Datasets:

hackint0sh
/

md_dataset

Dataset card Viewer Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder - NCT ID: NCT06270433 - Study ID: 2023-KY142-01 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-12-31 - Lead Sponsor: Jiangsu Province Nanjing Brain Hospital ### Study Description The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use. ### Conditions - Anhedonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Toludesvenlafaxine hydrochloride sustained-release tablets - Desvenlafaxine succinate sustained-release tablets ### Outcomes Primary Outcomes - Snaith-Hamilton Pleasure Scale (SHAPS) Total Score Secondary Outcomes - Snaith-Hamilton Pleasure Scale (SHAPS) Total Score - Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate - Dimensional Anhedonia Rating Scale (DARS) Score - Montgomery-Asberg Depression Rating Scale (MADRS) Score - 17-item Hamilton Depression Rating Scale (HAM-D17) Score - Sheehan Disability Scale (SDS) Score - Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score ### Location - Facility: Nanjing Brian Hospital, Nanjing, Jiangsu, 210024, China @@
## Technological Devices and Home Automation System in Neurological Rehabilitation - NCT ID: NCT06270420 - Study ID: 2022.04 - Status: RECRUITING - Start Date: 2023-02-05 - Completion Date: 2024-05-30 - Lead Sponsor: IRCCS San Camillo, Venezia, Italy ### Study Description The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room. ### Conditions - Neurological Disease - Motor Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Technological Motor Rehabilitation ### Outcomes Primary Outcomes - Key performance indicator (KPI) of the room - Number of treatments - Key performance indicator (KPI) ot the room - Number of sessions - Room Key performance indicator (KPI) of the room - Number of minutes of therapy - Key performance indicator (KPI) of the room - Number of physiotherapists involved - Key performance indicator (KPI) of the room - Number of adverse events Secondary Outcomes - Box and Blocks Test - Reaching Performance Scale - Nine Hole Pegboard Test - Berg balance scale (BBS) - 10 Meter Walk Test (10MWT) - Functional Ambulation Categories (FAC) - Trunk Control Test (TCT) - EuroQol questionnaire (EQ-5D) - System Usability Scale (SUS) - Short Form Patient Satisfaction Questionnaire (PSQ-18) - User Experience Questionnaire (UEQ) - Number of falls ### Location - Facility: IRCCS San Camillo Hospital, Venice-Lido, Venice, 30126, Italy @@
## The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery. - NCT ID: NCT06270407 - Study ID: 270777 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-12-31 - Lead Sponsor: St. Olavs Hospital ### Study Description Study objective:This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.Eligible patients:Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.Study intervention:Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules. ### Conditions - Surgical Complication ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Tranexamic Acid 100 MG/ML - 0.9%sodium chloride ### Outcomes Primary Outcomes - Postoperative re-bleeding Secondary Outcomes - Postoperative wound infection - Postoperative wound rupture - Postoperative thromboembolic events - Postoperative seroma - Any other postoperative complication ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application - NCT ID: NCT06270394 - Study ID: MJX - Status: SUSPENDED - Start Date: 2022-04-28 - Completion Date: 2027-03-31 - Lead Sponsor: The First Affiliated Hospital of Anhui Medical University ### Study Description This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.Investigators will screen suitable participants among patients undergoing routine FDG examination.* Participants will sign an informed consent form* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test. ### Conditions - Malignant Tumors - Positron-Emission Tomography ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-Fibroblast activation protein inhibitor ### Outcomes Primary Outcomes - 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG Secondary Outcomes - Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers ### Location - Facility: FirstHAnhuiMU, Hefei, Anhui, 230032, China @@
## Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder - NCT ID: NCT06270381 - Study ID: UIDB/05299/2020 - Status: RECRUITING - Start Date: 2023-08-07 - Completion Date: 2024-11-01 - Lead Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida ### Study Description The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment. ### Conditions - Grief Disorder, Prolonged ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - EMPOWER - Treatment as usual (TAU) ### Outcomes Primary Outcomes - Prolonged Grief Secondary Outcomes - Anxiety and depression ### Location - Facility: Unidade Local de Saúde Santa Maria, Lisboa, N/A, N/A, Portugal @@
## Children Born Preterm: Sustainable Health Monitoring - NCT ID: NCT06270368 - Study ID: PREHMO - Status: RECRUITING - Start Date: 2020-08-05 - Completion Date: 2025-12-31 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data. ### Conditions - Premature Birth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Infant development - Childhood development Secondary Outcomes - Presence of visual or hearing impairement - Presence of asthma - Access to care ### Location - Facility: Azienda Ospedaliero-Universitaria Careggi (AOUC), Firenze, N/A, N/A, Italy @@
## Stockholm Mammography Risk Stratified Trial - NCT ID: NCT06270355 - Study ID: 2023-06555-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2032-04-08 - Lead Sponsor: Karolinska Institutet ### Study Description SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Risk based screening ### Outcomes Primary Outcomes - Incidence of interval cancers Secondary Outcomes - Number of recalled women ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients - NCT ID: NCT06270342 - Study ID: DTMS - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-12-15 - Lead Sponsor: Kutahya Health Sciences University ### Study Description The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - dual task assessment ### Outcomes Primary Outcomes - The Minnesota Manual Dexterity Test - Dual Task Questionnaire - Edinburgh Handedness Questionnaire - Expanded Disability Status Scale - Brief International Cognitive Assessment Battery for Multiple Sclerosis - Beck Depression Scale - Fatigue Impact Scale - Multiple Sclerosis Quality of Life Questionnaire-54 Secondary Outcomes ### Location - Facility: Kutahya Health Sciences University, Kütahya, N/A, 43100, Turkey @@
## Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis) - NCT ID: NCT06270329 - Study ID: NMTwithKOA - Status: COMPLETED - Start Date: 2022-01-15 - Completion Date: 2023-06-15 - Lead Sponsor: Kutahya Health Sciences University ### Study Description The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA). ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neuromuscular training program - conventional physical therapy program ### Outcomes Primary Outcomes - Visual Analog Scale - Western Ontario and McMasterUniversities Osteoarhritis Index - Time on One Leg Standing - Five Times Sit to Stand Test - Manual Muscle Test - Short Form Secondary Outcomes ### Location - Facility: Kutahya Health Science University, Kütahya, N/A, 43100, Turkey @@
## Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease - NCT ID: NCT06270316 - Study ID: CT-AMT-191-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-04-29 - Lead Sponsor: UniQure Biopharma B.V. ### Study Description This is an open-label multi-center study to evaluate safety and biomarkers of efficacy of a single dose of intravenously-administered AMT-191. The study will also include exploratory functional efficacy assessments. The plan is to investigate 2 sequential dose cohorts in 3-6 Participants per cohort. Participants will be monitored for 24 hours following AMT-191 administration then follow-up study visits will continue for 24 months, during which safety, pharmacokinetics/pharmacodynamics, biomarkers, and efficacy assessments will be performed. Participants will continue receiving their regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal. ### Conditions - Fabry Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AMT-191 ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] - Duration of Vector deoxyribonucleic acid (DNA) shedding presented in blood, saliva, feces, semen, and urine Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - NCT ID: NCT06270303 - Study ID: 2023-00383-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2036-03-01 - Lead Sponsor: Göteborg University ### Study Description The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated. ### Conditions - Periodontitis - Furcation Defects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Access flap & surgical debridement - Application of bone substitute material (BioOss Collagen) ### Outcomes Primary Outcomes - Proportion of patients/teeth displaying furcation closure. - Proportion of patients/teeth displaying furcation closure. - Proportion of patients/teeth displaying furcation closure. - Proportion of patients/teeth displaying furcation closure. - Proportion of patients/teeth displaying furcation closure. - Proportion of patients/teeth displaying furcation closure. Secondary Outcomes - Changes in probing pocket depth. - Changes in probing pocket depth. - Changes in probing pocket depth. - Changes in probing pocket depth. - Changes in probing pocket depth. - Changes in probing pocket depth. - Changes in bleeding on probing. - Changes in bleeding on probing. - Changes in bleeding on probing. - Changes in bleeding on probing. - Changes in bleeding on probing. - Changes in bleeding on probing. - Changes in vertical and horizontal clinical attachment level. - Changes in vertical and horizontal clinical attachment level. - Changes in vertical and horizontal clinical attachment level. - Changes in vertical and horizontal clinical attachment level. - Changes in vertical and horizontal clinical attachment level. - Changes in vertical and horizontal clinical attachment level. - Changes in marginal soft tissue levels. - Changes in marginal soft tissue levels. - Changes in marginal soft tissue levels. - Changes in marginal soft tissue levels. - Changes in marginal soft tissue levels. - Changes in marginal soft tissue levels. - Changes in radiographic bone levels. - Changes in radiographic bone levels. - Changes in radiographic bone levels. - Changes in radiographic bone levels. - Patient satisfaction assessed by visual analogue scale. - Patient satisfaction assessed by visual analogue scale. - Patient discomfort as expressed on a visual analogue scale. - Patient discomfort as expressed on a visual analogue scale. - Esthetic appreciation as expressed on a visual analogue scale. - Esthetic appreciation as expressed on a visual analogue scale. - Rate of adverse events. - Rate of adverse events. - Tooth loss. - Tooth loss. - Tooth loss. - Tooth loss. - Tooth loss. - Need for retreatment. - Need for retreatment. - Need for retreatment. - Need for retreatment. - Need for retreatment. - Change of inflammatory markers. - Change of inflammatory markers. ### Location - Facility: Department of Periodontology, Institute of Odontology, Göteborg, N/A, 40530, Sweden @@
## The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls - NCT ID: NCT06270290 - Study ID: 327648 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-03-30 - Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust ### Study Description The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).The main questions it aims to answer are:* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?* Is this proportion higher to that in control patients without a diagnosis of RBD?Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ. ### Conditions - REM Sleep Behavior Disorder - Concussion, Brain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exposure to contact sports or history of concussions ### Outcomes Primary Outcomes - Proportion of history of contact sports practice / concussion in RBD and control participants. Secondary Outcomes - Differences in concussions characteristics between RBD and control participants. - Demographic or clinical differences between RBD participants with and without concussions history. ### Location - Facility: Guy's & St Thomas' NHS Foundation Trust, London, N/A, SE1 9RT, United Kingdom @@
## Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease - NCT ID: NCT06270277 - Study ID: 30.01.2024-4272 - Status: COMPLETED - Start Date: 2024-02-14 - Completion Date: 2024-02-21 - Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital ### Study Description Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues. ### Conditions - Inflammatory Bowel Diseases - Psychosocial Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Pediatric Quality of Life Inventory (PedsQL) - Strengths and Difficulties Questionnaire (SDQ) ### Outcomes Primary Outcomes - Pediatric Quality of Life Inventory (PedsQL) score - Strengths and Difficulties Questionnaire (SDQ) Secondary Outcomes ### Location - Facility: Sisli Hamidiye Etfal Research and Training Hospital, Istanbul, N/A, N/A, Turkey @@
