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<|newrecord|> nctId: NCT06355466 id: 51-112334 briefTitle: Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors overallStatus: COMPLETED date: 2022-01-09 date: 2023-08-11 date: 2023-08-28 date: 2024-04-09 date: 2024-04-09 name: Golestan University of Medical sciences class: OTHER briefSummary: In this prospective cross-sectional study, patients with ESRD unfit for AVF/AVG were scheduled for a right or left trans-jugular tunneled catheter placement. All patients were asked about their catheters' function one year after its implantation and the presumed affecting factors on catheters' patency were evaluated. conditions: Vascular Access Devices studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 156 type: ACTUAL measure: one year patency rate of hemodialysis catheters measure: one year patency rate of hemodialysis catheters in age subgroups measure: one year patency rate of hemodialysis catheters in diabetic patients measure: one year patency rate of hemodialysis catheters in hypertensive patients measure: one year patency rate of hemodialysis catheters in patients on antiplatelet drugs measure: one year patency rate of hemodialysis catheters in sex subgroups sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Golestan University of Medical Sciences, faculty of medicine city: Gorgan state: Golestan zip: 4918936316 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False
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<|newrecord|> nctId: NCT06355453 id: 2023-090-MIC-GES briefTitle: Evaluation of the Goldcrest Patch Performance overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-30 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: GE Healthcare class: INDUSTRY briefSummary: The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
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The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity. conditions: Fetal Monitoring studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Goldcrest Patch and Three Patch Coupons name: Goldcrest Patch and Novii Patch measure: Primary Objective measure: Primary Objective measure: Secondary Objective measure: Secondary Objective measure: Incidence of Treatment-Emergent Adverse Events Objective sex: FEMALE minimumAge: 22 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355440 id: 2312288-16 briefTitle: Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China overallStatus: RECRUITING date: 2024-03-18 date: 2024-06-30 date: 2024-06-30 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.
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The main questions it aims to answer are:
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* Is the intervention feasible and acceptable among participants?
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* Does the intervention enhance participants' cost-related health literacy?
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* Does the intervention reduce participants' financial toxicity?
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Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.
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Participants will receive comprehensive information support, including:
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* Strategies on patient-physician costs discussion
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* Skills for inquiring and tracking treatment-related costs
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* Basic knowledge about health insurance
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* Guidance on accessing and applying for financial assistance
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* Suggestions for returning to normal life and work
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* Strategies for holding a financial-related family meeting conditions: Breast Neoplasm Female conditions: Financial Toxicity conditions: Financial Navigation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Financial Navigation name: Usual Care measure: Eligibility rate measure: Consent rate measure: Retention rate measure: Adherence rate measure: Patient-reported satisfaction measure: Qualitative assessment of the intervention measure: Cost-related health literacy measure: Financial toxicity measure: Material domain of financial toxicity measure: Behavioral domain of financial toxicity sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Xiaoyi Yuan, Master role: CONTACT phone: (+86) 18918305439 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06355427 id: 2023-507938-24-00 briefTitle: The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma acronym: FAPIChol overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-09-01 date: 2028-02-01 date: 2024-04-09 date: 2024-04-09 name: Mara Veenstra, MD class: OTHER name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) name: UMC Utrecht briefSummary: Background
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Bile duct cancer (cholangiocarcinoma) represents the second most common type of hepatobiliary cancer worldwide with an incidence of 0.35 to 2 per 100.000 annually. Currently, surgical resection is the only curative option. However, patients are not eligible for surgery if the tumor cannot be resected or the cancer has spread. For this group of patients, palliative chemotherapy is the most suited treatment option. To find out if a patient is suited for surgery, CT and MRI are performed. These imaging techniques, however, struggle to correctly identify small cancer spreads that are smaller than 1 cm. Therefore, cancer that has already spread can be found during surgery. In these cases, the tumor cannot be removed and the surgery therefore has not been of any benefit for the patient. These surgeries could be avoided by implementing a diagnostic tool with significantly higher accuracy than those currently used. Single center studies have shown that fibroblast activation protein inhibitor (FAPI) PET-CT is a very promising technique for determining metastases in tumors with prominent desmoplastic reactions, like cholangiocarcinoma. The investigators predict that implementation of preoperative FAPI PET-CT could prevent futile surgery for at least half of patients in whom intra-operative metastasized disease is found using the current work-up.
