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<\|newrecord\|> nctId: NCT06295588 id: STUDY00009135 id: T32CA102618 type: NIH link: https://reporter.nih.gov/quickSearch/T32CA102618 briefTitle: Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-03-06 date: 2024-03-06 name: University of Rochester class: OTHER name: National Cancer Institute (NCI) briefSummary: To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation. conditions: Fatigue conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Fucoidan extracted from F. Vesiculosus name: Fucoidan extracted from U. Pinnatifida measure: percentage of participants who are randomized to the study out of all participants approached measure: percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention measure: percentage of participants who take at least 80% of the fucoidan pills during the study measure: mean change in Brief Fatigue Inventory measure: mean change in plasma viscosity in blood measure: mean change in erythrocyte sedimentation rate in blood measure: mean change in thyroid stimulating hormone in blood measure: mean change in C-reactive protein in blood measure: mean change in leptin in blood measure: mean change in D Dimer in blood measure: mean change in TNF alpha in blood measure: mean change in neopterin in blood measure: mean change in lactase dehydrogenase in blood measure: mean change in procalcitonin in blood measure: mean change in frailty using a modified Fried's Frailty questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False
<\|newrecord\|> nctId: NCT06295575 id: ZZhang briefTitle: Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass overallStatus: COMPLETED date: 2021-06-01 date: 2022-07-01 date: 2022-07-01 date: 2024-03-06 date: 2024-03-06 name: Nanjing Children's Hospital class: OTHER briefSummary: A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora. conditions: Congenital Heart Disease conditions: Intestinal Disease conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: probiotics containing Bifidobacterium infantis and Lactobacillus name: placebos containing lactose measure: incidence of morbidity measure: gastrointestinal functional recovery indicators measure: biomarkers measure: microbiome sex: ALL minimumAge: 1 Month maximumAge: 1 Year stdAges: CHILD facility: Children's Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210093 country: China lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06295562 id: CMUH112-REC3-201 briefTitle: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-07-31 date: 2024-03-06 date: 2024-03-07 name: China Medical University Hospital class: OTHER briefSummary: This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters. conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Atomoxetine 80mg combined with oxybutynin 5mg name: Venlafaxine 37.5mg name: Atomoxetine 80mg combined with trazodone 100mg name: Placebo measure: Physiological parameter measure: Endotypic traits measure: Sleep quality measure: Waking sleepiness sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295549 id: LB2304-0001 briefTitle: Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma overallStatus: RECRUITING date: 2024-03-25 date: 2026-06-30 date: 2028-06-30 date: 2024-03-06 date: 2024-03-06 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER name: Nanjing Legend Biotech Co. briefSummary: A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma conditions: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: LUCAR-G39P cells product measure: Incidence, severity and type of TEAEs measure: Pharmacokinetics in peripheral blood measure: Pharmacokinetics in bone marrow measure: The recommended Phase II dose (RP2D) for this cell therapy measure: Overall Response Rate (ORR) measure: Progression-free survival (PFS) measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Duration of Response (DoR) measure: Immunogenicity assessment of LUCAR-G39P cells sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital status: RECRUITING city: Nanjin state: Jiangsu zip: 210029 country: China name: Huayuan Zhu, PhD，MD role: CONTACT phone: 86 25 68306034 email: huayuan.zhu@hotmail.com name: Yeqin Sha, MD role: CONTACT email: yeqinsha@njmu.edu.cn hasResults: False
<\|newrecord\|> nctId: NCT06295536 id: WS10363 briefTitle: Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-06 date: 2024-03-06 name: Essilor International class: INDUSTRY briefSummary: The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia. conditions: Ametropia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 115 type: ESTIMATED name: Comparator device, Closed-field autorefractometer measure: Objective refractive error sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06295523 id: STU_2019_1759_COPD briefTitle: Heat Waves and the Elderly With COPD overallStatus: RECRUITING date: 2024-01-01 date: 2025-12 date: 2025-12 date: 2024-03-06 date: 2024-03-06 name: University of Texas Southwestern Medical Center class: OTHER name: American Heart Association briefSummary: The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD. conditions: COPD conditions: Aging conditions: Hyperthermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 44 type: ESTIMATED name: Water Spray name: Control measure: Core body temperature measure: Forced expiratory volume (FEV1) measure: Forced vital capacity (FVC) measure: FEV1/FVC ratio sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Texas Health Presbyterian Hospital Dallas status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States name: Whitley Atkins, PhD role: CONTACT name: Courtney Kirby, BS RN role: CONTACT phone: 214-345-6502 name: Craig Crandall, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06295510 id: CDUTCM20240223 briefTitle: Observational Study of the Association Between Food Intake and Endometrial Polyps overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-01 date: 2024-05-01 date: 2024-03-06 date: 2024-03-06 name: qinxiu zhang class: OTHER briefSummary: There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps. conditions: Diet Habit conditions: Endometrial Polyp conditions: Women studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: No interventions. measure: Hormonal dietary intake measure: Comparison of daily living habits sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295497 id: LC-SHIELD briefTitle: Lung Cancer Screening by Artificial Intelligence Device overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-06-30 date: 2027-12-31 date: 2024-03-06 date: 2024-03-06 name: Chinese University of Hong Kong class: OTHER briefSummary: Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 1000 type: ESTIMATED name: Lung-SIGHT measure: The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population measure: Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment measure: Rate of invasive workup and incidence of associated complications. measure: Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT measure: Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value measure: To determine the quality adjusted life years (QALYs) gained through screening sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology, Prince of Wales Hospital city: Hong Kong country: Hong Kong name: Molly SC LI, MBBS, MRCP role: CONTACT phone: 3505 2166 email: molly@clo.cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06295484 id: 5136 briefTitle: Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants overallStatus: RECRUITING date: 2021-08-21 date: 2025-12-31 date: 2026-12-31 date: 2024-03-06 date: 2024-03-06 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: Background:
In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.
The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.
Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.
One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding. conditions: Preterm Birth conditions: Premature Lungs conditions: Respiratory Distress Syndrome in Premature Infant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. We will continue to record the Edi signals during the 3 methods.
Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, your baby will be put back to the originally prescribed breathing support.
Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 24 type: ESTIMATED name: Alternating traditional CPAP, NIPPV, and high CPAP measure: The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O). measure: 1. Neural respiratory rate per minute measure: 2. Edi peak measured in MicroVoltage measure: 3. The difference in transcutaneous pCO2 in mmHg measure: 4. The difference in oxygen requirements in percent (i.e, 21%) sex: ALL minimumAge: 1 Day maximumAge: 8 Months stdAges: CHILD facility: Sunnybrook Health Sciences Center status: RECRUITING city: Toronto state: Ontario zip: M4N 3M5 country: Canada name: Maher Shahroor, MD role: CONTACT phone: (416) 480-6100 phoneExt: 687939 email: maher.shahroor@sunnybrook.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06295471 id: 2024P000112 briefTitle: A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-06 date: 2024-03-06 name: Massachusetts General Hospital class: OTHER briefSummary: This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 23 type: ESTIMATED name: DFG Laser name: CO2 Laser name: Optical coherence tomography (OCT) measure: Visual Analog Scale (VAS) pain score measure: Wound healing time measure: Vessel density via OCT imaging measure: Vessel length via OCT imaging measure: Vessel thickness via OCT imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MGH Clinical Unit for Research Trials & Outcomes in Skin city: Boston state: Massachusetts zip: 02114 country: United States name: Alicia Van Cott, MSN role: CONTACT phone: 617-726-4454 email: avancott@mgb.org name: Abigail Carlson, BS role: CONTACT phone: 617-726-4454 email: acarlson9@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06295458 id: STUDY00006945 briefTitle: Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait acronym: Flicker w FOG overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-06 date: 2024-03-06 date: 2024-03-06 name: Emory University class: OTHER name: Parkinson's Foundation briefSummary: The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.
Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG.
Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence.
FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD. conditions: Gait Disorders, Neurologic conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: GammaSense Stimulation System name: Control Group measure: Number of participants with Adverse events measure: Number of participants compliant with the study procedures measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD measure: Change in the freezing of gait severity in participants with PD. measure: Change in subjective changes in FOG. measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) amyloid levels in patients with PD-FOG measure: Change in the effects of driving gamma on cerebrospinal fluid (CSF) inflammatory markers levels in patients with PD-FOG sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory Movement Disorders Center city: Atlanta state: Georgia zip: 30329 country: United States lat: 33.749 lon: -84.38798 hasResults: False
<\|newrecord\|> nctId: NCT06295445 id: Cardiopulmonary Ultrasound briefTitle: Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit overallStatus: COMPLETED date: 2022-03-01 date: 2023-09-01 date: 2023-09-15 date: 2024-03-06 date: 2024-03-12 name: Egymedicalpedia class: INDUSTRY briefSummary: Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients. conditions: Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 108 type: ACTUAL name: care cardio-pulmonary ultrasound name: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management measure: Mortality rate measure: Number of mortalities sex: ALL minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Al-Azhar University hospitals city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06295432 id: DZ2022E0001 briefTitle: A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) overallStatus: RECRUITING date: 2023-06-01 date: 2025-06 date: 2025-06 date: 2024-03-06 date: 2024-03-20 name: Dizal Pharmaceuticals class: INDUSTRY briefSummary: DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: DZD9008+AZD4205 measure: Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People'S Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Zhen Wang role: CONTACT phone: 020-83827812 email: wangzhen@gdph.org.cn lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06295419 id: Igdir182 briefTitle: The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-08-01 date: 2024-03-06 date: 2024-03-08 name: Igdir University class: OTHER briefSummary: The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers.
Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:
* Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.
* Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.
* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
* In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.
* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.
* The Body Control Measurement Scale will be applied for body evaluation purposes.
As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: dual task name: single task measure: Abilhand Kids measure: cognitive task (single task) measure: motor performance of manual skills (writing a paragraph) (single task) measure: motor performance of manual skills (single task) measure: motor performance of manual skills (dual task) measure: motor performance of manual skills (writing a paragraph) (dual task) measure: The Body Control Measurement Scale sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06295406 id: 21C310 briefTitle: Reading Ability in Childhood Obesity acronym: Lettura_evOB overallStatus: RECRUITING date: 2023-12-01 date: 2025-11-30 date: 2025-11-30 date: 2024-03-06 date: 2024-03-08 name: Istituto Auxologico Italiano class: OTHER briefSummary: There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.
In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory. conditions: Obesity, Childhood conditions: Obesity, Adolescent studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 64 type: ESTIMATED name: Neuropsychological assessment measure: Raw score at the neuropsychological assessment sex: ALL minimumAge: 11 Years maximumAge: 16 Years stdAges: CHILD facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Federica Scarpina, PhD role: CONTACT phone: +39032351 phoneExt: 4003 email: f.scarpina@auxologico.it hasResults: False
<\|newrecord\|> nctId: NCT06295393 id: 20-0229-CCMC briefTitle: Renin Angiotensin Aldosterone System In Septic Kids acronym: RISK overallStatus: RECRUITING date: 2024-01-24 date: 2025-06-01 date: 2025-06-01 date: 2024-03-06 date: 2024-03-06 name: Northwell Health class: OTHER briefSummary: Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.
Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.
Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups. conditions: Sepsis conditions: Acute Kidney Injury Due to Sepsis conditions: Acute Kidney Injury (Nontraumatic) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 74 type: ESTIMATED measure: Difference in serum renin in sepsis measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury measure: Septic induced kidney injury will be associated with alterations in renal blood flow measure: Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients measure: Changes in the components of the RAAS over the first three days in sepsis measure: Changes in renal blood flow on Ultrasound in Sepsis measure: Renal blood flow and RAAS in sepsis sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Cohen Children's Medical Center status: RECRUITING city: New Hyde Park state: New York zip: 11004 country: United States name: Grace Fisler, MD role: CONTACT email: gfisler@northwell.edu name: Shannon A Moriarty role: CONTACT phone: 631-834-0984 email: smoriarty2@northwell.edu lat: 40.7351 lon: -73.68791 hasResults: False
<\|newrecord\|> nctId: NCT06295380 id: CarenAmp briefTitle: Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2025-03 date: 2024-03-06 date: 2024-03-06 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase). conditions: Lower Limb Amputation Knee conditions: Injuries conditions: Biomechanical Lesion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Virtual environment practiced on the Caren name: Conventional physiotherapy measure: Kinematic data measure: Kinetic data measure: Electromyography sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Neurolesi city: Messina state: Sicily zip: 98124 country: Italy name: Rocco Salvatore Calabrò, MD role: CONTACT phone: 09060128179 phoneExt: +39 email: roccos.calabro@irccsme.it lat: 38.19394 lon: 15.55256 hasResults: False
<\|newrecord\|> nctId: NCT06295367 id: EAQ222CD id: NCI-2023-09944 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAQ222CD type: OTHER domain: ECOG-ACRIN Cancer Research Group id: ECOG-ACRIN-EAQ222CD type: OTHER domain: DCP id: EAQ222CD type: OTHER domain: CTEP id: R01CA272680 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA272680 id: UG1CA189828 type: NIH link: https://reporter.nih.gov/quickSearch/UG1CA189828 briefTitle: Cost Communication and Financial Navigation in Cancer Patients (COSTCOM) overallStatus: RECRUITING date: 2024-02-29 date: 2029-02-01 date: 2029-08-01 date: 2024-03-06 date: 2024-03-15 name: ECOG-ACRIN Cancer Research Group class: NETWORK name: National Cancer Institute (NCI) briefSummary: This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 760 type: ESTIMATED name: Best Practice name: Financial Navigation name: Interview name: Survey Administration measure: Cost-related cancer care non-adherence measure: Rate of Material Financial Hardship measure: Patient-reported financial worry measure: Patient-reported Quality of life - mental and physical health measure: Patient-reported satisfaction with care at 12 months measure: Out of pocket cost (OOPC) accuracy measure: Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population. measure: Patient reported satisfaction with intervention measure: Receipt of financial navigation via internal practice or external resources measure: Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care measure: longitudinal changes in cost-related cancer care non-adherence measure: longitudinal changes in cost-related cancer care material hardship measure: longitudinal changes in cost-related cancer care financial worry measure: longitudinal changes in cost-related cancer care quality of life measure: longitudinal changes in cost-related cancer care satisfaction with care sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mercy Hospital Fort Smith status: RECRUITING city: Fort Smith state: Arkansas zip: 72903 country: United States name: Site Public Contact role: CONTACT phone: 800-378-9373 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 35.38592 lon: -94.39855 facility: CARTI Cancer Center status: RECRUITING city: Little Rock state: Arkansas zip: 72205 country: United States name: Site Public Contact role: CONTACT phone: 501-906-4199 email: Research@CARTI.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: Saint Anthony's Health status: RECRUITING city: Alton state: Illinois zip: 62002 country: United States name: Site Public Contact role: CONTACT phone: 618-463-5623 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.8906 lon: -90.18428 facility: Saint Mary's Hospital status: RECRUITING city: Centralia state: Illinois zip: 62801 country: United States name: Site Public Contact role: CONTACT email: ecog.rss@jimmy.harvard.edu name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.52505 lon: -89.1334 facility: Good Samaritan Regional Health Center status: RECRUITING city: Mount Vernon state: Illinois zip: 62864 country: United States name: Site Public Contact role: CONTACT phone: 618-242-4600 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.31727 lon: -88.90312 facility: Central Care Cancer Center - Garden City status: RECRUITING city: Garden City state: Kansas zip: 67846 country: United States name: Site Public Contact role: CONTACT phone: 913-948-5588 email: aroland@kccop.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.97169 lon: -100.87266 facility: Central Care Cancer Center - Great Bend status: RECRUITING city: Great Bend state: Kansas zip: 67530 country: United States name: Site Public Contact role: CONTACT phone: 913-948-5588 email: aroland@kccop.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.36446 lon: -98.76481 facility: Saint Louis Cancer and Breast Institute-Ballwin status: RECRUITING city: Ballwin state: Missouri zip: 63011 country: United States name: Site Public Contact role: CONTACT phone: 314-251-7058 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.59505 lon: -90.54623 facility: Central Care Cancer Center - Bolivar status: RECRUITING city: Bolivar state: Missouri zip: 65613 country: United States name: Site Public Contact role: CONTACT phone: 913-948-5588 email: aroland@kccop.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.61448 lon: -93.41047 facility: Cox Cancer Center Branson status: RECRUITING city: Branson state: Missouri zip: 65616 country: United States name: Site Public Contact role: CONTACT phone: 417-269-4520 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 36.64367 lon: -93.21851 facility: Freeman Health System status: RECRUITING city: Joplin state: Missouri zip: 64804 country: United States name: Site Public Contact role: CONTACT phone: 417-347-4030 email: LJCrockett@freemanhealth.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.08423 lon: -94.51328 facility: Mercy Hospital Joplin status: RECRUITING city: Joplin state: Missouri zip: 64804 country: United States name: Site Public Contact role: CONTACT phone: 417-556-3074 email: esmeralda.carrillo@mercy.net name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.08423 lon: -94.51328 facility: Lake Regional Hospital status: RECRUITING city: Osage Beach state: Missouri zip: 65065 country: United States name: Site Public Contact role: CONTACT phone: 573-302-2768 email: clinicaltrials@lakeregional.