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## Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4） - NCT ID: NCT06319846 - Study ID: ZLRK202312 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description The CHANCE-4 study is a multicenter, double-blind, double-simulation, randomized controlled study. In patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic intracranial artery stenosis within 24 hours of onset, we will examine whether treatment with tirofiban for 48 hours reduce the risk of ischemic stroke recurrence within 90 days compared with placebo. ### Conditions - Ischemic Stroke, Acute - TIA - Symptomatic Intracranial Artery Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tirofiban - Tirofiban placebo ### Outcomes Primary Outcomes - New ischemic stroke - BARC type 3 or type 5 bleeding Secondary Outcomes - New ischemic stroke - Any new vascular events - Proportion of patients with disabling stroke - Occurrence and severity of stroke or transient ischemic attack - Proportion of patients with aggravated neurological impairment ### Location - Facility: The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150086, China @@
## Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project - NCT ID: NCT06319833 - Study ID: 348CER23 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-08 - Completion Date: 2024-07 - Lead Sponsor: University of the Balearic Islands ### Study Description A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy. ### Conditions - Physical Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical activity interacting with a video ### Outcomes Primary Outcomes - Academic achievement - Inhibition-attention and cognitive flexibility - Working memory - Selective attention - Design of active breaks: semi-structured questionnaires - Design of active breaks: semi-structured interviews Secondary Outcomes - Physical activity patterns - Self-report physical activity patterns - Self-report sedentary patterns - Self-report physical fitness - Socioeconomic level - Student's behavior - Body composition - Creativity ### Location - Facility: University of the Balearic Islands, Palma, Balearic Islands, 07122, Spain @@
## A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer - NCT ID: NCT06319820 - Study ID: 42756493BLC3004 - Status: RECRUITING - Start Date: 2024-04-18 - Completion Date: 2028-06-28 - Lead Sponsor: Janssen Research & Development, LLC ### Study Description The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC. ### Conditions - Non-Muscle Invasive Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TAR-210 - Gemcitabine - MMC ### Outcomes Primary Outcomes - Disease Free Survival (DFS) Secondary Outcomes - Time to next Treatment (TTNT) - High Grade Recurrence-free Survival (HG RFS) - Progression Free Survival (PFS) - Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment - Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) - Overall Survival (OS) - European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores - European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores - Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores - Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores ### Location - Facility: Arkansas Urology, Little Rock, Arkansas, 72211, United States @@
## GrowWell - Responsive Bottle Feeding - NCT ID: NCT06319807 - Study ID: IRB00110194 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-02 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads. ### Conditions - Bottle Feeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Digital Health Intervention - Safety Control ### Outcomes Primary Outcomes - Engagement - average text message completion rate Secondary Outcomes - Satisfaction Scores - Acceptability - Satisfaction Scores - Frequency - Satisfaction Scores - Timing ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis - NCT ID: NCT06319794 - Study ID: TQR-BTOP-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: TORQUR ### Study Description The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands ### Conditions - Actinic Keratosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bimiralisib - Bimiralisib ### Outcomes Primary Outcomes - Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 Secondary Outcomes - Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms) - Incidence of Treatment-Emergent Adverse Events - Incidence of local skin reactions ### Location - Facility: University Hospital Basel / Department of Dermatology, Basel, N/A, N/A, Switzerland @@
## A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo - NCT ID: NCT06319781 - Study ID: H-23038433 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2025-05 - Lead Sponsor: Blueskin AS ### Study Description The objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. The study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. The study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. The study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. A total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. Using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment. ### Conditions - Alopecia Areata - Vitiligo - Atopic Dermatitis - Psoriasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational ### Outcomes Primary Outcomes - Severity of the disease. - Clinical characteristics and disease activity. - Tissue profiling and disease activity. - Disease activity and biomarkers. - Quality of life. - Compliance of remote tasks. - Quality of smartphone collected photos. - Level of agreement between the in-person and remote scoring Secondary Outcomes ### Location - Facility: Sanos Clinic, Gandrup, Gandrup, N/A, 9362, Denmark @@
## Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars - NCT ID: NCT06319768 - Study ID: soh-med-24-01-04ms - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-06-15 - Lead Sponsor: Sohag University ### Study Description Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling. ### Conditions - Atrophic Acne Scar ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pentoxifylline - platelet rich plasma - combined pentoxifylline and platelet rich plasma ### Outcomes Primary Outcomes - goodman and baron qualitative grading system of postacne scarring Secondary Outcomes ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## Characteristics of Intestinal Microbiome Following Pancreatic Surgery - NCT ID: NCT06319755 - Study ID: X23-0230 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-02 - Lead Sponsor: Royal Prince Alfred Hospital, Sydney, Australia ### Study Description The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.The primary objectives of the study are:1. To explore and describe any differences in the gut microbiota especially Shannon diversity index2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.Participants will be asked to complete the following:* Three-day food, bowel and medication diary (see Protocol appendix 5)* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)* Quality of life questionnaire (see Protocol appendix 7)* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory) ### Conditions - Pancreatic Cancer - Microbiota - Pancreatoduodenectomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparison of microbiota profile between post-surgical participants and healthy controls. Secondary Outcomes - Compliance with 3-day food dairies - Pre-paid return rates - Ease of matching - Shannon diversity index - Gastrointestinal symptoms - Protein:fibre ratio of diet ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Extracellular Vesicle Surface Markers In Acute Cerebrovascular Syndromes. - NCT ID: NCT06319742 - Study ID: NSISTRCR_2201 - Status: RECRUITING - Start Date: 2022-11-18 - Completion Date: 2026-01-31 - Lead Sponsor: Ospedale Civico, Lugano ### Study Description Clinical implication of eventual blood biomarkers for stroke diagnosis and prognosis would be limited, mainly because clinical evaluation and scales (providing stroke severity) or neuroimaging (providing accurate size of the lesion) are more reliable predictors for clinical outcome prediction. In clinical practice, it would be more useful to find a biomarker, which can help to orientate the physician in conditions in which the clinical picture and imaging provide a limited support.Transient Ischemic Attacks (TIAs) represent a classical example for which a biomarker would be of interest to confirm and distinguish a brain ischemic process from a stroke mimic. Diagnostic biomarkers of TIA have been investigated, but none of the potential candidates reached enough accuracy for TIA diagnosis. Our group has found that Extracellular Vesicles (EVs) could be useful as biomarkers for detecting brain ischemia in patients with TIA because the EV-surface antigen profile appears to be different in patients with transient symptoms, adjudicated to be very likely caused by brain ischemia, compared to patients whose symptoms were less likely to due to brain ischemia. Our study has raised interest in the scientific community recognizing the promising role of of blood-derived EVs analysis in expanding the possibilities to correctly diagnose and classify TIA and stroke events, discriminate them from TIA or stroke mimics, with important future implications in management and therapy of the patients with acute ischemic cerebrovascular syndrome. the validity of our approach needs to be tested in a larger, prospective, multicenter study. ### Conditions - Stroke, TIA, Stroke-mimics, Stroke Biomarkers ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Extracellular vescicles (EV) analysis ### Outcomes Primary Outcomes - TIA differentiation from TIA mimics Secondary Outcomes - TIA differentiation from Stroke - Stroke etiology ### Location - Facility: Neurocenter of Southern Switzerland, Ospedale Civico, Lugano, Ticino, CH-6900, Switzerland @@
## A Chinese Herbal Medicine for IBS-C - NCT ID: NCT06319729 - Study ID: REC/22-23/0659 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-11-30 - Lead Sponsor: Hong Kong Baptist University ### Study Description This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up. ### Conditions - Constipation-predominant Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CDD-2105 - Placebo ### Outcomes Primary Outcomes - Abdominal Pain Responder Rate - Complete Spontaneous Bowel Movement (CSBM) Responder Rate Secondary Outcomes - Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10) - Change in the number of days of abdominal pain per week - Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency - Change in the average weekly Spontaneous Bowel Movement (SBM) frequency - Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire - Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM) - Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire - Safety: number of adverse events - Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants - NCT ID: NCT06319716 - Study ID: 23-01274 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-30 - Lead Sponsor: NYU Langone Health ### Study Description The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Video-Based Diabetes Self-Management Education and Support (DSMES) - Community Health Worker (CHW) Support ### Outcomes Primary Outcomes - Hemoglobin A1c (HbA1c) Levels - Hemoglobin A1c (HbA1c) Levels - Hemoglobin A1c (HbA1c) Levels Secondary Outcomes - Stanford Self-Efficacy for Diabetes Scale Score - Stanford Self-Efficacy for Diabetes Scale Score - Stanford Self-Efficacy for Diabetes Scale Score - Summary of Diabetes Self-Care Activities (SDSCA) Score - Summary of Diabetes Self-Care Activities (SDSCA) Score - Summary of Diabetes Self-Care Activities (SDSCA) Score - Starting the Conversation (STC) Diet Scale Score - Starting the Conversation (STC) Diet Scale Score - Starting the Conversation (STC) Diet Scale Score - International Physical Activity Questionnaire (IPAQ) Short-Version Score - International Physical Activity Questionnaire (IPAQ) Short-Version Score - International Physical Activity Questionnaire (IPAQ) Short-Version Score ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Implementing an Effective Diabetes Intervention Among Low-Income Immigrants - NCT ID: NCT06319703 - Study ID: 22-00634 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-03-31 - Lead Sponsor: NYU Langone Health ### Study Description The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Diabetes Self-Management Education and Support (DSMES) Videos - Community Health Worker Support (CHW) ### Outcomes Primary Outcomes - Change in Hemoglobin A1C (HbA1c) Test Scores - Change in Hemoglobin A1C (HbA1c) Test Scores Secondary Outcomes - Stanford Self-Efficacy for Diabetes Scale Score - Stanford Self-Efficacy for Diabetes Scale Score - Stanford Self-Efficacy for Diabetes Scale Score - Summary of Diabetes Self-Care Activities (SDSCA) Score - Summary of Diabetes Self-Care Activities (SDSCA) Score - Summary of Diabetes Self-Care Activities (SDSCA) Score - Starting the Conversation (STC) Diet Scale Score - Starting the Conversation (STC) Diet Scale Score - Starting the Conversation (STC) Diet Scale Score - National Cancer Institute Dietary Screener Questionnaire Score - National Cancer Institute Dietary Screener Questionnaire Score - National Cancer Institute Dietary Screener Questionnaire Score - International Physical Activity Questionnaire (IPAQ) Short-Version Score - International Physical Activity Questionnaire (IPAQ) Short-Version Score - International Physical Activity Questionnaire (IPAQ) Short-Version Score ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Combined