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Patient population
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Patients ≥18 years with potentially curable proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma) who are planned to undergo surgery based on imaging using CT thorax/abdomen and MRI of the upper abdomen. Exclusion criteria are previous abdominal surgery or chemotherapy, known pregnancy or lactation and indication for FDG PET-CT.
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Participation in this study
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Participation would mean to undergo FAPI PET-CT prior to the scheduled surgery. This will take up about half a day of the participant's time. Afterwards, participants receive questionnaires about quality of life and use of healthcare services over a period of six months in order for the researchers to be able to calculate the cost-effectiveness of additional FAPI PET-CT.
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Risks and benefits of participation
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Patients may benefit directly from \[18F\]F-FAPI PET-CT by allowing for more targeted treatment, possibly avoiding futile surgery and receiving chemotherapy or best clinical support instead, minimizing treatment delay. Avoiding futile surgery will also prevent patients from being exposed to the risks and discomfort associated with surgery: hospital stay, possibility of intraoperative or postoperative complications, postoperative pain and recovery, and mortality.
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Potential risks and burdens associated with this study are an extra hospital visit and a time burden of approximately half a day. Risks associated with administering FAPI are (re)bleed and infection. Both risks have a minimal probability of onset and can usually easily be treated. As \[18F\]F-FAPI is a sub-pharmacologically micro-dosed diagnostic tracer, the risk of allergic reactions is expected to be minimal and no tissue damage is expected. The burden associated with undergoing a PET-CT may be laying still for a certain time, and possible experience of claustrophobia. Possible metastases of the cancer will have to be confirmed when suspicious findings are seen on FAPI PET-CT. This could mean that participants will have to undergo additional testing such as imaging (CT or MRI) or biopsy. Undergoing FAPI PET-CT prior to surgery will result in a surgical delay when compared with the current clinical practice. The investigators do not expect this delay to influence the patient's prognosis. Follow-up will result in a time burden for patients to answer questionnaires on a two-weekly or monthly basis. conditions: Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 81 type: ESTIMATED name: [18F]F-FAPI PET-CT measure: Diagnostic accuracy of [18F]F-FAPI PET-CT measure: Change of treatment measure: Cost-effectiveness measure: Number of additional significant findings using [18F]F-FAPI PET-CT measure: Number of times nuclear medicine specialists' [18F]F-FAPI PET-CT conclusions differed from one another measure: Number of lesions found on [18F]F-FAPI PET-CT measure: Number of days between [18F]F-FAPI PET-CT and exploratory surgery measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 measure: Number of participants in which dynamic [18F]F-FAPI PET-CT followed by conventional [18F]F-FAPI PET-CT was able to distinguish benign lesions from malignant lesions measure: Change in volume of interest (cm3) using dynamic [18F]F-FAPI PET-CT measure: Difference in SUVmax between dynamic and conventional [18F]F-FAPI PET-CT measure: Difference in SUVmean between dynamic and conventional [18F]F-FAPI PET-CT measure: Difference in transport rate (k1 to k2) on dynamic [18F]F-FAPI PET-CT between participants with malignant lesions and particpants with benign lesions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355414 id: IRB00385932 id: R33AT012317 type: NIH link: https://reporter.nih.gov/quickSearch/R33AT012317 briefTitle: Psilocybin in Chronic Low Back Pain and Depression overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-30 date: 2026-08-30 date: 2024-04-09 date: 2024-04-23 name: Johns Hopkins University class: OTHER name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D).
