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A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning (CBR) methodology which is a branch of artificial intelligence.
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This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors.
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The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP. conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: SelfBack measure: The percentage of patients who utilize the SelfBack app measure: The percentage of clinicians who utilize the SelfBack app sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06347978 id: 24-41296 briefTitle: Personalized DBS for OCD Guided by Stereoencephalography Mapping overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-04 date: 2024-04-04 date: 2024-04-04 name: Andrew Moses Lee, MD, PhD class: OTHER briefSummary: This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment. conditions: Obsessive-Compulsive Disorder conditions: OCD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: Deep Brain Stimulation measure: Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms measure: Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD measure: Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement measure: Primary Feasibility Endpoint #4 - Completion of Stages 1 and 2 measure: Primary Safety Endpoint - Serious Adverse Events measure: Primary Efficacy Endpoint - Treatment Response measure: Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline measure: Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline measure: Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline sex: ALL minimumAge: 22 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06347965 id: IIT20220541B-R1 briefTitle: Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy overallStatus: COMPLETED date: 2023-02-01 date: 2023-11-30 date: 2024-02-20 date: 2024-04-04 date: 2024-04-04 name: Xin Wang class: OTHER briefSummary: The goal of this clinical trial is to verify the effectiveness and safety of the low load blood flow restriction training program. The intervention effect, tolerance and compliance of low load blood flow restriction training and progressive resistance training on lung cancer patients complicated with sarcopenia during chemotherapy will be compared, in order to provide new ideas for improving or reversing sarcopenia.
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The main questions it aims to answer are:
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Can low load blood flow restriction training improve sarcopenia in chemotherapy induced lung cancer patients? Which training method is more effective and tolerable between low load blood flow restriction training and progressive resistance training?
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Participants will be randomly divided into 3 groups：
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1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
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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.
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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
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<|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.
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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.
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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.
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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).
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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.
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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
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<|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).
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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: [email protected] 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: [email protected] lat: 63.82842 lon: 20.25972 hasResults: False
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<|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.
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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.
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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: [email protected] name: Angélique Bobrie, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
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<|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
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<|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: [email protected] lat: 26.55695 lon: 31.69478 hasResults: False
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<|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
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<|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
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<|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.
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This study looks at how the medicine is changed and removed from the body after a participant takes it.
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This study is seeking for participant who:
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* are healthy males, and healthy females who do not have the possibility to have children.
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* are 18 years of age or older.
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* weigh more than 45 Kilograms (99 pounds).
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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
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<|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
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<|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: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|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
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<|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
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<|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:
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* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?
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* What is the safety of MMAE and conventional open surgery in these patients?
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Participants will be asked to:
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* Share their medical history and undergo physical examinations
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* Have blood drawn
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* Have CT scans of the head
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* Answer questionnaires
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* Undergo MMAE or conventional open surgery
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* 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: [email protected] name: Peter Kan, MD role: PRINCIPAL_INVESTIGATOR lat: 29.30135 lon: -94.7977 hasResults: False
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<|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.
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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:
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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?
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Participants will be asked to:
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* Complete questionnaires regarding demographic data and diabetes history.
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* Complete surveys regarding sleep quality before and after starting an insulin pump.
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* 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.
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After 1-2 months after initiation of an insulin pump, participants will be asked again to:
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* Complete surveys regarding sleep quality
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* Wear a FitBit during sleep for 2 weeks
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* 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: [email protected] name: Ines Guttman-Bauman, MD role: CONTACT phone: 503-494-8509 email: [email protected] name: Rachel L Palting, DO role: PRINCIPAL_INVESTIGATOR name: Ines Guttman-Bauman, MD role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
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<|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
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<|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
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<|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
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<|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
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<|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:
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Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patients
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Phase 2:
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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
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<|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
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<|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.
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