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.12956 lon: -92.65277 facility: Delbert Day Cancer Institute at PCRMC status: RECRUITING city: Rolla state: Missouri zip: 65401 country: United States name: Site Public Contact role: CONTACT phone: 573-458-7504 email: research@phelpshealth.org name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.95143 lon: -91.77127 facility: Mercy Clinic-Rolla-Cancer and Hematology status: RECRUITING city: Rolla state: Missouri zip: 65401 country: United States name: Site Public Contact role: CONTACT phone: 573-458-6379 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.95143 lon: -91.77127 facility: Heartland Regional Medical Center status: RECRUITING city: Saint Joseph state: Missouri zip: 64506 country: United States name: Site Public Contact role: CONTACT phone: 816-271-7937 email: linda.schumacher@mymlc.com name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 39.76861 lon: -94.84663 facility: Saint Louis Cancer and Breast Institute-South City status: RECRUITING city: Saint Louis state: Missouri zip: 63109 country: United States name: Site Public Contact role: CONTACT phone: 314-353-1870 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Mercy Hospital South status: RECRUITING city: Saint Louis state: Missouri zip: 63128 country: United States name: Site Public Contact role: CONTACT phone: 314-525-6042 email: Danielle.Werle@mercy.net name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Mercy Hospital Saint Louis status: RECRUITING city: Saint Louis state: Missouri zip: 63141 country: United States name: Site Public Contact role: CONTACT phone: 314-251-7066 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Mercy Hospital Springfield status: RECRUITING city: Springfield state: Missouri zip: 65804 country: United States name: Site Public Contact role: CONTACT phone: 417-269-4520 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: CoxHealth South Hospital status: RECRUITING city: Springfield state: Missouri zip: 65807 country: United States name: Site Public Contact role: CONTACT phone: 417-269-4520 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Mercy Hospital Washington status: RECRUITING city: Washington state: Missouri zip: 63090 country: United States name: Site Public Contact role: CONTACT phone: 636-390-1600 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 38.55811 lon: -91.01209 facility: Strecker Cancer Center-Belpre status: RECRUITING city: Belpre state: Ohio zip: 45714 country: United States name: Site Public Contact role: CONTACT phone: 800-523-3977 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.27396 lon: -81.5729 facility: Adena Regional Medical Center status: RECRUITING city: Chillicothe state: Ohio zip: 45601 country: United States name: Site Public Contact role: CONTACT phone: 877-779-7585 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.33312 lon: -82.9824 facility: Mount Carmel East Hospital status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: The Mark H Zangmeister Center status: RECRUITING city: Columbus state: Ohio zip: 43219 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Mount Carmel Health Center West status: RECRUITING city: Columbus state: Ohio zip: 43222 country: United States name: Site Public Contact role: CONTACT phone: 614-234-5433 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Central Ohio Breast and Endocrine Surgery status: RECRUITING city: Gahanna state: Ohio zip: 43230 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2745 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.01923 lon: -82.87934 facility: Mount Carmel Grove City Hospital status: RECRUITING city: Grove City state: Ohio zip: 43123 country: United States name: Site Public Contact role: CONTACT phone: 877-779-7585 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.88145 lon: -83.09296 facility: Zangmeister Center Grove City status: RECRUITING city: Grove City state: Ohio zip: 43123 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2745 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.88145 lon: -83.09296 facility: Fairfield Medical Center status: RECRUITING city: Lancaster state: Ohio zip: 43130 country: United States name: Site Public Contact role: CONTACT phone: 740-687-8863 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.71368 lon: -82.59933 facility: Saint Rita's Medical Center status: RECRUITING city: Lima state: Ohio zip: 45801 country: United States name: Site Public Contact role: CONTACT phone: 419-226-9617 name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.74255 lon: -84.10523 facility: Marietta Memorial Hospital status: RECRUITING city: Marietta state: Ohio zip: 45750 country: United States name: Site Public Contact role: CONTACT phone: 800-523-3977 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.41535 lon: -81.45484 facility: Memorial Hospital status: RECRUITING city: Marysville state: Ohio zip: 43040 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.23645 lon: -83.36714 facility: Knox Community Hospital status: RECRUITING city: Mount Vernon state: Ohio zip: 43050 country: United States name: Site Public Contact role: CONTACT phone: 740-393-9000 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.3934 lon: -82.48572 facility: Mount Carmel New Albany Surgical Hospital status: RECRUITING city: New Albany state: Ohio zip: 43054 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2745 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.08117 lon: -82.80879 facility: Licking Memorial Hospital status: RECRUITING city: Newark state: Ohio zip: 43055 country: United States name: Site Public Contact role: CONTACT phone: 740-348-4000 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.05812 lon: -82.40126 facility: Newark Radiation Oncology status: RECRUITING city: Newark state: Ohio zip: 43055 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.05812 lon: -82.40126 facility: Mercy Health Perrysburg Cancer Center status: RECRUITING city: Perrysburg state: Ohio zip: 43551 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 41.557 lon: -83.62716 facility: Southern Ohio Medical Center status: RECRUITING city: Portsmouth state: Ohio zip: 45662 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 38.73174 lon: -82.99767 facility: Springfield Regional Cancer Center status: RECRUITING city: Springfield state: Ohio zip: 45504 country: United States name: Site Public Contact role: CONTACT phone: 937-528-2900 email: clinical.trials@daytonncorp.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.92423 lon: -83.80882 facility: Springfield Regional Medical Center status: RECRUITING city: Springfield state: Ohio zip: 45505 country: United States name: Site Public Contact role: CONTACT phone: 937-528-2900 email: clinical.trials@daytonncorp.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.92423 lon: -83.80882 facility: Saint Vincent Mercy Medical Center status: RECRUITING city: Toledo state: Ohio zip: 43608 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 41.66394 lon: -83.55521 facility: Mercy Health - Saint Anne Hospital status: RECRUITING city: Toledo state: Ohio zip: 43623 country: United States name: Site Public Contact role: CONTACT phone: 614-488-2118 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 41.66394 lon: -83.55521 facility: Saint Ann's Hospital status: RECRUITING city: Westerville state: Ohio zip: 43081 country: United States name: Site Public Contact role: CONTACT phone: 614-234-5433 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 40.12617 lon: -82.92907 facility: Clinton Memorial Hospital status: RECRUITING city: Wilmington state: Ohio zip: 45177 country: United States name: Site Public Contact role: CONTACT phone: 937-283-2273 name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.44534 lon: -83.82854 facility: Genesis Healthcare System Cancer Care Center status: RECRUITING city: Zanesville state: Ohio zip: 43701 country: United States name: Site Public Contact role: CONTACT phone: 740-454-5232 email: sheree@columbusccop.org name: Timothy D. Moore role: PRINCIPAL_INVESTIGATOR lat: 39.94035 lon: -82.01319 facility: Mercy Hospital Oklahoma City status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73120 country: United States name: Site Public Contact role: CONTACT phone: 405-752-3402 name: Jay W. Carlson role: PRINCIPAL_INVESTIGATOR lat: 35.46756 lon: -97.51643 hasResults: False
<\|newrecord\|> nctId: NCT06295354 id: 2024-17062 briefTitle: Early Variations in Immune Aging acronym: EVIA-NL overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2028-12 date: 2024-03-06 date: 2024-03-06 name: Radboud University Medical Center class: OTHER briefSummary: Background:
Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.