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Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects. conditions: Chronic Low-back Pain conditions: Depression studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, active control study comparing the effects of psilocybin (25mg fixed dose) and methylphenidate (40mg fixed dose) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: This is a double-blind trial, and efforts will be made to mask the study drug (psilocybin) and the active control (methylphenidate) from participants, guides, and study staff. Participants will be debriefed about their randomly assigned drug condition after the completion of the final follow-up assessment, or after discontinuation/withdrawal, whichever comes first. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Psilocybin name: Methylphenidate measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) measure: Pain as assessed by discrete pain items assessed via EMA measure: Dynamic association between affect and pain using micro-longitudinal EMA data of affective variables (positive, negative affect outcomes) and pain outcomes measure: Changes in mood as measured by a selection of discrete items derived from the Positive and Negative Affect Schedule- Expanded Form (PANAS-X). measure: Changes in self-reported Pain Impact as measured by Pain intensity (P), interference with Enjoyment of life (E), and interference with General activity (G) Scale (PEG) measure: Changes in Pressure Pain Threshold (Quantitative Sensory Testing) measure: Changes in Conditioned Pain Modulation (Quantitative Sensory Testing) measure: Chronic Pain Exacerbation as measured by the Graded Chronic Pain Scale- Revised (GCPS-R) measure: Changes in neuropathic pain features as assessed by the painDETECT questionnaire (PDQ) measure: Changes in CLBP-related disability as measured by the Oswestry Disability Index (ODI) measure: Change in Emotion Regulation as assessed by the Difficulties in Emotion Regulation Scale (DERS) measure: Pain intensity and related dimensions of health (i.e., sleep) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.0). measure: Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale (PIPS) measure: Personal values and the degree of success in following those values as measured by the Chronic Pain Values Inventory (CPVI). measure: Dispositional tendencies to feel positive emotions towards others in daily life as measured by the Dispositional Positive Emotion Scale (DPES) measure: Mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ-15) measure: Subjective experiences: Awe Experience Scale (AWE-S) measure: Subjective experiences: Mystical Experience Questionnaire (MEQ30) measure: Subjective experiences: Challenging Experience Questionnaire (CEQ) measure: Subjective experiences: Altered States of Consciousness Questionnaire (5D-ASC) measure: Subjective experiences: Psychological Insight Questionnaire (PIQ) measure: Changes in basic beliefs about the world as measured by the Primals Inventory (PI-6) sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University School of Medicine status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: David Yaden, PhD role: CONTACT phone: 410-550-5250 phoneExt: 0-5250 email: [email protected] name: David Yaden, PhD role: PRINCIPAL_INVESTIGATOR name: Patrick Finan, PhD role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06355401 id: Soh-Med-24-03--06PD briefTitle: Maintenance Hormonal Therapy and DLBCL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2029-03 date: 2024-04-09 date: 2024-04-09 name: Sohag University class: OTHER briefSummary: the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL conditions: Diffuse Large B Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Tamoxifen 20mg measure: disease free survival measure: overall survival measure: side effects sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355388 id: TRAGUSHF briefTitle: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure acronym: TRAGUS-HF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2027-05-01 date: 2024-04-09 date: 2024-04-09 name: Fondazione Toscana Gabriele Monasterio class: OTHER name: Azienda Ospedaliera Città della Salute e della Scienza di Torino briefSummary: To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term). conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Midrange Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: In order to maintain the 'double-blind,' at the end of the experimental protocol, the data acquired in each phase (baseline, active tVNS, placebo tVNS) will be saved in three different files, made unrecognizable by one of the investigators not involved in the tabulation and data analysis. A second investigator, unaware of the stimulation phases, will proceed with the tabulation of the data for each individual recording (three per patient). Only at the end of the study (or after recruiting 50% of patients for any interim analyses), will the investigators responsible for data analysis be revealed the corresponding phase for each recording. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: Active tVNS name: Sham tVNS measure: Mean change in baroreflex gain (ms/mmHg) measure: Mean change in baroreflex gain (ms/mmHg) measure: Mean change in MSNA burst incidence (bursts/100 heartbeats) measure: Mean change in peak O2 consumption (mL/Kg/min) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michele Emdin city: Pisa state: Pi zip: 56120 country: Italy name: Michele Emdin, MD, PhD role: CONTACT email: [email protected] name: Francesco Gentile, MD role: SUB_INVESTIGATOR name: Claudio Passino, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False
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<|newrecord|> nctId: NCT06355375 id: 02.24 briefTitle: Exercise in Pregnancy and Risk of Postpartum Depression overallStatus: RECRUITING date: 2024-03-22 date: 2025-01-01 date: 2025-12-01 date: 2024-04-09 date: 2024-04-09 name: Federico II University class: OTHER briefSummary: The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day conditions: Depression conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Exercise during pregnancy primaryPurpose: PREVENTION masking: NONE count: 398 type: ESTIMATED name: exercise in pregnancy measure: edinburgh depression scale measure: Postpartum depression measure: preterm birth sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Gabriele Saccone status: RECRUITING city: Naples zip: 80100 country: Italy name: Gabriele Saccone role: CONTACT phone: 0817461111 email: [email protected] lat: 40.85216 lon: 14.26811 hasResults: False
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<|newrecord|> nctId: NCT06355362 id: HeCoMo briefTitle: Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality acronym: HeCoMo overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-06-30 date: 2024-04-09 date: 2024-04-22 name: Kliniken Essen-Mitte class: OTHER briefSummary: Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.