## Nociception Monitoring in Intensive Care - NCT ID: NCT06270264 - Study ID: 111-2023 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-01 - Lead Sponsor: Haseki Training and Research Hospital ### Study Description Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care. ### Conditions - Unconscious State - Pressure Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - the Nociception level index monitoring ### Outcomes Primary Outcomes - total fentanyl consumption Secondary Outcomes - systolic blood pressure - heart rate ### Location - Facility: Haseki Training and Research Hospital, Istanbul, Sultangazi, N/A, Turkey @@
## Modeling Tic Change During Behavior Therapy for Tics - NCT ID: NCT06270251 - Study ID: PSYCH-2023-32292 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-09-01 - Lead Sponsor: University of Minnesota ### Study Description Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. ### Conditions - Chronic Tic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CBIT ### Outcomes Primary Outcomes - Tic Severity - Sheehan Disability scale - Behavior Rating Inventory of Executive Function - Ask Suicide-Screening Questions (ASQ) - Child Attitudes Toward Illness Scale (CATIS) - Rosenberg Self-Esteem Scale - Caregiver Strain Questionnaire - Clinical Global Impressions (CGI) - Parent/Adult Tic Questionnaire Secondary Outcomes - Premonitory Urge for Tics Scale - Tic Suppression Task - Stop signal task ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients - NCT ID: NCT06270238 - Study ID: 2023-11-164 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2025-09-30 - Lead Sponsor: Samsung Medical Center ### Study Description The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-Frequency1 - cTBS1 - High-Frequency2 - cTBS2 - High-Frequency3 - cTBS3 ### Outcomes Primary Outcomes - Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) Secondary Outcomes - Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) - Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) - Differences of Fugl-Meyer Assessment score (FMA) - Differences of Fugl-Meyer Assessment score (FMA) - Differences of Fugl-Meyer Assessment score (FMA) - Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) - Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) - Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) - Differences of Box and block test - Differences of Box and block test - Differences of Box and block test - Differences of Functional Ambulation Category (FAC) - Differences of Functional Ambulation Category (FAC) - Differences of Functional Ambulation Category (FAC) - Differences of Action Research Arm Test (ARAT) - Differences of Action Research Arm Test (ARAT) - Differences of Action Research Arm Test (ARAT) - Differences of Jebsen-Taylor hand function test - Differences of Jebsen-Taylor hand function test - Differences of Jebsen-Taylor hand function test - Differences of Hand grip strength test - Differences of Hand grip strength test - Differences of Hand grip strength test ### Location - Facility: Samsung Medical Center, Seoul, N/A, 06351, Korea, Republic of @@
## A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. - NCT ID: NCT06270225 - Study ID: SSGJ-613-PGF-II-01 - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-12 - Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ### Study Description The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment. ### Conditions - Gout Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg - Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg - Colchicine 0.5 mg ### Outcomes Primary Outcomes - Numbers of acute gout flares Secondary Outcomes - Numbers of acute gout flares - Proportions of subjects with at least 1 acute gout flare - Proportions of subjects with at least 1 acute gout flare - Time from randomization to first acute flare. - Duration of acute gout flares. - Duration of acute gout flares. - Subject's overall assessment of response to treatment - Investigator's overall assessment of response to treatment - 36-item Short Form Survey (SF-36) - Adverse events (AE) ### Location - Facility: Shanghai Huashan Hospital Fudan University-Rheumatology, Shanghai, Shanghai, 200040, China @@
## Medical Device for Airway Patency During Sedation - NCT ID: NCT06270212 - Study ID: CIV-ID 23-08-043797 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12-31 - Lead Sponsor: Stairway Medical AB ### Study Description OVERALL SYNOPSISPART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants* of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position* of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position.PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration* of adjuvant manual airway support and ventilation* of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\])* of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and* of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients. ### Conditions - Airway Obstruction - Sedation Complication - Perioperative Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - STAIRWAY - NO DEVICE ### Outcomes Primary Outcomes - Transpharyngeal distance during moderate-to-deep steady-state sedation. - Duration of manual airway support during PS for clinical procedures. Secondary Outcomes - Transpharyngeal distance during mild steady-state sedation. - Duration of interrupted capnometric monitoring during sedation. - Duration of manual airway support during induction of steady-state sedation. - Sedational comfort - Conditions for sedation - Conditions for procedural intervention ### Location - Facility: Skåne University Hospital, Malmö, Skåne, 20502, Sweden @@
## Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia. - NCT ID: NCT06270199 - Study ID: PULMESCELL-2 - Status: RECRUITING - Start Date: 2024-01-11 - Completion Date: 2026-12 - Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal ### Study Description Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients. ### Conditions - Bronchopulmonary Dysplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Control - Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions - Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions ### Outcomes Primary Outcomes - Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia - feasibility variable Secondary Outcomes - Incidence of BPD and PH in very low birth weight babies treated with MSC - Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen - Exitus on week 36 and 40 of post-menstrual age or at hospital discharge - Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. - Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs). - Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. - Changes in modified respirator score during therapy and up to week 36 of port-menstrual age - Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age - Date of hospital discharge and respiratory care at discharge. - Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). - Duration of invasive and non-invasive mechanical ventilation. - Use of postnatal corticosteroids indicated - Respiratory readmission rates. - Bayley Neurodevelopmental Scale at 24 months - Date and cause of death. ### Location - Facility: Complejo Hospitalario La Coruña, La Coruña, N/A, N/A, Spain @@
## Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach - NCT ID: NCT06270186 - Study ID: 20-AOIP-04 - Status: WITHDRAWN - Start Date: 2023-11 - Completion Date: 2024-11 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased muscle volume). It also affects eyes, heart, endocrine system, gastrointestinal system and central nervous system. Specific cognitive abilities are impaired in patients with MD1 such as attention, visio-spatial or visio-building abilities as well as executive dysfunctions.Currently, the cognitive assessment of MD1 patients is based on classical neuropsychological tests, which are time-consuming and require a MD1 expert neuropsychologist. Moreover, it is usually very difficult for MD1 patients to accept performing these tests, and when they agree to perform them, they usually give up before the end. This finding is more frequent in MD1 patients with high level of cognitive impairment.In order to overcome these difficulties in assessing cognitive functions of MD1 patients, the investigators decided to use innovative tools such as virtual reality, which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet, glasses and joysticks.The start-up My Cyber Royaume from Lille, in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi, have developed a software "Good Diag NMD" which uses virtual reality to assess cognitive disorders, more specifically executive functions in patients with type 1 myotonic dystrophy. ### Conditions - Myotonic Dystrophy 1 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Type 1 myotonic dystrophy ### Outcomes Primary Outcomes - Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1 Secondary Outcomes - Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session - To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session - Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests - Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures - NCT ID: NCT06270173 - Study ID: TWM-C-2202 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-12-31 - Lead Sponsor: Wiltrom Co., Ltd. ### Study Description The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis. ### Conditions - Osteoporotic Vertebral Compression Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) ### Outcomes Primary Outcomes - Proportion of participants with study success Secondary Outcomes ### Location - Facility: Klinikum Friedrichshafen, Friedrichshafen, Baden-Württemberg, 88048, Germany @@
## Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda - NCT ID: NCT06270160 - Study ID: KampalaLivelihoodsStudy - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Toronto ### Study Description Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala. ### Conditions - Financial Stress - Social Functioning - Social Skills ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - HIVST - mHealth - Creating Futures Livelihoods program ### Outcomes Primary Outcomes - Number of participants engaged in HIV testing Secondary Outcomes - Number of participants with knowledge of their HIV status - Number of participants linked to confirmatory HIV testing - Frequency of linkage to HIV care - Brief HIV Knowledge Questionnaire - Sexual Risk ### Location - Facility: Young African Refugees for Integral Development, Kampala, N/A, N/A, Uganda @@
## Timing of TAP Blocks in Bariatric Surgery - NCT ID: NCT06270147 - Study ID: 16935 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-06-28 - Lead Sponsor: McMaster University ### Study Description This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs. ### Conditions - Opioid Use - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Bupivacaine-epinephrine ### Outcomes Primary Outcomes - Opioid Consumption Secondary Outcomes - Length of Stay - Anesthesia requirements - Sedation requirements - Nausea and vomiting - Respiratory Status - Opioid consumption ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate - NCT ID: NCT06270134 - Study ID: 14410 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2029-01 - Lead Sponsor: McMaster University ### Study Description This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel. ### Conditions - Hemolysis - Renal Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bicarbonate ### Outcomes Primary Outcomes - Non-elective hospitalizations or mortality Secondary Outcomes - Hospitalizations and fractures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Development of a Healthcare Service Platform for Successful Aging - NCT ID: NCT06270121 - Study ID: R2111483 - Status: RECRUITING - Start Date: 2020-10-21 - Completion Date: 2030-11-30 - Lead Sponsor: Sunmi Song ### Study Description The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are:* Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults* Develop digital health monitoring service to inform individualized daily health status of older adults users* Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information.Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers.If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group. ### Conditions - Depression in Old Age - Chronic Pain - Sleep Disorder Insomnia Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - Living-lab digital intervention group ### Outcomes Primary Outcomes - Patient Health Questionnaire-9 (PHQ-9) - Sleep fragmentation index - Daily steps - Intensity of physical activity - Heart rate variability Secondary Outcomes - Geriatic depression - SF-12 Quality of life - Pain related functional limitations - Chronic pain ### Location - Facility: Korea University, Seoul, N/A, 02841, Korea, Republic of @@
## The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia - NCT ID: NCT06270108 - Study ID: 22/SS/0040 - Status: RECRUITING - Start Date: 2022-11-14 - Completion Date: 2024-12-31 - Lead Sponsor: King's College London ### Study Description The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology.The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia. ### Conditions - Treatment-resistant Schizophrenia - Treatment-responsive Schizophrenia - Healthy Controls ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Riluzole ### Outcomes Primary Outcomes - Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration Secondary Outcomes - Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging) - Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging) - Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology ### Location - Facility: Institute of Psychiatry, Psychology and Neuroscience, London, N/A, SE5 8AB, United Kingdom @@
## " Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft" - NCT ID: NCT06270095 - Study ID: C21-57 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-04 - Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France ### Study Description The subject of the study focuses on commercial aircraft's cabins air quality, under conditions of both fume events and non-fume events. It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members. The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils. The epidemiological facet is geared towards the identification of potential neurological consequences. ### Conditions - Neurologic Symptoms - Neurologic Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neurocognitive, neuromuscular and neurosensitive tests. ### Outcomes Primary Outcomes - Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning - Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing - Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge - Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies - Neuromuscular test to evaluate muscle strength assessment - Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight Secondary Outcomes - Characteristics of plane and fume event and possible causes of fume event - Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of IK-595 in RAS- or RAF-altered Advanced Tumors - NCT ID: NCT06270082 - Study ID: IK595-001 - Status: RECRUITING - Start Date: 2023-12-18 - Completion Date: 2027-07 - Lead Sponsor: Ikena Oncology ### Study Description This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit. ### Conditions - Solid Tumor, Adult - Colorectal Cancer - Pancreatic Cancer - Malignant Melanoma - Ras (Kras or Nras) Gene Mutation - BRAF Gene Mutation - CRAF Gene Mutation - Non-Small Cell Lung Carcinoma - Thyroid Carcinoma - Gliomas, Malignant ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IK-595 ### Outcomes Primary Outcomes - Treatment-emergent adverse events, including treatment-related adverse events, and serious adverse events - Dose Limiting Toxicities - Treatment-Emergent Adverse Events - Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595 Secondary Outcomes - Pharmacokinetics of IK-595: half-life (t1/2) - Pharmacokinetics of IK-595: Area Under the Curve (AUC) - Pharmacokinetics of IK-595: Maximum Plasma Concentration (Cmax) - Pharmacokinetics of IK-595: Minimum Plasma Concentration (Cmin) - To evaluate pERK fold change from baseline in paired tumor biopsies - Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent - Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-595 as a single agent - Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent - Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent - Antitumor activity: Median progression-free survival (PFS) of IK-595 as a single agent ### Location - Facility: START Midwest, Grand Rapids, Michigan, 49546, United States @@
## Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain - NCT ID: NCT06270069 - Study ID: 2024-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-28 - Lead Sponsor: International Institute of Behavioral Medicines ### Study Description This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated. ### Conditions - Low Back Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Excercise-based therapy ### Outcomes Primary Outcomes - NRS - Gauge of pain Secondary Outcomes - ODI - PCS - TSK - PSEQ - GPE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Telemedicine Medical Abortion Service in Ecuador - NCT ID: NCT06270056 - Study ID: 1058 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-02 - Lead Sponsor: Gynuity Health Projects ### Study Description This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant. ### Conditions - Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Misoprostol ### Outcomes Primary Outcomes - Adverse events (safety) Secondary Outcomes - Feasibility of telemedicine service - Acceptability of telemedicine service ### Location - Facility: El Comité de Derechos Sexuales y Reproductivos de Ecuador (CODESER), Ambato, N/A, N/A, Ecuador @@
## Focal Therapy for Localized Prostate Cancer - NCT ID: NCT06270043 - Study ID: 809622 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2034-02-01 - Lead Sponsor: University of California, San Diego ### Study Description This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Focal Therapy ### Outcomes Primary Outcomes - Oncological Response Secondary Outcomes - Erectile Dysfunction - Incontinence - Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence. ### Location - Facility: University of California, San Diego, La Jolla, California, 92121, United States @@
## Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia - NCT ID: NCT06270030 - Study ID: JX07002 - Status: COMPLETED - Start Date: 2024-03-04 - Completion Date: 2024-04-10 - Lead Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. ### Study Description Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia ### Conditions - Presbyopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LNZ101 (Aceclidine /Brimonidine) ophthalmic solution - LNZ100 (Aceclidine) ophthalmic solution - Placebo (Vehicle) ophthalmic solution ### Outcomes Primary Outcomes - Cmax - Tmax - AUC0-t - AUC0-∞ - T1/2 - Safety: adverse event reporting Secondary Outcomes ### Location - Facility: Shanghai General Hospital, Shanghai, Shanghai, 200080, China @@
## Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars - NCT ID: NCT06270017 - Study ID: 282242 - Status: RECRUITING - Start Date: 2022-01-10 - Completion Date: 2028-12-31 - Lead Sponsor: University Hospital, Linkoeping ### Study Description In order to improve and individualize cancer treatment personalized treatments developed much further. Colon cancer is treated with surgery and thereafter adjuvant oncological treatment. The selection of chemotherapy is today mainly done according to best guess. Today only a small fraction of oncological treatment may be known to be effective in a person before treatment start, most often it is trial and error. A fast reliable system for looking at response to different treatments in each unique patient is much needed and would, if successful, completely change the way we give oncological treatment today. This system would also be possible to use to evaluate new treatments and if successful, implement in the clinical setting. In this project we will implant a part of the patient's tumour tissue into a zebrafish embryo and evaluate tumour growth and frequency of metastatic disease as well as response to given oncological treatment.2.2 Objective: The objective of this project is to explore the usefulness of zebrafish (Danio Rerio) embryo models to determine tumor biology and treatment response in colon cancer. An overarching goal would be, before start of any oncological treatment in a patient, to have evaluated the response of oncological treatment in the zebrafish avatar and only treat with a combination of drugs known to have effect against the patient's own tumour.2.3 Study design: This protocol describes a series of prospective studies in different cohorts of patients with colon cancer to investigate the applicability of zebrafish embryo models. The common denominator of the sub-studies is prospective collection of tumor tissue implanted in zebrafish embryos in order to evaluate if the model is robust enough for growing colon cancer tissue and evaluate growth pattern and response to chemotherapy. This study protocol is designed according to and in adherence with the SPIRIT guidelines.2.4 Intervention: In all sub-studies the intervention is inoculation of tumor cells in zebrafish embryos followed by observation of tumor behavior and testing of treatments. ### Conditions - Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Chemotherapy drug ### Outcomes Primary Outcomes - Tumour growth Secondary Outcomes - response evaluation ### Location - Facility: Per Sandström, Linköping, Ostergotland, 58185, Sweden @@
## Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients - NCT ID: NCT06270004 - Study ID: nonsurgical periodontal - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: University of Baghdad ### Study Description 1. To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .2. To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months) ### Conditions - Non Surgical Periodontal Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - nonsurgical periodontal therapy ### Outcomes Primary Outcomes - Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. Secondary Outcomes - Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. - Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fascial Anthropometry in Archery Athletes - NCT ID: NCT06269991 - Study ID: SBA23/083 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-09-06 - Lead Sponsor: Hacettepe University ### Study Description In archery, the body morphological and anthropometric characteristics of the prominent athletes change. It is important to examine facial anthropometry, especially since the athlete's equipment touches the facial area, and there are no studies on this subject. The aim of this study is to determine the relationship between facial anthropometric measurements and anthropometry-related parameters and sports performance in archery athletes. ### Conditions - Sports Physical Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - evaluation of cervical region biomechanic - fat tissue distribution - head circumference - extremity circumference - extremity lengt measurement - knee and elbow diameter - nose width - chin width - face width - head width - nose protrusion - nose lenght - head lenght - face lenght - lip lenght Secondary Outcomes - Assessment of Perıpheral Muscle Strength - postural analysis - Evaluation of shooting performance - The seated medicine ball throw (SMBT) - Closed Kinetic Chain Upper Extremity Stability Test - Upper Quarter Y Balance Test ### Location - Facility: Hacettepe University, Ankara, N/A, 06100, Turkey @@
## Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer - NCT ID: NCT06269978 - Study ID: OSU-23195 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Arjun Mittra ### Study Description This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer. ### Conditions - Metastatic Colorectal Carcinoma - Metastatic Malignant Neoplasm in the Peritoneum - Stage IV Colorectal Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Computed Tomography - Diagnostic Laparoscopy - Fluorouracil - Magnetic Resonance Imaging - Oxaliplatin - Surgical Procedure ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) - Incidence of adverse events - Area under the curve - Clearance - Volume of distribution - Half-life Secondary Outcomes - Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin - Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin - Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin - Rate of conversion from unresectable to resectable - Overall response rate ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair - NCT ID: NCT06269965 - Study ID: 2023-A02181-44 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-04-15 - Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche ### Study Description Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream.Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired.Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing. ### Conditions - Cuff Rotator Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Regeneten® adding ### Outcomes Primary Outcomes - Rotator cuff healing quality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intimate Partner Violence Among People Who Inject Drugs - Prevalence, Risk Factors and Experiences - NCT ID: NCT06269952 - Study ID: MVarmafalk - Status: RECRUITING - Start Date: 2023-10-05 - Completion Date: 2028-12 - Lead Sponsor: Region Stockholm ### Study Description There are around 15,6 million people who inject drugs (PWID) worldwide, of which around 3,5 million are women who inject drugs (WWID) (1). In Sweden, estimates suggest 8000-21000 PWID (2). PWID are exposed to substantial health risks that are directly linked to injection drug use, such as blood borne viruses (hepatitis and HIV), overdoses and skin and tissue infections. Additionally psychiatric disorders are common and PWID's general health is often neglected (3,4,5).In Sweden, harm reduction units such as needle and syringe programs (NSP) have scaled-up in recent years. In Stockholm the first NSP opened in 2013 and the second in 2018. In 2022, 4600 individuals were enrolled in the program since it opened, of which approximately 25% were women. Around 2000 were active participants, defined as having visited the program at least once during the last 12 months. In 2021 54% of the participants stated amphetamine as the last drug injected, 31% heroin, 4% buprenorphine and 11% other drugs. Most participants were between 30-49 years of age. In addition to distribution of sterile needles and injection paraphernalia, the NSP staff (nurses, doctors, midwifes, counselors) provides services such as testing for blood borne viruses, vaccinations, wound care, take-home naloxone, reproductive health services, counselling, support in contact with social service and referrals for substance use disorder treatment and hepatitis C/HIV treatment.Gender-based violence (GBV) is a global health issue and WHO estimates that one in three women globally have been exposed to some sort of partner violence during their lifespan (7). Intimate partner violence (IPV) is defined as violent behavior between two people who have a close relationship, such as partners, ex-partners, siblings, relatives, friends and alike. In Sweden around 14% of women and 5% of men are exposed to physical violence in an intimate partner relationship during their lifespan however 20-25% of women and around 17% of men are exposed to psychological violence during their lifespan (8; 9). The prevalence of IPV among PWID is estimated to be significantly higher than in the general population (10). A study from USA found the risk of IPV to be three times higher and the prevalence estimated between 35-57% (7). In international studies, IPV exposure is found to be a significant risk factor for needle sharing among WWID (11, 12). There are other well-known consequences of IPV including impact on sexual and reproductive health rights, physical and psychological wellbeing, increased risk of contracting HIV and hepatitis C (13; 14). IPV exposure disproportionately affects WWID worldwide, however studies in Sweden on IPV exposure in the PWID population is scarce. To date there are studies that address this among women with substance use disorders but none with an exclusive focus on PWID or WWID. In clinical research of women diagnosed with substance use disorders (SUD) with psychiatric comorbidities and social challenges, one study indicates that the majority (91%, n=79) of women had been exposed to some form of IPV (15). Another study of women with SUD (n=52), 50% reported exposure of serious violence and the majority (96%) reported exposure to psychological violence (10). There are different types of IPV; psychological, physical, sexual, financial, latent, digital, neglect, honor related, aftermath of IPV (16). Our research team has previously carried out a qualitative interview study among WWID at the Stockholm NSP in 2019 to investigate reasons and barriers for participation among women (17). The interviews illustrated that IPV is common. In the proposed studies, for this doctoral thesis, we have chosen to focus on physical, sexual, psychological and financial violence among PWID motivated by findings in our previous research.PWID and specifically WWID are regarded as groups who are especially vulnerable for IPV exposure and should therefore be prioritized in the national efforts to prevent IPV (15). However, there are no studies estimating the prevalence and frequency of IPV among PWID in Sweden. Previous international studies suggest that PWID are exposed to IPV to a greater extent than the general population, and women with substance use disorders are exposed to an alarming degree of violence (15). In Sweden there are no tailored interventions for PWID or WWID who are exposed to IPV, it is reasonable to believe that there is a need for a multi-faceted program for PWID exposed to IPV, however this is still unexplored.The overall aim of this project is to increase knowledge about IPV among PWID and WWID as particularly vulnerable groups in regards to IPV. More specifically, the aim is to investigate the prevalence and frequency of different types of IPV among PWID at the Stockholm NSP and to explore the experiences' of IPV, needs and preferences for IPV support among WWID to facilitate tailored support and prevention programs for those exposed. ### Conditions - People Who Inject Drugs, Injection Risk Behaviour, Gender-based Violence, Intimate Partner Violence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Intimate partner violence Secondary Outcomes ### Location - Facility: Needle syringe program, Stockholm, N/A, N/A, Sweden @@
## Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI - NCT ID: NCT06269939 - Study ID: R-1253-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-30 - Lead Sponsor: Kessler Foundation ### Study Description The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in an aging population. ### Conditions - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - STEM ### Outcomes Primary Outcomes - Verbal Leaning task - Participation in Everyday life Secondary Outcomes - Functional Neuroimaging ### Location - Facility: Kessler Foundation, East Hanover, New Jersey, 07936, United States @@
## Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy - NCT ID: NCT06269926 - Study ID: IRB00431182 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-04 - Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. ### Study Description The purpose of this study is to understand if cognitive behavioral therapy can improve pain-related thought patterns and pain-related impairment in adults with cerebral palsy. ### Conditions - Cerebral Palsy - Pain, Chronic - Pain Catastrophizing - Brain Diseases - Central Nervous System Diseases - Coping Strategies - Catastrophizing Pain - Coping Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Therapy for Chronic Pain - Pain education ### Outcomes Primary Outcomes - Pain Catastrophizing Secondary Outcomes - Global Impressions of Change - Pain Interference - Pain Intensity - Anxiety/Mood symptoms ### Location - Facility: Kennedy Krieger Institute, Baltimore, Maryland, 21205, United States @@
## A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II - NCT ID: NCT06269913 - Study ID: 23-0826 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: University of Calgary ### Study Description Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females. ### Conditions - Iron Deficiencies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FeSC ### Outcomes Primary Outcomes - Iron Status - Hemoglobin - Upper Gut Microbiome - Lower Gut microbiome Secondary Outcomes - Exercise Capacity - Hemoglobin Mass - Gastrointestinal Symptoms 1 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype - NCT ID: NCT06269900 - Study ID: RC23_0358 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-08-15 - Lead Sponsor: Nantes University Hospital ### Study Description Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial. ### Conditions - Hospital Acquired Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexamethasone - Placebo ### Outcomes Primary Outcomes - Clinical cure rate at the test-of-cure visit (TOC visit) - The rate of all-cause mortality on Day 28. Secondary Outcomes - Rate of death - Rate of pleural empyema at Day 28. - Rate of microbiological failure - Rate of pneumonia relapse - Duration of hospitalization and hospital-free days - Rates of non-respiratory hospital-acquired infection - Antibiotic-free days at Day 28 - Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days - Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event) - Rate of gastric ulcer - Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale - Changes in subjective well-being with the Satisfaction With Life Scale (SWLS) - Changes in health-related quality of life measured with the Short Form (SF)-36 - the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER) ### Location - Facility: CHU Angers, Angers, N/A, N/A, France @@
## Dominant Non-Dominant Upper Extremity in Gender - NCT ID: NCT06269887 - Study ID: Karabuk-001 - Status: RECRUITING - Start Date: 2023-11-07 - Completion Date: 2024-03-30 - Lead Sponsor: Karabuk University ### Study Description There are strength and functional differences between non-dominant and dominant extremities. This is important in the hand and extremity rehabilitation process. This situation also differs between genders. Comparison of the dominant and non-dominant limb can provide important clinical or rehabilitation field-related information. It is reported in the literature that manual dexterity, grip strength and joint position sense may differ between extremities. However, the relationship between this situation and the difference between genders has not been explained. It is thought that examining this difference can be extremely useful in determining achievable goals in hand rehabilitation and in customizing care for different groups. ### Conditions - Upper Extremity Problem - Gender Issues ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Hand Preference - Grip Strength - Joint Position Sense - Manual Dexterity Secondary Outcomes ### Location - Facility: Karabük University, Karabük, N/A, 78000, Turkey @@
## Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment - NCT ID: NCT06269874 - Study ID: ASPERA-ANOCA - Status: NOT_YET_RECRUITING - Start Date: 2024-03-02 - Completion Date: 2024-08-31 - Lead Sponsor: Johannes Gutenberg University Mainz ### Study Description The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.Goals of this study are:1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).3. Time required for IMR measurements ### Conditions - Microvascular Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - microvascular function assessment ### Outcomes Primary Outcomes - Agreement between intravenous and intracoronary adenosine responses (IMR) Secondary Outcomes - Agreement between secondary parameters and reproducibility as compared with absolute - Time required for IMR measurements ### Location - Facility: Center of Cardiology, Cardiology I, university hospital Mainz, Mainz, Rheinland-Pfalz, 55131, Germany @@
## Comparison of Body Weights Via Visual Estimation, Anthropometric Calculation, and Actual Measured in Critically Ill Patients - NCT ID: NCT06269861 - Study ID: GaziUtipNBDundar003 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-10-31 - Lead Sponsor: Gazi University ### Study Description Rapid and accurate determination of body weight in adult intensive care patients is very important for both calculating target tidal volume during invasive mechanical ventilation support and dose dependent drug administration. In this patient group, measuring actual body weight with a calibrated scale by standing the patient up is often impossible due to acute illness. Instead, estimated body weight determined by health care personnel or estimated body weights calculated according to anthropometric measurements are used. These calculations have some limitations in showing actual body weight, and there is some controversial information in current literature regarding their validity in critically ill patients. There is newly developed patient transfer scale called Marsden M-999® manufactured by Marsden Weighing Machine Group Ltd, which has the advantage of being used in patients who are unable to stand up, in rapidly and accurately measuring the current body weight in critically ill patients. This study aimed to evaluate the validity of these methods by comparing the body weights calculated by visual estimation and various anthropometric methods in critically ill Turkish patients with the actual weight measured by the mentioned scale. ### Conditions - Critically Ill - Body Weight ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SCREENING ### Interventions - patient transfer scale ### Outcomes Primary Outcomes - determining actual weight - determining the ideal estimated body weight in critically ill patients Secondary Outcomes ### Location - Facility: Gazi University, Ankara, Yenimahalle, 06560, Turkey @@
## Identification of Sports Talents in Boxers - NCT ID: NCT06269848 - Study ID: ITaDeBo - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-06-30 - Lead Sponsor: Dynamical Business and Science Society - DBSS International SAS ### Study Description This study aims to identify sporting talents by profiling a group of young boxers residing in the State of Mexico using unsupervised machine learning methods. This