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* Objective response rate (ORR) for evaluation
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* Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。 conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: TKI+Cardunilimab measure: ORR Full single-arm, open, multicenter prospective clinical study measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Duration of Response (DOR) measure: Stable Disease (SD) measure: Progression free survival rate measure: Any adverse events related with treatment with TKI plus Cardonizumab. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Haitao Zhao, Professor role: CONTACT phone: +861069156042 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362993 id: STUDY00021561 briefTitle: Breast Cancer Screening in Ghana overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-03 date: 2024-04-12 date: 2024-04-15 name: Penn State University class: OTHER name: University of Ghana briefSummary: This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Bundling name: MEGH measure: Clinical breast exam (CBE) utilization at the local clinic sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362980 id: BPI-1178-IIT01 briefTitle: A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations acronym: EGFR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-04-12 date: 2024-04-12 name: National Cancer Center, China class: OTHER briefSummary: BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: BPI-1178 name: Osimertinib measure: Number of patients with dose-limiting toxicity (DLT) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DoR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Intracranial ORR (iORR) measure: Intracranial DCR (iDCR) measure: Intracranial DoR (iDoR) measure: Intracranial Time to Progression (iTTP) measure: Intracranial PFS (iPFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362967 id: Anti-HLA antibody briefTitle: The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation conditions: High Titers of Anti-HLA Antibody (MFI ≥5000) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG measure: Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment measure: Incidence of primary graft failure measure: Incidence of TRM after allo-HSCT measure: Incidence of ineffective platelet transfusion after allo-HSCT measure: Cumulative incidence of neutrophil engraftment after allo-HSCT measure: Cumulative incidence of II-IV° acute GVHD measure: Cumulative incidence of relapse at 1 year post-transplant measure: Probability of overall survival post transplantation measure: Incidence of allergies and allergic reactions measure: Incidence of haemorrhagic events measure: Incidence of viral, bacterial and fungal infections measure: Incidence of hypocalcaemia sex: ALL minimumAge: 14 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) city: Hefei state: Anhui zip: 230036 country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06362954 id: AnkaraMedipolU-FTR-SS-01 briefTitle: The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients overallStatus: RECRUITING date: 2023-12-31 date: 2024-04-01 date: 2024-06-01 date: 2024-04-12 date: 2024-04-12 name: Ankara Medipol University class: OTHER name: Gazi University briefSummary: Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow.
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This study aims to investigate the relationship between muscle oxygenation and spasticity in post-stroke hemiparetic patients based on the idea that oxygenation may be insufficient as a result of restriction of blood flow on the affected side due to spasticity in stroke patients. conditions: Stroke conditions: Hemiparesis;Poststroke/CVA conditions: Spasticity as Sequela of Stroke studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 18 type: ESTIMATED name: Assessment measure: Plantar Flexors Muscle Oxygenation measure: Spasticity measure: Motor Function measure: 6-Minute Walk Test measure: Stair Climbing Test measure: Adipose tissue thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation status: RECRUITING city: Ankara state: Çankaya country: Turkey name: Gökhan Yazıcı, Assos. Prof. role: CONTACT phone: +90 506 316 0572 email: [email protected] name: Gökhan Yazıcı, Assos. Prof. role: PRINCIPAL_INVESTIGATOR name: Taylan Altıparmak, Asst. Prof. role: SUB_INVESTIGATOR name: Çağla Çağatay role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06362941 id: NW-HGN-01 briefTitle: Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-01 date: 2025-03-30 date: 2024-04-12 date: 2024-04-18 name: Nutraceutical Wellness Inc. class: INDUSTRY briefSummary: A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning. conditions: Hair Thinning studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Nutrafol Women's Hair Growth Supplemnt name: Nutrafol Women's Balance Hair Growth Supplement name: Nutrafol Women's Vegan Hair Growth Supplement name: Nutrafol Women's Postpartum Hair Growth Supplement name: Nutrafol Men's Hair Growth Supplement measure: Change in hair shaft diameter compared to baseline at Day 180. measure: Change in hair shaft diameter compared to baseline at Day 90. measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 180 measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 90 measure: Change in hair breakage during the hair pull test compared to baseline at Day 180 measure: Change in hair breakage during the hair pull test compared to baseline at Day 90 measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180 measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90 measure: Subject Self-Perceived Improvement in Hair Quality at Day 180 measure: Subject Self-Perceived Improvement in Hair Quality at Day 90 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatology Consulting Services city: High Point state: North Carolina zip: 27262 country: United States name: Zoe Draelos role: CONTACT phone: 336-841-2040 email: [email protected] lat: 35.95569 lon: -80.00532 hasResults: False
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<|newrecord|> nctId: NCT06362928 id: CP-60005 briefTitle: Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-06 date: 2025-08 date: 2024-04-12 date: 2024-04-12 name: Akura Medical class: INDUSTRY briefSummary: This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE). conditions: Pulmonary Embolism Acute studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: ATC System measure: Effectiveness measure: Safety: Composite of Major Adverse Device-Related Events measure: Safety: Composite of Major Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362915 id: FMASUR66/2024 briefTitle: Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study) overallStatus: RECRUITING date: 2024-01-02 date: 2024-07-15 date: 2024-08-30 date: 2024-04-12 date: 2024-04-12 name: Ain Shams University class: OTHER briefSummary: The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: * Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1% (9).
