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1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
2. Low load blood flow restriction group (LL-BFRT): The researchers will provide participants with a low load blood flow restriction training program constructed by our research group.
3. Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training. conditions: Sarcopenia conditions: Lung Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ACTUAL name: Low load blood flow restriction training name: Progressive resistance training group measure: Grip strength measure: Appendicular Skeletal Muscle Index (ASMI) measure: Step speed measure: Body mass index (BMI) measure: Quality of life for lung cancer patients measure: Exercise compliance measure: Exercise safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, Zhejiang University School of Medicine city: HangZhou state: Zhejiang zip: 310020 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06347952 id: SE1188 briefTitle: Mapping Arterial Perforators Within the Breast During Mammoplasty acronym: Map-total overallStatus: COMPLETED date: 2022-04-27 date: 2024-01-25 date: 2024-01-29 date: 2024-04-04 date: 2024-04-04 name: Royal Marsden NHS Foundation Trust class: OTHER briefSummary: Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.
In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.
We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.
A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).
We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.
In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ACTUAL name: Use of Acoustic and color imaging doppler during surgery for breast cancer measure: Full-thickness (complete or partial) necrosis of nipple-areolar complex sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Marsden - Surrey city: Sutton state: England zip: SM2 5PT country: United Kingdom lat: 51.35 lon: -0.2 hasResults: False
<\|newrecord\|> nctId: NCT06347939 id: 2023-06638-01 briefTitle: Mediastinal EBUS Cryobiopsy Study In Sweden acronym: MECRIS overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2028-12-31 date: 2024-04-04 date: 2024-04-19 name: Region Skane class: OTHER briefSummary: This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).
Follow up four weeks after the procedure to assess the risk for postoperative complications. conditions: Mediastinal Lymphadenopathy conditions: Lung Cancer conditions: Sarcoidosis conditions: Lymphoma conditions: Tuberculosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Mediastinal lymph nodes cryobiopsies measure: Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis. measure: Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Respiratory medicine and allergy department, Skåne University Hospital status: RECRUITING city: Lund country: Sweden name: Hamid Akbarshahi, MD, PhD role: CONTACT phone: 004646171000 email: hamid.akbarshahi@med.lu.se lat: 55.70584 lon: 13.19321 facility: Norrlands universitetssjukhus status: RECRUITING city: Umeå country: Sweden name: Annelie Behndig, MD, PhD role: CONTACT phone: 0907850000 email: annelie.behndig@umu.se lat: 63.82842 lon: 20.25972 hasResults: False
<\|newrecord\|> nctId: NCT06347926 id: PROICM 2023-11 EVA briefTitle: Evaluation of the Effect of Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer acronym: EVABIOSEIN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-08 date: 2025-08 date: 2024-04-04 date: 2024-04-04 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge.
Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France.
Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. A study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Treatment by photobiomodulation primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Photobiomodulation measure: Sexual satisfaction score on one dimension of the SHQ-22 questionnaire measure: Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire measure: Patient Global Impression of Improvement (PGI-I) score measure: Determination of the Vaginal Health Index clinical score measure: Determination of symptoms of vulvovaginal atrophy by a visual numerical scale measure: Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute. measure: Number of patients taking other treatments for treating sexual troubles sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Cancer in Montpellier city: Montpellier state: Hérault zip: 34298 country: France name: Angélique Bobrie, MD role: CONTACT phone: 467618576 phoneExt: +33 email: angelique.bobrie@icm.unicancer.fr name: Angélique Bobrie, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
<\|newrecord\|> nctId: NCT06347913 id: Soh-Med-24-03-09MS briefTitle: Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2025-03 date: 2024-04-04 date: 2024-04-04 name: Sohag University class: OTHER briefSummary: Antepartum fetal surveillance is the cornerstone of management in pregnancy. \[1\] It is done primarily to reduce the incidence of adverse fetal outcomes. It minimizes morbidity by optimizing the timing of delivery. Fetus at risk of chronic hypoxia is identified and unnecessary interventions are avoided. However, fetal surveillance acts as a diagnostic modality to detect the influence of maternal, placental, and fetal factors on the fetus. The timely detection of morbid changes in the fetal status followed by adequate interventions to avoid death or disability is one of the most important objectives of prenatal care. \[2\] Tests now commonly done for antepartum fetal surveillance are nonstress test (NST), amniotic fluid index (AFI), biophysical profile, Doppler study of umbilical artery (UA), and middle cerebral artery (MCA).