study is supported by Asociación de Boxeo del Estado de México AC (ABEM) and powered by DBSS. ### Conditions - Body Composition - Exercise Test - Psychological Well-Being ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Anthropometry-Based Analysis of Adiposity - The acceleration of the fists in straight boxing punches - Number of punches thrown within a specific timeframe - Punch impact force - Reactive force index - Cardiorespiratory fitness - Isometric Mid-Thigh Pull - Load-velocity profile Secondary Outcomes - Well-being profile - Ways of Coping Questionnaire - Attention and Perceptual Processes ### Location - Facility: Centro Ceremonial Otomí, México, N/A, 50868, Mexico @@
## Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia - NCT ID: NCT06269835 - Study ID: NAOTAN-IOE - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-12 - Lead Sponsor: Zeng Changhao ### Study Description This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - systemic therapy - Intermittent Oro-Esophageal Tube Feeding - Persistent Nasogastric Tube Feeding ### Outcomes Primary Outcomes - The Oral Motor Assessment Scale Secondary Outcomes - Pneumonia - Hemoglobin - Total Protein - Albumin - Prealbumin - body weight - upper arm circumference - Penetration-Aspiration Scale - Functional Oral Intake Scale for Infants - Feeding amount ### Location - Facility: Center Rehabilitation Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP - NCT ID: NCT06269822 - Study ID: SSR, HRV, QEEG in TLE - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2024-01-01 - Lead Sponsor: Cairo University ### Study Description The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques.Moreover, it aimed at finding any correlation between electrophysiological tests and SUDEP risk. ### Conditions - Temporal Lobe Epilepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sympathetic skin response, heart rate variability test, quantitative EEG ### Outcomes Primary Outcomes - Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy - Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy Secondary Outcomes - Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients ### Location - Facility: Clinical Neurophysiology unit- Kasr alainy-Cairo University, Cairo, Cairo Governorate, Cairo, Egypt, Egypt @@
## Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial - NCT ID: NCT06269809 - Study ID: s67279 - Status: RECRUITING - Start Date: 2023-05-04 - Completion Date: 2025-05-30 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time. ### Conditions - Fibroid Uterus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Temporary clipping of the uterine arteries and the utero-ovarian ligmants. - No temporary clipping of the uterine arteries and the utero-ovarian ligmants. ### Outcomes Primary Outcomes - Peri-operative blood loss: Estimated blood loss - Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL - Peri-operative blood loss: Need for peri-operative blood transfusion Secondary Outcomes - Hospitalisation time - Operation time in minutes - Number of patients with complications postoperatively, graded by Clavien Dindo classification - Number of patients requiring secondary hemostatic measures ### Location - Facility: University Hospitals Leuven, Leuven, N/A, 3000, Belgium @@
## Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder - NCT ID: NCT06269796 - Study ID: little-dcdq - Status: COMPLETED - Start Date: 2021-03-01 - Completion Date: 2021-09-30 - Lead Sponsor: University of Thessaly ### Study Description This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment. ### Conditions - Motor Skills Disorders - Child Development - Child, Preschool ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Little Developmental Coordination Disorder Questionnaire (LDCDQ) - Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2) ### Outcomes Primary Outcomes - Parent Screening Questionnaire for Motor Coordination Difficulties (DCD) - Screening Test for Detection of Developmental Coordination Disorder (DCD) Secondary Outcomes ### Location - Facility: Human Performance & Rehabilitation Laboratory, Department of Physiotherapy, University of Thessaly, Lamía, Pthiotis, 35100, Greece @@
## Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis - NCT ID: NCT06269783 - Study ID: STUDY00022968 - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2024-10-31 - Lead Sponsor: Penn State University ### Study Description The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period. ### Conditions - Kidney Stone - Urolithiasis - Nephrolithiasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - sipIT ### Outcomes Primary Outcomes - Urine volume (intervention) Secondary Outcomes - Urine volume (maintenance) ### Location - Facility: The Pennsylvania State University, University Park, Pennsylvania, 16802, United States @@
## Tapentadol vs Tramadol in Total Knee Arthroplasty - NCT ID: NCT06269770 - Study ID: Tapentadol - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: University of Thessaly ### Study Description Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR). ### Conditions - Total Knee Replacement - Post-operative Pain - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tapentadol - Tramadol ### Outcomes Primary Outcomes - Post-operative pain - Post-operative pain - Post-operative pain - Post-operative pain - Post-operative pain Secondary Outcomes - Post-operative pain - Post-operative pain - Post-operative pain - Neuropathic pain - Quality of life postoperatively - Patient Satisfaction - Depression - Function - Outcome - Arthritis impact - Health Status - Pain severity ### Location - Facility: University Hospital Of Larissa, Larissa, Thessaly, 41110, Greece @@
## Exercise Program for ITB Syndrome - NCT ID: NCT06269757 - Study ID: 23-01514 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: NYU Langone Health ### Study Description Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes. ### Conditions - Iliotibial Band Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Individualized Exercise Program - Standard Physical Therapy ### Outcomes Primary Outcomes - Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score - Visual Analogue Scale (VAS) Score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Proactive Outreach With FIT - NCT ID: NCT06269744 - Study ID: 23-01032 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-13 - Completion Date: 2026-04-30 - Lead Sponsor: NYU Langone Health ### Study Description The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Proactive Screening Outreach ### Outcomes Primary Outcomes - Proportion of Participants who Complete FIT Test by Month 6 Secondary Outcomes - Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6 ### Location - Facility: NYU Langone Health, Brooklyn, New York, 11203, United States @@
## Anxiety & Depression in Thyroid Cancer Patients - NCT ID: NCT06269731 - Study ID: Thyroid cancer - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Assiut University ### Study Description 1. To identify the prevalence of both anxiety and depression in thyroid cancer patients2. To assess quality of life in thyroid cancer patients ### Conditions - Thyroid Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hamilton depression Rating Scale ### Outcomes Primary Outcomes - the prevalence of anxiety in thyroid cancer patients - the prevalence of depression in thyroid cancer patients Secondary Outcomes - assess quality of life in thyroid cancer patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia - NCT ID: NCT06269718 - Study ID: CMRPG8N0471 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-07-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description The aims of this study are:1. Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function2. To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.3. To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - swallowing therapy - IOPI therapy ### Outcomes Primary Outcomes - the change from baseline to time of swallowing muscle strength - the change from baseline to time of Masster thickness - the change from baseline to time of tongue muscles thickness Secondary Outcomes - the change from baseline to time of general muscle mass - Measure the change in grip strength (by Jamar hand dynamometer) - the change from baseline to time of swallowing functions - the change from baseline to time of clinical nutrition status - the change from baseline to time of swallowing functions 100 ml water test - the change from baseline to time of quality of life ### Location - Facility: ChangGungMH, Kaohsiung, N/A, 833, Taiwan @@
## ZILRETTA in Subjects With Glenohumeral Osteoarthritis - NCT ID: NCT06269705 - Study ID: 006-C-301 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2025-08 - Lead Sponsor: Pacira Pharmaceuticals, Inc ### Study Description Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placeboSecondary Objective:* To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo* To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR ### Conditions - Glenohumeral Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ZILRETTA - TCA-IR - Placebo ### Outcomes Primary Outcomes - Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to placebo Secondary Outcomes - Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to TCA-IR - Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 18 for ZILRETTA relative to TCA-IR - Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 2 for ZILRETTA relative to placebo - Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 4 for ZILRETTA relative to placebo - Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 8 for ZILRETTA relative to placebo - Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to placebo - Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to TCA-IR ### Location - Facility: Alabama Orthopaedic Center- Research, Birmingham, Alabama, 35243, United States @@
## MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators - NCT ID: NCT06269692 - Study ID: 2023-A01353-42 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2030-04-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients. ### Conditions - Myocardial Infarction - Ventricular Tachycardia - Ventricular Fibrillation - Sudden Cardiac Death ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MRI screening - Implantable Loop Recorder - Implantable Cardioverter Defibrillator ### Outcomes Primary Outcomes - Occurrence of Sudden Cardiac Death (SCD) during the follow-up period Secondary Outcomes - Total number of deaths during the follow-up period - Total number of deaths from cardiovascular cause during the follow-up period - Total number of SCD due to ventricular arrhythmia during the follow-up period - Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period - Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period - Total number of hospitalizations due to cardiovascular causes during the follow-up period - Duration of hospitalizations due to cardiovascular causes during the follow-up period - Total number of hospitalizations from any cause during the follow-up period - Duration of hospitalizations from any cause during the follow-up period - Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period - Measurements of the estimated costs - Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences - Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences - Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar - Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar ### Location - Facility: CHRU Nancy, Vandœuvre-lès-Nancy, N/A, 54511, France @@
## CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. - NCT ID: NCT06269679 - Study ID: RC23_0336 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-01 - Lead Sponsor: Nantes University Hospital ### Study Description 1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes. ### Conditions - Infective Endocarditis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - CBCT ### Outcomes Primary Outcomes - Superiority of CBCT - Superiority of CBCT - Superiority of CBCT Secondary Outcomes - Diagnostic at inclusion - Incident symptomatic OIF - Incident asymptomatic OIF - Oral hygiene - Follow-up habits - Follow-up habits - Oral health quality of life - Premature end of study ### Location - Facility: CHU Bordeaux - Site Pellegrin, Bordeaux, N/A, N/A, France @@
## P200TxE Diseased Eye Image Collection - NCT ID: NCT06269666 - Study ID: OPT1100 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-06-30 - Lead Sponsor: Optos, PLC ### Study Description The primary objective is to collect images on the P200TxE device in diseased eyes. ### Conditions - Retinal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - P200TxE ### Outcomes Primary Outcomes - Number of images Secondary Outcomes ### Location - Facility: Bennett and Bloom Eye Centers, Louisville, Kentucky, 40215, United States @@
## Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide - NCT ID: NCT06269653 - Study ID: 10001944 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-01 - Lead Sponsor: National Institute on Aging (NIA) ### Study Description Background:Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover.Objective:To measure rates of protein turnover in healthy adults.Eligibility:Healthy people aged 20 years and older with a body mass index between 20 and 30.Design:Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit.Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs.Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years.Participants will have tests during study visits, including:Imaging scans of a leg.Exercise on a treadmill.Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen.Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes.Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands.D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle. ### Conditions - Healthy Volunteers ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Measure the turnover proteins in humans across tissues, age, and sex. Secondary Outcomes - Test the hypothesis that older age is associated with diminished protein turnover. ### Location - Facility: National Institute of Aging, Clinical Research Unit, Baltimore, Maryland, 21224, United States @@
## NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study - NCT ID: NCT06269640 - Study ID: 10001640 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-10-01 - Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI) ### Study Description Background:Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO.Objective:To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME).Eligibility:Adults aged 21 years with LVOTO.Design:Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life.Participants will stay in the hospital 2 to 6 days for the SESAME procedure.They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart.Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum.Participants will have 3 follow-up visits within 1 year. ### Conditions - Hypertrophic Cardiomyopathy - Left Ventricular Septal Hypertrophy - Mitral Valve Disease - Aortic Valve Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Septal Scoring Along Midline Endocardium ### Outcomes Primary Outcomes - Technical success - Safety Secondary Outcomes - Complete heart block requiring permanent pacemaker ### Location - Facility: Emory University Hospital, Atlanta, Georgia, 30322, United States @@
## Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder - NCT ID: NCT06269627 - Study ID: 10001644 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) ### Study Description Background:Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.Objective:To learn more about how acamprosate affects brain function in people with AUD.Eligibility:People aged 21 to 65 years with moderate to severe AUD.Design:Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.Participants may have up to three follow-up visits for 6 months. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Acamprosate calcium - Placebo ### Outcomes Primary Outcomes - Reduction of beta power Secondary Outcomes - Promotion of alpha power in active group compared to placebo group. - No change in slow band (delta and theta) power in active group compared to placebo group. - Reduction of theta event-related synchronization in active group compared to placebo group. - Amplification and hastening of P300 in active group compared to placebo group. - Correlation of EEG markers of acamprosate treatment with clinical measures of anxiety and alcohol craving - Correlation of EEG markers of acamprosate treatment with polysomnography markers - Correlation of polysomnography markers of acamprosate treatment with clinical measures of anxiety and alcohol craving ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition - NCT ID: NCT06269614 - Study ID: QOL334829 - Status: RECRUITING - Start Date: 2023-01-12 - Completion Date: 2025-12-31 - Lead Sponsor: Nova Southeastern University ### Study Description Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group. ### Conditions - Autism Spectrum Disorder - Adverse Childhood Experiences - Stress Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Probiotic ### Outcomes Primary Outcomes - Enteric Microbiome abundance - Enteric Microbiome diversity Secondary Outcomes - Improved response to stressor - Improved physiological response to stressor ### Location - Facility: Nova Southeastern University College of Nursing, Davie, Florida, 33314, United States @@
## The Reliability of the Upper Limb Rotation Test in Adolescent Male Basketball Players - NCT ID: NCT06269601 - Study ID: HÜ- FTR- BD- 02 - Status: COMPLETED - Start Date: 2023-08-10 - Completion Date: 2023-09-15 - Lead Sponsor: Hacettepe University ### Study Description The objective of the study is to examine the reliability of the Upper Limb Rotation Test in adolescent male basketball players aged between 14 and 16. According to the sample size calculation for the study, 51 athletes were included. The Upper Limb Rotation Test was administered to the athletes twice, with a one-week interval. The athlete was positioned in a plank stance with shoulder, elbow lateral epicondyle, greater trochanter, and ankle lateral malleolus making contact with the wall. The athletes were instructed to perform a 90° abduction and 90° external rotation of the shoulder, accompanied by trunk rotation for a duration of 15 seconds. The number of repetitions was recorded. The tested side was the upper extremity in which the closed kinetic chain position was maintained. The test was repeated three times, and the average of the results was calculated. The Upper Extremity Rotation Test is a reliable assessment tool for evaluating performance in adolescent basketball players aged 14-16, particularly in relation to shooting skills. ### Conditions - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Upper Limb Rotation Test ### Outcomes Primary Outcomes - The Reliability of the Upper Limb Rotation Test Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, N/A, N/A, Turkey @@
## Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding - NCT ID: NCT06269588 - Study ID: NBM-NP004 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-12 - Lead Sponsor: Changi General Hospital ### Study Description The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore ### Conditions - Gastrointestinal Hemorrhage - Hematemesis; With Ulcer - Endoscopy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nexpowder ### Outcomes Primary Outcomes - endoscopic hemostasis Secondary Outcomes - recurrent bleeding rate on second-look endoscopy - hydrogel persistence rate at the bleeding site - Recurrent bleeding within 30 days after endoscopic therapy ### Location - Facility: Changi General Hospital, Singapore, N/A, 529889, Singapore @@
## Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia - NCT ID: NCT06269575 - Study ID: Dysphagia - Status: COMPLETED - Start Date: 2020-10-05 - Completion Date: 2023-12-15 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia? ### Conditions - DYSPHAGIA ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - SAFE NUTRITION PROGRAM ### Outcomes Primary Outcomes - Complications of dysphagia - Complications of dysphagia - Complications of dysphagia Secondary Outcomes - Stroke-Specific Quality of Life Scale (SS-QOL) - Swallowing Anxiety Scale (YKÖ) ### Location - Facility: Istanbul Universitesi-Cerrahpasa, Istanbul, N/A, N/A, Turkey @@
## SPSIPB and CPB on Clavicle Surgeries - NCT ID: NCT06269562 - Study ID: clavicle - Status: COMPLETED - Start Date: 2023-06-20 - Completion Date: 2024-02-04 - Lead Sponsor: Cumhuriyet University ### Study Description Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS). ### Conditions - Clavicle Fracture - Postoperative Pain - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Serratus posterior superior intercostal plane block and clavipectoral plane block ### Outcomes Primary Outcomes - Numerical Rating Scale Secondary Outcomes - tramadol consumption ### Location - Facility: Sivas Cumhuriyet University, Sivas, N/A, 58050, Turkey @@
## Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis - NCT ID: NCT06269549 - Study ID: KDS_KOA - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12-31 - Lead Sponsor: University of Primorska ### Study Description The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:* Is adding a dietary supplement to exercise additionally effective in managing KOA?* Is adding exercise to the dietary supplement additionally effective in managing KOA?Participants will be given in three groups:1. Real dietary supplement alone2. Real dietary supplement with exercise3. Placebo dietary supplement with exerciseInvestigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone. ### Conditions - Osteoarthritis, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Non-training Real Dietary Supplement (G1) - Training Placebo Dietary Supplement (G2) - Training Real Dietary Supplement (G3) ### Outcomes Primary Outcomes - Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12 - Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12 - Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 - Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12 - Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12 - Change from baseline in knee pain on visual analogue scale at week 12 - Change from baseline in static balance time at week 12 - Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12 - Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12 - Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12 - Change from baseline in number of repetitions in Chair Stand Test at week 12 - Change from baseline in time for Five Times Sit to Stand Test at week 12 - Change from baseline in number of repetitions in Arm Curl Test at week 12 - Change from baseline in lower body flexibility at week 12 - Change from baseline in upper body flexibility at week 12 - Change from baseline in 6-minute walk distance at week 12 - Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor at week 12 - Change from baseline in explosive strength of knee extensor at week 12 - Change from baseline in 24-hour time use at week 12 - Change from baseline in presence of inflammatory markers in blood sample at week 12 Secondary Outcomes ### Location - Facility: University of Primorska, Faculty of Health Sciences, Izola, N/A, 6310, Slovenia @@
## Stress-reducing Intervention in Urothelial Carcinoma - NCT ID: NCT06269536 - Study ID: UC-SK004 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2029-02-15 - Lead Sponsor: Comenius University ### Study Description The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - HRV biofeedback ### Outcomes Primary Outcomes - Primary Objective: Inflammation - Primary Objective: Heart Rate Variability (HRV) - Primary Objective: Quality of Life (QoL) - Primary Objective: Working memory - Primary objective: Executive function - Primary objective: Salivary Cortisol Slopes - Primary objective: Sleep Quality Secondary Outcomes - Secondary objective: Serious Adverse Events - Secondary objective: Disease-Free Survival (DFS) - Secondary objective: Overall Survival (OS) ### Location - Facility: National Cancer Institute, Bratislava, N/A, 83310, Slovakia @@
## Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery - NCT ID: NCT06269523 - Study ID: MFR032024 - Status: COMPLETED - Start Date: 2021-07-21 - Completion Date: 2024-01-31 - Lead Sponsor: University of Palermo ### Study Description Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery. ### Conditions - Axillary Web Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Kinesio taping, Lymphatic drainage - Lymphatic drainage ### Outcomes Primary Outcomes - NRS Scale - Joint excursion shoulder - Muscular strength of the upper limbs Secondary Outcomes - Constant Murley Score - upper limbs circumferenze (cyrtometry) ### Location - Facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone, Palermo, N/A, 90127, Italy @@
## Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients - NCT ID: NCT06269510 - Study ID: HUM00242997 - Status: NOT_YET_RECRUITING - Start Date: 2025-04 - Completion Date: 2027-07 - Lead Sponsor: University of Michigan ### Study Description The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions. ### Conditions - Alcohol-related Liver Disease - Liver Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ENGAGE-ALD Application (APP) - Treatment Facilitation bundle - Enhanced Usual Care ### Outcomes Primary Outcomes - Alcohol treatment engagement Secondary Outcomes - Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method - Percent heavy drinking days (PHDD) - Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants - Change in Liver health based on liver laboratory values (total bilirubin) for all participants - Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## TiO2-scaffolds for Alveolar Ridge Preservation - NCT ID: NCT06269497 - Study ID: 2018/2300 - Status: COMPLETED - Start Date: 2021-11-09 - Completion Date: 2023-08-10 - Lead Sponsor: University of Oslo ### Study Description The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction. ### Conditions - Alveolar Bone Resorption ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Scaffold placement - CBCT ### Outcomes Primary Outcomes - Adverse reactions Secondary Outcomes - Anatomy - Inflammation - Mineralization ### Location - Facility: Faculty of Dentistry, University of Oslo, Oslo, N/A, Postboks 1142 Blindern, Norway @@