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* Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Lidocaine name: Bupivacain measure: Extra Demand of sedation measure: Patient and surgeon satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: maha sadek El Derh status: RECRUITING city: Cairo state: Heliopolis zip: 11721 country: Egypt lat: 30.06263 lon: 31.24967 facility: Ain Shams University status: RECRUITING city: Cairo country: Egypt name: maha S elDerh, Ass.prof role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06362902 id: NOSES-VIII B briefTitle: Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2025-09-01 date: 2024-04-12 date: 2024-04-12 name: National Cancer Center, China class: OTHER briefSummary: The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients. conditions: Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Laparoscopic right hemicolectomy with transrectal specimen extraction measure: The rate of postoperative complications measure: Operating time measure: Estimated blood loss measure: The time of first flatus measure: Postoperative hospitalization sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Haitao Zhou, M.D. role: CONTACT phone: +8613381167333 email: [email protected] name: Yueyang Zhang, M.D. role: CONTACT phone: +8613552910035 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362889 id: HealMD-CBD-1 briefTitle: Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-11 date: 2024-04-12 date: 2024-04-12 name: Rejuva Medical Aesthetics class: OTHER name: HealMD, LLC briefSummary: This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne. conditions: Acne Vulgaris (Disorder) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Microneedling with CBD measure: Primary efficacy endpoints measure: Secondary efficacy endpoints sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rejuva Medical Aesthetics city: Los Angeles state: California zip: 90025 country: United States name: LaRyel A Waldon, B.S. role: CONTACT phone: 424-644-2400 email: [email protected] name: Margaux Oldfield role: CONTACT phone: 4246442400 email: [email protected] lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06362876 id: BAlis briefTitle: The Effect of Breastfeeding Counseling Based on Motivational Interviewing overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-15 date: 2024-08-15 date: 2024-12-15 date: 2024-04-12 date: 2024-04-12 name: Mersin University class: OTHER briefSummary: This research was planned to determine the effect of breastfeeding counseling based on motivational interviewing method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section. conditions: Breastfeeding Counseling Based on Motivational Interviewing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 74 type: ESTIMATED name: Breastfeeding Counseling Based on Motivational Interviewing name: Standard Breastfeeding Consultancy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Mersin University city: Mersin zip: 33180 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06362863 id: WDRY2024-K027 briefTitle: Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Ping An class: OTHER briefSummary: By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions. conditions: Crohn's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized controlled study divided into intervention and control groups. primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: enteral nutrition biscuits measure: Crohn's disease activity index, CDAI measure: Induced remission success rate measure: Gastrointestinal Symptom Rating Scale (GSRS) score measure: Gastrointestinal symptom remission measure: Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics measure: Incidence and severity of perianal lesions in both groups measure: Rate of endoscopic remission of small bowel and colon lesions in both groups measure: Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups measure: Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362850 id: 1253/2023 briefTitle: Tele-Support for Emergency Medical Technicians acronym: POHCA overallStatus: RECRUITING date: 2024-04-08 date: 2024-04-18 date: 2024-12-01 date: 2024-04-12 date: 2024-04-12 name: Medical University of Vienna class: OTHER name: Ludwig Boltzmann Institute Digital Health and Patient Safety briefSummary: In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed. conditions: Cardiac Arrest studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In a manikin-based simulation study, the participants will be randomized to either performing the scenario with tele-support or without tele-support (80 participants 40 groups, 20 groups with tele-support, 20 groups without tele-support). primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Tele-support measure: guideline adherence measure: gaze behavior measure: teamwork performance measure: cognitive load measure: Performance of cardiopulmonary resuscitation measure: Technical feasibility measure: Usability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Christina Hafner, MD, PhD role: CONTACT phone: 004314040041020 email: [email protected] lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06362837 id: P0117910-001 briefTitle: Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services acronym: REACTS-IN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-06-30 date: 2030-05-24 date: 2024-04-12 date: 2024-04-12 name: McGill University class: OTHER name: World Vision Canada name: Global Affairs Canada briefSummary: This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators. conditions: Stunting conditions: Gender Equality conditions: Acceptability of Health Care conditions: Diet; Deficiency conditions: Empowerment studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a quasi-experimental design for the evaluation of an intervention that is in the community (including schools) as well as in the local health service facilities. The data collection at baseline, midline, and end-line will occur simultaneously in the intervention and comparison selected communities. primaryPurpose: OTHER masking: NONE count: 13500 type: ESTIMATED name: Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights name: school-based iron-folic acid supplement program name: Health service training on equitable access to nutrition, health, and sexual and reproductive services name: bio-fortified crops measure: Gender equality measure: Child anthropometry measure: Antenatal care measure: Contraception use by women and partners measure: Child diet measure: Sexual and reproductive health services for adolescents measure: Gender equitable health services for nutrition, health, and sexual and reproductive health sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Brac University city: Dhaka country: Bangladesh name: Malay K Mridha, PhD role: CONTACT email: [email protected] lat: 23.7104 lon: 90.40744 facility: Connar Consultants city: Nairobi country: Kenya name: Elizabeth Kamau, PhD role: CONTACT email: [email protected] lat: -1.28333 lon: 36.81667 facility: Ifakara Health Institute city: Ifakara country: Tanzania name: Ester Elisaria, PhD role: CONTACT email: [email protected] lat: -8.13333 lon: 36.68333 hasResults: False