\[3 6\] However, AFI and UA Doppler velocimetry both form an essential part of the antenatal surveillance in the assessment of fetal well being. UA Doppler is a powerful tool that allows the obstetrician to follow a sequence of fetal hemodynamic events that happen in response to placental insufficiency. \[7\] However, several studies have reported higher sensitivities and specificities for UA Doppler ratio for prediction of fetal prognosis. \[3 6\] Amniotic fluid is the product of complex and dynamic fetal and placental physiologic processes. Disruption of the fine balance may result in overproduction or underproduction of fluid. Liquor adequacy often reflects the fetal status. Oligohydramnios is associated with increased perinatal loss. Furthermore, other studies indicate that UA velocimetry is a predictor of adverse outcomes in pregnancies complicated by oligohydramnios. \[8,9\] Thus, arterial Doppler velocimetry measurement may be useful in predicting adverse pregnancy outcomes adjunct to other antenatal surveillance tests, especially the AFI. Therefore, the present study will be done to evaluate the comparative assessment of UA ratio and AFI in predicting adverse perinatal outcomes. conditions: Umblical Artery Doppler in Term Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 213 type: ESTIMATED name: ultrasound measure: Umbilical Artery Systolic/Diastolic Ratio sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Sohag university Hospital city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06347900 id: Soh-Med-23-09-7PD briefTitle: Corneal Topographic Changes in Different Grades of OSA overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-30 date: 2024-06-30 date: 2024-04-04 date: 2024-04-04 name: Sohag University class: OTHER briefSummary: Corneal topographic parameters in different degrees of obstructive sleep apnea conditions: Corneal Ectasia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Pentacam (corneal topographic changes detection), Polysymnography measure: Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values. sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ophthalmology department, Sohag University status: RECRUITING city: Sohag zip: 82511 country: Egypt name: Elshimaa A.Mateen role: CONTACT phone: 0201282223427 email: elshimaa.moussa@yahoo.com lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06347887 id: SGI-PCR-01 briefTitle: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection overallStatus: COMPLETED date: 2021-05-31 date: 2024-01-16 date: 2024-01-16 date: 2024-04-04 date: 2024-04-04 name: Singlera Genomics Inc. class: INDUSTRY briefSummary: The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1965 type: ACTUAL name: ColonAiQ test and Colonoscopy measure: Sensitivity for colorectal cancer with ColonAiQ test measure: Specificity for colorectal cancer with ColonAiQ test measure: PPV for colorectal cancer with ColonAiQ test measure: NPV for colorectal cancer with ColonAiQ test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Hospital of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: The First Affiliated Hospital of Shandong First Medical University city: Jinan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 facility: Shanxi Provincial People's Hospital city: Taiyuan state: Shanxi zip: 030012 country: China lat: 37.86944 lon: 112.56028 facility: Xi'an Daxing Hospital city: Xi'an state: Shanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 facility: Xi'an Gaoxin Hospital city: Xi'an state: Shanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 facility: Zhejiang provincial people's hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 facility: Fudan University Shanghai Cancer Center city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06347874 id: ANES-2024-32820 briefTitle: Cryo Rib Fracture Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-31 date: 2026-11-30 date: 2024-04-04 date: 2024-04-04 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter. conditions: Rib Fractures studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The individual doing the outcome assessments will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Cryoablation name: ESP Catheter measure: Maximum pain score on POD (Post Operative Day) 7 measure: Opioid Use measure: Functional Pain Scores measure: Number of Patients using opioids at POD 30 measure: Length of hospital stay measure: Number of patients returned home by POD 30 measure: time to first ambulation measure: number of patients admitted to ICU measure: number of patients that required mechanical ventilation measure: Pulmonary Function Testing. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06347861 id: C4891003 briefTitle: A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults overallStatus: RECRUITING date: 2024-04-02 date: 2024-06-16 date: 2024-07-05 date: 2024-04-04 date: 2024-04-16 name: Pfizer class: INDUSTRY name: Arvinas Estrogen Receptor, Inc. briefSummary: The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food.
This study looks at how the medicine is changed and removed from the body after a participant takes it.
This study is seeking for participant who:
* are healthy males, and healthy females who do not have the possibility to have children.
* are 18 years of age or older.
* weigh more than 45 Kilograms (99 pounds).
The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 48 type: ESTIMATED name: single dose of vepdegestrant as tablet formulation (Treatment A) name: single dose of vepdegestrant as tablet formulation (Treatment B) name: single dose of vepdegestrant as tablet formulation (Treatment C) measure: Maximum observed concentration (Cmax) for vepdegestrant measure: Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants With Clinical Laboratory Abnormalities measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs measure: Number of Participants With Electrocardiogram (ECG) Abnormalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prism Research LLC dba Nucleus Network status: RECRUITING city: Saint Paul state: Minnesota zip: 55114 country: United States lat: 44.94441 lon: -93.09327 hasResults: False
