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* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires conditions: Post-Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomised into two groups.
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One group will receive nine sessions of Trauma-Informed Goal Management Training, and the other group will receive nine sessions of standard Goal Management Training.
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Each group session will be 2 hours long, and offered virtually (using Zoom for Healthcare). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Trauma-Informed Goal Management Training (TI-GMT) name: Goal Management Training (GMT) measure: Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up measure: Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up measure: Demographic Information measure: Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline measure: Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline measure: Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline measure: Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up measure: Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up measure: Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up measure: Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up measure: Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up measure: Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up measure: Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up measure: Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel ('MIA-PSP') at post-intervention and follow-up measure: Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up measure: Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up measure: Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up measure: Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06354348 id: GastrectomyUSG briefTitle: Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy overallStatus: COMPLETED date: 2023-12-06 date: 2024-03-30 date: 2024-03-30 date: 2024-04-09 date: 2024-04-09 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: The investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with USG, which is a more specific and easy method. conditions: Sarcopenia conditions: Gastrectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ACTUAL name: USG, Grip strength, Chair stand test (CST) measure: Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI ) sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06354335 id: 1-16-02-62-20 briefTitle: Impact of a Major Organizational Change on Employee Productivity and Mental Health acronym: PRO-MENTA overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2024-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-11 name: Aarhus University Hospital class: OTHER name: University of Aarhus name: Herning Hospital name: Bispebjerg Hospital briefSummary: The study investigates the short- and long-term impact of a major organizational change on employee health and productivity. Changes in organizations is a common aspect of modern work life in all sectors and public healthcare is no exception. However, emerging evidence suggests that organizational changes may be a potential stressor which can impact on employee well-being and contribute to stress-related health problems. Using a large-scale natural experiment, the overall aim of the study is to investigate the impact of a major organizational change that took place during 2016-19 on employee health and productivity. In addition, we aim to identify groups that may be at increased risk of experiencing negative consequences of the reorganization. These at-risk groups can in turn be candidates for extended preventive measures when planning future major organizational changes. conditions: Work Related Stress conditions: Mental Health Issue conditions: Work-related Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 31555 type: ACTUAL name: Employees exposed to a major hospital reorganisation measure: Employee health measured by rate of absenteeism, use of health care services and redeemed drug prescriptions measure: Workplace productivity measured by number of patient contacts and medical procedures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06354322 id: APHP230630 briefTitle: Unclassified GENotypes of Autoinflammatory Diseases and AA Amyloidosis acronym: IPHYGENI MAI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2034-05 date: 2024-04-09 date: 2024-04-09 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Patients with autoinflammatory diseases (AID) have recurrent episodes of systemic inflammation accompanied by nonspecific elevation of blood inflammation markers typically absent between attacks. A complication of autoinflammatory diseases is AA amyloidosis, which can lead to renal failure and dialysis. Advances in genetic analysis have led to the identification of new autoinflammatory diseases and thus new pathophysiological pathways.
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However, genetic analyses are sometimes confronted with results that are difficult to interpret. These are the Variants of Unknown Significance, for which genetic analysis alone does not allow to determine if the genetic mutation is responsible for the symptoms.
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genetic analysis sometimes has limitations in the diagnosis of AID which can only be overcome by pathophysiological studies of the variants found. conditions: AA Amyloidosis conditions: Autoinflammatory Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Exploration of VUS in AutoInflammatory Diseases measure: Pathophysiology of Autoinflammatory Diseases measure: Role of other innate immune cells in AutoInflammatory Diseases measure: Improve knowledge of AA amyloidosis sex: ALL minimumAge: 3 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06354309 id: vr_study briefTitle: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study overallStatus: COMPLETED date: 2023-08-01 date: 2023-10-20 date: 2023-10-20 date: 2024-04-09 date: 2024-04-09 name: He Eye Hospital class: OTHER briefSummary: The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score. conditions: Amblyopia conditions: Motion Sickness conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 38 type: ACTUAL name: Virtual reality game measure: Simulator Sickness Questionnaire Score measure: Postural stability measure: Non-invasive tear breakup time measure: Tear meniscus height measure: Lipid layer classification measure: Eye blink frequency measure: Eye surface temperature measure: Ocular surface disease index dry eye questionnaire score measure: Visual quality questionnaire score measure: Visual fatigue questionnaire score sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: He Eye Hospital city: Shenyang state: Liaoning zip: 110034 country: China lat: 41.79222 lon: 123.43278 hasResults: False
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<|newrecord|> nctId: NCT06354296 id: CAF2024 briefTitle: Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-15 date: 2024-08-31 date: 2024-04-09 date: 2024-04-09 name: He Eye Hospital class: OTHER briefSummary: The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) \[Holladay 1 (D-K)\] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula. conditions: Cataract studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Accuracy of the IOL formula sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06354283 id: Progresif briefTitle: Progressive Muscle Relaxation Exercises Women With Low Sexual Satisfaction Sexual Satisfaction and Functioning of Women and Their Partners overallStatus: COMPLETED date: 2023-04-10 date: 2024-01-30 date: 2024-02-08 date: 2024-04-09 date: 2024-04-09 name: Halic University class: OTHER briefSummary: This study was conducted to investigate the effect of progressive muscle relaxation exercises on sexual satisfaction and functioning of women and their partners in women with low sexual satisfaction.