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<|newrecord|> nctId: NCT06362824 id: 2094138 briefTitle: Promoting Physical Activity in Older Hispanic/Latino(a) Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-09-30 date: 2029-09-30 date: 2024-04-12 date: 2024-04-15 name: Kaiser Permanente class: OTHER name: University of California, San Diego briefSummary: In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week). conditions: Sedentary Behavior conditions: Physical Inactivity conditions: Alzheimer Disease, Protection Against studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: De Pie Intervention name: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) measure: Change in Moderate Intensity Physical Activity (MIPA) minutes/day measure: Meet MIPA guidelines of 150 minutes physical activity per week sex: ALL minimumAge: 55 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Diego city: San Diego state: California zip: 92093 country: United States name: Zvinka Z Zlatar, PhD role: CONTACT email: [email protected] name: Zvinka Z Zlatar, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06362811 id: 483730 briefTitle: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-12 date: 2024-04-16 name: Istanbul University class: OTHER briefSummary: The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia. conditions: Analgesia conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Sacral Erector Spinae Plane Block measure: Postoperative pain scores measure: Analgesia requirement measure: Complications sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Istanbul University Cerrahpasa city: Istanbul zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06362798 id: IRB22-0729 id: 1R01HD109293-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HD109293-01 id: 6-23FY-0012 type: OTHER_GRANT domain: March of Dimes briefTitle: Effect of Support for Low-Income Mothers of Preterm Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-15 name: Harvard School of Public Health (HSPH) class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development. conditions: Preterm Birth conditions: Low; Birthweight, Extremely (999 Grams or Less) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm single-blind 1:1 randomized controlled trial of financial transfers ($160 per week) versus usual care. Mothers in the intervention arm will access videos that explain the impact of the cash on their availability for benefits and social supports. They will also be able to ask questions to a benefits counselor about how the transfers affect their benefits during the trial. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.) whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Financial Transfers measure: Provision of breast milk (proportion) measure: Provision of skin-to-skin care measure: Duration of mother's milk expression measure: Gestational weight-for-age measure: Gestational length-for-age z-score measure: Gestational head circumference measure: Necrotizing enterocolitis (NEC) measure: Late-onset bacterial or fungal sepsis (LOS) measure: NICU Visitation measure: Postpartum Bonding measure: Provision of breast milk (volume) measure: Breastfeeding episode measure: Maternal physical health measure: Maternal mental health (anxiety) measure: Maternal mental health (depression) measure: Reaction Time Modified Flanker Task measure: Accuracy Performance Modified Flanker Task measure: Reaction Time Psychomotor Vigilance Task measure: Accuracy Psychomotor Vigilance Task measure: Happiness measure: Life satisfaction measure: Sleep measure: Routine postpartum care measure: Financial distress measure: Financial hardship measure: Food insecurity measure: Housing instability measure: Housing insecurity measure: Transportation insecurity measure: Length of stay measure: Mother readmission between 4-8 weeks post-discharge measure: Baby readmission between 4-8 weeks post-discharge measure: Mother emergency department visit between 4-8 weeks post-discharge measure: Baby emergency department visit between 4-8 weeks post-discharge measure: Sleep position measure: Sleep location measure: Breastfeeding expression continuation measure: Skin-to-skin care knowledge measure: Breastfeeding knowledge measure: Perception of hospital experience sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Healthcare of Atlanta and Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Michelle-Marie Peña, MD role: CONTACT email: [email protected] lat: 33.749 lon: -84.38798 facility: Boston Medical Center city: Boston state: Massachusetts zip: 02118 country: United States name: Gabriela Cordova Ramos, MD role: CONTACT email: [email protected] lat: 42.35843 lon: -71.05977 facility: Baystate Medical Center city: Springfield state: Massachusetts zip: 01199 country: United States name: Laura Madore, MD role: CONTACT email: [email protected] lat: 42.10148 lon: -72.58981 facility: UMass Memorial Medical Center city: Worcester state: Massachusetts zip: 01605 country: United States name: Margaret Parker, MD role: CONTACT email: [email protected] lat: 42.26259 lon: -71.80229 hasResults: False
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<|newrecord|> nctId: NCT06362785 id: Virtual Reality-Seniors briefTitle: Musculoskeletal Pain, Motor Control, Risk of Falls and Virtual Reality overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2026-06 date: 2024-04-12 date: 2024-04-12 name: Universidade da Coruña class: OTHER name: Centre for Information and Communications Technology Research (CITIC) briefSummary: The goal of this clinical trial is to learn about musculoskeletal pain, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:
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* What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain, functionality, and risk of falls?