<\|newrecord\|> nctId: NCT06347848 id: IstanbulUCKA briefTitle: The Effect of Psychoeducation Focused on Reducing Internalized Stigma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-05-01 date: 2024-09-01 date: 2024-04-04 date: 2024-04-04 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma. conditions: Schizophrenia conditions: Treatment Adherence conditions: Stigma, Social studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two parallel groups randomized control study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Psychoeducation Focused on Reducing Internalized Stigma measure: Internalized Stigma of Mental Illness Scale measure: Medication Adherence Reporting Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa (IUC) city: Istanbul state: Şişli country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06347835 id: Gut-Intervention-SAR-2024 briefTitle: Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-01 date: 2024-04-04 date: 2024-04-22 name: Peking Union Medical College Hospital class: OTHER briefSummary: The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: symbiotic name: whey protein name: symbiotic placebo name: whey protein placebo measure: Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks measure: Change from Baseline of grip strength at 12 weeks measure: Change from Baseline of Short Physical Performance Battery score at 12 weeks measure: Change from Baseline of gait speed at 12 weeks measure: Change from Baseline of gut microbiota composition at 12 weeks measure: Change from Baseline of inflammation status at 12 weeks measure: Change from Baseline of microbiota-derived metabolites at 12 weeks sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Kang Yu, MD role: CONTACT phone: +86 010-69155550 email: yuk1997@sina.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06347822 id: 23-011276 briefTitle: Increasing Access to Evidence-Based Care in Integrated Behavioral Health overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-10 date: 2024-04-04 date: 2024-04-04 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future. conditions: Psychotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 34 type: ESTIMATED name: Therapy Session measure: Satisfaction with IBH therapy measure: Satisfaction with Action Plan measure: Change in readiness for change scores measure: Change in PHQ-9 scores measure: Change in GAD-7 scores measure: Change in Valuing Questionnaire (Values Progress subscale) measure: Change in Valuing Questionnaire (Values Obstruction subscale) measure: Change in CompACT scores (Valued Action) measure: Change in CompACT scores (Openness to Experience) measure: Change in CompACT scores (Behavioral Awareness) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06347809 id: 18-006343 id: NCI-2024-01225 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-006343 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine overallStatus: ENROLLING_BY_INVITATION date: 2018-11-07 date: 2029-02-01 date: 2029-02-01 date: 2024-04-04 date: 2024-04-19 name: Mayo Clinic class: OTHER briefSummary: This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests. conditions: Prostate Adenocarcinoma conditions: Prostate Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED name: Non-Interventional Study measure: Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP) measure: Accuracy of CAP detection measure: Comparison of sample volumes sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06347796 id: 23-0160 id: 1UG3NS128397-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3NS128397-01A1 briefTitle: Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study acronym: CHESS overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2029-09 date: 2029-09 date: 2024-04-04 date: 2024-04-04 name: The University of Texas Medical Branch, Galveston class: OTHER name: National Institute of Neurological Disorders and Stroke (NINDS) briefSummary: The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:
* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?
* What is the safety of MMAE and conventional open surgery in these patients?
Participants will be asked to:
* Share their medical history and undergo physical examinations
* Have blood drawn
* Have CT scans of the head
* Answer questionnaires
* Undergo MMAE or conventional open surgery
* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety. conditions: Chronic Subdural Hematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 520 type: ESTIMATED name: Conventional Surgery name: Middle Meningeal Artery Embolization (MMAE) measure: Need for Rescue Surgery or Death measure: Safety of MMAE and Conventional Open Surgery sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Medical Branch city: Galveston state: Texas zip: 77555 country: United States name: Study Manager role: CONTACT phone: 262-470-4293 email: jlspahn@utmb.edu name: Peter Kan, MD role: PRINCIPAL_INVESTIGATOR lat: 29.30135 lon: -94.7977 hasResults: False
<\|newrecord\|> nctId: NCT06347783 id: STUDY00026893 briefTitle: Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-04 date: 2024-04-04 name: Oregon Health and Science University class: OTHER briefSummary: The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.
The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:
Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?
Participants will be asked to:
* Complete questionnaires regarding demographic data and diabetes history.
* Complete surveys regarding sleep quality before and after starting an insulin pump.
* Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.
After 1-2 months after initiation of an insulin pump, participants will be asked again to:
* Complete surveys regarding sleep quality
* Wear a FitBit during sleep for 2 weeks
* Fill out daily sleep diaries over the same 2 week period. conditions: Type1diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Insulin pump measure: Sleep duration measure: Sleep efficiency measure: Sleep Disturbance Scale for Children measure: Promis Short Form 8a measure: Time in range sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Oregon Health and Science University city: Portland state: Oregon zip: 97239 country: United States name: Rachel L Palting, DO role: CONTACT phone: 503-494-1966 email: palting@ohsu.edu name: Ines Guttman-Bauman, MD role: CONTACT phone: 503-494-8509 email: Guttman@ohsu.edu name: Rachel L Palting, DO role: PRINCIPAL_INVESTIGATOR name: Ines Guttman-Bauman, MD role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