Effects of Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients - NCT ID: NCT06319690 - Study ID: REC/RCR&AHS/23/0362 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-15 - Lead Sponsor: Riphah International University ### Study Description This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure. ### Conditions - Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lion's Breath Technique - Chest Percussion Therapy ### Outcomes Primary Outcomes - George respiratory questionnaire - Forced vital capacity (FVC) - Borg Dyspnea Scale - Forced expiratory volume (FEV1) - FEV1/FVC Ratio Secondary Outcomes ### Location - Facility: Jinnah Hospital, Lahore, Punjab, 42000, Pakistan @@
## PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment - NCT ID: NCT06319677 - Study ID: Ivljingjing - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: The Third Xiangya Hospital of Central South University ### Study Description Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients. ### Conditions - Critical Illness - Extracorporeal Membrane Oxygenation Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ECMO treatment ### Outcomes Primary Outcomes - Blood drug concentration - Pharmacokinetic parameter - Pharmacokinetic parameter Secondary Outcomes - Mortality at 14 and 28 days ### Location - Facility: Xiangya Third Hospital, Central South University, Changsha, Hunan, N/A, China @@
## Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas - NCT ID: NCT06319664 - Study ID: sjnkzzj - Status: COMPLETED - Start Date: 2021-05-27 - Completion Date: 2021-09-10 - Lead Sponsor: Xiangya Hospital of Central South University ### Study Description Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. We retrospectively analyzed the clinical characteristics, surgical approaches, outcomes and follow-up data from 179 cases of PCM from January 2011 to December 2020. We modified the previous classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P \< 0.05 was considered statistically significant. ### Conditions - Skull Base Meningioma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - retrosigmoid approach (RSA) - subtemporal transtentorial transpetrosal approach (STTA) - extended pterional transtentorial approach (EPTA) - pretemporal trancavernous anterior transpetrosal approach (PTCA) - presigmoid combined supra-infratentorial approach (PCA) - inoperable ### Outcomes Primary Outcomes - QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score Secondary Outcomes ### Location - Facility: Xiangya Hospital, Central South University, Changsha, Hunan, 410000, China @@
## Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation - NCT ID: NCT06319651 - Study ID: REC/RCR&AHS/23/0360 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-15 - Lead Sponsor: Riphah International University ### Study Description This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure. ### Conditions - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Lower Limb Resistance Band Exercises - Routine Phase 1 cardiac rehabilitation ### Outcomes Primary Outcomes - Functional Independence Measure - 6 Minute Walk Test - Forced expiratory volume (FEV1) - Forced vital capacity (FVC) - FEV1/FVC ratio Secondary Outcomes ### Location - Facility: Rehmatul lil Alameen Institute of cardiology, Lahore, Punjab, 42000, Pakistan @@
## Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients - NCT ID: NCT06319638 - Study ID: SGB TBI - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Stellate ganglion block - Placebo block - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Modified Barthel Index - Swallowing duration - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Stellate Ganglion Block in Patients Diagnosed With Parkinson's Disease - NCT ID: NCT06319625 - Study ID: SGB PARKINSON - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Stellate ganglion block - Lidocaine hydrochloride - Placebo injection ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Modified Barthel Index - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea - NCT ID: NCT06319612 - Study ID: SGB OSA DOUBLE BLIND - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - routine rehabilitation treatment - Stellate ganglion block - Lidocaine Hydrochloride - Placebo injection ### Outcomes Primary Outcomes - Epworth Sleepiness Scale Secondary Outcomes - Apnea-Hypopnea Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stellate Ganglion Block in Children With Autistic Disorder - NCT ID: NCT06319599 - Study ID: SGB GUDU - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated. ### Conditions - Autistic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine therapy - Stellate ganglion block - Lidocaine hydrochloride - placebo injection ### Outcomes Primary Outcomes - Childhood Autism Rating Scale Secondary Outcomes - Children's Communication Checklist - Social Interaction Assessment Scale - Children's Depression Inventory - Childhood Anxiety Sensitivity Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries - NCT ID: NCT06319586 - Study ID: Soh-Med-24-02-08MS - Status: COMPLETED - Start Date: 2024-02-07 - Completion Date: 2024-02-07 - Lead Sponsor: Sohag University ### Study Description The radial forearm flap is a very useful and versatile flap with a long vascular pedicle and a thin, pliable skin. It's used in reconstruction of the mutilated hand as a reverse pedicled flap. The dominant pedicle is the radial artery, with venous outflow through the dual system of the venae comitantes and cephalic vein. Sensory innervation may be derived from the medial and lateral antebrachial cutaneous nerves. The radial forearm flap offers the advantage of a large area of donor tissue from the involved extremity with the potential for inclusion of bone, nerve, and tendon grafts. Sacrifice of the radial artery has not been associated with significant patient symptoms However, the donor defect can be troublesome, frequently requiring skin grafting directly over the paratenon of the flexor tendons, producing an undesirable donor site appearance ### Conditions - for Upper Limb Soft Tissue Coverage ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radial Forearm Flap ### Outcomes Primary Outcomes - Viability of the flap Secondary Outcomes ### Location - Facility: Sohag University hospitals, Sohag, N/A, N/A, Egypt @@
## The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization - NCT ID: NCT06319573 - Study ID: 2305-UNIVF-070-DC - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2026-02-28 - Lead Sponsor: Ginefiv ### Study Description This study will be conducted in two phases. In the first phase, research subjects will be assigned to receive standard counseling. In the second phase, research subjects will receive Univfy counseling. ### Conditions - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Counseling Supported by Univfy® Report - Standard Counseling ### Outcomes Primary Outcomes - Treatment utilization (conversion) rate in the two groups - Patient experience responses - Validation of Univfy prediction upon CLBdR - Retention Rate - Time to Pregnancy Secondary Outcomes - Self-reported satisfaction related to psychological support and cost of treatment ### Location - Facility: Ginefiv S.L, Barcelona, N/A, 08015, Spain @@
## Hydroxychloroquine in Type 2 Diabetes During Pregnancy - NCT ID: NCT06319560 - Study ID: JEP-2023-866 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2027-01-01 - Lead Sponsor: National University of Malaysia ### Study Description The goal of this clinical trial is to compare the use of hydroxychloroquine as an adjunct to the current treatment of pregnant women with Type 2 diabetes mellitus.The main questions it aims to answer are:* Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy?* Does hydroxychloroquine improve the inflammatory markers in women with type 2 diabetes during pregnancy? Participants will be randomised into the intervention and control group. The control group will be on standard treatment where as the intervention group will receive hydroxychloroquine as an adjunct of standard treatment ### Conditions - Diabetes in Pregnancy - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hydroxychloroquine Oral Tablet ### Outcomes Primary Outcomes - To compare the serum glycated haemoglobin between the two groups - To compare the serum fructosamine between the two groups - To compare the serum interleukin-6 between the two groups - To compare the serum interleukin-10 between the two groups - To compare the serum tumour necrosis factor alpha between the two groups - To compare the shearwave elastography of the placenta between the two groups Secondary Outcomes - To compare the gestational age at delivery between the two groups - Type of labour - Mode of delivery - Postpartum haemorrhage - Third or fourth degree perineal tear - Neonatal birth weight at delivery - Large for gestational age or macrosomia - Shoulder dystocia - Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes - Arterial cord pH at birth - Number of neonates needing admission into neonatal intensive care unit - Height or length of neonates - Weight of the neonates - Hospital admission ### Location - Facility: Antenatal clinic, UKM Medical Centre, Cheras, Kuala Lumpur, 56000, Malaysia @@
## Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax - NCT ID: NCT06319547 - Study ID: Soh-Med-24-02-07MS - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-03 - Lead Sponsor: Sohag University ### Study Description Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022). ### Conditions - Hepatic Hydrothorax ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thoracocentasis ### Outcomes Primary Outcomes - percentage of empyema in patients with hepatic hydrothorax after thoracocentesis Secondary Outcomes ### Location - Facility: Sohag University hospitals, Sohag, N/A, N/A, Egypt @@
## Stellate Ganglion Block in Bulbar Palsy - NCT ID: NCT06319534 - Study ID: SGB-ZHENQIU - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function. ### Conditions - Bulbar Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive rehabilitation - Stellate ganglion block - Lidocaine Hydrochloride - placebo injection ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Functional Oral Intake Scale - Murray secretion severity scale - Yale pharyngeal residue severity rating scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stellate Ganglion Block on Gastroesophageal Reflux Disease - NCT ID: NCT06319521 - Study ID: SGB-REFLUX - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom. ### Conditions - Gastroesophageal Reflux Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Stellate ganglion block - Lidocaine hydrochloride - Placebo injection ### Outcomes Primary Outcomes - Gastroesophageal Reflux Disease Questionnaire Secondary Outcomes - Pressure pain threshold - Modified Mayo Clinic Dysphagia-30 questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stellate Ganglion Block in Cerebral Palsy - NCT ID: NCT06319508 - Study ID: SGB-NT - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - routine rehabilitation treatment - Stellate ganglion block - Lidocaine hydrochloride - Placebo injection ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Swallowing duration - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease - NCT ID: NCT06319495 - Study ID: SGB-CSVD - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Copka Sonpashan ### Study Description This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index. ### Conditions - Cerebral Small Vessel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Stellate ganglion block - Lidocaine Hydrochloride - placebo injection ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Modified Barthel Index - Mini-Mental State Examination - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Adherence of Proactive Sleep Apnea Therapy - NCT ID: NCT06319482 - Study ID: Adherence Study - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-08-01 - Lead Sponsor: NovaResp Technologies Inc ### Study Description The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients.2. To compare health outcomes (AHI, nightly pressure, and patient-reported outcomes) between proactive therapy and conventional APAP therapy. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Proactive CPAP Therapy - Conventional APAP Therapy ### Outcomes Primary Outcomes - Adherence Secondary Outcomes - Apnea-Hypopnea Index - Pressure - Self-assessed sleep outcomes - Self-assessed functional outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention - NCT ID: NCT06319469 - Study ID: FMBSUREC/06122022/Mohamed - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-01-30 - Lead Sponsor: Beni-Suef University ### Study Description Acute urine retention, AUR, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. This study aims to evaluate whether pyridostigmine bromide added to silodosin is beneficial in treating acute urine retention caused by BPH. ### Conditions - Prostatic Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet - silodosin 8 mg capsule ### Outcomes Primary Outcomes - International Prostate Symptom Score (IPSS) Secondary Outcomes ### Location - Facility: Beni-Seuf University Hospital, Banī Suwayf, N/A, N/A, Egypt @@
## A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. - NCT ID: NCT06319456 - Study ID: APG2575CC301 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-08 - Lead Sponsor: Ascentage Pharma Group Inc. ### Study Description This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL. ### Conditions - CLL/SLL ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lisaftoclax (APG-2575) - Acalabrutinib - Fludarabine - Cyclophosphamide，CTX - Rituximab - Chlorambucil ### Outcomes Primary Outcomes - Progress Free Survival (PFS) Secondary Outcomes - Objective Response Rate (ORR) - Minimal Residual Disease (MRD) negativity rate - Safety evaluation based on the adverse event concurrence ### Location - Facility: The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233004, China @@
## Daily Vinegar Ingestion and 24-Hour Blood Glucose Control - NCT ID: NCT06319443 - Study ID: STUDY00019235 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-04 - Lead Sponsor: Arizona State University ### Study Description When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7.Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant. ### Conditions - Glucose Intolerance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Liquid vinegar - vinegar pill ### Outcomes Primary Outcomes - Average glucose - Glucose: time in range Secondary Outcomes ### Location - Facility: 850 PBC, Phoenix, Arizona, 85004, United States @@
## Technology in Play for Children With Physical Disabilities: the Dice Model of Play - NCT ID: NCT06319430 - Study ID: HS26236(H2023:343) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-28 - Lead Sponsor: University of Manitoba ### Study Description Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to kids that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study. ### Conditions - Physical Disability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - robots - conventional ### Outcomes Primary Outcomes - Test of Playfulness - The Child Initiated Pretend Play Assessment (ChIPPA-2) - The Pretend Play Enjoyment-Developmental Checklist (PPE-DC) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients - NCT ID: NCT06319417 - Study ID: HT-UCAM - Status: COMPLETED - Start Date: 2022-04-15 - Completion Date: 2023-03-23 - Lead Sponsor: Universidad Católica San Antonio de Murcia ### Study Description The goal of this double-blind crossover randomized clinical trial is to evaluate the impact of a phenolic natural compound called hydroxytyrosol (HT) on patients at cardiovascular risk (CVR). The main questions it aims to answer are:* Evaluating the effect of HT caramels on CVR biomarkers.* Assessing the impact of HT caramels on cellular phenotype.Participants will take 4 caramels/day, each containing 15 mg of HT, consuming a daily intake of 60 mg for 28 days. One group will begin with HT caramel consumption for 28 days, while the other group will start with a placebo treatment. Following a 2-week washout period, the treatments will be switched between the groups. Those who initially consumed HT will then switch to the placebo treatment, and vice-versa, each for a duration of 28 days. ### Conditions - Cardiovascular Pathology ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - HT treatment - Placebo treatment ### Outcomes Primary Outcomes - Change of cardiovascular biomarkers - Change of cellular phenotype of platelets Secondary Outcomes ### Location - Facility: Catholic University of Murcia (UCAM), Murcia, N/A, 30107, Spain @@
## Immune Function of Colorectal Cancer Lymph Nodes - NCT ID: NCT06319404 - Study ID: 2022YFC2505700 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Shanxi Province Cancer Hospital ### Study Description Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data. ### Conditions - Colorectal Cancer - Lymph Node ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - N/A ### Outcomes Primary Outcomes - To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics - To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics - The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Analysis of the Effect of Donor CYP3A5 Gene Polymorphism on Early Tacrolimus Concentration and Postoperative Acute Renal Injury After Liver Transplantation - NCT ID: NCT06319391 - Study ID: JSZ007 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-01 - Completion Date: 2025-10-01 - Lead Sponsor: Ziqiang Li ### Study Description Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or high dose will lead to infection and liver and kidney toxicity and other adverse reactions. Moreover, the conventional drug testing can not fully reflect the efficacy of tacrolimus, and there are shortcomings of lag, experience and passivity. FK506 is metabolized primarily by cytochrome P450 member 3A5 in the liver and intestines. CYP3A5\3 is the most important factor determining the expression level of CYP3A5. This mutation can cause variable shear and produce unstable protein, so that patients carrying CYP3A5\3/\3 gene do not express CYP3A5. Acute kidney injury is a common and important complication after liver transplantation. Despite recent advances in organ preservation, surgical techniques, and immunosuppressive protocols, the incidence of AKI after orthotopic liver transplantation remains high. AKI has a significant impact on both short - and long-term prognosis of orthotopic liver transplantation recipients. Studies have shown that orthotopic liver transplantation recipients with AKI have significantly higher mortality rates in hospital, at 28 days and at 1 year after surgery than those without AKI. In this study, the relationship between donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration was investigated, and the effect of donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration on acute kidney injury after liver transplantation was investigated. To provide guidance for individual administration of gene-directed tacrolimus in patients, and provide basis for prevention and reduction of postoperative acute kidney injury in liver transplantation patients. ### Conditions - Complete and Accurate Statistical Data of 60 Patients - CYP3A53 Genotypes of 60 Donors and Recipients Were Analyzed Accurately - Postoperative Tacrolimus Concentrations Were Accurately Recorded in 60 Patients - According to the Diagnosis and Grading Criteria of Acute Kidney Injury, the Cases and Grading of Postoperative Acute Kidney Injury in 60 Patients Were Counted - Scientific and Rigorous Statistical Analysis of Data ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CYP3A51、CYP3A513 - CYP3A533 ### Outcomes Primary Outcomes - Fk506 - Scr Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital), Jinan, Shandong, 250013, China @@
## Cancer Related Major Depression Treated With a Single Dose of Psilocybin - NCT ID: NCT06319378 - Study ID: CAPSI no 2 date 231024 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2025-12 - Lead Sponsor: Section for Affective Disorders; Northern Stockholm Psychiatry ### Study Description The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives). ### Conditions - MDD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - psilocybin 25 mg sod - psilocybin 1 mg sod ### Outcomes Primary Outcomes - MADRS at day 42 Secondary Outcomes - MADRS day 8 - MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1) - SDS at Day 42 - CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6) - EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6) - AQOL-6D at Day 42 (ANCOVA x1) - MADRS at Day 90 and Day 180 (ANCOVA x2) - MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1) - SDS at Day 180 (ANCOVA x3) - GAD-7 at Day 180 (ANCOVA x3) - HADS at Day 180 (ANCOVA x3) - CGI at Day 90 and Day 180 (ANCOVA x6) - EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6) - AQOL-6D at Day 90 and Day 180 (ANCOVA x2) - GAD-7 at Day 42 - HADS at Day 42 ### Location - Facility: region Västra Götaland, Göteborg, N/A, N/A, Sweden @@
## Yoga on Women's Blood Pressure, Sexual Life, And Marital Compliance - NCT ID: NCT06319365 - Study ID: gurcansolmaz - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-03-22 - Lead Sponsor: University of Yalova ### Study Description Introduction This study will examine the effects of a 12-week yoga program consisting of one-hour sessions three times a week on blood pressure, sexual life and marital adjustment among hypertensive women. Hypertension can adversely affect vascular health and affect marital relationships by contributing to sexual dysfunction.Method. The study will be a pre-post test randomized controlled study in accordance with CONSORT rules. Personal Information Form, Bloood pressure measurement, Arizona Sexual Experience Scale and Marital Adjustment Test will be used for data collection. ### Conditions - Hypertension - Sexuality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - yoga ### Outcomes Primary Outcomes - blood presure Secondary Outcomes ### Location - Facility: Yalova University, Yalova, N/A, N/A, Turkey @@
## Evaluation of Quality-of-Life Improvements Using UroShield Device - NCT ID: NCT06319352 - Study ID: HUM00243293 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2024-10 - Lead Sponsor: University of Michigan ### Study Description The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.The main questions the investigators aim to answer focus on implementation and practicality:* Recruitment feasibility and time to recruit* How well do participants adhere to device protocol?* How often do device components (i.e., actuators and drivers) have to be replaced?* How much time is required for data collection and what sources or methods for data collection are used?Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow. ### Conditions - Quality of Life - Catheter-Associated Urinary Tract Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Active UroShield - Sham UroShield ### Outcomes Primary Outcomes - Recruitment rate Secondary Outcomes - Device use adherence - Device accountability - Efficiency of data collection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease - NCT ID: NCT06319339 - Study ID: 0419-23-FB - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-08 - Lead Sponsor: University of Nebraska ### Study Description Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate. ### Conditions - Peripheral Artery Disease - Peripheral Vascular Diseases - Peripheral Arterial Disease - Peripheral Arterial Occlusive Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Vumerity - Placebo ### Outcomes Primary Outcomes - Macrovascular Endothelial Function - Oxygen Transfer and Utilization - Femoral and Popliteal Artery Blood Flow - Walking capacity Secondary Outcomes - Autonomic Nervous Activity - Arterial Stiffness - Circulating blood markers of Oxidative Stress and Antioxidants ### Location - Facility: University of Nebraska - Omaha, Omaha, Nebraska, 68182, United States @@
## Intestinal Perfusion After Feeding in Preterm and Term Infants - NCT ID: NCT06319326 - Study ID: Postfeed Intestinal Perfusion - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-08-31 - Lead Sponsor: The Hospital for Sick Children ### Study Description This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants. ### Conditions - Premature - Necrotizing Enterocolitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding. ### Outcomes Primary Outcomes - Time-averaged mean velocity of the superior mesenteric artery Secondary Outcomes - Bowel wall perfusion ### Location - Facility: Children's Hospital of Fudan University (Xiamen Branch), Xiamen, Fujian, 361000, China @@
## Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer - NCT ID: NCT06319313 - Study ID: JMT101-013 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-01 - Lead Sponsor: Shanghai JMT-Bio Inc. ### Study Description This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）. ### Conditions - Squamous Cell Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JMT101 - docetaxel - HB1801 ### Outcomes Primary Outcomes - Overall response rate (ORR) - Overall Survival (OS) - Incidence and severity of adverse events (AE) and serious adverse events (SAE) Secondary Outcomes - Progression-free Survival (PFS) - Disease Control Rate (DCR) - Duration of response（DOR） - JMT101 Concentrations in Plasma - Total and Free Docetaxel Concentrations in Plasma ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards - NCT ID: NCT06319300 - Study ID: 20240115023245436 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2026-05-20 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups. ### Conditions - Diabetes Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AI-assisted insulin dose adjustment model - doctor's insulin dose adjustment ### Outcomes Primary Outcomes - time in target range (3.9-10.0 mmol/L ) Secondary Outcomes - sensor glucose - capillary blood sugar - hypoglycaemic event - hyperglycaemic event - insulin dosage - satisfaction score of doctors - Length of hospitalisation - Other/Serious Adverse Events ### Location - Facility: Zhongshan Hospital, Fudan University, Shanghai, Shanghai, 200032, China @@
## Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU) - NCT ID: NCT06319287 - Study ID: PRO-00125 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-07-12 - Lead Sponsor: Rion Inc. ### Study Description A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU) ### Conditions - Diabetic Foot Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PEP (Purified Exosome Product) / TISSEEL ### Outcomes Primary Outcomes - Wound Closure - Safety Secondary Outcomes - Percent Area Reduction of Wound at 12 Weeks ### Location - Facility: Professional Education & Research Institute (PERI), Blue Ash, Ohio, 45242, United States @@
## Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure - NCT ID: NCT06319274 - Study ID: COMBAT-ARF - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-30 - Lead Sponsor: Pär Johansson ### Study Description The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival. ### Conditions - Acute Respiratory Failure - Endothelial Dysfunction - Pulmonary Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Iloprost - Isotonic saline ### Outcomes Primary Outcomes - 28-day mortality Secondary Outcomes - 90-day mortality - Vasopressor-free days - Renal replacement-free days - Mechanical ventilation free days - Serious adverse reactions (SARs) - Serious adverse events (SAEs) ### Location - Facility: Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital, Copenhagen, N/A, 2400, Denmark @@
## Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets. - NCT ID: NCT06319261 - Study ID: 858623 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: University of Baghdad ### Study Description the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.the objectives are1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.For each patient, each site will be randomly assigned to either treatment protocol:1. Sites treated with GBT.2. Sites treated with conventional manual instrumentation only. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - guided biofilm therapy - root surface debridement ### Outcomes Primary Outcomes - Periodontal pocket depth (PPD) Secondary Outcomes - Plaque index - Bleeding on probing - Relative attachment level - Changes in the bacterial load ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of Midodrine in Septic Shock Patients - NCT ID: NCT06319248 - Study ID: 24-000121 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-07-30 - Lead Sponsor: Mayo Clinic ### Study Description This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall. ### Conditions - Sepsis - Low Blood Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Midodrine - Placebo ### Outcomes Primary Outcomes - Time alive and without vasopressor support Secondary Outcomes - Total vasopressor requirements - Central venous access duration - Cumulative fluid balance over the first 48 hours - Cumulative fluid balance up to 7 days of ICU stay - ICU Length of Stay - Hospital Length of Stay - ICU, hospital, and organ support-free days ### Location - Facility: Mayo Clinic Minnesota, Rochester, Minnesota, 55905, United States @@
## Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® - NCT ID: NCT06319235 - Study ID: DUO2022_01 - Status: RECRUITING - Start Date: 2023-10-27 - Completion Date: 2025-12-31 - Lead Sponsor: MB PHARMA s.r.o. ### Study Description DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S. aureus and P. aeruginosa.The primary objective of the study is to demonstrate the safety of DUOFAG® and the clinical and microbiological change within 10 weeks after the start of treatment or until healing. ### Conditions - Surgical Site Infection - Staphylococcus Aureus Infection - Pseudomonas Aeruginosa Infection - Bacterial Infections - Surgical Wound Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IMP - Placebo ### Outcomes Primary Outcomes - Primary endpoint - Cohort 1 - Primary endpoint - pooled Cohorts 1 & 2 Secondary Outcomes - Safety endpoints (assessed in pooled Cohorts 1 & 2) - Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2) - Clinical efficacy endpoints ### Location - Facility: St. Anne's University Hospital Brno, Brno, Czech Republic, 602 00, Czechia @@
## Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC) - NCT ID: NCT06319222 - Study ID: 23-007870 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-04 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment. ### Conditions - Alcohol Use Disorder - Liver Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - DALC Digital Clinic ### Outcomes Primary Outcomes - Median delta MELD-3.0 from baseline to end of study. Secondary Outcomes - Sustained alcohol abstinence - Reduction of Number of hospitalizations - Greater provider satisfaction in DALC arm ### Location - Facility: Mayo Clinic Arizona, Scottsdale, Arizona, 85259, United States @@
## Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection - NCT ID: NCT06319209 - Study ID: 2024KY023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-03-31 - Lead Sponsor: Fujian Medical University Union Hospital ### Study Description Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors. ### Conditions - Breast Cancer - COVID-19 - Postoperative Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Preoperative resolved COVID-19 ### Outcomes Primary Outcomes - 30-day postoperative outcomes Secondary Outcomes - Postoperative outcomes at the time of the initial tumor assessment after surgery - 12-month postoperative outcomes ### Location - Facility: Fujian Medical University Union Hospital, Fuzhou, Fujian, N/A, China @@
## Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma - NCT ID: NCT06319196 - Study ID: Clear Me - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-02-15 - Lead Sponsor: University Health Network, Toronto ### Study Description Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study. ### Conditions - Cutaneous Melanoma - Melanoma Stage IV - Mucosal Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Opdualag - Nivolumab ### Outcomes Primary Outcomes - Clearance of ctDNA at 12 months after starting adjuvant treatment. ctDNA clearance is defined as no detection of plasma ctDNA Secondary Outcomes - Recurrence-free survival (RFS) - Number and severity of treatment related adverse events according to CTCAE v5.0. ### Location - Facility: UHN- Princess Margaret Cancer Center, Toronto, Ontario, M5G 1Z5, Canada @@
## The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis - NCT ID: NCT06319183 - Study ID: 2023tjdxsy045 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Tongji University ### Study Description In recent years, obesity and its complications have severely threatened human health. Given the limited options for obesity treatment currently available, there is an urgent need to develop new drugs and therapeutic methods to alleviate patient suffering.Mammalian adipose tissue is primarily divided into energy-storing white fat and energy-consuming brown fat. Physical activity, exposure to cold, and other factors induce the transformation of white fat into energy-consuming brown fat, a process known as adipose tissue browning. The occurrence of adipose tissue browning increases the body's energy expenditure and dissipates it in the form of heat, effectively mitigating the onset of obesity. Therefore, the regulatory mechanism of adipose tissue browning has become an important potential target for obesity treatment.The main component of asthma medication is the β2 adrenergic receptor agonist, which can act on GPCR receptors on the surface of the tracheal smooth muscle through inhalation, causing bronchial dilation and thereby alleviating asthma symptoms. Preliminary experimental results have shown that pulmonary epithelial cells can secrete protein factors that regulate the browning process of adipose tissue, and the expression of these secretory factors is regulated by the cell surface GPCR receptor signaling pathway. Therefore, our goal is to validate the regulatory effect of the asthma medication salbutamol on adipose tissue browning through inhalation administration in humans, establishing a new function for asthma medication in obesity treatment. ### Conditions - Effect of Asthma Medication Salbutamol on Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Salbutamol ### Outcomes Primary Outcomes - Temperature of Scapular Region Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder - NCT ID: NCT06319170 - Study ID: TV44749-NPC-10205 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-12-11 - Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. ### Study Description The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine.Another secondary objective is to characterize the pharmacokinetics of ZYPREXA.The planned duration of the study for each participant is 19 weeks. ### Conditions - Schizophrenia, Schizoaffective Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Olanzapine Extended Release - Olanzapine ### Outcomes Primary Outcomes - Maximum observed plasma drug concentration (Cmax) - Area under the plasma drug concentration-time curve (AUC) - AUC extrapolated to infinity (AUC0-∞) Secondary Outcomes - Number of participants with at least 1 treatment-emergent adverse event (TEAE) - Number of participants with at least 1 serious adverse event (SAE) - Cmax of ZYPREXA - AUC of ZYPREXA - Apparent plasma terminal elimination rate constant (λz) of ZYPREXA ### Location - Facility: Teva Investigational Site 15727, Hollywood, Florida, 33024, United States @@
## Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction - NCT ID: NCT06319157 - Study ID: SYSKY-2023-1263-02 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2028-11 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction. ### Conditions - Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - minimal access breast reconstruction with a latissimus dorsi muscle flap - conventional breast reconstruction with a latissimus dorsi muscle flap ### Outcomes Primary Outcomes - Breast Q-satisfaction with back Secondary Outcomes - Patient satisfaction - Latissimus dorsi acquisition time - Intraoperative blood loss - Postoperative pain - Postoperative complications ### Location - Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China @@
## Effect of Intravenous 5% Dextrose Infusion During Recovery From Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy - NCT ID: NCT06319144 - Study ID: KYLL20240306-1 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-05-05 - Lead Sponsor: Weifang Medical University ### Study Description The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period. ### Conditions - Insulin Resistance - Postoperative Nausea and Vomiting - Quality of Recovery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 5% glucose - 0.9% Normal Saline ### Outcomes Primary Outcomes - Preoperative blood glucose 30min - Postoperative blood glucose 30min - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Postoperative nausea and vomiting Secondary Outcomes - Anesthesia awakening time - Dizziness level - Dizziness level - Dizziness level - Quality of postoperative recovery (QoR40) ### Location - Facility: Lin Cheng, Weifang, Shandong, 261041, China @@
## Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT - NCT ID: NCT06319131 - Study ID: Tipharosis - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-30 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial ### Conditions - Portal Vein Thrombosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TIPS - Nadroparin ### Outcomes Primary Outcomes - complete recanalization rate of PVT Secondary Outcomes - partial recanalization rate of PVT - Bleeding rate - Mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease. - NCT ID: NCT06319118 - Study ID: JD-LK2023091-I01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-12-30 - Lead Sponsor: Second Affiliated Hospital of Soochow University ### Study Description Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\'s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\'s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients. ### Conditions - Salivation in Parkinson's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - dihydroergotine mesylate sustained-release tablets ### Outcomes Primary Outcomes - the objective weight of saliva in patients with Parkinson's disease changed from baseline Secondary Outcomes ### Location - Facility: The Second Arilliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China @@
## PathToScale: An Implementation Evaluation - NCT ID: NCT06319105 - Study ID: 775736 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-04-01 - Lead Sponsor: Georgetown University ### Study Description The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels. ### Conditions - Oral Pre-exposure Prophylaxis (PrEP) - Long-acting Injectable Cabotegravir for PrEP ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Standard intervention: Offer PrEP choice ### Outcomes Primary Outcomes - Pre-exposure prophylaxis uptake by modality - Pre-exposure prophylaxis uptake by delivery channel - Pre-exposure prophylaxis uptake by population - Pre-exposure prophylaxis continuation by modality - Pre-exposure prophylaxis continuation by delivery channel - Pre-exposure prophylaxis continuation by population - Rates of switching between oral and injectable pre-exposure prophylaxis Secondary Outcomes - Implementation readiness - Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users - Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users ### Location - Facility: Community Health Science Unit, Lilongwe, N/A, N/A, Malawi @@
## Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test - NCT ID: NCT06319092 - Study ID: 2023/175 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-12-01 - Lead Sponsor: Gaziantep Islam Science and Technology University ### Study Description The 6 Minute Pegboard and Ring Test is a test applicable to the upper extremities. The upper extremity plays an important role in activities of daily living, especially in tasks related to reaching, grasping and holding objects. Various activities of daily living, such as combing hair, brushing teeth and picking up objects, require supported or unsupported upper limb activity. Therefore, evaluation of upper extremity function is important. In addition, it is a simple test, it is also seen as a game, its application is functional, and there is no need for expensive equipment. Its validity and reliability have been demonstrated only for patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy adults. In addition, to the best of our knowledge, the suitability of this test in a virtual environment has not been evaluated in the literature. Therefore, the main aim of this study is to examine the applicability of this test in a virtual environment. ### Conditions - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 6 Minute Pegboard and Ring Test - Immersive virtual reality version of the 6 Minute Pegboard and Ring Test Secondary Outcomes - Quick Shoulder-Hand Syndromes Questionnaire - Assessment of handgrip - 9 Hole Peg Test ### Location - Facility: Gaziantep İslamic Science and Technology University, Gaziantep, Şahinbey, 27000, Turkey @@
## Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition - NCT ID: NCT06319079 - Study ID: UCTH 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-07 - Lead Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri ### Study Description Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients and this will have consequences on the growth and development of the child. In 2021 at IDIP, a specific milk product for pregnant and lactating women Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals and DHA ) has been designed and developed as part of a key strategy to incorporate in public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level.The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life. ### Conditions - Lactating Mothers - Infants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Fortified powder milk - Powder milk ### Outcomes Primary Outcomes - breast milk DHA concentration - breast milk Vitamin A concentration - breast milk Vitamin E concentration - breast milk Vitamin D concentration - breast milk Zinc concentration - breast milk Calcium concentration - breast milk Iron concentration - breast milk Iodine concentration Secondary Outcomes - mother red blood cell DHA concentration - mother Vit A concentration - mother Vit E concentration - mother Vit D concentration - mother Zinc concentration - mother hemoglobin concentration - mother serum ferritin concentration - child hemoglobin concentration - child serum ferritin concentration - child red blood cell DHA concentration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain - NCT ID: NCT06319066 - Study ID: RGNS65-152 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Mahidol University ### Study Description The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant. ### Conditions - Foot Orthoses - Fasciitis, Plantar ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - orthotic wedge - CFO ### Outcomes Primary Outcomes - Pain intensity and foot function - Plantar Fascia Thickness - Gait assessment - Balance assessment Secondary Outcomes - Low back and Lower-extremity pain - Transversus abdominis (TrA) Thickness ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Turbine-based Insufflator Safety and Feasibility Study - NCT ID: NCT06319053 - Study ID: NL85402.078.23 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-10 - Lead Sponsor: Erasmus Medical Center ### Study Description The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device. ### Conditions - Laparoscopy - Pneumoperitoneum ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Turbine-based insufflator ### Outcomes Primary Outcomes - Occurrence of (serious) adverse device effects [Safety and feasibility of the device] Secondary Outcomes - Observation of insufflation pressure stability by continuously monitoring and recording. - Gas volume exchange - Estimation of the abdominal compliance - Intra-abdominal target pressure in relation to the abdominal compliance ### Location - Facility: Erasmus MC, University Medical Center Rotterdam, Rotterdam, Zuid Holland, 3015 GD, Netherlands @@
## The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery - NCT ID: NCT06319040 - Study ID: MEDİPOL MEGA 1 - Status: COMPLETED - Start Date: 2018-12-06 - Completion Date: 2019-06-07 - Lead Sponsor: Medipol University ### Study Description Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR. ### Conditions - Anterior Cruciate Ligament Injuries - Meniscus Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Muscle strength measurement - Knee joint proprioception - Balance - Fall risk test - Tegner Activity Level - Lysholm Knee Scoring Scale ### Outcomes Primary Outcomes - muscle strength measurement Secondary Outcomes ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, N/A, Turkey @@
## Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial - NCT ID: NCT06319027 - Study ID: EAF223 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2027-05-31 - Lead Sponsor: ECOG-ACRIN Cancer Research Group ### Study Description This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor. ### Conditions - Glioblastoma, IDH-Wildtype ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging - Fluciclovine F18 - Gadolinium-Chelate - Magnetic Resonance Spectroscopy - Positron Emission Tomography ### Outcomes Primary Outcomes - Overall survival (OS) - Event free survival (EFS) Secondary Outcomes - True disease progression and pseudo-progression (PsP) - Progression-free survival (PFS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Physical Activity to Mitigate PreEclampsia Risk - NCT ID: NCT06319014 - Study ID: 23-001568 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2026-10-01 - Lead Sponsor: East Carolina University ### Study Description The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes.Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health.Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes. ### Conditions - Pre-Eclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Exercise Modes ### Outcomes Primary Outcomes - Systolic Blood Pressure (16wks) - Systolic Blood Pressure (20wks) - Systolic Blood Pressure (24wks) - Systolic Blood Pressure (28wks) - Systolic Blood Pressure (32wks) - Systolic Blood Pressure (36wks) - Maternal Cardiometabolic Risk (CMR) Score - Symptom Occurrence - Placental Efficiency - Birth Weight - Infant Cardiometabolic Risk (CMR) Score Secondary Outcomes - Maternal Heart Rate (16wks) - Maternal Heart Rate (20wks) - Maternal Heart Rate (24wks) - Maternal Heart Rate (28wks) - Maternal Heart Rate (32wks) - Maternal Heart Rate (36wks) - Maternal Blood Pressure (16wks) - Maternal Blood Pressure (20wks) - Maternal Blood Pressure (24wks) - Maternal Blood Pressure (28wks) - Maternal Blood Pressure (32wks) - Maternal Blood Pressure (36wks) - Maternal Body Fat % (16wks) - Maternal Body Fat % (20wks) - Maternal Body Fat % (24wks) - Maternal Body Fat % (28wks) - Maternal Body Fat % (32wks) - Maternal Body Fat % (36wks) - Maternal Circumferences (16wks) - Maternal Circumferences (20wks) - Maternal Circumferences (24wks) - Maternal Circumferences (28wks) - Maternal Circumferences (32wks) - Maternal Circumferences (36wks) - Gestational Weight Gain - Delivery Mode - Maternal Blood Glucose (16wks) - Maternal Blood Glucose (20wks) - Maternal Blood Glucose (24wks) - Maternal Blood Glucose (28wks) - Maternal Blood Glucose (32wks) - Maternal Blood Glucose (36wks) - Maternal Blood Lipids (16wks) - Maternal Blood Lipids (20wks) - Maternal Blood Lipids (24wks) - Maternal Blood Lipids (28wks) - Maternal Blood Lipids (32wks) - Maternal Blood Lipids (36wks) - Maternal Plasma Inflammatory Markers (16wks) - Maternal Plasma Inflammatory Markers (20wks) - Maternal Plasma Inflammatory Markers (24wks) - Maternal Plasma Inflammatory Markers (28wks) - Maternal Plasma Inflammatory Markers (32wks) - Maternal Plasma Inflammatory Markers (36wks) - -omics Metabolites (16wks) - -omics Metabolites (20wks) - -omics Metabolites (24wks) - -omics Metabolites (28wks) - -omics Metabolites (32wks) - -omics Metabolites (36wks) - Cord Blood and Placental Inflammatory Markers - Cord Blood and Placental -omics Metabolites - Infant Body Morphometric Measures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardiovascular Reactivity to Physical Stress - NCT ID: NCT06319001 - Study ID: 2688791 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2027-01-01 - Lead Sponsor: Western Norway University of Applied Sciences ### Study Description It is well-accepted that an exaggerated blood pressure (BP) response to physical stress has a prognostic value, indicating a higher cardiovascular risk (e.g., sudden cardiac death, myocardial infarction, future hypertension, and left ventricular hypertrophy). However, there is a limited understanding of the underlying mechanisms and therapuetic strategies modulating this response. Therefore, this pilot project aims to explore whether one session of low-volume high-intensity interval training (low-volume HIIT) or combined intermittent heat and cold bath (sauna+cold bath) can decrease BP responses to physical stress. Furthermore, the secondary goal is to investigate whether one brief session learning about positive stress expectations magnifies the decrease in BP following low-volume HIIT and sauna+ cold bath. ### Conditions - Blood Pressure - Stress, Physiological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Low-volume high intensity exercise - Combined intermittent sauna and cold water bath (sauna+cold bath). ### Outcomes Primary Outcomes - Blood pressure (unit: mmHg) response to laboratory stressors Secondary Outcomes - Resting blood pressure (mmHg). - Endothelial function (% dilation) - Subjective ratings of expectancies (point score). ### Location - Facility: Western Norway University of Applied Sciences, Bergen, Vestland, 5063, Norway @@
## Outcomes of Different Treatment Options in Chronic Venous Disease - NCT ID: NCT06318988 - Study ID: S67030 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months. ### Conditions - Chronic Venous Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radiofrequency ablation using Closure fast - Aethoxysclerol - Daflon - Compression stocking ### Outcomes Primary Outcomes - Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score Secondary Outcomes - Intervention as secondary/add-on treatment - The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20) - The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification) - The change in the revised Venous Clinical Severity Score (rVCSS) - The change in the symptoms, recorded with a questionnaire - The change in satisfaction score - Adverse Events (AEs). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use - NCT ID: NCT06318975 - Study ID: RAPTOR - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2028-12-31 - Lead Sponsor: University of Virginia ### Study Description Binge drinking, and its health/social consequences are substantial public health concerns, with a high prevalence in young adults, especially in the US military. Alcohol consumption in the military is very high and normative, but there is zero tolerance for alcohol-related legal trouble, and Air Force Airmen who experience this (e.g., DUI, sexual assault) typically receive a disciplinary action referred to as an Alcohol Related Incident (ARI).Brief Alcohol Interventions (BAIs) for alcohol misuse are effective in young adults who report binge drinking. Many BAI studies targeted young adults who drink hazardously; these individuals are typically not interested in abstaining but may try decreasing the amount or change the manner in which they drink in order to reduce harmful consequences. The investigators previously published the results of a BAI group-based intervention that reduced ARIs in over 150,000 Airmen on average by 16%. Since 2010, the BAI has been disseminated to most USAF Airmen in Technical Training. However, it is clear additional research is needed to enhance the efficacy of the intervention and reduce risks associated with problem drinking. One strategy to improve health outcomes is well-timed, tailored, and automated text messages. Building on the researchers' preliminary study where text messages reduced driving after drinking as well as total drinks consumed before driving, text messaging may be highly effective when sent at the precise time that Airmen gain access to alcohol (the first time they are allowed off base), a standard time for all Technical Trainees.One challenge to conducting alcohol research in the military is the lack of privileged communication. As a result, it is difficult to obtain valid self-reports due to a tendency to deny or minimize use. The investigators recently developed and validated a method for collecting anonymous data over time. This will be the first study in the military, as well as the first large scale, adequately powered trial, where intervention effects will be tracked out to a 6-month follow-up. The study's Specific Aims are to randomize approximately 3000 Airmen to either the current BAI versus the BAI+Text messages timed to occur before, during, and after Airmen have access to alcohol; and to evaluate the efficacy of the intervention at the end of training and 6 months post-training using repeated surveys with unique identifiers allowing researchers to match surveys while maintaining anonymity. ### Conditions - Alcohol Drinking - Binge Drinking - Text Messaging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Brief Alcohol Intervention - Automated and Tailored Text Messages ### Outcomes Primary Outcomes - AUDIT - Daily Drinking Questionnaire with NIAAA recommended assessment items Secondary Outcomes ### Location - Facility: JBSA Lackland, San Antonio, Texas, 78236, United States @@
## Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors - NCT ID: NCT06318962 - Study ID: UMemphis - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2027-08-01 - Lead Sponsor: University of Memphis ### Study Description The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial. ### Conditions - Suicidal Behaviors - Suicide Ideation - Depression/Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aviva ### Outcomes Primary Outcomes - Self Injurious Thoughts and Behaviors Interview Revised Secondary Outcomes - Beck Scale for Suicide Ideation - Beck Hopelessness Scale ### Location - Facility: Fort Carson, Colorado Springs, Colorado, 80829, United States @@