Study design:
A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between. conditions: Aging conditions: Aging Well conditions: Immuno Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: No intervention, we just study 'aging' measure: Immunological function measure: Immunological Aging Score measure: Biological Aging Score measure: Metagenomics measure: Genetics and epigenetics measure: Clinical events sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295341 id: 01C312 briefTitle: Short Stature and Psychological Well-being acronym: PSICOSHORT overallStatus: RECRUITING date: 2023-05-10 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Istituto Auxologico Italiano class: OTHER briefSummary: The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA. conditions: Short Stature conditions: Short; Stature, Psychosocial studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 80 type: ESTIMATED name: Recombinant human growth hormone (only for children with growth hormone deficiency) measure: Psychological well-being through the Psychological Well-Being Scales (PWB) measure: Psychological distress through the Depression Anxiety Stress Scale (DASS-21) measure: Quality of life through the Quality of Life in Short Stature Youth (QoLISSY), measure: Skills and problems through the Strengths and Difficulties Questionnaire (SDQ) measure: Behavioral problems through the Child Behaviour Checklist for Children (CBCL) sex: ALL minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD facility: Istituto Auxologico Italiano status: RECRUITING city: Milano zip: 20145 country: Italy name: Alessandro Sartorio, MD role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06295328 id: NL 72439.018.19 briefTitle: From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients acronym: HepBTer overallStatus: RECRUITING date: 2022-04-13 date: 2024-04-01 date: 2024-04-01 date: 2024-03-06 date: 2024-03-06 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB).
Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group.
Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial.
Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir \> 6 months (group B, n=16).
Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B).
Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg \>0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA \>0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage. conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 1b study with two parallel treatment arms and placebo controls. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Terbinafine name: Placebo name: Tenofovir measure: Change in level of serum HBsAG measure: Change in serum HBV DNA measure: Safety of terbinafine measure: Tolerability of terbinafine measure: Serum levels of HBsAG measure: Serum levels of HBV DNA measure: Serum levels of HBV RNA measure: Serum levels of HBcrAg sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: M.W. Peters, RN role: CONTACT phone: +31207320393 email: m.w.peters@amsterdamumc.nl name: D.J. van Doorn, MD role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06295315 id: 01C310 briefTitle: Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome acronym: PROPSICOPWS overallStatus: RECRUITING date: 2023-04-21 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Istituto Auxologico Italiano class: OTHER briefSummary: The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated. conditions: Prader-Willi Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED measure: Psychological well-being through the Psychological General Well-Being Index (PGWBI) measure: Perception of life quality through the 36-Item Short Form Survey (SF-36) measure: Mental distress through the Symptom Checklist-90-R (SCL-90-R) measure: Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21) measure: Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version). measure: Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Istituto Auxologico Italiano IRCCS, site Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28824 country: Italy name: Alessandro Sartorio, MD role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.99088 lon: 8.64663 hasResults: False
<\|newrecord\|> nctId: NCT06295302 id: RFCU-IIa-202308 briefTitle: A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria overallStatus: RECRUITING date: 2023-12-13 date: 2025-12 date: 2026-01 date: 2024-03-06 date: 2024-03-07 name: Hubei Biological Medicine Industrial Technology Institute Co., Ltd. class: OTHER briefSummary: This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated. conditions: Chronic Spontaneous Urticaria studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: HWH486 name: Placebo measure: Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) measure: Change in Hive Severity Score (HSS) over a 7-day period (HSS7) measure: Change in Itch Severity Score (ISS) over a 7-day period (ISS7) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital,Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Bioethics Committee of West China Hospital role: CONTACT phone: +86 28 8512 3237 lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06295289 id: ZRKY-2023-04 briefTitle: Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial overallStatus: RECRUITING date: 2023-10-16 date: 2024-10-04 date: 2024-12-04 date: 2024-03-06 date: 2024-03-06 name: Huazhong University of Science and Technology class: OTHER briefSummary: Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period. conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Hybrid Closed-loop Insulin Delivery System name: Insulin pump measure: TIR measure: TAR measure: TBR measure: MBG measure: postoperative infection sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Xuefeng Yu role: CONTACT phone: 02783662883 email: xfyu188@163.com lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06295276 id: HSOsnabruck briefTitle: Effect of Teletherapy-supported Training on Nursing Students overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-06 name: Hochschule Osnabruck class: OTHER briefSummary: Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.
The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.
The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale conditions: Low Back Pain conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel comparative randomized controlled trial primaryPurpose: TREATMENT masking: NONE maskingDescription: Allocation concealment:
The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality. count: 40 type: ESTIMATED name: teletherapy-guided exercise programme name: Waiting list/control intervention measure: Neck Disability Index (NDI) measure: Oswestry Disability Index (ODI) measure: NRS Numeric rating scale for pain measure: Short-Form: SF 36-Quality of life measure: Global rating scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Diakonie Pflege Schule status: RECRUITING city: Osnabrück state: Niedersachsen zip: 49078 country: Germany name: Roland Simon, BScPTc role: CONTACT phone: 05068932755 email: helmut.simon@hs-osnabrueck.de lat: 52.27264 lon: 8.0498 hasResults: False
<\|newrecord\|> nctId: NCT06295263 id: KYLL-202203-028-1 briefTitle: Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases overallStatus: RECRUITING date: 2022-03-01 date: 2026-06-28 date: 2026-06-29 date: 2024-03-06 date: 2024-03-15 name: Qilu Hospital of Shandong University class: OTHER name: Shandong University briefSummary: 1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease.
(2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease.
(3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders.