<\|newrecord\|> nctId: NCT06347770 id: ThirdSunYat-senECII202329903 briefTitle: Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women overallStatus: RECRUITING date: 2023-11-01 date: 2025-10 date: 2025-10 date: 2024-04-04 date: 2024-04-08 name: Third Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them. conditions: Microbiota conditions: Postoperative Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Probiotic Blend Oral Tablet measure: analysis of postoperative recovery measure: 16S rRNA amplicon sequencing of the V4 region sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Zhe Li status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Yiwen Zhang, MD role: CONTACT phone: +86-18145701061 lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06347757 id: NorthernJiangsuhospital1 briefTitle: A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy overallStatus: COMPLETED date: 2020-01-01 date: 2023-12-31 date: 2024-03-15 date: 2024-04-04 date: 2024-04-04 name: Northern Jiangsu People's Hospital class: OTHER briefSummary: The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial. conditions: Anti-Reflux Alimentary Reconstruction conditions: Laparoscopic Proximal Gastrectomy conditions: Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ACTUAL name: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy measure: Incidence of reflux esophagitis measure: Incidence of anastomotic leakage measure: Incidence of anastomotic stenosis measure: Operative time measure: Intra-operative blood loss measure: Overall survival, and disease-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiajie Zhou city: Yangzhou country: China lat: 32.39722 lon: 119.43583 hasResults: False
<\|newrecord\|> nctId: NCT06347744 id: RADX-P-2401 briefTitle: Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-09 date: 2024-12 date: 2024-04-04 date: 2024-04-08 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes. conditions: Sleep conditions: Sleep Disturbance conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1200 type: ESTIMATED name: Radicle Rest Placebo Control Form 1 name: Radicle Rest Active Study Product 1.1 Usage name: Radicle Rest Placebo Control Form 2 name: Radicle Rest Active Study Product 2.1 Usage measure: Change in sleep measure: Change in feelings of anxiety measure: Change in fatigue measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in sleep measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in fatigue measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radicle Science, Inc city: Del Mar state: California zip: 92014 country: United States lat: 32.95949 lon: -117.26531 hasResults: False
<\|newrecord\|> nctId: NCT06347731 id: VAR-2024-01 briefTitle: Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan) overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-03 date: 2025-03 date: 2024-04-04 date: 2024-04-17 name: Varian, a Siemens Healthineers Company class: INDUSTRY briefSummary: This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. conditions: Tumor, Solid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: prospective, open-label, non-randomized, single-arm objective performance criteria primaryPurpose: TREATMENT masking: NONE count: 47 type: ESTIMATED name: Proton Radiation Therapy measure: Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%) measure: Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%) measure: Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06347718 id: CASTLE id: 2022-001366-35 type: EUDRACT_NUMBER id: DRKS00032279 type: REGISTRY domain: Deutsches Register Klinischer Studien (DRKS) briefTitle: CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease acronym: CASTLE overallStatus: RECRUITING date: 2023-07-17 date: 2026-05-31 date: 2026-05-31 date: 2024-04-04 date: 2024-04-04 name: University of Erlangen-Nürnberg Medical School class: OTHER briefSummary: The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells. conditions: Systemic Lupus Erythematosus conditions: Systemic Sclerosis conditions: Dermatomyositis conditions: Polymyositis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase 1:
Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patients
Phase 2:
Evaluating the efficiency of CAR-T-Cells in systemic autoimmune diseases with 16 patients primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: anti-CD19 CAR T cell therapy measure: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM). measure: Clinical efficacy SSc measure: Clinical efficacy SLE measure: Clinical efficacy DM measure: Cellular response measure: Serological response measure: Success of IMP process measure: Physicians Global Assessment to measure quality of life measure: Patient's Global Assessment to measure quality of life measure: Health Assessment Questionnaire measure: Functional Assessment of Chronic Illness Therapy measure: SLE-specific disease activity over time per subject measure: SSc-specific disease activity over time per subject measure: DM/PM-specific disease activity over time per subject measure: SLE-specific disease activity over time per subject measure: DM/PM-specific disease activity over time per subject sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Erlangen status: RECRUITING city: Erlangen state: Bavaria zip: 91054 country: Germany name: Georg Schett, Prof. Dr. role: CONTACT name: Daniela Bohr, Dr. role: CONTACT lat: 49.59099 lon: 11.00783 hasResults: False
<\|newrecord\|> nctId: NCT06347705 id: 23-252 briefTitle: A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer overallStatus: RECRUITING date: 2024-03-28 date: 2029-03-28 date: 2029-03-28 date: 2024-04-04 date: 2024-04-05 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 99 type: ESTIMATED name: 2141-V11 Antibody measure: Number of participants with a complete response or minimal residual disease. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All protocol activites) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites) status: RECRUITING city: Rockville Centre state: New York zip: 11553 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.65871 lon: -73.64124 hasResults: False
<\|newrecord\|> nctId: NCT06347692 id: SCBR-240/2024 briefTitle: Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill) acronym: AGTreadmill overallStatus: NOT_YET_RECRUITING date: 2024-04-07 date: 2024-04-20 date: 2025-04-20 date: 2024-04-04 date: 2024-04-04 name: Prince Sattam Bin Abdulaziz University class: OTHER briefSummary: To date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation.
Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20). For 12 weeks, the antigravity treadmill group received training on the Alter G treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. During the same period, the control group received only traditional physical therapy. The Visual Analogue Scale, Walkway System, and the Western Ontario and McMaster Universities Arthritis Index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. All outcome measures were obtained pretreatment, post-treatment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients were randomly assigned to either the antigravity treadmill group (n = 20) or the control group (n = 20 ) using an online randomization website (www.randomization.com). The control group received a conventional physical therapy program. The therapists responsible for measuring and assessing the outcomes remained blinded to the group assignments. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: antigravity treadmill name: physical therapy exercise program measure: Assessment of patient pain measure: Evaluation of gait parameters (step length) measure: Evaluation of gait parameters (step time) measure: Evaluation of gait parameters (velocity) measure: Evaluation of patient function sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06347679 id: WCHSIRB-CT-2024-160 briefTitle: Effects of Aromatherapy on Anxiety and Pain During Dental Treatments in Adults: a Randomized Controlled Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-04-04 date: 2024-04-04 name: Sichuan University class: OTHER briefSummary: Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Aroma diffuser with single-note sweet orange essential oil name: Aroma diffuser with single-note tea tree essential oil name: Aroma diffuser with water measure: Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS) measure: Pain scale - Visual Analog Scale (VAS) measure: Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) measure: Vital sign 1 - systolic blood pressure (SBP) measure: Vital sign 2 - diastolic blood pressure (DBP) measure: Vital sign 3 - heart rate (HR） measure: Vital sign 4 - oxygen saturation (SpO2） sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06347666 id: 23082905 briefTitle: Coaching in Early Development Project overallStatus: RECRUITING date: 2024-01-12 date: 2025-02 date: 2025-07 date: 2024-04-04 date: 2024-04-04 name: Rush University Medical Center class: OTHER briefSummary: Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff. conditions: Developmental Delay studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will receive the caregiver coaching intervention. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Caregiver coaching measure: Parenting Sense of Competence Scale measure: Parenting Stress Scale measure: Mullen Scales of Early Learning measure: Maternal Behavior Responsivity Scale sex: ALL minimumAge: 12 Months maximumAge: 6 Years stdAges: CHILD facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Lauren Little role: CONTACT phone: 312-942-1759 email: lauren_little@rush.edu lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06347653 id: 2023KT127 briefTitle: Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) overallStatus: RECRUITING date: 2023-11-28 date: 2027-01-31 date: 2030-01-31 date: 2024-04-04 date: 2024-04-04 name: Peking University class: OTHER briefSummary: This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients. conditions: Nodal T-follicular Helper Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: linperlisib combined with CHOP regimen measure: progression-free survival measure: ORR measure: CR rate measure: Success rate of stem cell collection measure: overall survival (OS) measure: time to next anti-lymphoma treatment measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bejing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: PING WEI LIU, master role: CONTACT phone: 0086-13522796323 lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06347640 id: KingAbdullahUH2 briefTitle: Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin overallStatus: RECRUITING date: 2023-04-01 date: 2025-12-01 date: 2027-12-01 date: 2024-04-04 date: 2024-04-04 name: King Abdullah University Hospital class: OTHER name: Jordan University of Science and Technology briefSummary: Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration.
However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks.
A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF).
This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS. conditions: Pulp Revascularization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: induced bleeding name: plasma rich fibrin measure: Complete healing measure: regain the pulp sensibility sex: ALL minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Jordan University of Science and Technology status: RECRUITING city: Irbid zip: POBOX 3030 country: Jordan name: Lama A Awawdeh role: CONTACT phone: 0795412954 email: lawawdeh@hotmail.com lat: 32.55556 lon: 35.85 hasResults: False
<\|newrecord\|> nctId: NCT06347627 id: UW23139 briefTitle: Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18 overallStatus: ENROLLING_BY_INVITATION date: 2023-12-22 date: 2024-12 date: 2024-12 date: 2024-04-04 date: 2024-04-04 name: The University of Hong Kong class: OTHER name: London School of Hygiene and Tropical Medicine name: Nagasaki University briefSummary: This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1600 type: ESTIMATED name: Group 1 (I x S x S x F) name: Group 2 (O x S x S x F) name: Group 3 (I x E x S x F) name: Group 4 (O x E x S x F) name: Group 5 (I x S x S x M) name: Group 6 (O x S x S x M) name: Group 7 (I x E x S x M) name: Group 8 (O x E x S x M) name: Group 9 (I x S x D x F) name: Group 10 (O x S x D x F) name: Group 11 (I x E x D x F) name: Group 12 (O x E x D x F) name: Group 13 (I x S x D x M) name: Group 14 (O x S x D x M) name: Group 15 (I x E x D x M) name: Group 16 (O x E x D x M) measure: Willingness to receive HPV vaccines for daughters measure: Confidence in HPV vaccine safety sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London School of Hygiene and Tropical Medicine city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06347614 id: 2021-FXY-042 briefTitle: Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study acronym: Two-step RP overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-01 date: 2024-12-01 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising? conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Two-step Radical Prostatectomy measure: Biochemical Recurrence-free Survival measure: Surgical time measure: Estimated blood loss measure: Hospital stay measure: Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence measure: Lower urinary tract symptoms measure: Erectile function measure: Positive surgical margin rate measure: Complication sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06347601 id: 2024-03-011AC briefTitle: Survey on Sexual and Gender in the Healthcare in Taiwan overallStatus: RECRUITING date: 2024-03-13 date: 2025-02-01 date: 2025-02-20 date: 2024-04-04 date: 2024-04-29 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: This study addresses the pervasive issue of sexual harassment within Taiwanese society, particularly within the medical field, where comprehensive research is lacking. The research objective is to explore patterns of sexual harassment and gender discrimination experiences among physicians and medical students in Taiwan, while also investigating potential associations with professional burnout and mental health. Employing a convergent mixed-methods design, the study combines quantitative surveys and qualitative in-depth interviews. While lacking a control group and utilizing non-blinding methods without random assignment, the study aims to recruit 1000 participants aged 18 or older, considering both valid responses and potential dropouts. Additionally, interviews will be conducted with 30 individuals who have experienced sexual harassment or are interested in gender issues. The research methods will assess sexual harassment experiences, professional burnout, and depressive symptoms as primary outcomes or indicators. conditions: Sexual Harassment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: Without Intervention measure: Center for Epidemiologic Studies Depression Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Jheng-Min Yu, M.D. role: CONTACT phone: 0933238592 email: TaipeiDU2017@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06347588 id: OBI&ICI briefTitle: Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-04-04 date: 2024-04-05 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study. conditions: Occult Hepatitis B Infection in Cancer Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA measure: To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV measure: Evaluation of the incidence of reactivation in patients during immunotherapy measure: Evaluation of the association between HBV-specific T-cell response and HBV reactivation measure: Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Matteo Pavia city: Pavia state: PV zip: 27100 country: Italy name: Alessandra Ferrari role: CONTACT phone: 0382.503689 email: alessandra.ferrari@smatteo.pv.it name: ANGIOLETTA LASAGNA role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06347575 id: APHP230522 briefTitle: Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients acronym: CAVERSTIM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2025-11 date: 2024-04-04 date: 2024-04-04 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Comphya SA briefSummary: The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured (SCI) by assessing and measuring complications.