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The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.
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In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.
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In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities. conditions: High-risk Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Incidence of postoperative complications measure: Incidence of postoperative mortalities measure: Implementation rate of preoperative factors impacting postoperative outcome measure: Intraoperative hemodynamic characteristics measure: Postoperative haemodynamic characteristics measure: Co-morbidities of patients measure: Transfusion of blood components and administration of coagulation factors measure: Score of the physical/pathological activity status of the patients measure: Clinical frailty scale measure: Characteristics of perioperative care, time in perioperative units and the hospital measure: Characteristics of provision of anesthesia and type of pain therapy measure: Implementation rate of items perioperatively impacting outcome within an Enhanced-Recovery-After-Surgery pathway description sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355349 id: JW22101 briefTitle: To Evaluate the Safety and PK Characteristics in Healthy Volunteers overallStatus: COMPLETED date: 2023-04-28 date: 2023-07-10 date: 2023-07-17 date: 2024-04-09 date: 2024-04-09 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 46 type: ACTUAL name: Reference Drug or Test Drug measure: AUCt measure: Cmax sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 hasResults: False
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<|newrecord|> nctId: NCT06355336 id: CCA/IRN-24-001 briefTitle: Real World Prostate Cancer Registry acronym: RWPCR overallStatus: RECRUITING date: 2024-03-18 date: 2034-03-18 date: 2034-03-18 date: 2024-04-09 date: 2024-04-09 name: Cincinnati Cancer Advisors class: NETWORK briefSummary: Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.
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Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: To determine practice patterns for prostate cancer in the region. measure: To determine progression free survival and overall survival of patients. measure: Prevalence of long term complications of prostate cancer treatment. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cincinnati Cancer Advisors status: RECRUITING city: Cincinnati state: Ohio zip: 45212 country: United States name: Dr. Jazieh role: CONTACT phone: 513-731-2273 email: [email protected] name: Amy Barber role: CONTACT phone: 5137312273 email: [email protected] name: Abdul R Jazieh, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False
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<|newrecord|> nctId: NCT06355323 id: PT22020 briefTitle: Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France acronym: PREDDICHA overallStatus: RECRUITING date: 2022-11-28 date: 2025-11-28 date: 2025-11-28 date: 2024-04-09 date: 2024-04-09 name: CHU de Reims class: OTHER briefSummary: Primary humoral immunodeficiency (PHID), such as common variable immunodefiency, are the most common symptomatic primary immunodeficiency in adults, in France. Patients are more prone to infections (particularly bacterial upper and lower respiratory tract infections), auto-immunity and atopic manifestations. Morbidity and mortality in PHID are mainly linked to the presence of bronchiectasis, which can lead to infections and to chronic respiratory failure. However, bronchiectasis in these patients can be asymptomatic for a long time. There is no known predictive factors to identify patients more susceptible to develop bronchiectasis and notably, there was no link between the number of previous infectious episodes and bronchiectasis. A marked IgM deficiency and switched memory B cell deficiency might be associated with bronchiectasis.