## Albumin Modifications as Early Biomarkers of Chronic Liver Diseases - NCT ID: NCT06318949 - Study ID: 87RI22_0007 (MALAHBAR) - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-12-01 - Lead Sponsor: University Hospital, Limoges ### Study Description Chronic liver diseases, affecting over 800 million people worldwide, lead to approximately 2 million annual deaths. The need for early, sensitive diagnostic strategies to prevent disease progression and reduce mortality is still unmet. The traditional serum markers lack sensitivity and specificity, leading to the integration of these biomarkers into panel tests with algorithms or imaging measures. Despite their widespread use, these tests have limitations at an individual level, including an inability to predict disease progression or response to treatment. To address these shortcomings, our project proposes utilizing albumin post-translational modifications (PTM) as a predictive biomarker for liver disease progression. The hypothesis is that albumin modifications occur in the early stages of hepatocellular damage and are indicative of future liver diseases. These modifications can be detected through serum albumin isoform determination, albumin isoforms profiles or the albumin's ligand-binding capacities. Innovatively, the study will use the Serum Enhanced Binding (SEB) test, which identifies reduced ligand-binding capacities, and discusses a second patent for determining a typical isoform profile based on the hepatic injury type.Our preliminary results from animal models and a proof-of-concept studies with patients support this hypotheses. Our previous studies demonstrated also significant differences in albumin isoform profiles in response to different types of hepatic injury and high sensitivity and specificity in the SEB test among cirrhotic patients.The primary objective of the MALAHBAR project is to evaluate the capacity of albumin PTM to predict liver disease progression over three years in chronic liver disease patients. Secondary objectives include assessing the predictive ability of different albumin isoforms and the SEB test for liver disease progression, evaluating diagnostic performances and confirming characteristic albumin isoform profiles related to specific hepatic injuries. The study could represent a significant advancement in liver disease diagnostics and management, offering new insights into the role of albumin in liver pathology. ### Conditions - Chronic Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - blood sampling ### Outcomes Primary Outcomes - Ability of HSA PTM to predict the evolution of liver damage at 3 year in patients with an advanced chronic liver disease (ACLD) as recently defined in the BAVENO VII recommendations based on FibroScan. Secondary Outcomes - ability of post-translational HSA modifications to predict the evolution of liver damage at 3 years based on liver-related events or on the worsening of the disease stage evaluated by the de Child Pugh or MELD score. - ability of the different isoforms of HSA to predict the evolution of liver damage at 1 and 2 years provided that data are available in the medical file. - ability of SEB test to predict the evolution of liver damage at 3 years (and at 1 and 2 years provided data are available in the medical file). - diagnostic performances of the SEB test and of the different isoforms of HSA at each stage of the liver disease. - confirm that the isoforms of HAS present in the characteristic patterns (type of isoform and intensity) of the nature of the liver damage. ### Location - Facility: Angers Univeristy Hospital, Angers, N/A, 49100, France @@
## Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands - NCT ID: NCT06318936 - Study ID: 22-677 - Status: RECRUITING - Start Date: 2022-11-01 - Completion Date: 2024-05-01 - Lead Sponsor: UMC Utrecht ### Study Description RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adultsWith this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting. ### Conditions - RSV Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Burden of medically attended RSV infection in the Dutch primary care Secondary Outcomes - RSV-related health care consumption and indirect costs in older adults - Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting - Association between disease severity and several clinical and demographic parameters (e.g. age, cardiopulmonary comorbidity, smoking status, chronic immunosuppressive medication use) and RSV burden (by disease severity and healthcare usage) - Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use ### Location - Facility: University Medical Center Utrecht, Utrecht, N/A, 3584CX, Netherlands @@
## Social and Moral Cognition in Multiple Sclerosis - NCT ID: NCT06318923 - Study ID: RC-P00117 - Status: RECRUITING - Start Date: 2023-12-19 - Completion Date: 2025-10-30 - Lead Sponsor: Lille Catholic University ### Study Description Multiple Sclerosis (MS) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Within social cognition, the moral judgment has been an object of research in order to understand the determinants of moral decision-making: how and why individuals make moral choices with regard to a set of prescriptions and social norms. Compared to control subjects, MS patients show a decrease in moral permissiveness, as well as an increase in moral relativity and emotional reactivity. Thus, it would seem that MS patients issue more deontological choices (lower moral permissiveness). Given that these patients also exhibit empathy deficits and higher alexithymia, these patterns are surprising. Indeed, in other clinical populations, low empathic abilities and high alexithymia are linked to utilitarian rather than deontological moral judgments.The objective of this project is to analyze the process of decision-making carried out by patients during moral dilemma situations in comparison with control individuals and verify whether the presence of a positivity bias could explain the more deontological choices made by some patients. Indeed, some work has shown that older individuals make more deontological moral judgments than younger adults. These results are also observed with young individuals when their future temporal perspectives have been experimentally constrained. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment - MS questionnaire - MONTREAL COGNITIVE ASSESSMENT (MoCA) test ### Outcomes Primary Outcomes - Moral dilemma judgments Secondary Outcomes - Explicit time perspective inventory test - Implicit time perspective inventory test - Dot Probe Task - Level of moral permissibility - Level of emotional reactivity - Moral relativity level - Brief International Cognitive Assessment for Multiple Sclerosis - The Beck Depression Inventory - State-Trait Anxiety Inventory - Toronto Alexithymia Scale (TAS)-20 - Empathy quotient-8 (EQ-8) - Electrodermal response ### Location - Facility: Hôpital Saint-Vincent-de-Paul - Neurologie, Lille, N/A, N/A, France @@
## Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain - NCT ID: NCT06318910 - Study ID: MU-SRF-RS-27 C/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Mahidol University ### Study Description The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant. ### Conditions - Foot Orthoses - Fasciitis, Plantar ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - orthotic wedge - CFO ### Outcomes Primary Outcomes - Pain intensity and foot function - EMG of lower leg muscles Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer - NCT ID: NCT06318897 - Study ID: 2023-0645 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2027-09-30 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer. ### Conditions - Stage 1 cT1b-T1cN0M0 - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Carboplatin - Paclitaxel - Pembrolizumab - Doxorubicin - Cyclophosphamide ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma - NCT ID: NCT06318884 - Study ID: SCTB35-X101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-12 - Lead Sponsor: Sinocelltech Ltd. ### Study Description This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. ### Conditions - Non-Hodgkin Lymphoma, B-cell ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SCTB35 injection ### Outcomes Primary Outcomes - Dose-escalation part: dose limited toxicity (DLT) - Dose-escalation part: incidence rate of adverse event (AE) - Dose-expansion part: objective response rate (ORR) Secondary Outcomes - Dose-escalation part: ORR - Dose-escalation part: CR rate (CRR) - Dose-escalation part: best of overall response (BOR) - Dose-escalation part: duration of response (DOR) - Dose-escalation part: progression-free survival (PFS) - Dose-escalation part: time to response (TTR) - Dose-escalation part: overall survival (OS) - Dose-escalation part: blood concentrations of SCTB35 - Dose-escalation part: anti-drug antibodies of SCTB35 - Dose-expansion part: CRR - Dose-expansion part: BOR - Dose-expansion part: DOR - Dose-expansion part: PFS - Dose-expansion part: TTR - Dose-expansion part: OS - Dose-expansion part: AE - Dose-expansion part: blood concentrations of SCTB35 - Dose-expansion part: anti-drug antibodies of SCTB35 ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, 100142, China @@
## A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Combination With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma - NCT ID: NCT06318871 - Study ID: 23-688 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2030-02-28 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with N-803, a medication that increases the activity of Interleukin-15, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma.Names of the study therapies involved in this study are/is:* CIML NK cell therapy (a NK cell therapy)* N-803 (a type of recombinant human IL-15 superagonist) ### Conditions - Renal Carcinoma - Renal Cell Carcinoma - Urothelial Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cytokine Induced Memory-like Natural Killer (CIML NK) Cells - N-803 ### Outcomes Primary Outcomes - Feasibility Failure Rate (FFR) Secondary Outcomes ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States @@
## Daily and Weekly Iron Supplementation in Infants - NCT ID: NCT06318858 - Study ID: MU-CIRB 2022/313.1411 - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2024-10-14 - Lead Sponsor: Mahidol University ### Study Description This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months. ### Conditions - Anemia - Iron Status - Infants - Iron ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Iron supplement ### Outcomes Primary Outcomes - Anemia status - Iron status Secondary Outcomes - Weight - Length - Dietary intake - Head circumference (HC) ### Location - Facility: Samphran District Hospital, Sam Phran, Nakhon Pathom, 73110, Thailand @@
## Phase 1 Study to Evaluate the Safety and Pharmacokinetic Drug Interaction of DHP2302R1 and DHP2302R2 - NCT ID: NCT06318845 - Study ID: 2302CS-1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-08-02 - Lead Sponsor: Daehwa Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - DHP2302R1 - DHP2302R2 ### Outcomes Primary Outcomes - AUClast of DHP2302R1 and DHP2302R2 - Cmax of DHP2302R1 and DHP2302R2 Secondary Outcomes - Tmax of DHP2302R1 and DHP2302R2 - AUC0-48 of DHP2302R1 and DHP2302R2 - AUCinf of DHP2302R1 and DHP2302R2 - t1/2 of DHP2302R1 and DHP2302R2 - CL/F of DHP2302R1 and DHP2302R2 - Vz/F of DHP2302R1 and DHP2302R2 ### Location - Facility: H Plus Yangji Hospital, Seoul, Gwanak-gu, 08779, Korea, Republic of @@
## Optimizing a Wellbeing Program for Care-partners of Those With SCI - NCT ID: NCT06318832 - Study ID: 124609 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: Lawson Health Research Institute ### Study Description Spinal cord injuries (SCI) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. Family care-partners of those with SCI (fcSCI) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. Cognitive behaviour therapy (CBT) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. Internet delivered CBT (ICBT) has the potential to reach a much wider group of people that may have unequal access to health care.In a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored ICBT Wellbeing program for fcSCI. However, our understanding of which components of the program can result in optimal management is limited. The main purpose of this study is to evaluate the effectiveness of different components of the Wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcSCI. The team will evaluate which intervention components result in meaningful improvement in symptoms of depression. Through collaborations with SCI community organizations and rehabilitation institutions, participants will be recruited across Canada. The researchers will also develop a model to examine the most cost-effective intervention package from the different components. The Wellbeing for fcSCI program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services. ### Conditions - Internet-Delivered Cognitive Behavioural Therapy - Depression - Anxiety - Spinal Cord Injuries - Caregiver Burnout ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - ICBT ### Outcomes Primary Outcomes - Change in depression Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults - NCT ID: NCT06318819 - Study ID: 159-11-19. - Status: COMPLETED - Start Date: 2019-11-01 - Completion Date: 2020-05-31 - Lead Sponsor: Maha A. Bahammam ### Study Description * Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing.* Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch.Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Participants were monitored to ensure proper coverage of all the areas following precise instructions. They then brushed their teeth for approximately 2 minutes using modified bass technique. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch. Finally, participants were given a questionnaire to assess their satisfaction of the device.* Results: The differences between the groups showed the DFH group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the CF group, respectively (p = 0.01). The DFH was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the CF which averaged in 00:02:07 (p \< 0.001). A total of 26 participants (86.7%) preferred using the DFH over the CF.* Conclusion: With the combination of toothbrushing, the Dental Floss Holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces. ### Conditions - Tooth Decay - Cavities of Teeth - Gingivitis - Plaque ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dental Floss Holders ### Outcomes Primary Outcomes - Dental Floss Holders (DFH) - Conventional flossing (CF) Secondary Outcomes ### Location - Facility: King Abdulaziz University, Jeddah, N/A, N/A, Saudi Arabia @@
## Towards Remission and Full Recovery From Obsessive-compulsive Disorder - NCT ID: NCT06318806 - Study ID: 2024-3633 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-09-30 - Lead Sponsor: Ciusss de L'Est de l'Île de Montréal ### Study Description Obsessive-compulsive disorder (OCD) is a disabling psychiatric illness that is characterized by distressing obsessional thoughts and time-consuming compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice that requires patients to face their fears by being exposed to feared stimuli. This treatment has been shown to reduce symptoms in a significant proportion of patients. However, it is considered a difficult treatment and only a minority reach remission. Residual symptoms typically remain, or reappear after treatment, which is a risk for relapse. Inference-based Cognitive Behavioral Therapy (I-CBT) is a promising evidence-based treatment developed to overcome these limitations. I-CBT has already been found to be as effective as ERP and significantly more acceptable and easier to adhere to. There is also evidence that I-CBT is more effective for subgroups of patients. Consequently, the current research project is focused on improving treatments outcomes for those provide those who have previously unable to reach remission of their symptoms with ERP. Following an initial treatment with ERP, those that have been unable to reach remission, will be randomized to either I-CBT or more ERP. It is expected that I-CBT will be significantly more effective than providing patients with more of the same. In addition, the study aims to predict treatment outcome in order to be able to tell in advance which patients do not respond to ERP. The project is designed to maximize beneficial health outcomes with a stepped-care approach to treatment, but also to work towards a more personalized choice by being able to match patients in advance with the treatment that works best for them ### Conditions - Obsessive-Compulsive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psychological ### Outcomes Primary Outcomes - Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2) - Clinical Global Impression Scale (CGI) Secondary Outcomes - Vancouver Obsessional Compulsive Inventory (VOCI) - Beck Depression Inventory (BDI) - Beck Anxiety Inventory (BAI) - Inferential Confusion Questionnaire (ICQ) - Dysfunctional Reasoning Processes Task (DRPT) - Fear of Self Questionnaire (FSQ-20) - Obsessive Beliefs Questionnaire (OBQ-20) - Brunnsviken Brief Quality of Life Scale (BBQ) - Sheehan Disability Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis - NCT ID: NCT06318793 - Study ID: 2024Ao001* - Status: COMPLETED - Start Date: 2012-09 - Completion Date: 2023-12 - Lead Sponsor: CHU de Reims ### Study Description A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis (PC) of colo-rectal cancer (CRC), between September 2012 and July 2023 at Reims Hospital-University was conducted. Inclusion criteria were: patients older than 18 years with a performance status ≤ 2, who underwent complete (no macroscopic residual disease) CRS-HIPEC was performed. Exclusion criteria were the presence of an infectious disease prior to surgery, CRS without HIPEC, incomplete CRS and expressed refusal to participate in the study.During the month prior to surgery, patients underwent a thorough diagnostic workup, including chest and abdominopelvic computed tomography (CT) scans, complete haematological and biochemical tests, and cytobacteriological analysis of urine. Blood tests included leukocytes, neutrophils, lymphocytes, platelet count, albumin and CRP. Within one week before surgery, patients were examined by both the surgeon and the anaesthetist.Variables with a normal distribution are presented as mean-SD, while those with a non-normal distribution are presented as median and range. Categorical variables are presented as counts and percentages. Chi-Square or Fisher's exact test was used to compare qualitative variables. Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics. Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication (POC) and patients with POC and major POC using the non-parametric Mann-Whitney U test. Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index. Receiver operating curves (ROC) were calculated to determine the area under the curve (AUC). Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios (OR). All tests were two-tailed and results were considered significant if the p-value was \< 0.05. Statistical analyses were performed using R software (version 4.0.5). ### Conditions - Peritoneal Carcinomatosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Concentration of C-reactive protein (CRP) Secondary Outcomes ### Location - Facility: Chu Reims, Reims, N/A, 51092, France @@
## Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis - NCT ID: NCT06318780 - Study ID: PI2023_843_0171 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2031-02 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks. ### Conditions - Aortic Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - three-phase CT angiography - CEUS ultrasound ### Outcomes Primary Outcomes - Endoleak classification using the CT angiography - Variation of Endoleak classification between CEUS ultrasound and the CT angiography Secondary Outcomes ### Location - Facility: CHU Amiens Picardie, Amiens, Picardie, 80054, France @@
## Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage - NCT ID: NCT06318767 - Study ID: PI2023_843_0141 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-09 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE). ### Conditions - Major Adverse Limb Events - Major Adverse Cardiovascular Events - Peripheral Artery Disease - Critical Limb Ischemia - Hemodynamic Measure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - hemodynamic measure of the Systolic Time Rise ### Outcomes Primary Outcomes - occurrence of limb ischemia Secondary Outcomes ### Location - Facility: CHU Amiens, Amiens, N/A, 80480, France @@
## Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis - NCT ID: NCT06318754 - Study ID: HP-00104241 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: University of Maryland, Baltimore ### Study Description A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT). ### Conditions - Thrombosis - Thrombectomy - Portal Vein ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Inari Triever Aspiration Catheter ### Outcomes Primary Outcomes - Technical Success - Clinical Success - Primary Patency - Intermediate functional success Secondary Outcomes - Secondary Patency - Duration of hospitalization - Duration of ICU days - Blood loss during intervention - Transfusion - Major and minor complications - 30-day mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Aerobic Exercise in Obese Patients With Atherosclerotic Cardiovascular Disease - NCT ID: NCT06318741 - Study ID: KayseriCHkinezyofobi - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-09 - Lead Sponsor: Kayseri City Hospital ### Study Description Obesity is classified using body mass index (BMI) (BMI ≥25 overweight, BMI ≥30 obese, BMI ≥40 morbidly obese). Obese patients are Class 1 according to BMI; BMI:30-34.9 and Class 2; BMI: It is classified as 35-39.9. Patients with classes 1 and 2 will be included in the study. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus, so obesity treatment should be managed multidisciplinary. The basic approach to obesity treatment is diet, exercise, medical treatment, treatment of comorbid conditions and surgery. Aerobic exercise therapy, which is one of the conservative approaches in the treatment of obesity, also has an important place in the treatment of cardiovascular diseases associated with obesity. Atherosclerotic cardiovascular disease (AKD) is one of the most important causes of morbidity and mortality worldwide. Negative changes in functional capacity, quality of life and psychosocial situations are observed due to disorders associated with this disease. Physical activity is among the modifiable risk factors in atherosclerotic diseases. However, patients have a fear of movement related to angina-like symptoms, with the thought that the symptoms may recur during exercise. Lack of physical activity due to fear of movement leads to obesity, which in turn leads to aggravation of atherosclerosis and an increase in the incidence of cardiovascular events, which negatively affects individual and psychosocial capacity. Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system. Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury. ### Conditions - Obesity - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints. - Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints. ### Outcomes Primary Outcomes - Tampa Kinesiophobia Scale Secondary Outcomes - Cardiopulmonary exercise test - 6 Minutes Walking Test - Body anthropometric measurements - Hospital anxiety and depression scale - international physical activity score - MacNew Heart Disease Health-Related Quality of Life Survey - Numerical Rating Scale ### Location - Facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital, Kayseri, N/A, 38080, Turkey @@
## Musculotendinous Adaptations in High and Low- Performance Triathletes - NCT ID: NCT06318728 - Study ID: CAEE - 70162723.0.0000.8093 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-04 - Lead Sponsor: University of Brasilia ### Study Description This study aims to investigate the musculotendinous adaptations in the Achilles tendon and the muscles composing the triceps surae induced by triathlon training and competitions in high-performance and low-performance athletes. Twenty high-performance triathletes, twenty low-performance triathletes, and twenty physically active and healthy individuals of both genders will be recruited to constitute the research groups. Ultrasonography will be employed as the assessment method for the structures of the Achilles tendon and the muscular architecture of the triceps surae. The quality and portability of ultrasonography, coupled with its real-time information capabilities, make it the appropriate choice for this evaluation. The VISA-A scale (Victorian Institute of Sport Achilles Assessment) will be used to measure pain and function of the Achilles tendon. The reliability of ultrasonography measures will be obtained by evaluating images of individuals using the intraclass correlation coefficient, allowing for the analysis of result reproducibility. Data analysis will involve comparisons among the high-performance, low-performance, and physically active groups, aiming to identify differences in musculotendinous adaptations related to performance and injury predisposition. Structural changes occurring in these structures and their potential association with sports performance and/or injury predisposition will be explored. Overall, this study utilizes a comparative cross-sectional research design, where different groups are assessed regarding musculotendinous adaptations in the Achilles tendon and triceps surae through ultrasound-derived measures. The use of the VISA-A scale and the assessment of measure reliability will provide additional data on pain, function, and result reproducibility. ### Conditions - Athletes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Morphological Properties: Tendon Length (TL). - Evaluation of Achilles Tendon Shape (fusiform or parallel) - Echogenicity of the Tendon (homogeneous and heterogeneous areas) - Mechanical properties of the Achilles Tendon: Force - Mechanical properties of the Achilles Tendon: Stress - Mechanical properties of the Achilles Tendon: Strain - Material Properties of the Achilles Tendon: Elastic Modulus - Muscle Thickness - Muscle Properties: Pennation Angle (PA) - Muscle Properties: Fascicle Length (FL) - Muscle Echogenicity - Assessment of Muscle Electrical Activation - Muscle Torque Evaluation - Evaluation of Muscle and Achilles Tendon Stiffness through 2D Shear Wave Elastography (SWE): Secondary Outcomes - Ankle pain and function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Modified Deep Extubation vs. Standard Awake Extubation - NCT ID: NCT06318715 - Study ID: 23-0009-A - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2025-03 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice. ### Conditions - Extubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - modified deep extubation (mDE) - standard awake extubation ### Outcomes Primary Outcomes - Time from the end of the surgery to leaving the OR Secondary Outcomes - Time from the end of the surgery to extubation - Time from the end of the surgery to discharge from PACU - oral airway - jaw-thrust maneuver - hypertension - breath holding - bag-mask ventilation - coughing - bucking - laryngospasm - treat laryngospasm - desaturation - reintubation - Patient's experience - BP - HR - EtCO2 - SaO2 - Sevorane MAC ### Location - Facility: Department of Anesthesia Mount Sinai Hospital, Toronto, Ontario, M5G 1X5, Canada @@
## The Effect of Constructivist Learning Model Based Gynecological Cancer Education - NCT ID: NCT06318702 - Study ID: 2023-KAEK-180 - Status: COMPLETED - Start Date: 2023-12-25 - Completion Date: 2024-02-20 - Lead Sponsor: Kastamonu University ### Study Description This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety. ### Conditions - Gynecologic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Education ### Outcomes Primary Outcomes - gynecologic cancer awareness - spiritual well-being - health anxiety scores Secondary Outcomes ### Location - Facility: Kastamonu University, Merkez, Kastamonu, 37150, Turkey @@
## In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass - NCT ID: NCT06318689 - Study ID: 2023/0211/OB - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2026-05-05 - Lead Sponsor: University Hospital, Rouen ### Study Description The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass.The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass.Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome.Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group. ### Conditions - Cardiac Surgical Procedures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion. Secondary Outcomes - Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours. - Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock. - Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock - Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2) obtained from Glycocheck with the presence of vasoplegic shock - Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock - Endothelial function markers (syndecan-1, pg/mL) with the presence of vasoplegic shock - Endothelial function markers (interleukin-6, pg/mL) with the presence of vasoplegic shock - Endothelial function markers (VCAM-1, pg/mL) with the presence of vasoplegic shock - Multivariate analysis explaining the occurrence of vasoplegic shock. - Multivariate analysis explaining the occurrence of an altered perfused boundary region (µm). ### Location - Facility: Rouen University Hospital, Rouen, Normandie, 76000, France @@
## A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment - NCT ID: NCT06318676 - Study ID: CA057-1009 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-05 - Lead Sponsor: Celgene ### Study Description The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment. ### Conditions - Renal Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Mezigdomide ### Outcomes Primary Outcomes - Maximum observed concentration (Cmax) - Area under the plasma concentration-time curve (AUC) - Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) Secondary Outcomes - Number of participants with adverse events (AEs) - Number of participants with serious adverse events (SAEs) - Number of participants with physical examination findings - Number of participants with vital sign abnormalities - Number of participants with 12-lead electrocardiogram (ECG) findings - Maximum observed concentration (Cmax) - Time of maximum observed concentration (Tmax) - Area under the plasma concentration-time curve (AUC) ### Location - Facility: PANAX, Miami Lakes, Florida, 33014, United States @@
## Survivor Mom Companion Comparison Study - NCT ID: NCT06318663 - Study ID: STUDY00007685 - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2024-12-12 - Lead Sponsor: State University of New York at Buffalo ### Study Description The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma. ### Conditions - Posttraumatic Stress Symptom ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Survivor Mom Companion ### Outcomes Primary Outcomes - Childhood Trauma Questionnaire - Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5 - Adverse Childhood Experiences Questionnaire - Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - Dissociative Subtype of Post Traumatic Stress Scale Secondary Outcomes - Patient Health Questionnaire-9 - State Trait Anger Expression Inventory - Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale - Difficulties in Emotion Regulation Scale Short Form ### Location - Facility: Buffalo Prenatal-Perinatal Network, Buffalo, New York, 14203, United States @@
## Post Extraction Changes After Ridge Preservation Using Allogeneic Dentin Matrix Vs Demineralized Freeze Dried Allograft - NCT ID: NCT06318650 - Study ID: 19124PER6_3_1 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12-01 - Lead Sponsor: Cairo University ### Study Description the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing techniqueIntervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability. ### Conditions - Socket Preservation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Demineralized Dentin Matrix - Demineralized freeze-dried bone allograft (DFDBA) ### Outcomes Primary Outcomes - Change in Ridge width over 6 months Secondary Outcomes - Change in the radiographic vertical bone level - Change in the radiographic horizontal bone level - Percentage of new vital bone formation and residual graft - Implant Primary Stability ### Location - Facility: Faculty of Dentistry Cairo University, Cairo, N/A, 12613, Egypt @@
## A Study to Evaluate the Acceptability and Feasibility of a Bedtime Routine for Neonates - NCT ID: NCT06318637 - Study ID: CCSSKB005432 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-21 - Completion Date: 2024-12-23 - Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) ### Study Description The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns. ### Conditions - Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Baby Wash/Shampoo - Daily Activities - Body Lotion ### Outcomes Primary Outcomes - Bedtime Routine Acceptability and Feasibility to Caregivers - Bedtime Routine Acceptability and Feasibility to Caregivers - Bedtime Routine Acceptability and Feasibility to Caregivers - Bedtime Routine Acceptability and Feasibility to Caregivers Secondary Outcomes ### Location - Facility: SGS North America, Inc., Richardson, Texas, 75081, United States @@
## Immediate Effects of Ankle MWM and Taping on Gait and Balance in Stroke Patients - NCT ID: NCT06318624 - Study ID: KHSU-2023/11 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2024-10-11 - Lead Sponsor: Kutahya Health Sciences University ### Study Description Disorders caused by stroke may lead to significant limitations, especially in ankle range of motion, and may cause impairments in walking and balance functions. This limitation in ankle range of motion leads to difficulties in weight transfer, stability, and balance. As a result, there is a decrease in walking performance and an increased risk of falls. Various interventions have been used to improve ankle dorsiflexion passive range of motion, including gastrosoleus muscle stretching, muscle strengthening training, functional electrical stimulation training, proprioceptive control training, taping, manual therapy, different mobilization techniques, and ankle mobilization with motion (MWM).There are limited studies investigating the immediate effects of MWM and taping on gait and balance in stroke patients. This study was planned to investigate the effect of Mulligan's ankle MWM technique and talus stabilization taping on spatiotemporal gait and balance parameters in stroke patients. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mobilisation with Movement and Taping - Sham ### Outcomes Primary Outcomes - Stride length - Stride width - Cadance - Walking speed - The symmetry of the center of pressure changes during walking - The maximum force on the feet during walking - The distribution of pressure on the feet - Balance Secondary Outcomes - 10-meter walk test - Timed up and go test ### Location - Facility: Kutahya Health Sciences University, Kütahya, N/A, 43100, Turkey @@
## Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes - NCT ID: NCT06318611 - Study ID: 09.2022.575 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2023-05-01 - Lead Sponsor: Koç University ### Study Description Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism.This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters. ### Conditions - Type1diabetes - Sleep - Chronotype ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - sleep, chronotype ### Outcomes Primary Outcomes - Sleep health composite - Chronotype Secondary Outcomes - Glycemic variability - Glycemic control ### Location - Facility: Necla İpar, İstanbul, N/A, 34010, Turkey @@
## Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis - NCT ID: NCT06318598 - Study ID: 23M202 - Status: RECRUITING - Start Date: 2023-04-11 - Completion Date: 2026-04-10 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?Participants will undergo:* neurological evaluation* neurophysiological evaluation* neuropsychological evaluation* whole exome sequencing* biomarker measurement in CSF and plasma ### Conditions - Amyotrophic Lateral Sclerosis - Motor Neuron Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - genetic screening - biomarker assessment Secondary Outcomes - clinical assessment - neuropsychological assessment ### Location - Facility: Ospedale San Raffaele, Milano, MI, 20132, Italy @@
## Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases - NCT ID: NCT06318585 - Study ID: 23C306 - Status: RECRUITING - Start Date: 2023-04-03 - Completion Date: 2026-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Study Description: Characterization of Motor Neuron Disease PhenotypesThe goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:* What are the specific clinical phenotypes associated with MND?* How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?Participants will undergo:* Clinical evaluation using validated scales* Neurophysiological and neuroradiological instrumental assessment* Neuropsychological evaluation* Collection of biological materials for genetic screening and biomarker assessment, if necessary. ### Conditions - Amyotrophic Lateral Sclerosis - Motor Neuron Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - no. of patients with classic ALS - no. of patients with bulbar ALS - no. of patients with LMN phenotypes (flail arm, flail leg, PMA) - no. of patients with UMN phenotypes (pyramidal ALS, PLS) Secondary Outcomes ### Location - Facility: Ospedale San Luca, Milano, MI, 20149, Italy @@
## Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders. - NCT ID: NCT06318572 - Study ID: PR(AG)166/2021 - Status: RECRUITING - Start Date: 2023-03-09 - Completion Date: 2025-04-30 - Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute ### Study Description Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay between the gut and the central nervous system. Several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. Recent surveys have shown that DGBI affect up to 40 % of the general population.Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. However, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions.OBJECTIVE: To determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with DGBI.METHODOLOGY: After development of a program of psycho-education on DGBI using interactive immersion by means of virtual reality (VR) a randomized clinical trial will be developed. Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient in the active treatment group a session of psychoeducation using specifically developed VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means VR). Patients in the placebo group willl take a placebo capsule daily.OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6 months. ### Conditions - Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psychological intervention - Placebo ### Outcomes Primary Outcomes - Severity of abdominal symptoms Secondary Outcomes - IBS related Quality of life - Stress - Anxiety and depression - Somatic co-morbidities - Rectal sensitivity - Analysis of gut microbiota composition ### Location - Facility: Hospital Universitari Vall d'Hebron, Barcelona, N/A, 08035, Spain @@
## Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention - NCT ID: NCT06318559 - Study ID: 027-FPO22 - Status: RECRUITING - Start Date: 2022-06-29 - Completion Date: 2027-12-31 - Lead Sponsor: Fondazione del Piemonte per l'Oncologia ### Study Description This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure. ### Conditions - Cancer of Prostate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy ### Outcomes Primary Outcomes - Perioperative surgical oncological outcomes Secondary Outcomes - Micturition outcomes - Sexual function outcomes - Oncological outcomes ### Location - Facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, 10060, Italy @@

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