As the secondary objectives, despite the limited cohort size, this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse, as well as to assess patient's satisfaction using:
* Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device.
* Subjective assessment of the erectile function with validated questionnaires:
1. A 6-item self-report instrument assessing male erectile function (Erectile Function domain of the International Index of Erectile Function, IIEF-EF);
2. A log-diary five item questionnaire completed after each sexual attempt (Sexual Encounter Profile, SEP);
3. A self-reporting measure that scores erection hardness on a 4-point scale (Erection Hardness Score, EHS);
4. The Global Assessment Question (GAQ).
In addition, the study aims to refine the method of implantation (step-by-step delineation of all technical approaches for device implantation, including duration of surgical procedure, blood loss, methods to access the periprostatic region, tissue dissection, device placement and fixation) prior to planning for larger scale clinical investigation. conditions: Spinal Cord Injuries conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Implantation of the caverStim device measure: Safety evaluation measure: Pain assessement measure: Complications related to implantation surgery measure: Evaluation of IIEF-EF measure: Evaluation of EHS measure: Evaluation of SEP measure: Evaluation of GAQ sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 facility: Department of Urology, La pitié Salpêtrière Hospital - APHP city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06347562 id: 934 briefTitle: Optical Genome Mapping for the Diagnosis of Neurodevelopmental Disorders overallStatus: RECRUITING date: 2022-06-15 date: 2025-06-14 date: 2025-06-14 date: 2024-04-04 date: 2024-04-04 name: IRCCS Eugenio Medea class: OTHER briefSummary: to evaluate the ability of the Optical genome Mapping (OGM) approach to detect simple and complex constitutional chromosomal aberrations of clinical relevance, which had previously been identified with standard diagnostic approaches (karyotyping, FISH, CNV-microarray) in the context of neurodevelopmental disorders (NDDs) with/wo congenital anomalies (CA) conditions: Neurodevelopmental Disorder (Diagnosis) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 58 type: ESTIMATED name: Optical Genome Mapping measure: Diagnostic concordance rate sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute E. Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Clara Bonaglia, PhD role: CONTACT phone: 031877913 phoneExt: +39 email: clara.bonaglia@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False
<\|newrecord\|> nctId: NCT06347549 id: HE-SF2024/09 briefTitle: The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2026-04-15 date: 2024-04-04 date: 2024-04-04 name: Hong Kong Metropolitan University class: OTHER briefSummary: This is a cross-sectional obsessional study.
This study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults.
Participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography. conditions: Diaphragm studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED name: Various intensities of inspiratory muscle training measure: Diaphragmatic thickening fraction measure: Muscle activation of the sternocleidomastoid muscle measure: Perceived Exertion Borg scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-25 uploadDate: 2024-03-28T00:38 filename: Prot_SAP_000.pdf size: 185477 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-28T00:39 filename: ICF_001.pdf size: 204027 hasResults: False
<\|newrecord\|> nctId: NCT06347536 id: IRAS331831 id: NIHR156698 type: OTHER_GRANT domain: NIHR HTA briefTitle: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease acronym: RAPID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12-31 date: 2027-12-31 date: 2024-04-04 date: 2024-04-19 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: King's College London name: University College, London name: Imperial College London name: University of Cambridge name: University of Southampton name: University of Nottingham name: University of Leicester name: Frimley Health NHS Foundation Trust name: Newcastle University name: University of Bristol name: Asthma and Lung UK briefSummary: Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.
Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.
