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<|newrecord|> nctId: NCT06381206 id: No 475 briefTitle: Silodosin in Management of Lower Ureteral Stones overallStatus: COMPLETED date: 2022-10-20 date: 2023-10-20 date: 2023-10-25 date: 2024-04-24 date: 2024-04-24 name: Syrian Private University class: OTHER briefSummary: This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin. conditions: Stone, Kidney studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Silodosin measure: Stone expulsion (yes) measure: Stone expulsion (no) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus university city: Damascus zip: 1 country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False |
<|newrecord|> nctId: NCT06381193 id: ESTR-01-2022 briefTitle: Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics overallStatus: COMPLETED date: 2023-03-03 date: 2023-07-10 date: 2023-07-10 date: 2024-04-24 date: 2024-04-24 name: Centros de Investigación de Nutrición y Salud class: OTHER name: Nutribiotica briefSummary: The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are: |
* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks. |
* To evaluate the stool consistency after 8 weeks (Bristol scale). |
* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks. |
Participants are randomized into the following groups: |
* Group A: 20 assigned to probiotic + placebo |
* Group B: 20 assigned to prebiotic + placebo |
* Group C: 20 assigned to probiotic + prebiotic |
* Group D: 20 assigned to the placebo + placebo |
Participants took 4 units of product per day (2 of each assigned product) for 2 months. conditions: Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: Probiotic name: Prebiotic name: Probiotic + Prebiotic name: Placebo measure: 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation. measure: To evaluate the stool consistency (Bristol scale). measure: To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20) measure: To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale). sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA) city: Madrid zip: 28036 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False |
<|newrecord|> nctId: NCT06381180 id: Warrior CARE: CBH briefTitle: Warrior CARE: Cannabis Behavioral Health acronym: CBH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-12-31 date: 2030-12-31 date: 2024-04-24 date: 2024-04-24 name: Wayne State University class: OTHER briefSummary: This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation. conditions: Post Traumatic Stress Disorder conditions: Cannabis Use conditions: Suicide conditions: Veterans conditions: Marijuana studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ESTIMATED name: Tetrahydrocannabinol name: Cannabidiol name: Placebo measure: Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. measure: Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment measure: Assessing Suicidality over time using the C-SSRS assessment. measure: Assessing Suicidality throughout the study using the SBQ-R assessment. measure: Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires. measure: Assess emotional state pre- and post-treatment using the PANAS questionnaire. measure: Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment. measure: Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires. measure: Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments. measure: Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales. measure: Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires. measure: Assess demographics using a self-report assessment measure: Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments. measure: Assess smoking habits and history using the FTND assessment measure: Assess general health and history pre- and post-treatment using the SF-36 assessment. measure: Assess healthcare utilization throughout the study. measure: Assess pain pre- and post-treatment using the BPI assessment. measure: Assess sleepiness pre- and post-treatment using the ESS questionnaire. measure: Assess overall quality of life pre- and post-treatment using the QOL questionnaire. measure: Assess substance use throughout the study using the TLFB assessment. measure: Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks measure: Assess physiological measures throughout the study as a safety check measure: Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD. sex: ALL minimumAge: 19 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wayne State University city: Detroit state: Michigan zip: 48201 country: United States name: Nareen Sadik, B.S. role: CONTACT lat: 42.33143 lon: -83.04575 hasResults: False |