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Method: The single-blind, randomized controlled study was conducted between April 2023 and January 2024. The sample of the study was women with low sexual satisfaction and their partners were randomized into two groups as intervention and control. Each group consisted of 120 couples, n=60. The women in the intervention group were given progressive muscle relaxation techniques three times a week for four weeks. The results of the study focused on the effect on sexual satisfaction and functioning of men and women. conditions: Women With Low Sexual Satisfaction conditions: Partners of Women With Low Sexual Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Group and Control Group primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The progressive relaxation intervention and follow-up was conducted by the researcher who was not blinded to the interventions (PSI). Randomization was performed by another academic who was not an investigator in the study. In order to avoid bias, the researcher who conducted the intervention did not participate in any step of the pre-test, post-test and statistical evaluation process. Group information was not shared with the statistician who performed the analysis. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Progressive Muscle Relaxation Exercises measure: Sexual Satisfaction measure: Sexual Function sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fatma Şule Bilgiç city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06354270 id: 300104 briefTitle: A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-11 date: 2024-06-24 date: 2024-06-24 date: 2024-04-09 date: 2024-04-25 name: HALEON class: INDUSTRY briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 115 type: ACTUAL name: Stannous fluoride toothpaste name: Regular fluoride toothpaste (Crest Cavity Protection) measure: Change from Baseline in Schiff Sensitivity Score at Day 56 measure: Change from Baseline in Tactile Threshold at Day 56 measure: Change from Baseline in Schiff Sensitivity Score at Day 28 measure: Change from Baseline in Tactile Threshold at Day 28 measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Family and Cosmetic Dentistry, All Sums Research Center Ltd. city: Melbourne state: Florida zip: 32940 country: United States lat: 28.08363 lon: -80.60811 hasResults: False
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<|newrecord|> nctId: NCT06354257 id: 220104 briefTitle: A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-10-30 date: 2024-10-30 date: 2024-04-09 date: 2024-04-09 name: GlaxoSmithKline class: INDUSTRY briefSummary: The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used. conditions: Tuberculosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Fixed sequence primaryPurpose: PREVENTION masking: NONE maskingDescription: Open-label count: 25 type: ESTIMATED name: EE/LNG name: GSK3036656 Dose Level 1 name: GSK3036656 Dose Level 2 measure: Area under the plasma drug concentration (AUC)-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of EE after being administered with 14 days of GSK3036656 at DL 2 measure: Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2 measure: AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2 measure: Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2 measure: AUC over the dosing interval (0-tau) of GSK3036656 after being administered with a single dose of EE/LNG measure: Cmax of GSK3036656 after being administered with a single dose of EE/LNG measure: Steady state assessment using trough plasma concentration (Ctau) of GSK3036656 after being administered with a single dose of EE/LNG measure: Tmax of GSK3036656 after being administered with a single dose of EE/LNG measure: AUC versus time curve (AUC[0-t]) of EE/LNG after being administered with a single dose of EE/LNG measure: AUC(0-t) of EE/LNG after being administered with 14 days of treatment with GSK3036656 at DL 2 measure: Tmax of EE/LNG after being administered with a single dose of EE/LNG measure: Tmax of EE/LNG after being administered with 14 days of GSK3036656 DL 2 measure: Apparent terminal half-life (t1/2) of EE and LNG after a single dose of EE/LNG measure: t1/2 of EE and LNG after a single dose of EE/LNG in combination with 14 days of treatment with GSK3036656 at DL 2 measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with Grade 3 or higher severity adverse events (AEs) measure: Number of participants with drug-related AEs measure: Number of participants with drug-related AEs following the administration of GSK3036656 measure: Number of participants withdrawn from the treatment/study due to AEs measure: Percentage of participants with ECG values of Potential Clinical Importance (PCI) measure: Percentage of participants with clinical chemistry laboratory values of PCI measure: Percentage of participants with haematology laboratory values of PCI measure: Percentage of participants with vital signs parameters of PCI sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Madrid zip: 28046 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Alberto Borobia Perez role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06354244 id: 2023-183-KY-02 briefTitle: Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-09 date: 2024-04-09 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions conditions: Urinary Retention conditions: Lower Motor Neurone Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Electroacupuncture of 2 sessions per week name: Electroacupuncture of 3 sessions per week name: Electroacupuncture of 4 sessions per week measure: The response rate. measure: The response rate. measure: The change in post void residuals (PVR) from baseline. measure: The change in the proportion of patients reporting severe urinating difficulty from baseline. measure: The change in the proportion of patients having stool retention from baseline. measure: The change in the proportion of patients requiring catheterization from baseline. measure: The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I). measure: The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences status: RECRUITING city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: [email protected] name: Min Yang role: CONTACT