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Thoracic CT-scan is recommended at PHID diagnosis but there is no guideline for follow-up, thus leading to bronchiectasis being under-diagnosis or leading to delayed diagnosis conditions: Primary Immunodeficiency conditions: Common Variable Immunodeficiency conditions: Igg Subclass Deficiency conditions: Selective IgM Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 75 type: ESTIMATED name: Blood test name: chest CT scan measure: Thoracic CTscan measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: 6 minutes walking test measure: 6 minutes walking test measure: 6 minutes walking test measure: 6 minutes walking test measure: Quality of life questionnaires measure: Quality of life questionnaires measure: Immunophenotyping measure: Biochemical factors : desmosine seric concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damien JOLLY status: RECRUITING city: Reims country: France name: Amélie SERVETTAZ role: CONTACT phone: 03 26 83 27 68 9 phoneExt: 0033 email: [email protected] name: Ailsa ROBBINS role: CONTACT phone: 03 26 83 27 68 phoneExt: 0033 email: [email protected] lat: 49.25 lon: 4.03333 hasResults: False
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<|newrecord|> nctId: NCT06355310 id: IRB 2023-6429 briefTitle: Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease acronym: SHIELD overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2028-12-31 date: 2028-12-31 date: 2024-04-09 date: 2024-04-09 name: Ann & Robert H Lurie Children's Hospital of Chicago class: OTHER briefSummary: This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity. conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double blind placebo control whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Empagliflozin 10 MG name: Placebo Oral Tablet measure: Hepatic Fat measure: Body mass index sex: ALL minimumAge: 16 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06355297 id: 124CER19. briefTitle: Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD acronym: ACTITUD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-09 date: 2024-05-22 date: 2024-06-20 date: 2024-04-09 date: 2024-04-23 name: University of the Balearic Islands class: OTHER briefSummary: Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.
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New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.
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To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology. conditions: Pelvic Floor Disorders studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group. primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Education about pelvic floor measure: Knowledge about pelvic floor measure: Habits related to pelvic floor dysfunctions measure: Gender stereotypes beliefs measure: Occurrence of symptoms related to pelvic floor dysfunctions sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Balearic Islands city: Palma De Mallorca state: Balearic Islands zip: 07122 country: Spain lat: 39.56939 lon: 2.65024 hasResults: False
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<|newrecord|> nctId: NCT06355284 id: D5150-P briefTitle: Overcontrol and Suicide in PTSD acronym: OSP overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-02-27 date: 2026-04-30 date: 2024-04-09 date: 2024-04-09 name: VA Office of Research and Development class: FED briefSummary: High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time.
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New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently.
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In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of:
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1. Our recruitment strategy and social functioning and mental health symptom assessments
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2. A three-session, weekly fMRI protocol.
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3. A three-week online protocol for remote monitoring of social and emotional functioning. conditions: Compulsive Personality Disorder conditions: Stress Disorders, Post-Traumatic studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 74 type: ESTIMATED name: Functional MRI measure: Number of potential participants screened per month meeting the overcontrol criterion. measure: Percentage of sessions completed by participants receiving MRI. measure: Percentage of remote questionnaires completed. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Providence VA Medical Center, Providence, RI city: Providence state: Rhode Island zip: 02908-4734 country: United States name: Jennifer L Barredo role: CONTACT phone: 401-273-7100 phoneExt: 6290 email: [email protected] name: Jennifer L Barredo role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False
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<|newrecord|> nctId: NCT06355271 id: 2024-00019 briefTitle: Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery acronym: MoFe overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-08-31 date: 2025-09-01 date: 2024-04-09 date: 2024-04-10 name: Ente Ospedaliero Cantonale, Bellinzona class: OTHER briefSummary: Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery conditions: Obstetric Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study).
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Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 63 type: ESTIMATED name: Fentanyl 1 name: Fentanyl2 name: Fentanyl 3 measure: Patient Controlled Analgesia morphine consumption measure: obstetric quality of recovery score measure: Visual Analogue Scale measure: pruritus measure: nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity measure: intraoperative hypotension measure: intraoperative opioids measure: satisfaction rate measure: intraoperative pain sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355258 id: 20230817LX001 briefTitle: A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients overallStatus: RECRUITING date: 2023-09-15 date: 2024-09 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Westlake University class: OTHER name: Shaoxing Central Hospital briefSummary: The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are:
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* Does troxerutin lower the number of thrombotic events in participants?
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* What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.
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Participants will:
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* Take troxerutin or a placebo every day for 7 days.