<|newrecord|> nctId: NCT06381167 id: Endoscopic decompression briefTitle: Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-10 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis. conditions: Lumbar Spinal Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Endoscopic Decompressive Laminectomy measure: Oswestry Disability Index ODI scores for low back pain and neuropathic pain measure: visual analog scale (VAS) score for low back and lower extremity radiating pain measure: European Quality of Life-5 Dimensions (EQ-5D) score measure: painDETECT score sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381154 id: MC230404 id: NCI-2024-03078 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009036 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230404 type: OTHER domain: Mayo Clinic id: P01CA084203 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA084203 id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 briefTitle: Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2029-07-04 date: 2029-07-04 date: 2024-04-24 date: 2024-04-24 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer. conditions: Locally Advanced Pancreatic Adenocarcinoma conditions: Metastatic Pancreatic Adenocarcinoma conditions: Stage II Pancreatic Cancer AJCC v8 conditions: Stage III Pancreatic Cancer AJCC v8 conditions: Stage IV Pancreatic Cancer AJCC v8 conditions: Unresectable Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Endoscopic Ultrasound name: Fluorouracil name: Irinotecan name: Leucovorin name: Lymph Node Biopsy name: Magnetic Resonance Imaging name: Oxaliplatin name: Pembrolizumab name: Photodynamic Therapy name: Positron Emission Tomography name: Questionnaire Administration name: Verteporfin measure: Overall response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Vinay Chandrasekhara, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06381141 id: CLN-619-002 briefTitle: A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-03 date: 2024-04-24 date: 2024-04-24 name: Cullinan Therapeutics Inc. class: INDUSTRY briefSummary: A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CLN-619 measure: Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance measure: Incidence of Dose-Limiting toxicity (DLTs) measure: Best Overall Response (BOR) per patient measure: Overall Response Rate (ORR) measure: Duration of Response (DoR) measure: Clinical Benefit Rate (CBR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381128 id: CAA by CT in children with CHD briefTitle: Coronary Arteries Anomalies by CT in Children With CHD overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-01-01 date: 2029-12-31 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction. conditions: Cardiac Congenital Defects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Cardiac CT measure: Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06381115 id: 23-006685 briefTitle: App-Based Optimization of Long-Term CPAP Adherence and Quality of Life overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-24 date: 2024-04-24 name: Mayo Clinic class: OTHER name: Arizona State University (ASU) briefSummary: The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: SleepWell24 Application measure: CPAP Adoption measure: Change in Quality of Life measure: Change in sleep time measure: Change in physical activity measure: Change in sedentary time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona city: Scottsdale state: Arizona zip: 85259 country: United States lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06381102 id: 20240134 briefTitle: Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1 overallStatus: RECRUITING date: 2024-04-13 date: 2024-10-01 date: 2024-10-01 date: 2024-04-24 date: 2024-04-24 name: University of Miami class: OTHER briefSummary: The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: transcutaneous auricular vagus nerve stimulation 30/30 name: transcutaneous auricular vagus nerve stimulation 10/10 measure: Tolerability measured by tolerability questionnaire measure: Tolerability measured by self-report measure: Change in heart rate variability (HRV) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Gabriel Gonzalez, DPT role: CONTACT phone: 305-243-8117 email: [email protected] name: Marlon Wong, PT, PhD role: PRINCIPAL_INVESTIGATOR name: Gabriel Gonzalez, DPT role: SUB_INVESTIGATOR name: Jessica Bolanos, DPT role: SUB_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06381089 id: VNS004 briefTitle: Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients acronym: ERRVNS overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-07-10 date: 2024-08-10 date: 2024-04-24 date: 2024-04-24 name: SEFA HAKTAN HATIK class: OTHER briefSummary: This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system. |
40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p\<0.05 level. conditions: Ischemic Stroke conditions: Vagus Nerve Stimulation conditions: Robotic Rehabilitation conditions: Autonomic Nervous System studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Robotic Rehabilitation name: Transcutaneous Auricular Vagal Nerve Stimulation measure: Numerical Pain Rating Scale measure: Stroke Specific Quality of Life Scale measure: 10 Meter Walk Test measure: Fugl-Meyer Assessment Lower Extremity measure: Modified Ashworth Scale measure: Electromyography measure: Autonomic Nervous System sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381076 id: IRB202400087 briefTitle: Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2025-12 date: 2024-04-24 date: 2024-04-26 name: University of Florida class: OTHER briefSummary: A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey. conditions: Chronic Kidney Disease 5D studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized comparator-controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Liposomal curcumin name: Food colorant measure: high-sensitivity C-reactive protein measure: Advanced glycation end products measure: fatty acid byproduct - 4-hydroxynon-enal measure: fatty acid byproduct - malondialdehyde measure: fatty acid byproduct - 8-F2 isoprostanes measure: Klotho sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381063 id: PI2023_843_0152 briefTitle: Non-steroidal Anti-inflammatory in Cardiac Surgery acronym: KETOPAIN overallStatus: RECRUITING date: 2024-03-27 date: 2027-03 date: 2027-07 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: University Hospital, Rouen name: University Hospital, Lille briefSummary: Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication. conditions: Acute Postoperative Pain conditions: Non-steroidal Anti-inflammatory Drugs conditions: Cardiac Surgery conditions: Pain Intensity conditions: Multimodal Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 238 type: ESTIMATED name: pain management name: ketoprofen name: PLacebo measure: reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery measure: NSAIDs reduce postoperative at rest at 24 hours from the end of surgery measure: Change in pain trajectory during the first 7 days after cardiac surgery measure: Change in cumulative opioid within 48 hours after surgery measure: Change in pulmonary postoperative complications within 7 days after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie status: RECRUITING city: Amiens country: France name: Osama ABOU ARAB role: CONTACT email: [email protected] name: Emmanuel BESNIER, MD role: PRINCIPAL_INVESTIGATOR name: Mouhamed MOUSSA, MD role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False |
<|newrecord|> nctId: NCT06381050 id: SHR-7631-101 briefTitle: The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-24 date: 2024-04-24 name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: SHR-7631 measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD) measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0) measure: PK parameter: Tmax measure: PK parameter: Cmax measure: PK parameter: AUC0-t measure: PK parameter: AUC0-∞ measure: PK parameter: t1/2 measure: PK parameter: MRT (mean residence time) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381037 id: PID2021-127986OB-I00 briefTitle: Quality of Life and Psychological Strengths of Older People acronym: QUALIFRAG overallStatus: RECRUITING date: 2023-09-01 date: 2026-01-31 date: 2026-08-31 date: 2024-04-24 date: 2024-04-24 name: CEU San Pablo University class: OTHER briefSummary: As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors. conditions: Quality of Life conditions: Skills, Coping studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quantitative, observational and longitudinal study with three measurements (pre-intervention, post-intervention and monitoring). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 110 type: ESTIMATED name: "How to improve your strengths and quality of life". measure: Quality of life measure: Psychological wellbeing measure: Loneliness measure: Anxiety and depression Anxiety and depression measure: Gratitude measure: Experiential acceptance measure: Resilience measure: Family functioning sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Pablo CEU University (Campus Montepríncipe) status: RECRUITING city: Alcorcón state: Madrid zip: 28925 country: Spain name: Leyre Galarraga Cristóbal role: CONTACT phone: 913724700 phoneExt: 14607 email: [email protected] name: Gema Pérez Rojo role: CONTACT phone: 913724700 phoneExt: 14999 email: [email protected] lat: 40.34582 lon: -3.82487 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-12-01 uploadDate: 2023-12-11T03:43 filename: SAP_000.pdf size: 70923 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-01 uploadDate: 2023-12-11T03:42 filename: ICF_001.pdf size: 71559 hasResults: False |
<|newrecord|> nctId: NCT06381024 id: 2022 A02702-41 briefTitle: A Study of Telemonitoring in Cancer Patients acronym: MINERVA overallStatus: RECRUITING date: 2023-04-04 date: 2024-12-30 date: 2024-12-30 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier de Bligny class: OTHER name: Exystat name: Cureety name: Pharmaspecific name: ProPens briefSummary: The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny. |
Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either: |
* In-person care alone (Standard of care group). |
* In-person care with Cureety telemonitoring (Standard of care with Cureety group). |
Participants will: |
* be monitored with digital application Cureety (Standard of care with Cureety group) |
* fill out quality of life questionnaire (baseline, 2 months, 4 months) |
* fill out satisfaction questionnaire (2 months, 4 months) |
* have the ongoing and incoming phone calls logged (duration and type) conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either: |
* In-person care alone (Standard of care group). |
* In-person care with telemonitoring (Standard of care with Cureety group). |