phone: +8618810268077 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06354231 id: RC48-C012 briefTitle: DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC overallStatus: RECRUITING date: 2023-07-20 date: 2026-12-30 date: 2026-12-30 date: 2024-04-09 date: 2024-04-11 name: Fudan University class: OTHER briefSummary: Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment. conditions: Renal Insufficiency conditions: Upper Urinary Tract Urothelial Carcinoma conditions: Solitary Kidney studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: DV name: Toripalimab name: Laser surgery measure: Kidney-intact disease-free survival, KI-DFS measure: Time to progression, TTP measure: Time to RNU measure: Disease-specific survival time, DSS measure: Overall survival measure: 3m complete remission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai country: China name: dingwei ye role: CONTACT phone: 64175590-82800 lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06354218 id: GXL-005 briefTitle: Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age overallStatus: RECRUITING date: 2023-12-01 date: 2025-12-01 date: 2027-12-01 date: 2024-04-09 date: 2024-04-09 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. conditions: Esophageal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Serplulimab measure: mPFS measure: ORR measure: OS measure: DOR measure: Toxic side reactions sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Xiaolin MM Ge, PHD role: CONTACT phone: 13951818797 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06354205 id: 24-3.1T/98 briefTitle: Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels overallStatus: RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-09 date: 2024-04-09 name: Ege University class: OTHER name: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE briefSummary: Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.
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The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT. conditions: Bacterial Infections conditions: Children, Only conditions: Procalcitonin conditions: Saliva studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Sliva Procalcitonin measure: Correlation measure: Diagnose sex: ALL minimumAge: 0 Years maximumAge: 1 Year stdAges: CHILD facility: Ege University School of Medicine status: RECRUITING city: İzmir zip: 35100 country: Turkey name: Caner Turan role: CONTACT lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06354192 id: 0450 briefTitle: Precision Nudging for Hypertension Management: Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-10-11 date: 2026-10-11 date: 2024-04-09 date: 2024-04-09 name: Lirio class: INDUSTRY name: Cone Health briefSummary: The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP). conditions: Hypertension studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 12000 type: ESTIMATED name: Precision Nudging for Hypertension Management measure: Clinical encounter behavioral outcome measure: Blood pressure reading clinical outcome measure: Engagement measure: Medication adherence behavioral outcome measure: Self-monitoring of blood pressure behavioral outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06354179 id: 87RI23_0031 (EASY) briefTitle: Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY) acronym: EASY overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-07-01 date: 2024-04-09 date: 2024-04-11 name: University Hospital, Limoges class: OTHER briefSummary: World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.
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The immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.
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Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.
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The narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.
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Limited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.
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Even if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.
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In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®. conditions: Liver Transplantation conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: XR-tacrolimus QD + MMF BID name: LCP-tacrolimus QD + MMF BID name: LCP-tacrolimus QD + MMF QD measure: Treatment failure measure: Adherence to treatment measure: measuring of quality of life measure: Adherence to treatment measure: measuring of quality of life measure: Appearance Adverse events measure: Appearance Adverse events measure: Comparison tacrolimus daily exposure measure: Comparison of MPA daily exposure measure: Comparison of Tacrolimus dose measure: Comparison of Tacrolimus AUC 0-24h measure: Comparison of MPA AUC 0-24h sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon hospital - APHP city: Clichy zip: 92110 country: France lat: 48.90018 lon: 2.30952 facility: Lille university hospital city: Lille zip: 59000 country: France name: Sébastien DHARANCY, MD role: CONTACT email: [email protected] name: Sébastien DHARANCY, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Limoges university hospital city: Limoges zip: 87042 country: France name: Marilyne DEBETTE-GRATIEN, MD role: CONTACT email: [email protected] name: Marilyne DEBETTE-GRATIEN, MD role: PRINCIPAL_INVESTIGATOR lat: 45.83153 lon: 1.25781 facility: Lyon university hospital city: Lyon zip: 69000 country: France name: Teresa ANTONINI, MD role: CONTACT email: [email protected] name: Teresa ANTONINI, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Montpellier university hospital city: Montpellier zip: 34000 country: France name: Georges-Philippe PAGEAUX, MD role: CONTACT email: [email protected] name: Georges-Philippe PAGEAUX, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Nice university hospital city: Nice zip: 06202 country: France name: Rodolphe ANTY, MD role: CONTACT email: [email protected] name: Rodolphe ANTY, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Pitie Salpetriere hospital - APHP city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux university hospital city: Pessac zip: 33604 country: France name: Jean-Baptiste HIRIART, MD