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* Does an intervention with virtual reality lower musculoskeletal pain, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group that does not receive such intervention?
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Participants will:
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* Answer questionnaires.
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* Perform physical laboratory tests through a camera-based motion capture system.
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* Execute task-based exercises in a virtual environment through virtual reality.
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Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain, functionality, and lowers fall risk. conditions: Musculoskeletal Pain conditions: Task Performance and Analysis conditions: Accidental Falls conditions: Virtual Reality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Virtual Reality measure: Presence of musculoskeletal pain measure: Pain Intensity measure: Initial positioning measure: Final positioning measure: Angular velocity measure: Acceleration measure: Movement execution time measure: Range of joint movement measure: Neck disability measure: Lower back disability measure: Kinesiophobia measure: Falls history measure: General health status measure: Date of birth measure: Gender measure: Height measure: Weight measure: Body mass index (BMI) measure: Depressive symptoms measure: Cognitive capacity measure: Amount and type of medication consumed measure: Existence of comorbidity sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362772 id: MR-36-24-010944 briefTitle: Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer overallStatus: COMPLETED date: 2015-01-01 date: 2022-02-01 date: 2023-04-01 date: 2024-04-12 date: 2024-04-12 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80\~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance. conditions: Thyroid Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 36 type: ACTUAL name: Iodine-125 brachytherapy measure: Tumor size measure: Serological assessment measure: Pain score measure: Adverse event sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362759 id: TOUR006-C01 briefTitle: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP acronym: TRANQUILITY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-02 date: 2024-04-12 date: 2024-04-12 name: Tourmaline Bio, Inc. class: INDUSTRY briefSummary: This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP. conditions: Chronic Kidney Diseases conditions: Chronic Kidney Insufficiency conditions: Chronic Renal Diseases conditions: Chronic Renal Insufficiency conditions: Kidney Insufficiency, Chronic conditions: C-Reactive Protein conditions: High Sensitivity C-Reactive Protein conditions: Hs-CRP conditions: hsCRP studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: TOUR006 - 50 MG name: TOUR006 - 25 MG name: TOUR006 - 15 MG name: Placebo measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP measure: Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006 measure: Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362746 id: FORPE-2 briefTitle: Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-06-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-12 name: Supergene, LLC class: INDUSTRY briefSummary: Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE) conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: At clinical sites patients will be equally randomized into two groups to receive non-immunogenic recombinant staphylokinase or placebo.
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Non-immunogenic recombinant staphylokinase or placebo will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. All patients will be examined for 30 days. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Neither patient nor investigator knows treatment assignment. All eligible patients will be randomized in two equal groups for administration of non-immunogenic recombinant staphylokinase or placebo. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 486 type: ESTIMATED name: Non-immunogenic recombinant staphylokinase name: Placebo measure: Composite of death from any cause or hemodynamic collapse or recurrent PE measure: Right/left ventricular (RV/LV) end-diastolic diameter ratio measure: RV/LV end-diastolic diameter ratio measure: RV/LV end-diastolic diameter ratio measure: Right ventricular (RV) end-diastolic volume measure: Qanadli index measure: Systolic pulmonary artery pressure measure: In hospital death from all causes (assessed up to day 7) measure: Death from all causes measure: Safety endpoint - hemorrhagic stroke measure: Safety endpoint - BARC type 3 and 5 bleeding measure: Safety endpoint - number and severity of adverse events (AEs) and serious AEs in organs and systems sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: V.F. Dolgopolov Vyselki Central District Hospital city: Vyselki state: Krasnodar Region zip: 353100 country: Russian Federation name: Valerii V. Makukhin, PhD role: CONTACT phone: (86199) 123-53 phoneExt: +7 email: [email protected] name: Valerii V. Makukhin, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.58128 lon: 39.66409 facility: I.P. Pavlov Ryazan State Medical University city: Ryazan' state: Ryazan zip: 390026 country: Russian Federation name: Denis S. Yunevich, PhD role: CONTACT phone: (4912) 46-63-90 phoneExt: +7 email: [email protected] name: Denis S. Yunevich, PhD role: PRINCIPAL_INVESTIGATOR lat: 54.6269 lon: 39.6916 facility: Belgorod Regional Clinical Hospital of St. Joseph city: Belgorod zip: 308007 country: Russian Federation name: Sergei L Konstantinov, MD role: CONTACT email: [email protected] name: Sergei L Konstantinov, MD role: PRINCIPAL_INVESTIGATOR lat: 50.61074 lon: 36.58015 facility: Kuzbass Cardiology center city: Kemerovo zip: 650002 country: Russian Federation name: Vasilii V. Kashtalap, MD, PhD role: CONTACT