The randomization will be stratified by: |
• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients. primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: remote patient monitoring measure: Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment measure: Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment measure: Numbers of telephone calls during the first 4 months of cancer treatment in subgroups measure: Hospital-free survival rate measure: Quality of life at 2 and 4 months after initiation of cancer treatment. measure: Patient satisfaction with the healthcare provided measure: CH Bligny staff satisfaction with the healthcare provided sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Bligny status: RECRUITING city: Briis-sous-Forges zip: 91640 country: France name: Ingrid Alexandre, MD role: CONTACT phone: +33169263138 email: [email protected] name: Ingrid Alexandre, MD role: PRINCIPAL_INVESTIGATOR lat: 48.62399 lon: 2.12112 hasResults: False |
<|newrecord|> nctId: NCT06381011 id: BEUFTR-4 briefTitle: Local Vibration in Cervical Radiculopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-01 date: 2024-09-01 date: 2024-04-24 date: 2024-04-24 name: Bitlis Eren University class: OTHER briefSummary: The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Local Vibration measure: Neck Pain measure: Upper Limb Pain measure: Paresthesia measure: Cervical Range of Motion measure: The Change in the Pressure Pain Threshold of the Upper Trapezius measure: The Change in the Viscoelastic Properties of the Upper Trapezius sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bitlis Eren University city: Bitlis state: Merkez zip: 13000 country: Turkey name: Ömer Dursun, Asst. Prof. role: CONTACT phone: 5426088687 phoneExt: +90 email: [email protected] name: Erhan Dincer, M.Sc. role: CONTACT phone: 5442543857 phoneExt: +90 email: [email protected] lat: 38.40115 lon: 42.10784 hasResults: False |
<|newrecord|> nctId: NCT06380998 id: EPCPHCFAPAEWPSPSWAG briefTitle: Effects of Petroleum Compounds on Psychological Health and Cognitive Functions overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-10-01 date: 2027-10-01 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: Over the last decade, awareness of the effects of hydrocarbon fuels on neurodegenerative disorders has increased significantly, as they are ubiquitous environmentally toxic chemicals that affect the central nervous system and result in irreversible neuronal damage, as many hydrocarbons can cross the blood-brain barrier through multiple pathways and cause direct toxicity. conditions: Cognitive Deterioration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 196 type: ESTIMATED name: whey protien measure: Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut measure: To explore the relation between the level of petroleum hydrocarbon metabolites and the severity of psychological heath and cognitive functions disturbance of petrol station workers measure: To explore the role of supplements with whey protein in ameliorating these effects measure: To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of medicine city: Assiut state: Assiut University zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False |
<|newrecord|> nctId: NCT06380985 id: NURA-009-23F id: 1I01CX002715-01A1 type: OTHER_GRANT domain: Clinical Science Research & Development briefTitle: Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury acronym: TABM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2027-12-31 date: 2024-04-24 date: 2024-04-26 name: VA Office of Research and Development class: FED briefSummary: The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI. conditions: Alcohol Use Disorder conditions: Mild-Moderate Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a Phase II double-blind, randomized, sham-controlled clinical trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition name: Sham Condition measure: Percent of Heavy Drinking Days measure: Cue-induced fMRI BOLD-signal craving activation contrasts measure: Cognitive flexibility sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Francisco VA Medical Center, San Francisco, CA city: San Francisco state: California zip: 94121-1563 country: United States name: David L Pennington role: CONTACT phone: 415-221-4810 phoneExt: 24504 email: [email protected] name: Yim Fan Wong, BS role: CONTACT phone: (415) 221-4810 phoneExt: 22329 email: [email protected] name: David L Pennington role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 hasResults: False |