## A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK - NCT ID: NCT06269484 - Study ID: D4326C00004 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-01-17 - Lead Sponsor: AstraZeneca ### Study Description This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis. ### Conditions - Liver Cirrhosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet) - Zibotentan + placebo (placebo matching dapagliflozin tablet) - Zibotentan + dapagliflozin ### Outcomes Primary Outcomes - Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) - Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) Secondary Outcomes - Change in body weight (kg) over time course of study - Change in body weight (kg) over time course of study - Change in total dosage of loop-diuretic equivalents use - Change in total dosage of loop-diuretic equivalents use - Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use - Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use - Absolute change in systolic and diastolic blood pressure - Absolute change in systolic and diastolic blood pressure - Change from baseline in body weight - Change from baseline in total body water - Change from baseline in extracellular water volume - Change from baseline in intracellular water volume - Change from baseline in body fat mass - Change from baseline in body weight - Change from baseline in total body water - Change from baseline in extracellular water volume - Change from baseline in intracellular water volume - Change from baseline in body fat mass ### Location - Facility: Research Site, Englewood, Colorado, 80113, United States @@
## On the ICC's Path: a Prevalence Study - NCT ID: NCT06269471 - Study ID: 2023-A02039-36 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-07-30 - Lead Sponsor: University Hospital, Grenoble ### Study Description The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France. ### Conditions - Chronic Ankle Instability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of chronic ankle instability in trailers Secondary Outcomes - Socio-demographic data (1/4) - Socio-demographic data (2/4) - Socio-demographic data (3/4) - Socio-demographic data (4/4) - Trail running and prevalence reports (1/11) - Trail running and prevalence reports (2/11) - Trail running and prevalence reports (3/11) - Trail running and prevalence reports (4/11) - Trail running and prevalence reports (5/11) - Trail running and prevalence reports (6/11) - Trail running and prevalence reports (7/11) - Trail running and prevalence reports (8/11) - Trail running and prevalence reports (9/11) - Trail running and prevalence reports (10/11) - Trail running and prevalence reports (11/11) - Associated pathologies (1/2) - Associated pathologies (2/2) - Medical care (1/3) - Medical care (2/3) - Medical care (3/3) ### Location - Facility: University Grenoble Alpes, Grenoble, N/A, 38000, France @@
## The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep - NCT ID: NCT06269458 - Study ID: ABU-001 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-26 - Lead Sponsor: Antalya Bilim University ### Study Description Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated. ### Conditions - Newborn - Yoga - Mother-Infant Interaction - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Baby Massage - Monther-Baby Yoga ### Outcomes Primary Outcomes - Attachment - Weight and Sleep Secondary Outcomes ### Location - Facility: Antalya Bilim Üniversitesi, Antalya, N/A, N/A, Turkey @@
## The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer - NCT ID: NCT06269445 - Study ID: 2023-942-01 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-02-01 - Lead Sponsor: Sir Run Run Shaw Hospital ### Study Description To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Icaritin Combined With Bevacizumab and FOLFIRI ### Outcomes Primary Outcomes - Progression-free survival(PFS) Secondary Outcomes - Objective remission rate (ORR) - Overall survival (OS) - Disease Control Rate (DCR) - Duration of ongoing remission (DOR) - TRAEs - Quality of life of the patients ### Location - Facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE（PATH-STROKE） - NCT ID: NCT06269432 - Study ID: 2023YFS0042 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Sichuan Provincial People's Hospital ### Study Description Objectives of Study:To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic cerebral infarction under the guidance of platelet aggregation function. ### Conditions - Ischemic Stroke - Antiplatelet Drug ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Precision Antiplatelet Therapy Trial Group - Traditional Antiplatelet Therapy Control Group ### Outcomes Primary Outcomes - 3-month major ischemic events and major bleeding events Secondary Outcomes - disability - Cardiovascular or cerebrovascular mortality ### Location - Facility: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China @@
## Study of Natural Course Progression of Diabetic Retinopathy - NCT ID: NCT06269419 - Study ID: 2023-KY295 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2029-01-01 - Lead Sponsor: Jie Li ### Study Description The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.The contents of follow-up examinations are:History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.Urinary microalbumin/urinary creatinine ACR. Microvisual field. ### Conditions - Biomarkers of Diabetic Retinopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Observation and follow-up of biomarkers of diabetic retinopathy - Level of Glycosylated hemoglobin - Creatinine - Total cholesterol - Urinary microalbumin - Urea - Glomerular filtration rate - Triglycerides - Low-density lipoprotein cholesterol - High-density lipoprotein cholesterol - Urinary creatinine ACR Secondary Outcomes ### Location - Facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial, Chendu, Sichuan, 610014, China @@
## A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults - NCT ID: NCT06269406 - Study ID: SW008 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-09-10 - Lead Sponsor: S.LAB (SOLOWAYS) ### Study Description Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy. ### Conditions - Dental Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg - ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg - The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure ### Outcomes Primary Outcomes - Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points) Secondary Outcomes - Total pain relief (TOTPAR) % - Time to pain half pain gone (in minutes) - Duration of pain half gone (in minutes) - Any adverse events (facial swelling, nausea, vomiting, headache) (%) ### Location - Facility: Nmsi Dentmaster, Novosibirsk, Novosibirsk Region, 630090, Russian Federation @@
## A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy - NCT ID: NCT06269393 - Study ID: CIBI311Y101 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-02-01 - Lead Sponsor: Peking University People's Hospital ### Study Description This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity. ### Conditions - Thyroid Associated Ophthalmopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - IBI311 ### Outcomes Primary Outcomes - The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye. Secondary Outcomes - Overall responder rate in proptosis of the study eye. - Percentage of subjects with a CAS value of 0 or 1 - Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia) ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, 100034, China @@
## Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy - NCT ID: NCT06269380 - Study ID: 30.01.2024-4274 - Status: COMPLETED - Start Date: 2024-02-13 - Completion Date: 2024-02-21 - Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital ### Study Description Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal. ### Conditions - Gastritis H Pylori - Gastritis Chronic - Intestinal Metaplasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Esophagogastroduodenoscopy - Endoscopic biopsy sampling ### Outcomes Primary Outcomes - Rate of abnormal histopathologic findings Secondary Outcomes - Rate of intestinal metaplasia - Rates of gastritis severity and activity - Rate of Helicobacter Pylori positivity ### Location - Facility: Sisli Hamidiye Etfal Research and Training Hospital, Istanbul, N/A, N/A, Turkey @@
## NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) - NCT ID: NCT06269367 - Study ID: HUM00226149 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12 - Lead Sponsor: University of Michigan ### Study Description An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - NewGait - Control wearable limb orthotic device ### Outcomes Primary Outcomes - Gait speed - Ankle Muscle Activation Secondary Outcomes - Changes in paretic leg propulsive force ### Location - Facility: Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011, Ann Arbor, Michigan, 48108, United States @@
## Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology - NCT ID: NCT06269354 - Study ID: 20231121-71479 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society. ### Conditions - Bone Defects ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 3D printed prostheses ### Outcomes Primary Outcomes - Evaluation of implant stability, new bone growth- limb length - Evaluation of bone healing Secondary Outcomes - Pain assessment - Evaluation of life quality and health status. - Evaluation of knee function - Evaluation of hip function - Evaluation of ankle function ### Location - Facility: Peking University Third Hospital, Beijing, Haidian, N/A, China @@
## Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy - NCT ID: NCT06269341 - Study ID: SCCH-TS2208 - Status: RECRUITING - Start Date: 2010-02-01 - Completion Date: 2024-08-30 - Lead Sponsor: Sichuan Cancer Hospital and Research Institute ### Study Description Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank ### Conditions - Outcomes of Smoker and Drinker After Esophagectomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Overall Survival Secondary Outcomes ### Location - Facility: Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610041, China @@
## Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng - NCT ID: NCT06269328 - Study ID: 2011-KAEK-26/463 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2024-01-01 - Lead Sponsor: Uludag University ### Study Description Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort. ### Conditions - Sleep Disorder - Sleep, Inadequate - Total ıntravenous Anesthesia - Inhalation Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance - Inhalation anesthesia with sevoflurane for anesthetic maintenance ### Outcomes Primary Outcomes - Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) Secondary Outcomes - Subjective anxiety level - Subjective pain level ### Location - Facility: Elifgül Ulutaş, Bursa, Nilüfer, 16240, Turkey @@
## Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants - NCT ID: NCT06269315 - Study ID: SBDDCP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Swiss Institute of Allergy and Asthma Research ### Study Description The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.The main questions it aims to answer are:* How does exposure to household detergents and hand disinfectants impact skin barrier function?* Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?Participants will:Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.If there is a comparison group:Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact. ### Conditions - Control Condition (PBS) - Household Detergent Exposure - Hand Disinfectant Exposure - Surfactant Exposure - Other Ingredients Exposure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Cleaning product exposure ### Outcomes Primary Outcomes - Skin barrier evaluation Secondary Outcomes ### Location - Facility: Swiss Institute of Allergy and Asthma Research, Davos, Graubuenden, 7265, Switzerland @@
