - Scores of One shot feasibility questionnaire (5-point likert scale) - Tele-rehabilitation feasibility measures: Adherence to the study - Tele-rehabilitation feasibility measures: Adherence to the training - Tele-rehabilitation feasibility measures: Number of dropouts - Tele-rehabilitation feasibility measures: Number of sessions completed in the target time - Tele-rehabilitation feasibility measures: Technical problems encountered that prevent the program from running - Scores of training feasibility questionnaire (5-point likert scale) Secondary Outcomes - Changes in the Sustained attention subtest of Leiter 3 - Changes in the visual attention subtest (CP) of Italian battery for ADHD (BIA) - Changes in the Conners' Parent Rating Scale - Brief version - Changes in the Visuo-motor precision subtest of NEPSY II - Changes in the Developmental Test Of Visuo-Motor Integration (VMI) - Changes in the digit span forwards and backward subtests of BVN both for children aged 5-11 and for children aged 12-18 - Changes in the Corsi Block Tapping test subtest of BVS-Corsi - Changes in the Behaviour Rating inventory of executive function (BRIEF 2/P ) for parents - Changes in the route finding subtest of NEPSY II - Changes in the arrow subtest of NEPSY II - Changes in the Gross Motor Function Measure 88 (GMFM-88) - Changes in the Assisting Hand Assessment (AHA) - Changes in Both Hand Assessment (BoHA) - Changes in the Melbourne Assessment of Unilateral Upper Limb Function o Melbourne Assessment 2 (MUUL o MA2) - Changes in the Abilhand Kids - Changes in the Box and Block test (BBT) - Changes in the Movement Disorders - Childhood Rating Scale 4-18 revised (MD-CRS 4-18 R) - Changes in the 6 minutes walk test (6MWT) - Changes in the Functional Reach Test (FRT) - Changes in the Pediatric Berg Balance Scale (PBS) - Changes in the Timed up and go (TUG) ### Location - Facility: IRCCS Fondazione Stella Maris, Pisa, PI, 56128, Italy @@
## Comparison Between Mini-midline and the Peripheral Intravenous Catheter - NCT ID: NCT06290284 - Study ID: 6322 - Status: COMPLETED - Start Date: 2023-09-25 - Completion Date: 2023-12-28 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.The main questions it aims to answer are:* Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;* Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms. ### Conditions - Vascular Access Devices - Venous Puncture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Long Peripheral Catheter - Peripheral Intra-Venous Catheter ### Outcomes Primary Outcomes - Difference in proportion Secondary Outcomes - Adverse events associated with use of LPC and PIVC ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## Arterial Wall Shear Stress After Intracranial Artery Recanalization - NCT ID: NCT06290271 - Study ID: CISTAR - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-12 - Lead Sponsor: Chonbuk National University Hospital ### Study Description There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries. However, studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking. Time-of-flight magnetic resonance angiography (TOF-MRA) is extensively utilized to evaluate the intracranial arteries. The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes, leading to the development of the Signal Intensity Gradient (SIG) concept. SIG has demonstrated a strong correlation with Computational Fluid Dynamics (CFD), a known method for reflecting wall shear stress. SIG could be associated with the pathophysiology of wall shear stress. We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG. ### Conditions - Intracranial Artery Occlusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intracranial artery flow pattern ### Outcomes Primary Outcomes - Neurological Severity at discharge Secondary Outcomes ### Location - Facility: Korea University Ansan Hospital, Ansan, Gyeonggi-do, 15355, Korea, Republic of @@
## Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. - NCT ID: NCT06290258 - Study ID: 202202143A0 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-07-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis. ### Conditions - Autism Spectrum Disorder - Gastrointestinal Diseases - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fecal microbiota transplantation ### Outcomes Primary Outcomes - Changes of gastrointestinal symptoms of patients with ASD after FMT - Changes of autistic symptoms of patients with ASD after FMT Secondary Outcomes - Changes of the diversity of intestinal microbiota of patients with ASD after FMT - Changes of cytokine levels of patients with ASD after FMT - Changes of repetitive behavior symptoms of patients with ASD after FMT - Changes of autistic behavior symptoms of patients with ASD after FMT - Changes of emotion and behavior symptoms of patients with ASD after FMT - Changes of inattention and hyperactivity of patients with ASD after FMT - Changes of quality of life of patients with ASD after FMT ### Location - Facility: Wei-Chih Chin, Taoyuan city, N/A, 333423, Taiwan @@
## PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients - NCT ID: NCT06290245 - Study ID: P.T.REC/012/005045 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Cairo University ### Study Description Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life. ### Conditions - Pulmonary Disease, Chronic Obstructive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PEP Buddy - aerobic exercise ### Outcomes Primary Outcomes - dyspnea Secondary Outcomes - pulmonary function - exercise capacity - Sleep quality - Health-related quality of life (HRQoL) ### Location - Facility: Faculty of Physical Therapy, Giza, Dokki, 11432, Egypt @@
## Fetoscopic Laser Photocoagulation in Management of Vasa Previa - NCT ID: NCT06290232 - Study ID: IRB-P00044498 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Boston Children's Hospital ### Study Description In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section. ### Conditions - Vasa Previa - Pregnancy Complications - Maternal; Procedure - In Utero Procedure Affecting Fetus or Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fetoscopic Laser Photocoagulation ### Outcomes Primary Outcomes - Mode of delivery - Gestational age at delivery - Successful visualization and mapping of vasa previa - The rate of successful coagulation of the vasa previa - intraoperative imaging - The rate of successful coagulation of the vasa previa - postoperative imaging - The rate of successful coagulation of the vasa previa - pathology - Placental function Secondary Outcomes - GA at hospital admission - Duration of hospital stay - Cause for hospital admission - The rate of spontaneous preterm labor - The rate of preterm premature rupture of membranes (PPROM) - The rate of placental abruption - The rate of chorioamnionitis - The rate of chorioamniotic separation - Interval from procedure to delivery - The rate of fetal growth restriction - Fetal brain structure - The rate of NICU admission - NICU length of stay - Short term neonatal morbidity - Neonatal survival - Maternal mental health score - Postnatal examination of the placenta ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02115, United States @@
## The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction - NCT ID: NCT06290219 - Study ID: CF23509A - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-12-31 - Lead Sponsor: Taichung Veterans General Hospital ### Study Description The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia. ### Conditions - Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis) - Effect of Drug ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - platelet-rich plasma combined with hyaluronic acid - Zinc Gluconate 10 MG Oral Tablet - 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil ### Outcomes Primary Outcomes - phenyl ethyl alcohol odor detection threshold test - traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT) Secondary Outcomes - Visual Analogue Scale ### Location - Facility: Taichung Veterans General Hospital, Taichung, N/A, 40705, Taiwan @@
## PREVENT HPV-Related Cancers - NCT ID: NCT06290206 - Study ID: UU_IRB_00161649 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-06-01 - Lead Sponsor: University of Utah ### Study Description This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination. ### Conditions - Vaccine Hesitancy - HPV Vaccination - Vaccine; Uptake - Vaccination; Series Completion - Vaccine Refusal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - PREVENT ### Outcomes Primary Outcomes - Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) - RCT Arm Effectiveness: Next HPV Vaccination Step Completion Secondary Outcomes - Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) - RCT Arm Effectiveness: Next HPV Vaccination Step Completion ### Location - Facility: Sea Mar Community Health Centers, Seattle, Washington, 98108, United States @@
## Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery - NCT ID: NCT06290193 - Study ID: 23-392 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2029-02-23 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive surgery. ### Conditions - Ovarian Cancer - Fallopian Tube Carcinoma - Ovarian Carcinoma - Peritoneal Carcinoma - Ovarian Cancer Stage IIIC - Fallopian Tube Cancer Stage IIIC - Ovarian Cancer Stage IV - Fallopian Tube Cancer Stage IV - Fallopian Tube Cancer - Peritoneal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acute Normovolemic Hemodilution/ANH ### Outcomes Primary Outcomes - Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm Secondary Outcomes ### Location - Facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Healing Lodge First Face Training Evaluation Study - NCT ID: NCT06290180 - Study ID: 13632 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-03-31 - Lead Sponsor: Cambridge Health Alliance ### Study Description The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training.To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations. ### Conditions - Addiction - Depression/Anxiety - Trauma, Psychological - Self-harm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - First Face for Mental Heatlh ### Outcomes Primary Outcomes - Attitudes Towards Serious Mental Illness - Adolescent Version - First Face knowledge assessment - Perceived Competence to Respond Secondary Outcomes - Satisfaction with Training - Use of First Face learnings in professional/personal life - Intended Use of First Face learnings in professional/personal life ### Location - Facility: Healing Lodge of the Seven Nations, Spokane Valley, Washington, 99212, United States @@