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* Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests
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* Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia conditions: COVID 19 Associated Coagulopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: According to the inclusion criteria, participants will be randomly divided into mild patients and severe patients, and then patients with severe disease were randomly assigned to placebo + low molecular weight heparin group or troxerutin + low molecular weight heparin group, and patients with mild disease were randomly assigned to placebo group or troxerutin group primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Troxerutin name: Placebo name: placebo + low molecular weight heparin name: troxerutin + low molecular weight heparin measure: Overall number of thrombotic events through 28 days measure: Tolerability of anticoagulation therapy measure: Time to clinical improvement in patients through 28 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaoxing central hospital status: RECRUITING city: Shaoxing state: Zhejiang country: China name: Xu Li, Doctor role: CONTACT phone: 13811635032 email: [email protected] lat: 30.00237 lon: 120.57864 hasResults: False
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<|newrecord|> nctId: NCT06355245 id: 2017/2160-31/1 briefTitle: MEDECA - Markers in Early Detection of Cancer acronym: MEDECA overallStatus: RECRUITING date: 2018-03-01 date: 2026-12 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: Danderyd Hospital class: OTHER briefSummary: Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning. conditions: Cancer conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Blood sampling measure: Cancer diagnosis measure: Other diagnosis measure: Mortality measure: Cancer diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyd Hospital status: RECRUITING city: Stockholm country: Sweden name: Charlotte Thålin, M.D., Ph.D. role: CONTACT phone: +46709565120 email: [email protected] lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06355232 id: Vaxine-2301 briefTitle: Covid-19 and Influenza Oral Vaccine Study overallStatus: NOT_YET_RECRUITING date: 2024-04-21 date: 2024-04-21 date: 2025-04-21 date: 2024-04-09 date: 2024-04-09 name: Vaxine Pty Ltd class: INDUSTRY name: Australian Respiratory and Sleep Medicine Institute Ltd briefSummary: The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines. conditions: covid19 Infection conditions: Influenza, Human studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised, controlled cross-over study primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: A comparator vaccine (influenza) with an identical appearance will be used as the control. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Covid-19 vaccine name: Influenza vaccine measure: SARS-CoV-2 Seroconversion measure: Influenza Seroconversion measure: SARS-CoV-2 Seroprotection measure: Influenza Seroprotection measure: SARS-CoV-2 Geometric mean titer fold change measure: Influenza geometric mean titer fold change measure: Safety assessment 1 measure: Safety assessment 2 measure: SARS-CoV-2 infection measure: Influenza infection measure: Antibody durability measure: Seroconversion in participants with and without evidence of past infection measure: Antibody GMT in participants with and without evidence of past infection measure: Antibody correlates of protection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ARASMI city: Adelaide state: South Australia zip: 5042 country: Australia lat: -34.92866 lon: 138.59863 hasResults: False
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<|newrecord|> nctId: NCT06355219 id: IRB #19-066 briefTitle: Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines acronym: M6 overallStatus: ACTIVE_NOT_RECRUITING date: 2010-01-01 date: 2022-12-31 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: Ali Aminian class: OTHER briefSummary: The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths. conditions: Type 2 Diabetes Mellitus conditions: Obesity conditions: Microvascular Disease conditions: Macrovascular Disease conditions: Major Adverse Cardiovascular Events conditions: Nephropathy conditions: Retinopathy conditions: Heart Failure conditions: All Cause Mortality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3932 type: ACTUAL measure: All-cause Mortality Rate measure: Incidence of MACE measure: Incidence of Nephropathy measure: Incidence of Retinopathy measure: Incidence of Components of MACE Separately measure: Change in weight percentage measure: Change HBA1c percentage measure: Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions measure: Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline measure: Cost-effectiveness of Metabolic Surgery vs GLP-1RAs measure: Incidence of Adverse Events After Metabolic Surgery sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355206 id: NACRE20230306 briefTitle: Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis acronym: NACRE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2034-12 date: 2034-12 date: 2024-04-09 date: 2024-04-09 name: Changhai Hospital class: OTHER briefSummary: The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:
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Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?