## Comparison of the Effect of Warfarin and Direct Oral Anticoagulants - NCT ID: NCT06269302 - Study ID: 2 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2022-12-31 - Lead Sponsor: Samsun Education and Research Hospital ### Study Description In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding ### Conditions - Anticoagulants and Bleeding Disorders - Gastrointestinal Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in the incidence of recurrent bleeding Secondary Outcomes ### Location - Facility: Samsun Education and Research Hospital, Samsun, İlkadım, N/A, Turkey @@
## Effects of Web-Based Education on Patient Empowerment and Asthma Control in Asthma Patients - NCT ID: NCT06269289 - Study ID: SBU-KOMSERN-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2024-09-30 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Asthma is defined as a chronic inflammatory disorder of the airways associated with an extreme increase in airway hyperresponsiveness leading to recurrent wheezing, shortness of breath, chest tightness, and coughing attacks. The World Health Organization states that approximately 339 million individuals worldwide have asthma and more than 400 thousand deaths occur due to asthma every year.With effective and sustainable asthma management, it is possible to reduce disease-related complaints, admissions to emergency units and hospitalizations, limit the physiological and psychological effects of the disease, prevent dependence on healthcare professionals and caregivers, increase the quality of life and reduce the mortality of the disease. Patient education, which is within the educational role of professional nurses, is very important in asthma management. The research was planned in a single-center, randomized control group pretest-posttest design. The sample will consist of individuals who applied to the Allergy and Immunology clinic of Sureyyapasa Chest Diseases and Surgery Training and Research Hospital between May 2024 and January 2024, who have been diagnosed with asthma for at least one year and who accept the study \[25 intervention group - 25 control group\]. Groups will be determined using the random numbers table from the simple random sampling method. A web-based asthma education module will be created in line with the literature, and participants in the intervention group will be given synchronous training in 5 modules. After meeting the individuals in the intervention and control groups and obtaining verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test prepared via Google Forms. A 30-minute training session will be given to the intervention group every week and there will be short evaluations after each training. When the 5th Module is completed, the intervention group will be asked to fill out the Patient Empowerment Scale and Asthma Control Test Scale. No intervention will be applied to the control group. 5. At the end of the module, the Patient Empowerment Scale and Asthma Control Test will be completed by individuals in the control group. It is thought that web-based asthma education that individuals will receive will positively affect their empowerment levels and increase their disease control. ### Conditions - Asthma - Patient Empowerment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - web based education - Standard education brochure ### Outcomes Primary Outcomes - patient empowerment scale (PES) Secondary Outcomes - Asthma Control Test (ACT) ### Location - Facility: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, N/A, 34854, Turkey @@
## Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study - NCT ID: NCT06269276 - Study ID: CAVCU - Status: COMPLETED - Start Date: 2020-09-20 - Completion Date: 2021-01-15 - Lead Sponsor: Namik Kemal University ### Study Description This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used.At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish. ### Conditions - Stoma Colostomy - Stoma Ileostomy - Caregiver - Self Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Caregiver Contribution to Self-Care in Ostomy Patient Index ### Outcomes Primary Outcomes - Caregiver Contribution to Self-Care in Ostomy Patient Index Secondary Outcomes ### Location - Facility: Tekirdag Namık Kemal University, Tekirdag, Suleymanpasa, 59000, Turkey @@
## Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF) - NCT ID: NCT06269263 - Study ID: 339/23-ek - Status: NOT_YET_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-02 - Lead Sponsor: University of Leipzig ### Study Description The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, we will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, we will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Home-based cardiac rehabilitation ### Outcomes Primary Outcomes - Percentage of patients completing the program Secondary Outcomes - Quality of life - Exercise capacity ### Location - Facility: Universitätsklinikum Leipzig, Leipzig, Saxony, 04103, Germany @@
## Acceptance and Perceived Benefits of Digitalization by Medical Assistants - NCT ID: NCT06269250 - Study ID: ANDI-MFA2023_10 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-12-31 - Lead Sponsor: Jacobs University Bremen gGmbH ### Study Description The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare. ### Conditions - Health Care Providers - Patient Safety - eHealth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Policy Change ### Outcomes Primary Outcomes - Adoption and acceptance of information technology (IT) - Requests by patients regarding IT - Perceived Benefits of IT Secondary Outcomes - Knowledge and Digital health literacy - Preferred learning format ### Location - Facility: Germany, Bremen, N/A, 28759, Germany @@
## Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment - NCT ID: NCT06269237 - Study ID: 2023LTA - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-07-01 - Lead Sponsor: He Eye Hospital ### Study Description To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment. ### Conditions - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - M22 - sham M22 ### Outcomes Primary Outcomes - LTA - Non-invasive tear break-up time (NITBUT) Secondary Outcomes - Fluorescein and lissamine conjunctival and cornea staining (CFS) - Meibomian quality - Tear Film Lipid Layer Score(TFLL) - Tear meniscus height (TMH) - Conjunctival hyperemia (RS score) - Ocular Surface Disease Index (OSDI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Examining Factors Influencing Thoracolumbar Mobility in Runners - NCT ID: NCT06269224 - Study ID: HU-FTR-KS-01 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2024-01-01 - Lead Sponsor: Hacettepe University ### Study Description The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. ### Conditions - Runners - Mobility - Fascia - Range of Motion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners. ### Outcomes Primary Outcomes - Myoton Assessment Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, Altındağ, 06100, Turkey @@
## Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer With EGFR Mutation and PD-L1 Positive Expression - NCT ID: NCT06269211 - Study ID: RTS-019 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2030-01-31 - Lead Sponsor: Ruijin Hospital ### Study Description The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression. ### Conditions - Carcinoma, Non-Small-Cell Lung ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Toripalimab ### Outcomes Primary Outcomes - Major Pathological Response (MPR) Secondary Outcomes - Pathological Complete Response (pCR) - Objective Response Rate (ORR) - 2-year Event Free Survival (EFS) - 2-year Overall Survival (OS) - Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) - Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies) ### Location - Facility: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510180, China @@
## Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System - NCT ID: NCT06269198 - Study ID: WARD - SX - RCT II - Status: RECRUITING - Start Date: 2023-10-31 - Completion Date: 2027-04-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy. ### Conditions - Postoperative Complications - Cancer, Treatment-Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - WARD-CSS ### Outcomes Primary Outcomes - Overall complication severity - 30 days Secondary Outcomes - Overall complication severity - 7 days - Frequency of Serious adverse events - Days alive and out of hospital - Days alive and out of hospital - Time to initiation of post-operative adjuvant chemotherapy - Completion of post-operative adjuvant chemotherapy ### Location - Facility: Copenhagen University hospital - Rigshospitalet, Copenhagen, Other (Non US), 1665, Denmark @@
## Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - NCT ID: NCT06269185 - Study ID: 2024_IFXvsADAinUC - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2025-03-01 - Lead Sponsor: Vastra Gotaland Region ### Study Description Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment. ### Conditions - Ulcerative Colitis - Inflammatory Bowel Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Infliximab - Adalimumab ### Outcomes Primary Outcomes - Percentage of patients achieving steroid-free clinical remission Secondary Outcomes - Percentage of patients achieving clinical response - Percentage of patients achieving clinical remission - Percentage of patients achieving biochemical remission - Percentage of patients achieving clinical remission - Percentage of patients achieving biochemical remission - Percentage of patients achieving endoscopic response - Percentage of patients achieving endoscopic remission ### Location - Facility: Västra Götalandsregionen, Göteborg, N/A, N/A, Sweden @@
## Perceptions Across Ethnicities to Develop an Adapted Intervention for Breathlessness - NCT ID: NCT06269172 - Study ID: 162076 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2025-11-30 - Lead Sponsor: University Hospitals, Leicester ### Study Description An individual's experience of their breathlessness is influenced by multiple factors including their medical condition, psychology, sociological and situational circumstances which will include ethnicity. There is currently a lack of evidence exploring the impact of ethnicity in the experience and presentation of breathlessness.The non-medical management of breathlessness in respiratory diseases includes pulmonary rehabilitation (PR). PR is a highly evidenced exercise-based intervention to help manage breathlessness, improving health-related quality of life and improving survival. Recent audits in England and Wales showed 89% of patients attending PR were recorded as having a White British ethnicity which is in contrast to national ethnicity demographics. This may be because the cultural acceptability of PR components are not fully considered. Therefore, this study will explore how individuals with cardiorespiratory disease from different ethnicities from the Leicestershire population experience and manage their breathlessness through art workshops, focus groups and interviews. Informed by these results, the study team will work with individuals from under-represented ethnicities and key stakeholders to co-design adaptations of PR that may improve the management of breathlessness in underrepresented ethnicities that do not attend conventional PR programmes.The study is funded by the Wellcome Trust as part of the Leicestershire Health Inequalities Improvement Programme at the University of Leiceste ### Conditions - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - intereviews ### Outcomes Primary Outcomes - Art Workshops, Focus Groups and Semi-Structured Interviews Secondary Outcomes - : Experience Based Co-design The co-development of an intervention for breathlessness for under-represented ethnicities. ### Location - Facility: Glenfield Hospital, Leicester, Leicestershire, LE39QP, United Kingdom @@
## The Power of 24-hour: Co-designing Intervention Components - NCT ID: NCT06269159 - Study ID: ONZ-2023-0185 - Status: RECRUITING - Start Date: 2023-09-05 - Completion Date: 2025-03-31 - Lead Sponsor: University Hospital, Ghent ### Study Description Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients. ### Conditions - Overweight and Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Concept mapping: brainstorm - Concept mapping: clustering and rating ### Outcomes Primary Outcomes - Themes - Score of effectiveness - Score of feasibility - Score of modifiability Secondary Outcomes ### Location - Facility: Ghent university Hospital, Ghent, N/A, 9000, Belgium @@
## Pramipexole to Enhance Social Connections - NCT ID: NCT06269146 - Study ID: 806035 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-03 - Lead Sponsor: University of California, San Diego ### Study Description This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention. ### Conditions - Anxiety Disorders - Anxiety - Depression - Social Disconnection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pramipexole Pill - Placebo Pill ### Outcomes Primary Outcomes - Neural activation during social reward anticipation Secondary Outcomes - Neural activation during opportunities to disclose to others - Motivation to engage in shared experiences with others - Positive affect in response to the social affiliation task - Social approach goals during the social affiliation task - Social approach behavior during the social affiliation task - Future approach motivation - Blood plasma pramipexole concentrations ### Location - Facility: University of California, San Diego, San Diego, California, 92093, United States @@