phone: +7 (3842) 64-22-41 email: [email protected] name: Vasilii V. Kashtalap, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.33333 lon: 86.08333 facility: City Clinical Hospital №1 city: Kirov zip: 610035 country: Russian Federation name: Oleg V. Solovyev, PhD role: CONTACT phone: (8332) 56-35-74 phoneExt: +7 email: [email protected] name: Oleg V. Solovyev, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.59665 lon: 49.66007 facility: Regional Clinical Hospital №2 city: Krasnodar zip: 350012 country: Russian Federation name: Tamara A. Chirva, MD role: CONTACT phone: (861) 222-000-2 phoneExt: +7 email: [email protected] name: Tamara A. Chirva, MD role: PRINCIPAL_INVESTIGATOR lat: 45.04484 lon: 38.97603 facility: S.S. Yudin City Clinical Hospital city: Moscow zip: 115446 country: Russian Federation name: Bogdan B Orlov, MD, PhD role: CONTACT phone: 7 (499) 612-45-66 email: [email protected] name: Bogdan B Orlov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: V.V. Vinogradov City Clinical Hospital city: Moscow zip: 117292 country: Russian Federation name: Imad Merai, MD, PhD role: CONTACT phone: +7 (495) 103 46 66 email: [email protected] name: Imad Merai, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: S.P. Botkin City Clinical Hospital city: Moscow country: Russian Federation name: Yuri V. Karabach, PhD role: CONTACT phone: (499) 490-03-03 phoneExt: +7 email: [email protected] name: Yuri V. Karabach, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: N.N. Burdenko Penza Regional Clinical hospital city: Penza zip: 440026 country: Russian Federation name: Valentin E. Oleynikov, MD, PhD role: CONTACT phone: +7 (8412) 54-84-07 email: [email protected] name: Valentin E. Oleynikov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20066 lon: 45.00464 facility: G.A. Zakharyin Clinical hospital №6 city: Penza zip: 440071 country: Russian Federation name: Elena S. Panina, PhD role: CONTACT phone: (8412) 98-33-55 phoneExt: +7 email: [email protected] name: Elena S. panina, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20066 lon: 45.00464 facility: City Clinical Hospital №4 city: Perm zip: 614107 country: Russian Federation name: Oleg M. Lapin, PhD role: CONTACT phone: 342-263-01-06 phoneExt: +7 email: [email protected] name: Oleg M. Lapin, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.01046 lon: 56.25017 facility: V.P. Polyakov Samara Regional Clinical Cardiology Dispensary city: Samara zip: 443070 country: Russian Federation name: Dmitrii V Duplyakov, MD, PhD role: CONTACT phone: 8 (846) 373-70-63 email: [email protected] name: Dmitrii V Duplyakov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20007 lon: 50.15 hasResults: False
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<|newrecord|> nctId: NCT06362733 id: IRB-74165 briefTitle: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-06-01 date: 2024-04-12 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: The purpose of this open label trial is to examine the preliminary effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and child-focused intervention. conditions: Autism Spectrum Disorder conditions: Restricted Behavior conditions: Autism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth measure: Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). measure: Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. measure: Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. measure: Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale. measure: Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). measure: Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). measure: Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). measure: Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS). measure: Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). measure: Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). measure: Caregiver Report Executive Functioning Scale (EFS). measure: Daily Living Skills Scale (DLSS). sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06362720 id: 720/2566(IRB2) briefTitle: The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen acronym: CMV overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: Siriraj Hospital class: OTHER briefSummary: The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:
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* How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
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* progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
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* The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
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* Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record. conditions: CMV Infection or Reactivation After Allogenic HSCT studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 158 type: ESTIMATED measure: Number of participants with CMV infection and reactivation measure: progression-free survival measure: Median overall survival measure: cumulative incidence of relapse measure: non-relapsed mortality measure: GvHD measure: Averse events sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362707 id: 2023161001 briefTitle: Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD) acronym: FEAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-01 date: 2026-10-01 date: 2024-04-12 date: 2024-04-15 name: Helse Stavanger HF class: OTHER_GOV name: University of Exeter briefSummary: The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease.
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The main questions it aims to answer are:
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* Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months?
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* What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)?
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* Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations.