role: CONTACT email: [email protected] name: Jean-Baptiste HIRIART, MD role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 facility: Poitiers university hospital city: Poitiers zip: 86000 country: France name: Christine SILVAIN, MD role: CONTACT email: [email protected] name: Christine SILVAIN, MD role: PRINCIPAL_INVESTIGATOR lat: 46.58333 lon: 0.33333 facility: Rennes university hospital city: Rennes zip: 35033 country: France name: Pauline HOUSSEL-DEBRY, MD role: CONTACT email: [email protected] name: Pauline HOUSSEL-DEBRY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: Strasbourg university hospital city: Strasbourg zip: 67000 country: France name: Camille BESCH, MD role: CONTACT email: [email protected] name: Camille BESCH, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Tours university Hospital city: Tours zip: 37000 country: France lat: 47.38333 lon: 0.68333 facility: Paul Brousse Hospital - APHP city: Villejuif zip: 94800 country: France lat: 48.7939 lon: 2.35992 hasResults: False
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<|newrecord|> nctId: NCT06354166 id: 2023-A02745-40 briefTitle: Study Human Digital Support Transitional Care acronym: SUNH-ST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Divoluci class: OTHER briefSummary: The purpose of the study is to compare the effectiveness of Divomed in organising complex hospital discharges with a conventional organisation. Effectiveness will be assessed by reducing the length of stay of patients in geriatric short-stay care. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional, randomised (1:1 ratio), single-centre study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: open-label study count: 150 type: ESTIMATED name: Unscheduled hospital admissions measure: length of stay sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: CHRU de Tours - Hôpital Bretonneau city: Tours zip: 37044 country: France name: Wassim GANA, MD role: CONTACT email: [email protected] lat: 47.38333 lon: 0.68333 hasResults: False
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<|newrecord|> nctId: NCT06354153 id: 0305898 briefTitle: Polarity Management Training Program for First Line Nurse Manager overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-09 date: 2024-04-09 name: Matrouh University class: OTHER briefSummary: Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance. conditions: Intervention conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Polarity Management Training Program measure: Questionnaire to measure nurse managers' knowledge measure: Nursing polarity case study situations to assess first-line nurse manager's ability to differentiate between problems to solve and polarities to manage measure: Questionnaire to measure creativity behavior of first-line nurse managers measure: questionnaire to measure intrinsic work motivation among first-line nurse managers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Marsa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False
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<|newrecord|> nctId: NCT06354140 id: WeGuo briefTitle: PPIO-008S-1 Combined With Tislelizumab in Patients With Primary Residual Node-negative Esophageal Squamous Cell Carcinoma (ESCC) After Radical Resection With Neoadjuvant Immunotherapy Combined With Chemotherapy, PHASE II STUDY overallStatus: RECRUITING date: 2024-04-07 date: 2027-04-30 date: 2028-04-30 date: 2024-04-09 date: 2024-04-09 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy conditions: Postoperative Assistance for Esophageal Squamous Cell Carcinoma With Negative Lymph Nodes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: The study was a one-arm open study count: 45 type: ESTIMATED name: Tegafur measure: 1-year DFS rate measure: Overall survival measure: Progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Army Medical Center of the People's Liberation Army status: RECRUITING city: Chongqing state: Chongqing zip: 400042 country: China name: Guo role: CONTACT phone: +8613527323568 email: [email protected] lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06354127 id: DW_DWP450009 briefTitle: DWP450 for Treating Moderate to Severe Glabellar Lines overallStatus: COMPLETED date: 2020-08-12 date: 2020-11-24 date: 2021-01-25 date: 2024-04-09 date: 2024-04-09 name: Daewoong Pharmaceutical Co. LTD. class: INDUSTRY briefSummary: A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines conditions: Moderate to Severe Glabellar Lines studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 473 type: ACTUAL name: DWP450 name: Botox® measure: Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06354114 id: SYHX2011-003 briefTitle: A Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10-31 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011 conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: SYHX2011 measure: Objective Response Rate (ORR) by Investigator measure: Progression-Free-Survival (PFS) measure: Time to progression (TTP) measure: Incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Harbin Medical University Cancer Hospital city: Harbin state: Heilongjiang country: China name: Qingyuan Zhang role: CONTACT phone: 86-13313612989 email: [email protected] lat: 45.75 lon: 126.65 hasResults: False
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<|newrecord|> nctId: NCT06354101 id: CorEvitas-VITALITY briefTitle: The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study. overallStatus: WITHDRAWN date: 2023-07-01 date: 2023-07-01 date: 2023-07-01 date: 2024-04-09 date: 2024-04-09 name: CorEvitas class: NETWORK name: Eli Lilly and Company briefSummary: The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study. conditions: Metabolic Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 0 type: ACTUAL name: Tirzepatide name: Semaglutide measure: Main Objective of Registry sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06354088 id: AAAU9636 briefTitle: Human Models of Selective Insulin Resistance: Alpelisib, Part I overallStatus: RECRUITING date: 2024-04-24 date: 2026-05 date: 2026-12 date: 2024-04-09 date: 2024-04-29 name: Columbia University class: OTHER name: University of California, Berkeley briefSummary: The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.