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Patients will be closely followed and clinical information will be recorded. conditions: Cohort Study conditions: Recurrent Acute Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: endoscopic intervention, surgery or conservative treatment measure: Recurrence rate of acute pancreatitis measure: Proportion of patients with different treatment measure: Characteristics of acute pancreatitis measure: Proportion of patients wtih pain in RAP patients measure: Proportion of patients with chronic pancreatitis measure: Evaluation of quality of life measure: Evaluation of psychological condition sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355193 id: MZhou briefTitle: The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study overallStatus: COMPLETED date: 2022-11-01 date: 2022-12-30 date: 2022-12-31 date: 2024-04-09 date: 2024-04-09 name: Central South University class: OTHER briefSummary: This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies. conditions: Treatment of Mild Cases of COVID-19 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 253 type: ACTUAL name: Langenlianqiao name: LianhuaQingWen name: placebo control group measure: Treatment and symptomatic improvement effects of LGLQ sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changde Hospital city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 hasResults: False
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<|newrecord|> nctId: NCT06355180 id: Shoudufazhan2024-1-2122 briefTitle: Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: Capital Medical University class: OTHER name: Wuhu Fourth People's Hospital name: The Second People's Hospital of Dali Bai Autonomous Prefecture name: Inner Mongolia Autonomous Region Mental Health Center name: Beijing Chaoyang District Third Hospital name: Beijing Daxing District Xinkang Hospital name: Capital's Funds for Health Improvement and Research briefSummary: This study is a multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial aimed at evaluating the effectiveness of esketamine versus modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders. Additionally, it seeks to explore the potential mechanisms of esketamine's anti-suicidal effects. conditions: Mood Disorders conditions: Suicidal Ideation conditions: Depressive Episode studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients will be randomized to either the esketamine group or the MECT group, but due to the differences in treatment modalities, it will not be possible to blind the subjects and investigators. To ensure the objectivity of the measurements, independent assessors will be established. These assessors are psychiatrists trained in the consistency of the scales and will remain blinded to the group allocation of the subjects throughout the entire assessment process. whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: Subanesthetic dose intravenous esketamine name: Modified electroconvulsive therapy measure: Suicide remission rate based on the Scale for Suicidal Ideation (SSI) measure: Quick Inventory of Depressive Symptoms Self Report (QIDS-SR) measure: Columbia Suicide Severity Rating Scale (CSSR-S) measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Clinical Global Impressions(CGI) measure: Short Form 12 Health Survey(SF-12) measure: Sheehan Disability Scale(SDS) measure: Digital Span Test(DST) measure: Digit Symbol Substitution Test(DSST) measure: Perceived Deficit Questionnaire for Depression 5-item(PDQ-D-5) measure: Young Mania Rating Scale (YMRS) measure: Clinician Administered Dissociative States Scale(CADSS) measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06355167 id: Bacoxy_I briefTitle: Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress acronym: Bacoxy_I overallStatus: COMPLETED date: 2022-03-15 date: 2022-05-25 date: 2022-09-30 date: 2024-04-09 date: 2024-04-10 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress. conditions: Oxidative Stress conditions: Cardiovascular Diseases conditions: Bacopaside II conditions: Bacopa Monnieri conditions: Endothelial Dysfunction conditions: Aquaporin 1 conditions: AQP1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri primaryPurpose: PREVENTION masking: NONE count: 20 type: ACTUAL name: Bacopa monnieri measure: Ex vivo DCFDA test on red blood cells (RBCs) measure: Plasma lipid peroxydes measure: Methemoglobin in red blood cells measure: Nitrosylated hemoglobin (HbNO) in red blood cells measure: haemoglobin measure: haematocrit measure: Red blood cells count measure: Sodium measure: Potassium measure: Bicarbonate measure: Total cholesterol measure: High-Density Lipoprotein (HDL) cholesterol measure: Low-Density Lipoprotein (LDL) cholesterol measure: Triglycerides measure: aspartate aminotransferase (ASAT), (U/L) measure: alanine aminotransferase (ALAT) (U/L) measure: gamma-glutamyl-transferase (GGT) level measure: Creatinine measure: Glomerular filtration rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique universitaires saint luc city: Brussels zip: 1200 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06355154 id: 069823- HMO-CTIL briefTitle: Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-02-01 date: 2024-04-09 date: 2024-04-09 name: Hadassah Medical Organization class: OTHER briefSummary: Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.
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