## A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab - NCT ID: NCT06290167 - Study ID: 30M201 - Status: RECRUITING - Start Date: 2023-07-03 - Completion Date: 2026-04-10 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The main objective of this project is two-fold1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments. ### Conditions - Cognitive Decline ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - 360° media - Treatment As Usual (TAU) - In hospital sessions - at home sessions - Mild Cognitive Impairment - Subjective Memory Complain ### Outcomes Primary Outcomes - Cognitive functions - Motor functions Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, MI, 20149, Italy @@
## Factors Associated With Posttransplant Cardiac Outcomes - NCT ID: NCT06290154 - Study ID: RG2024-022-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant. ### Conditions - Cardiovascular Diseases - Liver Transplantation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - a composite outcome of new cardiovascular disease after liver transplantation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - NCT ID: NCT06290141 - Study ID: EFC18156 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2027-05-19 - Lead Sponsor: Sanofi ### Study Description The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. ### Conditions - Chronic Inflammatory Demyelinating Polyneuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - riliprubart - Placebo - riliprubart - Placebo - IVIg - Placebo - IVIg premedication ### Outcomes Primary Outcomes - Percentage of participants experiencing a response - Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period Secondary Outcomes - Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score - Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score - Change from baseline in grip strength (kilopascals, dominant hand) - Change from baseline in Medical Research Council Sum Score (MRC-SS) - Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) - Percentage of participants experiencing a relapse - Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L) - Number of participants with TEAEs, including SAEs and AESIs - Number of participants with treatment-emergent ADA in participants treated with riliprubart - Number of participants with TEAEs, including SAEs and AESIs - Percentage of participants randomized to riliprubart experiencing a relapse - Percentage of participants randomized to IVIg continuation experiencing a relapse - Number of participants and titer of anti-drug antibodies (ADA) - Change from baseline in I-RODS - Change from baseline in adjusted INCAT score - Change from baseline in grip strength (kilopascals; dominant hand) - Change from baseline in MRC-SS - Change from baseline in RT-FSS - Change from baseline in EQ-5D-5L score - Percentage of participants randomized to riliprubart who experience a response during the open-label period without prior response in the double-blind period (delayed response) - Percentage of participants randomized to IVIg continuation who experience a response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work - NCT ID: NCT06290128 - Study ID: EFC17236 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2027-10-12 - Lead Sponsor: Sanofi ### Study Description The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. ### Conditions - Chronic Inflammatory Demyelinating Polyradiculoneuropathy - Polyneuropathy, Inflammatory Demyelinating, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Riliprubart - Placebo - Riliprubart - Placebo ### Outcomes Primary Outcomes - Percentage of participants refractory to standard of care (SOC) experiencing a response - Percentage of participants randomized to riliprubart with lasting response - Percentage of participants randomized to placebo who experience a response - Percentage of participants randomized to riliprubart who experience a response Secondary Outcomes - Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score - Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score - Change from baseline in grip strength (kilopascals; dominant hand) - Change from baseline in Medical Research Council Sum Score (MRCSS) - Percentage of participants refractory to immunoglobulins experiencing a response - Change from baseline in the EuroQol 5 Dimension, 5Level Health Scale (EQ5D5L) - Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) - Number of participants with treatmentemergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) - Incidence and titer of anti-riliprubart antibodies (ADA) - Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) - Incidence and titer of anti-riliprubart antibodies - Change from baseline in I RODS score - Change from baseline in adjusted INCAT score - Change from baseline in grip strength (kilopascals; dominant hand) - Change from baseline in MRC-SS - Change from baseline in EQ-5D-5L score - Change from baseline in RT-FSS ### Location - Facility: Alabama Neurology Associates Site Number : 8400019, Birmingham, Alabama, 35209, United States @@
## Adolescents' Non-suicidal Behavior and Perception of Parents' Negative Emotional Expression and Family Communication - NCT ID: NCT06290115 - Study ID: 202301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The starting point of this project is to study young people and adolescents, aiming to explore the correlation between non-suicidal behavior of young