A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum. conditions: COPD conditions: COPD Exacerbation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1400 type: ESTIMATED name: Supported rescue pack measure: Time to first all-cause readmission within 90 days of discharge measure: Time to and frequency of COPD-related readmissions at 30 and 90 days measure: Days alive and out of hospital at day 90 measure: Time to and frequency of all COPD exacerbations at days 30 and 90 measure: Cumulative systemic oral corticosteroids use over 90 days measure: Cumulative systemic antibiotic use over 90 days measure: Health care contacts at baseline, days 90 and 180, and 1 year measure: All cause readmission at 30 days measure: All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months measure: EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 1 year measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year measure: Qualitative interviews to examine and describe usual care measure: Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm measure: Serious adverse events measure: Antimicrobial resistance measure: Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Birminham NHS Foundation Trust city: Birmingham country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Blackpool Teaching Hospitals city: Blackpool country: United Kingdom lat: 53.81667 lon: -3.05 facility: Bradford Teaching Hospitals NHS Foundation Trust city: Bradford country: United Kingdom lat: 53.79391 lon: -1.75206 facility: University Hospitals Sussex NHS Foundation Trust city: Brighton country: United Kingdom lat: 50.82838 lon: -0.13947 facility: North Bristol University Trust city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 facility: County Durham and Darlington NHS Foundation Trust city: Durham country: United Kingdom lat: 54.77676 lon: -1.57566 facility: East Suffolk and North Essex Foundation Trust city: Ipswich country: United Kingdom lat: 52.05917 lon: 1.15545 facility: University Hospitals of Morecambe Bay NHS Foundation Trust city: Lancaster country: United Kingdom lat: 54.04649 lon: -2.79988 facility: University Hospitals of Leicester NHS Trust city: Leicester country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Cardiff and Vale University Health Board city: Llandough country: United Kingdom lat: 51.44556 lon: -3.44722 facility: Guy's and St Thomas' NHS Foundation Trust city: London country: United Kingdom name: Mona Bafadhel, Professor role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Royal Free London NHS Foundation Trust city: London country: United Kingdom name: John Hurst, Professor role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Maidstone and Tunbridge Wells NHS Trust city: Maidstone country: United Kingdom lat: 51.26667 lon: 0.51667 facility: South Tees NHS Foundation Trust city: Middlesbrough country: United Kingdom lat: 54.57623 lon: -1.23483 facility: Milton Keynes University Hospital NHS Foundation Trust city: Milton Keynes country: United Kingdom lat: 52.04172 lon: -0.75583 facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust city: Newcastle Upon Tyne country: United Kingdom lat: 54.97328 lon: -1.61396 facility: Northumbria Healthcare NHS Foundation Trust city: North Shields country: United Kingdom lat: 55.01646 lon: -1.44925 facility: Nottingham University Hospitals Trust city: Nottingham country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Oxford University Hospitals NHS Foundation Trust city: Oxford country: United Kingdom lat: 51.75222 lon: -1.25596 facility: Salisbury NHS Foundation Trust city: Salisbury country: United Kingdom lat: 51.06931 lon: -1.79569 facility: University Hospital Southampton NHS Foundation Trust city: Shirley country: United Kingdom lat: 52.41074 lon: -1.81952 facility: Frimley Health NHS Foundation Trust city: Slough country: United Kingdom lat: 51.50949 lon: -0.59541 facility: South Tyneside and Sunderland NHS Trust city: South Shields country: United Kingdom lat: 54.99859 lon: -1.4323 facility: Stockport NHS Foundation Trust city: Stockport country: United Kingdom lat: 53.40979 lon: -2.15761 facility: North Tees and Hartlepool NHS Foundation Trust city: Stockton-on-Tees country: United Kingdom lat: 54.56848 lon: -1.3187 facility: Sherwood Forest Hospitals NHS Foundation Trust city: Sutton In Ashfield country: United Kingdom lat: 53.12542 lon: -1.26135 facility: Somerset Foundation Trust city: Taunton country: United Kingdom lat: 51.01494 lon: -3.10293 facility: Somerset Foundation Trust city: Yeovil country: United Kingdom lat: 50.94159 lon: -2.63211 hasResults: False
<\|newrecord\|> nctId: NCT06347523 id: FirstShantou briefTitle: VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction overallStatus: RECRUITING date: 2024-04-02 date: 2024-10-01 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: First Affiliated Hospital of Shantou University Medical College class: OTHER briefSummary: Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group. conditions: Anterior Cruciate Ligament (ACL) Reconstruction conditions: Preoperative Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: The VR-based preoperative rehabilitation program; name: standard nursing care, measure: knee joint range of motion measure: Lysholm knee function score measure: SAS self-rating anxiety scale scale measure: SDS self-rating depression scale scale measure: Visual Analog Scale pain score measure: Barthel Index for basic activities of daily living measure: time to first ambulation post-surgery measure: postoperative complications measure: nursing satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: "The First Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Shantou state: Guangdong zip: 515000 country: China name: Zeshan Chen role: CONTACT phone: +8613592896271 lat: 23.36814 lon: 116.71479 hasResults: False
<\|newrecord\|> nctId: NCT06347510 id: E-25403353-050.99-174660 briefTitle: The Level of sST2 in Pediatric Heart Failure overallStatus: COMPLETED date: 2021-08-16 date: 2024-02-16 date: 2024-02-16 date: 2024-04-04 date: 2024-04-04 name: Eskisehir Osmangazi University class: OTHER briefSummary: Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.
Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis. conditions: Congenital Heart Disease conditions: Congestive Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 59 type: ACTUAL name: Suppression of tumorigenicity 2 (ST2) measure: Soluble suppression of tumorigenicity levels with or without major cardiovascular event measure: Pro BNP levels measure: Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Eskisehir Osmangazi University city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
<\|newrecord\|> nctId: NCT06347497 id: 000001230988 briefTitle: Zonisamide Versus Topiramate in Migraine overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-02 date: 2025-05-01 date: 2024-04-04 date: 2024-04-24 name: Kafrelsheikh University class: OTHER briefSummary: Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency conditions: Migraine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or topiramate and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included topiramate and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Zonisamide 50 MG name: Topiramate 50 MG measure: The change in migraine days per 28 days measure: The total number of migraine days after three months of treatment measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. measure: HIT-6 score absolute reduction in each group after three months of treatment measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. sex: ALL minimumAge: 10 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False
<\|newrecord\|> nctId: NCT06347484 id: IRB00411716 briefTitle: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT) acronym: CONNECT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Johns Hopkins University class: OTHER name: Morgan State University name: American Heart Association briefSummary: The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning community that provides tailored education on cardiovascular (CV) health and research participation; connects community members to CV-related research; and disseminates CV-related study findings. The overreaching goal of CONNECT is to improve participation of underrepresented communities in CV research, including as women, Black adults, and Latino adults, through increasing participants' clinical trial awareness, trust in biomedical research, and willingness to participate in clinical trials. CONNECT will use digital and community-engaged approaches to identify and recruit 1000 adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on CV health and research participation via text message. Participants will also have the opportunity to be matched to ongoing CV research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The investigators hypothesize that CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials and that the proportion of Black and Latin adults and women enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. conditions: Cardiovascular Diseases conditions: Hypertension conditions: Diabetes Type 2 conditions: Stroke conditions: Recruitment conditions: Overweight and Obesity conditions: Hyperlipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Formal Toned Educational Messages name: Understanding Toned Educational Messages name: Casual Toned Educational Messages measure: Participant accrual measure: Participant accrual in partnering cardiovascular research studies measure: Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT) measure: Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS) measure: Willingness to participate in research will be measured by asking participants one related question sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06347471 id: SBS-2023-477 briefTitle: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy acronym: SPARTAN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-04-04 date: 2024-04-04 name: Infectious Diseases Research Collaboration, Uganda class: OTHER name: London School of Hygiene and Tropical Medicine name: Radboud University Medical Center briefSummary: A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.
Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.
The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.
Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment. conditions: Falciparum; Malaria studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Artemether-lumefantrine name: Dihydroartemisinin-Piperaquine measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline. measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline measure: Mean oocyst intensity (in all/all infected mosquitoes) measure: Male and female gametocyte sex ratio (proportion male) measure: Gametocyte circulation time measure: Gametocyte area under the curve measure: Asexual parasite prevalence measure: Asexual parasite density measure: Total parasite prevalence measure: Total parasite density measure: The density of ΔPfK13 vs wild type genotypes measure: The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Ambrosoli Memorial Hospital city: Kalongo state: Agago District country: Uganda name: Maurice Akao, MBChB role: CONTACT facility: Patongo Health Facility IV city: Patongo state: Agago District country: Uganda name: MD role: CONTACT lat: 2.74472 lon: 33.32417 hasResults: False
<\|newrecord\|> nctId: NCT06347458 id: BG-CA-23-001 briefTitle: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-08 date: 2024-04-04 date: 2024-04-04 name: Guangzhou Bio-gene Technology Co., Ltd class: INDUSTRY briefSummary: This is a single-arm, single-dose dose-escalation and dose-expansion study. conditions: Leukemia conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: BG1805 measure: 1.Dose Limited Toxicity Rate measure: 2.Incidence of Treatment-Emergent Adverse Events measure: 3.Concentration of CAR-T cells after Infusion (PK) measure: 4.overall response rate, ORR measure: 5.Concentration of Cytokine after Infusion (PD) sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06347445 id: GSM012024 briefTitle: Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study) acronym: TEMD-2 overallStatus: COMPLETED date: 2022-10-01 date: 2023-01-30 date: 2023-01-30 date: 2024-04-04 date: 2024-04-04 name: Gulhane School of Medicine class: OTHER briefSummary: This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey. conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 5707 type: ACTUAL name: There is no intervention. measure: Glycemia control status of Turkish adult patients with diabetes mellitus measure: Blood pressure control status of Turkish adult patients with diabetes mellitus measure: Lipid control status of Turkish adult patients with diabetes mellitus. measure: Weight control status of Turkish adult patients with diabetes mellitus. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulhane School of Medicine Department of Endocrinology and Metabolism city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06347432 id: 24-119-H briefTitle: Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-03 date: 2027-03 date: 2024-04-04 date: 2024-04-04 name: Grand Valley State University class: OTHER briefSummary: For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Power wheelchair skills training using the IndieTrainer system measure: Change in understanding how to use a power wheelchair measure: Change in power wheelchair skill performance measure: Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance measure: Change in children's perceptions of changes in their performance of power wheelchair skill performance sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Grand Valley State University city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 hasResults: False

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