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The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels. conditions: Insulin Resistance conditions: Prediabetic State conditions: Overweight and Obesity conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Alpelisib 300 mg name: Placebo name: [1-13C] sodium acetate name: [6,6-2H2] D-glucose name: Nestlé BOOST Plus measure: Hepatic de novo lipogenesis (DNL) (absolute value) measure: Hepatic de novo lipogenesis (DNL) (relative value) measure: Endogenous glucose production (EGP) (absolute value) measure: Endogenous glucose production (EGP) (relative value) measure: Serum insulin level measure: Plasma glucose level measure: Triglycerides level measure: Free fatty acids level measure: Glucose kinetics: rate of appearance (absolute value) measure: Glucose kinetics: rate of appearance (relative value) measure: Glucose kinetics: rate of disappearance (absolute value) measure: Glucose kinetics: rate of disappearance (relative value) measure: Apolipoprotein B level sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Columbia University Irving Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Joshua R Cook, MD, PhD role: CONTACT phone: 212-305-6289 email: [email protected] name: Zachary D Sone role: CONTACT phone: 2123059336 email: [email protected] name: Joshua R Cook, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Blandine Laferrère, MD, PhD role: SUB_INVESTIGATOR name: Henry N Ginsberg, MD role: SUB_INVESTIGATOR name: Julia J Wattacheril, MD role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06354075 id: IRBN302024/CHUSTE briefTitle: Evaluation of Patient Information in Interventional Radiology overallStatus: RECRUITING date: 2024-04-01 date: 2026-03 date: 2026-03 date: 2024-04-09 date: 2024-04-10 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos. conditions: Patient Satisfaction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Questionary measure: to evaluate satisfaction of patient of explanatory videos in interventional radiology measure: To evaluate satisfaction of patient of comic book in interventional radiology sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Sylvain GRANGE, MD role: PRINCIPAL_INVESTIGATOR name: Rémi GRANGE, MD role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06354062 id: 0305896 briefTitle: Talent Management Intervention Program for First-Line Nurse Managers overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-09 date: 2024-04-09 name: Matrouh University class: OTHER briefSummary: Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems. conditions: Intervention conditions: Behavior conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A quasi-experimental design primaryPurpose: OTHER masking: SINGLE maskingDescription: First Line Nurse Managers received talent Management intervention program whoMasked: PARTICIPANT count: 125 type: ACTUAL name: Talent management intervention program measure: Questionnaire to measure nurse managers' knowledge measure: Questionnaire to measure talent management practice among first line nurse managers. measure: Questionnaire to measure first-line nurse manager job performance sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Mersa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False
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<|newrecord|> nctId: NCT06354049 id: CASE3Z24 briefTitle: Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI) overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-31 date: 2025-03-31 date: 2024-04-09 date: 2024-04-09 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population. conditions: Cancer Pain conditions: Oncology Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Reiki measure: Recruitment rate as measured by the percentage of participants enrolled measure: Retention rate as measured by the number of participants retained until the final survey point measure: Attendance rate as measured by number of sessions attended per 6 sessions measure: Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention measure: Acceptability as measured by the patient mean of participant satisfaction survey measure: Data completeness rate measure: Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score measure: Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06354036 id: NCC4465 briefTitle: Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy overallStatus: RECRUITING date: 2023-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-04-09 date: 2024-04-10 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.
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Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.
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Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: the Transhiatal Tunnel Valvuloplasty technique measure: The incidence of postoperative reflux esophagitis measure: the incidence of postoperative anastomotic fistula measure: the incidence of anastomotic stenosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing zip: 100021 country: China name: Dongbing R Zhao, M.D. role: CONTACT phone: +86-13901331816 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06354023 id: IAGH for Osteoarthritis briefTitle: Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2025-05-08 date: 2025-05-08 date: 2024-04-09 date: 2024-04-17 name: John Sledge class: OTHER briefSummary: The goal of this clinical trial is to learn if growth hormone injections can be used to treat osteoarthritis (OA) in the knee. Human studies have shown that repeated injections of human growth hormone leads to the production of articular chondrocytes, which are the cells that make up the cartilage in the knee joint. Restoring cartilage in the knee can alleviate pain, improve function, and postpone the need for a joint replacement procedure. The main questions the study aims to answer are:
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* Do growth hormone injections in the knee joint stimulate cartilage growth?