people and adolescents and the negative emotional expression of their parents and family communication. The purpose of this project is to investigate the non-suicidal self-injury behavior of teenagers aged 15-25 years by issuing questionnaires (sample size: 327 people). In order to find out whether there is any connection between family communication and non-suicidal self-injury behavior of young people and adolescents. ### Conditions - Adolescents ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires set 1 - Questionnaires set 2 - Questionnaires set 3 ### Outcomes Primary Outcomes - Non-suicidal self-injury behavior of young people and adolescents - Expression of negative emotions of parents - Parent-Adolescent communication scale Secondary Outcomes - Childhood Trauma Questionnaire - Parental Bongding Instrument - The parent-child relationship intimacy scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old - NCT ID: NCT06290102 - Study ID: TV56248-RES-10204 - Status: RECRUITING - Start Date: 2024-05-02 - Completion Date: 2024-11-09 - Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. ### Study Description The primary objectives of this study are:* To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma* To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248The secondary objective is:• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - TEV-56248 - Fp MDPI ### Outcomes Primary Outcomes - Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp) - Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS) - Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp - Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS - Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp - Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS - Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp - Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS - Last Measurable Concentration Above the Quantification Limit (Clast) of Fp - Last Measurable Concentration Above the Quantification Limit (Clast) of ABS - Time of Last Measurable Concentration (tlast) of Fp - Time of Last Measurable Concentration (tlast) of ABS Secondary Outcomes - Number of Participants with Adverse Events (AEs) - Number of Participants with Serious Adverse Events (SAEs) - Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs) ### Location - Facility: Teva Investigational Site 12001, Boerne, Texas, 78006, United States @@
## Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose - NCT ID: NCT06290089 - Study ID: OEV-131 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-09 - Lead Sponsor: Scandinavian Biopharma AB ### Study Description This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E. coli (ETEC) strain. This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine.The study will be conducted at one site; the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, United States. ### Conditions - ETEC Diarrhea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Enterotoxigenic E. coli (ETEC) strain ### Outcomes Primary Outcomes - The incidence of moderate and severe diarrhea Secondary Outcomes ### Location - Facility: Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, 21205, United States @@
## A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy - NCT ID: NCT06290076 - Study ID: IAT-PROACT - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-09-30 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials. ### Conditions - Acute Ischemic Stroke - Endovascular Thrombectomy - Symptomatic Intracranial Hemorrhage - Malignant Cerebral Edema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of severe complications Secondary Outcomes - Rate of mRS score of 3-6 - Rate of mRS score of 5-6 - Rate of symptomatic intracranial hemorrhage - Rate of malignant cerebral edema - Change of NIHSS score - Rate of modified Rankin Scale (mRS) score of 0-2 - All-cause mortality ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100053, China @@
## Cannabidiol and Older Adult Cannabis Users - NCT ID: NCT06290063 - Study ID: 22-08-0138 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-08-31 - Lead Sponsor: University of Colorado, Boulder ### Study Description Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market. ### Conditions - Sleep - Anxiety - Depression - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - fsCBD Cannabidiol - bsCBD Cannabidiol - Placebo ### Outcomes Primary Outcomes - Subjective Motor Function - Balance - Anxiety - Depression - Blood Cytokine Levels - Depression/Anxiety - Drug Effects - Inhibitory Control - Cognitive Function - Pain Intensity and Interference - Cognitive Ability - Pain Intensity - Change in Condition - Sleep Disturbance - Sleep-Related Impairment - Memory Secondary Outcomes - Polypharmacy-Pain Medications - Polypharmacy-Psychiatric Medications - Polypharmacy-Sleep Medications - Strength and Endurance - Sleep Quality ### Location - Facility: University of Colorado at Boulder, Boulder, Colorado, 80309, United States @@
## A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults - NCT ID: NCT06290050 - Study ID: TAK-279-1006 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2024-05-16 - Lead Sponsor: Takeda ### Study Description The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally). ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Midazolam - Repaglinide - TAK-279 ### Outcomes Primary Outcomes - Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 - AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279 - AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 Secondary Outcomes - Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) ### Location - Facility: Celerion, Tempe, Arizona, 85283, United States @@
## Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers. - NCT ID: NCT06290037 - Study ID: 2024-01-003 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-31 - Lead Sponsor: Seoul National University Hospital ### Study Description The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result ### Conditions - Automobile Driving ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - VR Driving Simulator - Computerized Neurocognitive Function Test - Driver Test Station - Short Physical Performance Battery - On-road field driving Test ### Outcomes Primary Outcomes - Feasibility of VR driving simulator - Driving performance in simulator, measured by driving errors Secondary Outcomes ### Location - Facility: Seoul National University Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data - NCT ID: NCT06290024 - Study ID: XH-23-013 - Status: RECRUITING - Start Date: 2023-08-15 - Completion Date: 2024-08-15 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function ### Conditions - Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function ### Outcomes Primary Outcomes - Visual Analogue Scale/Score（VAS） - digital pain grading method (NRS) - neuropathic pain assessment scale (DN4) - sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale) - EEG - Barrett impulse scale (BIS) - (Generalized Anxiety Disorder,GAD-7) - (Patient Health Questionnaire-9 Secondary Outcomes - Montreal cognitive assessment scale (MoCA) - ocial support assessment scale (SSQ) ### Location - Facility: Ke Ma, Shanghai, Yangpu, 200092, China @@
## A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR - NCT ID: NCT06290011 - Study ID: XH-23-014 - Status: RECRUITING - Start Date: 2023-10-11 - Completion Date: 2024-10-11 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain ### Conditions - Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pain key group ### Outcomes Primary Outcomes - Visual Analogue Scale/Score（VAS） Secondary Outcomes ### Location - Facility: Ke Ma, Shanghai, Yangpu, 200092, China @@
## Study of Tamibarotene in Patients With ADPKD - NCT ID: NCT06289998 - Study ID: RP014-01 - Status: RECRUITING - Start Date: 2023-12-22 - Completion Date: 2025-12 - Lead Sponsor: Rege Nephro Co., Ltd. ### Study Description Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease ### Conditions - Autosomal Dominant Polycystic Kidney Disease (ADPKD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tamibarotene - Placebo ### Outcomes Primary Outcomes - Changes in TKV from baseline Secondary Outcomes - Changes in TLV from baseline - Changes in eGFR from baseline - Incidence of adverse events ### Location - Facility: Kurume University Hospital, Kurume, Fukuoka, 830-0011, Japan @@
## StrokeNet Thrombectomy Endovascular Platform - NCT ID: NCT06289985 - Study ID: STEP - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-09 - Lead Sponsor: Medical University of South Carolina ### Study Description STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO). ### Conditions - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Endovascular thrombectomy with any FDA-approved category POL or NRY device - Medical Management ### Outcomes Primary Outcomes - Global disability measured by Modified Rankin Score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire - NCT ID: NCT06289972 - Study ID: HUvbayraktaroglu1 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-02-20 - Lead Sponsor: Halic University ### Study Description The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis. ### Conditions - Cystic Fibrosis - Parents ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C) Secondary Outcomes - Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version - Parent Attitude Scale (PAS) - Perceived Social Support Scale (PSS) - Parent Attitude Scale ### Location - Facility: Haliç University, Istanbul, Eyup, 34060, Turkey @@
## Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL - NCT ID: NCT06289959 - Study ID: JD-LC2023006-I01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2029-01-01 - Lead Sponsor: Second Affiliated Hospital of Soochow University ### Study Description A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients. ### Conditions - Lymphoma, Large B-Cell, Diffuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cfDNA ### Outcomes Primary Outcomes - Progression-free survival（PFS） Secondary Outcomes - Sensitivity, and specificity of plasma cfDNA in DLBCL patients - Overall survivals(OS) ### Location - Facility: The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China @@
## Topical Nitro or Placebo Pre-Cath - NCT ID: NCT06289946 - Study ID: NitroRadialLHC - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-31 - Lead Sponsor: Thomas Jefferson University ### Study Description Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NitroBid - Placebo ### Outcomes Primary Outcomes - Crossover rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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