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* Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review.
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The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET. conditions: Cognitive Decline, Mild conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Fasudil name: Placebo measure: Cognition measure: Brain metabolism measure: Plasma levels of ptau217 measure: Plasma levels of nfl measure: Levels of cerebrospinal Aβ1-40 and Aβ1-42 measure: Levels of cerebrospinal tau and p-tau measure: Blood pressure (Safety assessments) measure: Pulse (Safety assessments) measure: Urine testing (Safety assessments) measure: Blood urea nitrogen (BUN) (Safety assessments) measure: Potassium (Safety assessments) measure: Sodium (Safety assessments) measure: Calcium (Safety assessments) measure: Glucose (Safety assessments) measure: Hemoglobin (Safety assessments) measure: Creatinine (Safety assessments) measure: Total and direct bilirubin (Safety assessments) measure: CRP (C-reactive protein) (Safety assessments) measure: Aspartate aminotransferase (AST) (Safety assessments) measure: Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments) measure: Alanine aminotransferase (ALT) (Safety assessments) measure: Serum glutamic-pyruvic transaminase (SGPT) (Safety assessments) measure: Alkaline phosphatase (Safety assessments) measure: Electrocardiogram (ECG) (Safety assessments) measure: Columbia Suicide Severity Rating Scale (C-SSRS) (Safety assessments) sex: ALL minimumAge: 50 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362694 id: 34 briefTitle: Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-06-25 date: 2024-04-12 date: 2024-04-12 name: Saint Petersburg State University, Russia class: OTHER briefSummary: This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints. conditions: Anaplastic Thyroid Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dabrafenib + Trametinib measure: Objective response rate measure: Progression-Free Survival measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) measure: Overall survival measure: The assessment of conversion to resectability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Hospital status: RECRUITING city: Saint Petersburg zip: 190020 country: Russian Federation name: Ernest Dzhelialov role: CONTACT phone: +7(911)134-50-44 email: [email protected] lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06362681 id: CF-2023-I-13 briefTitle: Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-30 date: 2026-03-30 date: 2024-04-12 date: 2024-04-12 name: Universidad Nacional Autonoma de Mexico class: OTHER briefSummary: The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico. conditions: Molar Incisor Hypomineralization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: using a block randomization technique in which a computer-generated sequence would be used to assign each participant to a particular group in the allocation ratio of 1:1. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Fluoride measure: Mineral Density sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Alvaro Garcia Pérez status: RECRUITING city: San Pedro Apatlaco state: Morelos country: Mexico lat: 18.79306 lon: -98.95972 hasResults: False
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<|newrecord|> nctId: NCT06362668 id: RCV-0006-EU briefTitle: EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU) acronym: FASTR-EU overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-10-01 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: Reprieve Cardiovascular, Inc class: INDUSTRY briefSummary: The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Reprieve Decongestion Management System name: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) measure: Total sodium loss (in mmol of sodium) per 24 hours measure: Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency. measure: Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours measure: Weight loss per 24 hours at end of randomized therapy measure: Time on IV loop diuretic measure: Number of participants with ≥ 0.3 mg/dL increase in serum creatinine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen country: Netherlands name: Kevin Damman, MD role: CONTACT lat: 53.21917 lon: 6.56667 facility: Wroclaw Medical University city: Wrocław country: Poland name: Jan Biegus, MD role: CONTACT lat: 51.1 lon: 17.03333 hasResults: False
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<|newrecord|> nctId: NCT06362655 id: ANID/FONDECYT 2013/1230801 briefTitle: ACTIBESE Project - Active Behaviour in School Education acronym: ACTIBESE overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2023-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Pontificia Universidad Catolica de Valparaiso class: OTHER name: Universidad de La Frontera briefSummary: The ACtive BEhaviour in School Education (ACTIBESE) project aims to assess and intervene in Chilean schoolchildren's active behaviours by examining the influence of personal, interpersonal, and school factors. This study includes a cross-sectional and intervention study involving 152 schools in the Valparaíso and Araucanía Regions, representing urban and rural areas. Participants, divided into children (8-11 years old) and adolescents (12-17 years old), will undergo a comprehensive evaluation, including sociodemographic characteristics, physical activity (PA) levels, parental and peer support, teaching styles of the teachers, and school environment characteristics.
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For the cross-sectional study, questionnaires, interviews, accelerometry, and pedometry will be used to collect data on various factors influencing PA in schoolchildren. In the intervention study, a 5-month continuous training program for teachers will be implemented, focusing on improving teaching styles and enhancing teaching competencies related to physical education and health classes. The program aims to positively affect schoolchildren's PA indirectly through improved teaching practices.