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* Do the injections lower pain and stiffness in the participant's treated knee?
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* Does the participant have more mobility after the injections?
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The physician will monitor the participant's progress through X-ray images, questionnaires, and physical evaluation of the treated knee.
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For the trial, participants will:
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* Receive a growth hormone injection in their knee once per week for six weeks, for a total of 6 injections.
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* Complete at-home exercises during the treatment period.
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* Use crutches as needed during the trial.
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* Have X-rays taken at 8 weeks, 6 months, and 12 months after the first injection.
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* Go to follow-up visits at 8 weeks, 6 months, and 12 months after the first injection.
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* Complete treatment surveys before treatment starts and after it is finished. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The proposed clinical trial is a single-arm intervention model. Once per week for six weeks, each participant will receive an intra-articular injection of recombinant human growth hormone (rGH) 15 IU in their affected knee. During the treatment course, the participants will use the same knee brace and crutches (as needed) and be given the same exercises to complete at home. They will all be evaluated 8 weeks, 6 months, and 12 months after their initial injection. primaryPurpose: TREATMENT masking: NONE maskingDescription: None, each participant will receive the same treatment count: 23 type: ESTIMATED name: Recombinant human growth hormone measure: Knee Society Score measure: Kellgren-Lawrence Grading Scale measure: Serum IGF-1 Levels sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BioShift Life Sciences city: Santa Monica state: California zip: 90404 country: United States name: Maggie Phillips role: CONTACT phone: 301-655-4651 email: [email protected] lat: 34.01945 lon: -118.49119 hasResults: False
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<|newrecord|> nctId: NCT06354010 id: SENS-NH02 briefTitle: Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis acronym: SONG overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-07 date: 2027-07 date: 2024-04-09 date: 2024-04-09 name: Sensorion class: INDUSTRY briefSummary: The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene. conditions: Sensorineural Hearing Loss, Bilateral studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 100 type: ESTIMATED name: Genotyping name: Audiological assessments measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene. measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene measure: Genetic characteristics of adult patients with early-onset presbycusis measure: Audiological characteristics of adult patients with early-onset presbycusis measure: Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: CHU Gui de Chauliac city: Montpellier zip: 34295 country: France name: Frederic Venail, Pr role: CONTACT lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06353997 id: 2024000099 briefTitle: Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2029-06 date: 2024-04-09 date: 2024-04-09 name: Providence Health & Services class: OTHER name: Inhibrx, Inc. briefSummary: This is a Phase II trial to assess feasibility of pembrolizumab + INBRX-106 as a chemotherapy-sparing neoadjuvant therapy. One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule. conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Pembrolizumab name: INBRX-106 measure: Pathological response (post-IO) measure: Pathological response (post-chemotherapy) measure: IO-path response assessed prior to Cycle 2 measure: Volumetric response measure: Event free survival measure: Overall survival measure: Toxicity profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ellison Institute of Technology (EITM) city: Los Angeles state: California zip: 90064 country: United States name: Reva Basho, MD role: CONTACT phone: 310-272-7640 lat: 34.05223 lon: -118.24368 facility: Providence Portland Cancer Institute - Franz Clinic city: Portland state: Oregon zip: 97213 country: United States name: Nicole Moxon, RN role: CONTACT email: [email protected] name: Alison Conlin, MD role: SUB_INVESTIGATOR name: Evelyn Brosnan, MD role: SUB_INVESTIGATOR name: Evie Hobbs, MD role: SUB_INVESTIGATOR name: Rui Li, MD, PhD role: SUB_INVESTIGATOR name: Sasha Stanton, MD, PhD role: SUB_INVESTIGATOR name: Zheng Topp, MD role: SUB_INVESTIGATOR name: Amy Hartman, NP role: SUB_INVESTIGATOR name: Kathleen Dronkowski, NP role: SUB_INVESTIGATOR name: Kimberlie Dame, NP role: SUB_INVESTIGATOR name: Molly Davis, NP role: SUB_INVESTIGATOR name: RaYoung Chung, NP role: SUB_INVESTIGATOR name: Roxanne Griswold, NP role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Providence St. Vincent Medical Center city: Portland state: Oregon zip: 97225 country: United States name: Nicole Moxon, RN role: CONTACT email: [email protected] name: David Page, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Swedish Cancer Institute city: Seattle state: Washington zip: 98104 country: United States name: Danielle File, MD role: CONTACT phone: 206-386-3900 lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06353984 id: Minimeal 1.0 briefTitle: Effects of In-between Meal Products on Cognitive Function in Older Adults acronym: Minimeal overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2025-12 date: 2024-04-09 date: 2024-04-09 name: Örebro University, Sweden class: OTHER briefSummary: The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The present study has as the potential to prevent or slow down the onset of cognitive decline as it targets healthy older adults and gives additional insight regarding secondary and exploratory outcomes. conditions: Cognitive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Investigators and participants are partly blinded as the control group receives no placebo product whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Minimeal product name: Reference product measure: Functional brain activity measure: Fasting blood glucose/insulin measure: Blood fats/lipid status measure: Interleukin-6 measure: High-sensitivity C-reactive protein measure: Tumor necrosis factor measure: Interferon-gamma measure: Zonulin measure: Intestinal fatty-acid binding protein measure: Cognitive function measure: Magnetic resonance imaging (MRI) measure: The Perceived Stress Scale measure: Hospital Anxiety and Depression Scale measure: SF 36 measure: Western Ontario and McMaster Osteoarthritis Index measure: Clinical Outcomes in Routine Evaluation measure: Gastrointestinal Symptoms Rating Scale measure: Pittsburgh Sleep Quality Index measure: International Physical Activity Questionnaire for the Elderly short form measure: Historical Physical Activity Questionnaire measure: Food frequency questionnaire measure: Physical activity measure: Muscle mass measure: Fat mass measure: Body mass index measure: Waist circumference measure: Aerobic capacity measure: Balance measure: 30-sec repeated chair raise measure: Maximal leg strength measure: Maximal handgrip strength sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06353971 id: JSP-CP-010 id: 2023-507534-24 type: EUDRACT_NUMBER briefTitle: A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines acronym: SPOTLIGHT overallStatus: RECRUITING date: 2024-03-18 date: 2025-04-21 date: 2025-08-04 date: 2024-04-09 date: 2024-04-10 name: Jasper Therapeutics, Inc. class: INDUSTRY briefSummary: This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore two ascending dose levels which will be tested in two sequential cohorts. conditions: Chronic Inducible Urticaria studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This is an open-label, single ascending dose, Phase 1b/2a trial.
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Cohort 1 follows a 3+3 design and will be treated with a single 40mg dose. Cohort 2 will be treated with a single 120mg dose. primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Briquilimab measure: Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines. measure: Preliminary efficacy of briquilimab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - University Clinic Berlin status: RECRUITING city: Berlin zip: 12203 country: Germany lat: 52.52437 lon: 13.41053 facility: University Hospital Dresden status: RECRUITING city: Dresden zip: 01307 country: Germany lat: 51.05089 lon: 13.73832 facility: Medical University Hannover status: NOT_YET_RECRUITING city: Hannover zip: 30625 country: Germany lat: 52.37052 lon: 9.73322 facility: University Clinic Schleswig-Holstein status: RECRUITING city: Lübeck zip: 23538 country: Germany lat: 53.86893 lon: 10.68729 hasResults: False
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<|newrecord|> nctId: NCT06353958 id: MiSaver PIIa briefTitle: MiSaver® Stem Cell Treatment for Acute Myocardial Infarction acronym: MiSaver® overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-09 date: 2024-04-09 name: Honya Medical Inc class: INDUSTRY name: Chung Shan Medical University briefSummary: Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.
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Primary Endpoint:
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The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.