(4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients. conditions: Parkinson Disease conditions: Alzheimer Disease conditions: Nervous System Diseases conditions: Geriatric Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 460 type: ESTIMATED name: Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers measure: Handwriting measure: gait measure: speech measure: eye movements measure: biological samples (blood, urine, stool, saliva, etc.) measure: images measure: EEG measure: other relevant markers sex: ALL minimumAge: 8 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Wenjing Jiang role: CONTACT phone: 18560082210 email: jiangwenjing@qiluhospital.com lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06295250 id: STUDY00001114 id: 7R01MH127577 type: NIH link: https://reporter.nih.gov/quickSearch/7R01MH127577 briefTitle: ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-12-30 date: 2027-12-30 date: 2024-03-06 date: 2024-03-06 name: University of Massachusetts, Worcester class: OTHER name: International Centre for Diarrhoeal Disease Research, Bangladesh name: Georgetown University name: National Institute of Mental Health (NIMH) name: Albert Einstein College of Medicine briefSummary: The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months. conditions: Depression conditions: Economic Vulnerability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Interventionists and outcome assessors will not be informed regarding the study design and research question. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 660 type: ESTIMATED name: Manualized Group Based Psychotherapy name: Poverty Alleviation measure: Change in Depressive symptoms at 24 Months measure: Change in Depressive symptoms at intermediate timepoints measure: 24 Month Relapse measure: Economic vulnerability measure: Anxiety measure: Function measure: European Quality of Life Five Dimensions Five Level scale measure: Tension Scale measure: Implementation Outcomes--Adoption measure: Implementation Outcomes--Feasibility measure: Implementation outcomes--fidelity sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: International Centre for Diarrhoeal Disease Research city: Dhaka country: Bangladesh name: Fahmida Tofail, MBBS, PhD role: CONTACT email: ftofail@icddrb.org lat: 23.7104 lon: 90.40744 hasResults: False
<\|newrecord\|> nctId: NCT06295237 id: i-Sync briefTitle: Automatic Adjustment for Asynchronies During Mechanical Ventilation acronym: i-Sync overallStatus: RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-07-01 date: 2024-03-06 date: 2024-03-08 name: Hospital San Carlos, Madrid class: OTHER name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa briefSummary: Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software. conditions: Mechanical Ventilation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Two 2-hour periods: 1) "off mode" consisting of a control period with optimized ventilator parameters and 2) "on mode" with an active automated detection and adjustment for asynchronies. The starting first period is randomized. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Anonymized evaluation whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intellisync+ measure: Duration of asyncronies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clinico San Carlos status: RECRUITING city: Madrid zip: 28040 country: Spain name: Miguel Sanchez-Garcia, MD role: CONTACT phone: +34658762739 email: miguelsanchez.hcsc@gmail.com name: Paloma Gonzalez-Arenas, MD role: CONTACT phone: +34 670 57 66 45 email: pgarenas@gmail.com name: David Janeiro Lumbreras, MD role: SUB_INVESTIGATOR name: Fernando Suarez-Sipmann, MD role: PRINCIPAL_INVESTIGATOR name: José Antonio Sánchez-Giralt, MD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06295224 id: GOKAEK-2024/02.19 briefTitle: Retrospective Evaluation of Effect of Anterior Iliac Block overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-10 date: 2024-03-15 date: 2024-03-06 date: 2024-03-06 name: Kocaeli University class: OTHER briefSummary: In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure. conditions: Regional Anesthesia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 14 type: ESTIMATED measure: Morphine consumption measure: NRS score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli Universty status: RECRUITING city: Kocaeli country: Turkey name: Hadi Ufuk Yörükoğlu role: CONTACT email: ufukyorukoglu@gmail.com lat: 39.62497 lon: 27.51145 hasResults: False
<\|newrecord\|> nctId: NCT06295211 id: FEDII_HL_PR/R-Bv-Bs briefTitle: Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study. acronym: HL_PR/R-B overallStatus: COMPLETED date: 2013-09-01 date: 2023-09-01 date: 2024-02-22 date: 2024-03-06 date: 2024-03-06 name: Federico II University class: OTHER briefSummary: This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023. conditions: Hodgkin Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 32 type: ACTUAL name: observational measure: Overall survival measure: Progression overall survival measure: Response to treatment measure: Incidence of treatment emergent adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295198 id: OPMM-Ankle Instability briefTitle: The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain overallStatus: RECRUITING date: 2023-07-30 date: 2024-03-01 date: 2024-03-30 date: 2024-03-06 date: 2024-03-08 name: Bahçeşehir University class: OTHER briefSummary: Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players. conditions: Ankle Sprains conditions: Ankle Injuries conditions: Kinesiophobia conditions: Jumping From Height studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with lateral ankle sprains will be randomized to the Mulligan and Maithland groups, and their evaluations and treatments will be completed. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: After evaluations, the groups determined as a result of randomization via a website were placed in opaque envelopes. The participant is randomized to one of the Mulligan or Maitland groups by selecting an envelope. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Single lep drop jump test measure: Single-leg drop jump test measure: Weight-bearing lunge test measure: Tampa kinesiophobia scale measure: Fear Avoidance Belief Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Bahcesehir University status: RECRUITING city: Besiktas state: Istanbul zip: 34353 country: Turkey name: Pelin Pişirici, PT, PhD role: CONTACT phone: 05055016076 email: pelinpisirici@gmail.com name: Ozlem Feyzioglu, PT, PhD role: CONTACT phone: 05353529794 email: fztozlemfeyzioglu@gmail.com hasResults: False
<\|newrecord\|> nctId: NCT06295185 id: AJOUIRB-IV-2024-097 briefTitle: Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-07-01 date: 2024-03-06 date: 2024-03-06 name: Ajou University School of Medicine class: OTHER briefSummary: The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'. conditions: Depression conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: application MARO name: Sham application measure: Change in network on the Standard Name Generator Approach scale measure: Change in depression symptoms severity on the Patient Health Questionnaire-9 measure: Change in social capital on the Social Capital Scale measure: Change in perceived workload on the Perceived Workload Scale measure: Change in job self-efficacy on the Job Self-Efficacy Scale measure: Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale measure: Change in work orientation toward his or her job on the Work Orientation Scale measure: Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees measure: Change in firm performance on the Company weekly sales records measure: Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities measure: Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire measure: Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale measure: Change in perceived stress level on the Perceived Stress Scale measure: Change in social functioning on Social Adaptation Self Rating Scale measure: Change in positive psychological capital on Korean version of Positive Psychological Capital Scale measure: Change in Organizational Companionship on Organizational Culture Inventory measure: Change in individual's social network on Lubben Social Network Scale-18 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295172 id: LF15_NLF_301 briefTitle: A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2025-09-30 date: 2026-04-30 date: 2024-03-06 date: 2024-03-06 name: Samyang Biopharmaceuticals Corporation class: INDUSTRY briefSummary: The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds conditions: Nasolabial Folds studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 73 type: ESTIMATED name: Lafullen15 name: Lafullen measure: Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator sex: ALL minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295159 id: MCC-22574 briefTitle: Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma overallStatus: RECRUITING date: 2024-02-28 date: 2027-03 date: 2027-03 date: 2024-03-06 date: 2024-03-13 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER briefSummary: The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. conditions: Melanoma Stage III conditions: Melanoma Stage IV conditions: Advanced Melanoma conditions: Melanoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Nivolumab name: Nivolumab + Relatlimab name: Ipilimumab measure: Pathologic Major Response (pMR) measure: Preoperative Radiologic Response Rate measure: Complete Pathologic Response Rate (pCR) measure: Partial Pathologic Response Rate (pPR) measure: Non-Response Pathologic Response Rate (pNR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Justin Martin role: CONTACT phone: 813-745-7544 email: Justin.Martin@moffitt.org name: Ahmad Tarhini, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
<\|newrecord\|> nctId: NCT06295146 id: STUDY23050075 briefTitle: Virtual Peer Coaching in Manual Wheelchair Skills overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12-30 date: 2027-12-30 date: 2024-03-06 date: 2024-03-06 name: University of Pittsburgh class: OTHER briefSummary: The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3). conditions: Wheelchair conditions: Paraplegia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: For trainees, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 (N=40 per group) we will enroll participants into Group 3 ( N=40 per group). primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 132 type: ESTIMATED name: Intervention A: 1-on-1 wheelchair skills training by a peer coach name: Intervention B: Training via educational videos measure: Capacity, confidence, and performance of wheelchair skills will improve following training measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months) measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months) measure: Goal Attainment Scale (GAS) improvement from baseline (post training) measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months) measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (1 year) measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (6 months) measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (1 year) measure: Life Space Assessment (LSA) improvement from baseline (6 months) measure: Life Space Assessment (LSA) improvement from baseline (1 year) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295133 id: PROMESS - STRESS briefTitle: Preventive Remediation of Stress for Optimal MEdical StudentS overallStatus: RECRUITING date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-06 date: 2024-03-06 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.
Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.
Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.
The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction. conditions: Health Behavior conditions: Health-Related Behavior conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All volunteers will receive a stress management intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Stress measure: Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS). measure: Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory. measure: Big-5 : scores obtained at the Big-5 questionnaire. measure: Coping strategies : scores obtained at the Brief Cope Inventory (BCI). measure: Perceived level of stress : score obtained at the Perceived Stress Scale measure: Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention. measure: Heart rate variability (HRV) marker: SDNN during the pre-intervention. measure: Heart rate variability (HRV) marker: RMSSD during the pre-intervention. measure: Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention. measure: Heart rate variability (HRV) marker: pnn50% during the pre-intervention. measure: Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI). measure: Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention. measure: Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention. measure: Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention. measure: Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention. measure: Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention. measure: VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors measure: VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress. measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level. measure: VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations. measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE status: RECRUITING city: Lyon zip: 69008 country: France name: Sophie Schlatter, Dr. role: CONTACT phone: 07 68 21 05 51 phoneExt: 33 email: sophie.schlatter@univ-lyon1.fr name: Angèle Métais, Dr. role: CONTACT phone: 06 77 39 89 66 phoneExt: 33 email: angele.metais@univ-lyon1.fr lat: 45.74848 lon: 4.84669 hasResults: False
<\|newrecord\|> nctId: NCT06295120 id: 362-1 briefTitle: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D) acronym: CAP-D overallStatus: RECRUITING date: 2023-11-13 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-20 name: Research Unit for General Practice in Aalborg class: OTHER briefSummary: The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.
Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Phenoxymethylpenicillin 1.2 MIE 4 times daily measure: Treatment failure at day 30 measure: Clinical recovery at day 8 measure: The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score measure: Prolonged antibiotic treatment measure: Change in type of antibiotic measure: Relapse of acute Lower Respiratory Tract Infection (LRTI) measure: Reconsultation measure: New prescriptions within 30 days measure: Hospitalisation measure: Mortality measure: Adverse events measure: Treatment adherence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Research Unit for General Practice Aalborg status: RECRUITING city: Gistrup zip: 9260 country: Denmark name: Line Maj Jensen role: CONTACT phone: +45 25 69 99 33 email: lmj@dcm.aau.dk lat: 56.9943 lon: 9.99085 hasResults: False
<\|newrecord\|> nctId: NCT06295107 id: 2023-00195-01 briefTitle: Reliability of Range of Movement Measurements in Cerebral Palsy overallStatus: RECRUITING date: 2023-10-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-06 date: 2024-03-06 name: Region Skane class: OTHER briefSummary: The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability. conditions: Cerebral Palsy conditions: Movement Disorders in Children studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: Ankle Passive Range of Movement (pROM) name: Knee Passive Range of Movement (pROM) measure: Ankle range of motion measure: Knee range of motion sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Children Habilitation Unit status: RECRUITING city: Lund state: Skane zip: 22241 country: Sweden name: Olof Linden, MD role: CONTACT phone: 0046708475690 email: olof.linden@skane.se lat: 55.70584 lon: 13.19321 hasResults: False
<\|newrecord\|> nctId: NCT06295094 id: PIPAC-OPC6 briefTitle: The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. acronym: EPICURE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-01 date: 2028-01 date: 2024-03-06 date: 2024-03-06 name: Odense University Hospital class: OTHER name: Karolinska University Hospital briefSummary: The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment. conditions: Gastric Cancer conditions: Chemotherapy, Adjuvant conditions: Peritoneal Metastases conditions: Minimally Invasive Surgical Procedures studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 264 type: ESTIMATED name: Cisplatin name: Doxorubicin measure: Peritoneal disease-free survival measure: Disease-free survival measure: Overall survival measure: Length of stay measure: Postoperative toxicity measure: Postoperative complications measure: Postoperative mortality measure: Rate of positive peritoneal lavage measure: Patient-reported Quality of life measure: Patient-reported Quality of life measure: Number of patients not receiving adjuvant chemotherapy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Yanghee Woo, PhD role: CONTACT email: yhwoo@coh.org lat: 34.13945 lon: -117.97729 facility: Odense University Hospital city: Odense C zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: University Hospital Lille city: Lille country: France name: Clarisse Eveno, PhD role: CONTACT email: clarisse.eveno@gmail.com lat: 50.63297 lon: 3.05858 facility: Charité, University of Berlin city: Berlin country: Germany name: Beate Rau, PhD role: CONTACT email: beate.rau@charite.de lat: 52.52437 lon: 13.41053 facility: Karolinska University Hospital city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06295081 id: NL79864.091.22 id: 112927 type: OTHER domain: RadboudUMC briefTitle: TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance acronym: TREAT overallStatus: RECRUITING date: 2022-06-15 date: 2024-07-01 date: 2044-07-01 date: 2024-03-06 date: 2024-03-06 name: Radboud University Medical Center class: OTHER name: Maastricht University Medical Center briefSummary: The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes.
The main questions it aims to answer are:
Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types.
Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations.
Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up.
This study consists of three phases:
Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrations
Phase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease.
Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up.
Participants will visit our study centre two, three or four times:
Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn.
Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer.
Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Exercise exposure measure: High-sensitivity cardiac troponin I (hs-cTnI) measure: High-sensitivity cardiac troponin T (hs-cTnT) measure: General CT scan data measure: Coronary artery calcification score measure: Coronary stenosis and plaque characteristics measure: Computed tomography derived Fractional Flow Reserve measure: Incidence of mortality measure: Incidence of major adverse cardiovascular events measure: Participant characteristics (personal info) measure: Participant characteristics (baseline measurements) measure: Participant characteristics (Exercise characteristics): measure: Medical History questionnaire, part 1 (general info and cardiovascular complaints) measure: Medical History questionnaire, part 2 (diseases and/or conditions) measure: Medical History questionnaire, part 3 (family history, COVID-19 info and medication use) measure: Exercise History questionnaire, part 1 (exercise history, participation in endurance races and current training status) measure: Exercise History questionnaire, part 2 (strength exercise) measure: Other biomarker concentrations in blood sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RadboudUMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GC country: Netherlands name: Sylvan Janssen, MSc role: CONTACT phone: +31243613416 email: sylvan.janssen@radboudumc.nl name: IKS Integraal kwaliteitssysteem role: CONTACT phone: +31243614894 email: integraalkwaliteitssysteemwetenschappelijkonderzoek@radboudumc.nl lat: 51.8425 lon: 5.85278 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-01-16 uploadDate: 2023-04-13T09:57 filename: Prot_SAP_ICF_000.pdf size: 852144 hasResults: False
<\|newrecord\|> nctId: NCT06295068 id: PRT-1400-11 briefTitle: Evaluation of ARi With OpSens SavvyWire acronym: ARi overallStatus: RECRUITING date: 2023-11-30 date: 2024-04-30 date: 2024-04-30 date: 2024-03-06 date: 2024-03-06 name: Opsens, Inc. class: INDUSTRY briefSummary: The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography. conditions: Aortic Valve Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Transcatheter Aortic Valve Replacement (TAVR) name: Balloon Aortic Valvuloplasty (BAV) measure: Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography measure: Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography measure: Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AHS Morristown Medical Center status: RECRUITING city: Morristown state: New Jersey zip: 07960 country: United States name: Christine Ciprich role: CONTACT phone: 973-971-7541 email: christine.ciprich@atlantichealth.org name: Philippe Généreux, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79677 lon: -74.48154 hasResults: False
<\|newrecord\|> nctId: NCT06295055 id: Dentistry Prince of Songkla briefTitle: Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA) acronym: SSBS for ABA overallStatus: RECRUITING date: 2024-01-04 date: 2024-10-31 date: 2025-06-30 date: 2024-03-06 date: 2024-03-06 name: Prince of Songkla University class: OTHER briefSummary: This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement. conditions: Guided Bone Regeneration conditions: Bone Formation conditions: Bone Volume studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before- after augmentation in patients with alveolar bone defects primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Ridge augmentation with semi-rigid shell barrier system measure: Bone gain evaluation measure: Biocompatibility evaluation measure: Ridge volume change of alveolar ridge evaluation sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Songkla status: RECRUITING city: Songkhla state: Hatyai zip: 90110 country: Thailand name: panisa tantiwongs role: CONTACT phone: 0824864497 email: k-kampt@hotmail.com lat: 7.19882 lon: 100.5951 hasResults: False
<\|newrecord\|> nctId: NCT06295042 id: 32-235 ex 19/20 briefTitle: Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction overallStatus: COMPLETED date: 2019-10-10 date: 2023-11-28 date: 2024-02-01 date: 2024-03-06 date: 2024-03-06 name: Medical University of Graz class: OTHER briefSummary: Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.
This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction. conditions: Complications, Postoperative/Perioperative conditions: Quality of Life conditions: Satisfaction, Patient studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162 type: ACTUAL name: BREAST-Q Questionnaire measure: Complications measure: Health-related quality of life and satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz city: Graz zip: 8036 country: Austria lat: 47.06667 lon: 15.45 hasResults: False
<\|newrecord\|> nctId: NCT06295029 id: CPA-Z05-ZC-2023-002 briefTitle: Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-12-31 date: 2027-12-31 date: 2024-03-06 date: 2024-03-06 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Overall adverse event rate measure: Incidence of grade III and above adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06295016 id: NYCU112130AE briefTitle: Stressors and Recovery Regulation on the Super-compensation Effect overallStatus: RECRUITING date: 2023-09-01 date: 2024-08-31 date: 2025-08-31 date: 2024-03-06 date: 2024-03-06 name: National Yang Ming University class: OTHER briefSummary: Purpose: Investigating the effects of stressors and recovery regulation on the super-compensation effect of high-intensity intensive training (IT) in endurance athletes. Methods: This study will recruit 176 competitively trained endurance adult athletes. Participants will conduct a 7-week 3-stage experiment, including 3 weeks of regular training, 3 weeks of 130% progressive IT, and 1 week of 55% taper. Measurement will include training responses (performance and fatigue symptoms), stressors, recovery regulation, and mood state at baseline, during and after regular training, IT, and taper separately. According to the performance after taper, all participants will category into either the responder or non-responder of well-response to supercompensation effect. Statistic analysis: Independent t-test, Chi-squared test, and binary logistic regression will be used to compare the difference in training responses, stressors, recovery regulation, and mood state characteristics between responder and non-responder groups. P value sets at 0.15 for identifying the potential predictors. Logistic stepwise multiple regression will be used further to determine the significant predictors for the responders of well-response to the super-compensation among endurance athletes. P value sets at 0.05. conditions: Exercise Overtraining conditions: Stressor, Psychological studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The present study is designed as a prospective intervention and prognostic prediction study, employing a single-subject design with a reversal (ABA) design. This design involves a self-controlled intervention experiment with three phases: baseline training period (A), high-intensity, high-volume training period (B), and reduced training period (A). Subsequently, the study aims to explore predictive factors influencing the presence or absence of favorable compensatory training effects following the intervention. primaryPurpose: SCREENING masking: DOUBLE maskingDescription: Prior to the commencement of the experiment and during the experimental period, both the participants and the investigator will be unaware of whether the participants exhibit a good response to compensatory training effects. After the participants complete the entire experimental procedure, they will be grouped post hoc based on their outcomes following the intervention, according to predetermined criteria.
The criteria for determining whether there is a good response to compensatory training effects:

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