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The research will use mixed models, ANCOVA (Analysis of Covariance) , and logistic regressions for data analysis, incorporating multilevel logistic regressions to account for school-level dependencies. The study's outcomes will contribute valuable insights into the complex interactions between school, interpersonal, and personal factors influencing schoolchildren's PA, aiding the development of targeted interventions. This comprehensive approach aligns with the project's goal of fostering a physically active lifestyle among Chilean schoolchildren. conditions: Physical Inactivity conditions: Child Behavior conditions: Family Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Study primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: No apply count: 144 type: ESTIMATED name: Intervention measure: Physical activity levels sex: ALL minimumAge: 9 Years maximumAge: 17 Years stdAges: CHILD facility: IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile. city: Viña Del Mar state: Valparaiso zip: 2300000 country: Chile lat: -33.02457 lon: -71.55183 hasResults: False
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<|newrecord|> nctId: NCT06362642 id: PMV-586-105 briefTitle: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants overallStatus: RECRUITING date: 2024-03-28 date: 2024-08 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: PMV Pharmaceuticals, Inc class: INDUSTRY briefSummary: The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD. primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: PC14586 name: Itraconazole measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants. measure: Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States name: Christine Hale, MD role: CONTACT email: [email protected] lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06362629 id: WCH240407 briefTitle: AI App for Management of Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-12-31 date: 2029-08-31 date: 2024-04-12 date: 2024-04-12 name: West China Hospital class: OTHER briefSummary: Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings heavy economic burden to society. The Treat to Target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and it is emphasized patients' adherence and combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients' unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD.
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Hypothesis: An Artificial Intelligence assistant decision-making system (AIADMS) with implementation of the T2T framework could help control the disease progression and improve the clinical outcomes for AD.
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Overall objectives:
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We aim to develop an AIADMS in the form of smartphone app to integrate T2T approach for both clinicians and patients, and design clinical trials to verify the effectiveness and safety of the app. Methods: This project consists of three parts, AI training model for diagnosis and severity grading of AD based on deep learning, development of Artificial Intelligence assistant decision-making system (AIADMS) in the form of app, and design of a randomized controlled trial to verify the effectiveness and safety of AIADMS App for improvement of the clinical outcomes in AD patients.
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Expected results: With application of AIADMS based app, the goal of T2T for patients with AD could be realized better, the prognosis could be improved, and more satisfaction could be achieved for both patients and clinicians.
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Impact: This is the first AIADMS based app for AD management running through thediagnosis, patients' self-participation, medical follow-up, and evaluation of achievement of goal of T2T. conditions: Atopic Dermatitis conditions: Artificial Intelligence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 232 type: ESTIMATED name: Artificial Intelligence assistant decision-making system (AIADMS) App measure: The overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment measure: The seperated efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI measure: The economic consumption measure: Satisfaction evaluation sex: ALL minimumAge: 1 Year maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362616 id: N23PBD briefTitle: Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer acronym: PAPBI-3 overallStatus: RECRUITING date: 2024-04-12 date: 2026-10-11 date: 2027-04-11 date: 2024-04-12 date: 2024-04-18 name: The Netherlands Cancer Institute class: OTHER briefSummary: This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 31 type: ESTIMATED name: Preoperative accelerated partial breast irradiation name: Breast conserving surgery name: Sentinel node procedure name: Biopsy track removal measure: Acute post-treatment toxicity measure: Fibrosis/induration measure: Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 measure: Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 measure: Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis measure: Cosmetic outcome according to the BCCT.core software program sex: FEMALE minimumAge: 51 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Netherlands Cancer Institute status: RECRUITING city: Amsterdam zip: 1066CX country: Netherlands name: Astrid Scholten, MD PhD role: CONTACT phone: +31205129111 email: [email protected] lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06362603 id: FB2022NIH briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-12 date: 2024-04-12 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06362590 id: LV-SPIND-001 briefTitle: Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors overallStatus: AVAILABLE date: 2024-04-12 date: 2024-04-12 name: Seagen Inc. class: INDUSTRY briefSummary: The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005. studyType: EXPANDED_ACCESS name: ladiratuzumab vedotin stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362577 id: TSC202202 briefTitle: Clinical Study of HIFU for Localized Prostate Cancer acronym: HIFU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-11-30 date: 2026-12-31 date: 2024-04-12 date: 2024-04-12 name: RenJi Hospital class: OTHER briefSummary: In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications.