<|newrecord|> nctId: NCT06380972 id: HDM6009A-301 briefTitle: A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-09 date: 2025-10 date: 2024-04-24 date: 2024-04-24 name: AQTIS Medical B.V. class: OTHER briefSummary: A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour conditions: Forehead Contouring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator. whoMasked: OUTCOMES_ASSESSOR count: 189 type: ESTIMATED name: Polycaprolactone (PCL) Based Facial Injectable measure: The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS) measure: The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS) measure: The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS) measure: The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital city: Guangzhou state: Guangdong zip: 510317 country: China name: Shengkang Luo role: CONTACT phone: 02089168071 email: [email protected] name: WEIJIN HONG role: CONTACT phone: 02089168071 name: shengkang luo role: PRINCIPAL_INVESTIGATOR name: weijin hong role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06380959 id: 223K879 briefTitle: Art-based Activities in Stroke Patients overallStatus: COMPLETED date: 2023-10-02 date: 2023-12-31 date: 2024-02-29 date: 2024-04-24 date: 2024-04-29 name: Ege University class: OTHER briefSummary: Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients. |
Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: Art Based Activity measure: Herth Hope Index measure: Generalized Self-Efficacy Scale measure: Individual Introduction Form measure: Art Object Concretization Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False |
<|newrecord|> nctId: NCT06380946 id: 978/91 briefTitle: Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy overallStatus: ENROLLING_BY_INVITATION date: 2024-06-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-24 date: 2024-04-24 name: Al-Azhar University class: OTHER briefSummary: The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy. conditions: Effect of Platelet Rich FibrinDuring Clear Aligner Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 78 type: ESTIMATED name: iPRF measure: Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: AlAzhar university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06380933 id: B11103008 briefTitle: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort overallStatus: COMPLETED date: 2022-09-01 date: 2022-09-01 date: 2024-02-28 date: 2024-04-24 date: 2024-04-24 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath. conditions: Sleep Quality conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days. primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 94 type: ACTUAL name: experimental group measure: Richards-Campbell Sleep Questionnaire measure: Numerical Rating of Comfort sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hsu Mei-Lian city: Chiayi City country: Taiwan lat: 23.47917 lon: 120.44889 hasResults: False |
<|newrecord|> nctId: NCT06380920 id: Digital Health App briefTitle: Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-25 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention. conditions: Weight Loss conditions: Body Fat Rate Loss conditions: Body Composition Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: "AI Mindful Eating" App name: Outpatient regular follow-up measure: weight change measure: Parameters of Metabolic syndrome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380907 id: ZL-1102-002 briefTitle: A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02-28 date: 2026-03 date: 2024-04-24 date: 2024-04-26 name: Zai Lab (Hong Kong), Ltd. class: INDUSTRY name: Zai Lab (US) LLC briefSummary: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ZL-1102 1% w/w gel BID for 16 weeks name: ZL-1102 3% w/w gel BID for 16 weeks name: ZL-1102 3% w/w gel QD for 16 weeks name: Placebo ZL-1102 0% w/w gel BID for 16 weeks name: Placebo ZL-1102 0% w/w gel QD for 16 weeks measure: Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16. measure: The proportion of patients achieving IGA treatment success. measure: The proportion of patients achieving IGA score of 0 or 1. measure: The percent change from baseline in mPASI score. measure: The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20. measure: The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20. measure: Time to achieve mPASI 50/75/90. measure: Time to achieve IGA score of 0 or 1. measure: Time to achieve 1- or 2-point improvement in IGA. measure: Incidence of Treatment Related Adverse Events through Week 20. measure: Mean local tolerability scores (LTS) measure: Serum concentration of ZL-1102. measure: Anti-drug antibody (ADA) of ZL-1102. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zai Lab Site 5013 city: Phillip state: Australian Capital Territory zip: 2606 country: Australia lat: -31.13333 lon: 150.85 facility: Zai Lab Site 5016 city: Kotara state: New South Wales zip: 2289 country: Australia lat: -32.95 lon: 151.68333 facility: Zai Lab Site 5017 city: Woolloongabba state: Queensland zip: 4102 country: Australia lat: -27.48855 lon: 153.03655 facility: Zai Lab Site 5014 city: Carlton state: Victoria zip: 3053 country: Australia lat: -37.8 lon: 144.96667 facility: Zai Lab Site 5002 city: Melbourne E. state: Victoria country: Australia lat: -37.81667 lon: 144.9879 facility: Zai Lab Site 5015 city: Melbourne state: Victoria zip: 3124 country: Australia lat: -37.814 lon: 144.96332 hasResults: False |