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Secondary Outcomes:
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Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups. conditions: Acute Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 30 type: ACTUAL name: MiSaver measure: Safety and adverse events events measure: Efficacy on ventricular ejection fraction (LVEF) improvement sex: ALL minimumAge: 41 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Shan Medical University Hospital city: Taichung country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06353945 id: HB062-24 briefTitle: Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use. overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-05-07 date: 2024-05-15 date: 2024-04-09 date: 2024-04-09 name: Herbarium Laboratorio Botanico Ltda class: INDUSTRY briefSummary: The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone." conditions: Vaginal Atrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: vaginal moisturizer measure: evaluate the perceived effectiveness of the investigational product sex: FEMALE minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06353932 id: KA-23026 briefTitle: The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range overallStatus: COMPLETED date: 2024-01-25 date: 2024-02-25 date: 2024-02-25 date: 2024-04-09 date: 2024-04-09 name: Hacettepe University class: OTHER briefSummary: The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups. conditions: Endotracheal Tube conditions: Cuff Pressure conditions: Sore Throat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 263 type: ACTUAL name: keeping the endotracheal tube cuff pressure within a certain range measure: Sore throat measure: cough measure: hoarseness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University Hospital city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06353919 id: NUNM briefTitle: Remote Yoga Nidra for Deprescribing BZRAs overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-04-09 date: 2024-04-09 name: National University of Natural Medicine class: OTHER name: US Department of Veterans Affairs briefSummary: The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system. conditions: Anxiety conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Yoga Nidra name: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education measure: Demand measure: Recruitment Success measure: Implementation practicality measure: Acceptability measure: Retention measure: Adherence to Protocol measure: Use of Benzodiazepine Receptor Agonist medications measure: Cessation of Benzodiazepine Receptor Agonist medication measure: Baseline Urine Benzodiazepine Receptor Agonist Concentration measure: Close-out Urine Benzodiazepine Receptor Agonist Concentration measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Patient reported outcomes measurement information system 29 measure: Patient reported outcomes measurement information system 29 measure: Generalized Anxiety Disorder 7 Questionnaire measure: Generalized Anxiety Disorder 7 Questionnaire sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06353906 id: N22APC briefTitle: Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer acronym: PRIAM overallStatus: NOT_YET_RECRUITING date: 2024-06-14 date: 2026-10-14 date: 2028-01-14 date: 2024-04-09 date: 2024-04-09 name: The Netherlands Cancer Institute class: OTHER name: Merck Sharp & Dohme LLC briefSummary: This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis conditions: Urologic Neoplasms conditions: Urogenital Neoplasms conditions: Male Urogenital Diseases conditions: Penile Cancer conditions: Penile Squamous Cell Carcinoma conditions: Locally Advanced Penile Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Carboplatin/Paclitaxel name: Pembrolizumab name: Partial or total penectomy with inguinal and/or pelvic lymph node dissection measure: Pathological complete response (pCR) measure: Drug toxicity measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Assessment of correlation between clinical endpoints and tumor characteristics measure: Tumor tissue HPV status in relation to treatment response measure: Tumor tissue PD-L1 expression in relation to treatment response measure: Evaluation of changes in patient reported outcome regarding Quality of Life (QoL) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06353893 id: Integrity-001 briefTitle: MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-05-01 date: 2024-04-09 date: 2024-04-09 name: Foundation for Orthopaedic Research and Education class: OTHER name: Anika Therapeutics, Inc. briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:
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* How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?
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* What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?
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Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair. conditions: Rotator Cuff Tears studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Anika Integrity Implant System measure: MRI Assessment of Adverse Events and Structural Integrity measure: Effectiveness Evaluation with PROMIS outcome tool measure: Effectiveness Evaluation with PROMIS tool measure: Effectiveness Evaluation with SANE score measure: Effectiveness Evaluation with SANE score measure: Effectiveness Evaluation with ASES rating scale measure: Effectiveness Evaluation with ASES rating scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation for Orthopaedic Research and Education city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 hasResults: False
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<|newrecord|> nctId: NCT06353880 id: 24K08-001 briefTitle: Obesity With Sperm Quality in Men With Fertility Need overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-12 date: 2024-04-09 date: 2024-04-09 name: Yu xiaowei class: OTHER briefSummary: This study aims to investigate the impact of different types of obesity on sperm quality. Participants will be divided into three groups: a normal BMI group, an obese group without pudendal fat wrapping the testicles, and an obese group with pudendal fat wrapping the testicles. Sperm quality parameters will be compared among these groups to assess potential differences associated with different types of obesity. conditions: Sperm Quality conditions: Obesity conditions: Sex Hormones conditions: Visceral Fat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition. measure: Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors measure: Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups measure: Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06353867 id: 56365223-050.01.04-2023.13754 briefTitle: The Effect of Group Exercise in Children With Special Needs overallStatus: COMPLETED date: 2022-12-27 date: 2023-04-15 date: 2023-04-25 date: 2024-04-09 date: 2024-04-09 name: Istanbul Gedik University class: OTHER briefSummary: Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention. conditions: Developmental Disability conditions: Child Autism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Group Exercise measure: Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF) measure: Paediatric Balance Scale measure: Functional Reach Test measure: Timed Up and Go Test measure: Stroop Test sex: ALL minimumAge: 6 Years maximumAge: 15 Years stdAges: CHILD facility: Marmara University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06353854 id: FFCD 2112-CORESIM briefTitle: Prospective Cohort Study of Immunotherapy Resistance in Metastatic Colorectal Cancer Patients With MSI acronym: CORESIM overallStatus: RECRUITING date: 2024-02-12 date: 2029-02-12 date: 2030-02-12 date: 2024-04-09 date: 2024-04-09 name: Federation Francophone de Cancerologie Digestive class: OTHER briefSummary: Over the last ten years, the discovery of the mechanisms by which tumours escape the control of the immune system, and in particular the T lymphocyte response, has led to the emergence of new therapeutic strategies against cancer, such as the use of "immune checkpoint inhibitors" (ICI). The immune system plays a crucial role in controlling tumour proliferation, and involves several players.
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