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To analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer. conditions: Localized Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG measure: Incidence of postoperative complications measure: The time to reach the lowest point of PSA measure: Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery measure: The negative rate of tumor exclusion was evaluated by imaging (mainly mp-MRI) at 2 and 12 months after surgery measure: The incidence of biochemical recurrence that requires remedial or systemic treatment 12 months after surgery measure: Postoperative overall survival rate sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362564 id: CIPL-LBE-0101 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-12 date: 2024-04-12 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06362551 id: INC-GS-2024-002 briefTitle: Oocyte Donor Application Discrepancies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-25 date: 2024-05 date: 2025-05 date: 2024-04-12 date: 2024-04-12 name: Inception Fertility, LLC class: INDUSTRY name: GeneScreen Counseling, LLC briefSummary: Retrospective observational study comparing information received on Inception Central Donor Recruitment's standardized online egg donor application compared to information reported during a genetic risk assessment consultation with a certified genetic counselor with contracted third party genetic counseling service, GeneScreen. All donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included. conditions: Infertility studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Rate of additional information measure: Rate of applicant decline sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Inception Fertility LLC city: Houston state: Texas zip: 77081 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06362538 id: MCH-ProCardioPrev briefTitle: The Cardiovascular Prevention Program overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-12 date: 2024-04-16 name: Maria Cecilia Hospital class: OTHER briefSummary: Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk. conditions: Cardiovascular Prevention studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: International Physical Activity Questionnaire name: Six minute walking test name: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21. name: MEDAS name: Intima-media thickness (IMT) name: Blood sampling name: Stool Sample Culture Test measure: measure of body mass index measure: Adherence to the Mediterranean diet measure: blood test to check cholesterol levels measure: blood pressure measurement measure: blood glucose test sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06362525 id: 2022-389 briefTitle: Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room overallStatus: RECRUITING date: 2023-10-09 date: 2025-09-30 date: 2027-09-30 date: 2024-04-12 date: 2024-04-12 name: University of Liege class: OTHER name: Centre Hospitalier Universitaire de Liege briefSummary: This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care.
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Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display.
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Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated. conditions: Critical Illness conditions: Near-Death Experience conditions: Consciousness, Loss of conditions: Quality of Life conditions: Emergencies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Detection of potential episodes of disconnected consciousness measure: Detection of potential episodes of connected consciousness measure: Risk factors measure: Quality of life assessment measure: Memory content and evolution assessment measure: Detection of post-traumatic stress disorder (PTSD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU of Liège status: RECRUITING city: Liège zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 hasResults: False
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<|newrecord|> nctId: NCT06362512 id: Marco_PANG_2024 briefTitle: Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes. acronym: COGMOTION overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-12 date: 2024-04-16 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention. whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Dual-task training name: Single-task training name: Upper limb strengthening exercise measure: Dual-task step frequency measure: Dual-task cognitive performance accuracy measure: Blood oxygenation level changes of the brain measure: Single-task walking speed measure: Dual-task walking performance measure: Mini Balance Evaluation Systems Test measure: Activities-specific Balance Confidence Scale measure: Trail Making Test measure: Digit Span Test measure: Montreal Cognitive Assessment measure: Fall incidence measure: Dual-task ankle movement degree measure: Dual-task cognitive performance time sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 000000 country: China name: Marco Yiu Chung Pang, PhD role: CONTACT lat: 22.39407 lon: 114.13737 hasResults: False
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<|newrecord|> nctId: NCT06362499 id: 01 briefTitle: Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients. overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-12 date: 2024-04-17 name: Universidade Federal do Rio Grande do Norte class: OTHER briefSummary: Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment.
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In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Experimental Group measure: Ventilation variability and ventilation efficiency measure: Respiratory muscle strength measure: Pulmonary function measure: Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) measure: Peripheral muscle strength measure: Functional capacity measure: Adverse effects and adherence sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Federal University of Rio Grande do Norte status: RECRUITING city: Natal state: Rio Grande Do Norte zip: 59082-100 country: Brazil name: Gabriely Azevêdo role: CONTACT phone: 84999390004 email: [email protected] name: Patrícia Nogueira role: CONTACT lat: -5.795 lon: -35.20944 facility: Patrícia Nogueira status: RECRUITING city: Natal state: Rio Grande Do Norte country: Brazil name: Patrícia Nogueira role: CONTACT name: Gabriely Azevêdo role: CONTACT phone: 5584999390004 email: [email protected] lat: -5.795 lon: -35.20944 hasResults: False
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<|newrecord|> nctId: NCT06362486 id: SIGNATURE briefTitle: Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-01 date: 2023-08-01 date: 2024-08-01 date: 2024-04-12 date: 2024-04-12 name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla class: OTHER briefSummary: The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose.
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Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months?
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Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS. conditions: Covid19 and Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Severity of infection, time of infection. name: Mental health assessment name: biological measure: explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Virgen del Rocío city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 hasResults: False
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<|newrecord|> nctId: NCT06362473 id: LIPIGEN-001 briefTitle: Lipid Transport Disorder Italian Genetic Record (LIPIGEN) acronym: LIPIGEN overallStatus: RECRUITING date: 2015-08-04 date: 2026-09-30 date: 2026-09-30 date: 2024-04-12 date: 2024-04-12 name: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) class: OTHER briefSummary: LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels. This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias, including very common conditions such as familial hypercholesterolaemia (FH) and less common ones such as familial chylomicronidaemic syndrome (FCS).
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