<|newrecord|> nctId: NCT06380894 id: 2020/2239 briefTitle: Virtual Reality Cognitive Training for Mild Cognitive Impairment overallStatus: COMPLETED date: 2021-01-27 date: 2022-09-30 date: 2023-01-31 date: 2024-04-24 date: 2024-04-24 name: Changi General Hospital class: OTHER briefSummary: This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Virtual Reality Cognitive Training name: Active Control measure: Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11 measure: Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11 measure: Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11 measure: Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11 measure: Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11 sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore country: Singapore lat: 1.28967 lon: 103.85007 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-01-27 uploadDate: 2024-04-15T09:12 filename: Prot_SAP_000.pdf size: 384298 hasResults: False |
<|newrecord|> nctId: NCT06380881 id: SHR-2017-102 briefTitle: PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-07 date: 2024-04-24 date: 2024-04-24 name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain. conditions: Patients With Bone Metastases studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: SHR-2017 measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞ measure: The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2 measure: The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F measure: The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr measure: The pharmacodynamic parameter of SHR-2017 after administration include β-CTX measure: The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time measure: Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing measure: Incidence of skeletal-related event measure: Average daily total opioids consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Huiping Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06380868 id: Nanjing-2 briefTitle: IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus acronym: IVI-DIABETES overallStatus: ENROLLING_BY_INVITATION date: 2024-06-10 date: 2026-06-01 date: 2027-07-20 date: 2024-04-24 date: 2024-04-24 name: Nanjing First Hospital, Nanjing Medical University class: OTHER name: Shanxi Provincial People's Hospital briefSummary: Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial. |
Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI. |
Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will undergo 1:1 randomization to either intravascular imaging (including intravascular ultrasound or optical coherence tomography)-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group, stratified by research sites. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 1332 type: ESTIMATED name: Intravascular imaging-guided PCI name: Angiography-guided PCI group measure: Rate of target vessel failure (TVF) measure: Rate of target vessel failure without procedure-related MI measure: Rate of cardiac death measure: Rate of all-cause death measure: Rate of procedure-related myocardial infarction (PMI) measure: Rate of spontaneous myocardial infarction (SMI) measure: Rate of clinically-driven revascularization measure: Rate of stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210006 country: China lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06380855 id: GIHSYSU-34 briefTitle: Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME) overallStatus: RECRUITING date: 2022-08-24 date: 2025-08-24 date: 2025-08-24 date: 2024-04-24 date: 2024-04-24 name: Sun Yat-sen University class: OTHER briefSummary: The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury. conditions: Rectal Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5 type: ESTIMATED name: Flexible colonoscope assisted hybrid transanal total mesorectal resection measure: Success rate of operation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Liang Kang, MD, PhD role: CONTACT phone: 008613602886833 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06380842 id: 2023HX1970 briefTitle: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-30 date: 2026-12-30 date: 2024-04-24 date: 2024-04-24 name: Chunling Jiang class: OTHER briefSummary: The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy. conditions: Necrotizing Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Necrotizing Pancreatitis patients' organ dysfunction progression measure: Measure organ dysfunction change after open necrosectomy with respect to time measure: incidence of a composite of major complications measure: Incidence of ICU mortality measure: Incidence of hospital mortality measure: Incidence of 28-day mortality measure: Incidence of one year mortality measure: ICU length of hospital stay measure: Length of hospital stay measure: The pancreatic symptoms score measure: The levels of inflammatory factor CRP measure: The levels of inflammatory cytokines IL-6 measure: The levels of inflammatory procalcitonin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380829 id: Adnan Menderes briefTitle: Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form overallStatus: COMPLETED date: 2023-06-05 date: 2023-12-05 date: 2024-02-10 date: 2024-04-24 date: 2024-04-24 name: Aydin Adnan Menderes University class: OTHER briefSummary: This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability. |
Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale? conditions: Cerebral Palsy conditions: Self Care studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 127 type: ACTUAL name: Questionnaire measure: To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Bircan Kahraman Berberoğlu city: Aydın zip: 0900 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False |
<|newrecord|> nctId: NCT06380816 id: CRUKD/24/001 id: ISRCTN26628699 type: REGISTRY domain: ISRCTN briefTitle: A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-11 date: 2029-11 date: 2024-04-24 date: 2024-04-24 name: Cancer Research UK class: OTHER name: UCB Biopharma SRL briefSummary: This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. |
The four main aims of the clinical trial are to find out: |
1. The best dose of UCB4594 that can be given safely to participants in the trial. |
2. What the side effects of UCB4594 are and how they can be managed. |
3. What happens to UCB4594 inside the body and how it affects cancer cells. |
4. Whether UCB4594 can cause cancer to shrink. conditions: Advanced Solid Tumours conditions: Squamous Cell Carcinoma of Head and Neck conditions: Carcinoma, Non-Small-Cell Lung conditions: Colorectal Neoplasms conditions: Triple Negative Breast Neoplasms conditions: Carcinoma, Renal Cell (Clear Cell Only) conditions: Esophageal Neoplasms conditions: Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors) conditions: Uterine Cervical Neoplasms conditions: Ovarian Neoplasms conditions: Pancreatic Neoplasms studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 167 type: ESTIMATED name: UCB4594 measure: Recommended Phase 2 dose (RP2D) of UCB4594 measure: Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles). measure: Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules). measure: Maximum concentration of UCB4594 (monotherapy modules; Modules A and B). measure: Minimum concentration of UCB4594 (monotherapy modules; Modules A and B). measure: Area under the curve of UCB4594 (monotherapy modules; Modules A and B). measure: Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B). measure: Clearance of UCB4594 (monotherapy modules; Modules A and B). measure: Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Christie NHS Foundation Trust city: Manchester country: United Kingdom name: Fiona Thistlethwaite, Prof role: CONTACT phone: +44 (0)161 9187672 email: [email protected] lat: 53.48095 lon: -2.23743 facility: University Hospital Southampton NHS Foundation Trust city: Southampton country: United Kingdom name: Ioannis Karydis, Prof role: CONTACT email: [email protected] lat: 50.90395 lon: -1.40428 hasResults: False |
<|newrecord|> nctId: NCT06380803 id: 4-2020-1385 briefTitle: Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence acronym: ROMCAPO+AI overallStatus: RECRUITING date: 2021-04-29 date: 2025-01-26 date: 2025-01-26 date: 2024-04-24 date: 2024-04-24 name: Severance Hospital class: OTHER name: National Research Foundation of Korea briefSummary: The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery. |
The main question\[s\]it aims to evaluate : |
* Satisfaction questionnaire of a educational program |
* NASA-TLX of a educational program |
* global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiency |
Participants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX. |
The tutor evaluates GEARS for 15 minutes at the beginning and end of training. |
After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide. conditions: Breast Neoplasms conditions: Surgery conditions: Educational Problems conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: A educational program measure: Satisfaction questionnaire of a educational program measure: NASA-Task Load index of a educational program measure: Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency measure: The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide measure: The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide measure: The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University College of Medicine status: RECRUITING city: Seoul zip: 120-752 country: Korea, Republic of name: Hyung Seok Park, MD, PhD role: CONTACT phone: +82-2228-2100 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06380790 id: 8423 briefTitle: Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding overallStatus: RECRUITING date: 2023-05-01 date: 2024-05 date: 2024-10 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment conditions: Orthodontics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Laser-aided csf name: placebo laser-aided csf measure: Rate of tooth movement measure: Pain level measure: Periodontal health sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Faculty of dentistry cairo university status: RECRUITING city: Cairo country: Egypt name: Cairo University role: CONTACT phone: 0223638755 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06380777 id: DDT system for sarcopenia briefTitle: Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia overallStatus: RECRUITING date: 2023-09-01 date: 2028-12-31 date: 2028-12-31 date: 2024-04-24 date: 2024-04-24 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia. |
Research aims: |
Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey. |
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