text
stringlengths 0
197k
|
|---|
The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits. |
The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health. |
The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control. conditions: Behavior, Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: tele-exercise measure: Acceptability (quantitative) measure: Acceptability (qualitative) measure: Recruitment rate measure: Retention rate measure: Attendance rate measure: Compliance rate measure: Cardiorespiratory fitness measure: muscle strength measure: balance measure: % body fat measure: skeletal muscle mass measure: height measure: Shoulder joint range of motion (ROM) of affected side measure: Limb circumference and lymphedema measure: Health-related quality of life measure: Physical activity level (min/week) sex: FEMALE minimumAge: 40 Years maximumAge: 64 Years stdAges: ADULT facility: Xiong Zhennan city: Kowloon Tong state: Kowloon country: Hong Kong lat: 22.33312 lon: 114.17969 facility: Yan SUN city: Kowloon Tong state: Kowloon country: Hong Kong lat: 22.33312 lon: 114.17969 hasResults: False |
<|newrecord|> nctId: NCT06382428 id: T-DAYICAN-002 briefTitle: The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period overallStatus: COMPLETED date: 2022-12-30 date: 2023-11-30 date: 2024-01-30 date: 2024-04-24 date: 2024-04-24 name: Izmir Tinaztepe University class: OTHER name: Biruni University name: Yeditepe University name: Fenerbahce University briefSummary: Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum). conditions: Pelvic Floor Disorders conditions: Postpartum Disorder conditions: Quality of Life conditions: Mothers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 58 type: ACTUAL name: Pelvic floor muscle training measure: Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms measure: Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms measure: Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms measure: Pelvic Floor Distress Inventory-20 to measure the urinary symptoms measure: Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life measure: Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life measure: Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life measure: Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life measure: Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Yeditepe University city: Istanbul zip: 34010 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06382415 id: VINCat_PDO_2 briefTitle: Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery acronym: VINCat_PDO_2 overallStatus: COMPLETED date: 2011-01-01 date: 2016-12-31 date: 2024-03-31 date: 2024-04-24 date: 2024-04-24 name: Hospital de Granollers class: OTHER briefSummary: In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence. conditions: Rectal Cancer conditions: Organ-Space Surgical Site Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3826 type: ACTUAL measure: Rate of overall cancer recurrence measure: Overall survival measure: Rate of Organ-space surgical site infection measure: Rate of surgical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General de Granollers city: Granollers state: Barcelona zip: 08402 country: Spain lat: 41.60797 lon: 2.28773 hasResults: False |
<|newrecord|> nctId: NCT06382402 id: 23.0924 briefTitle: A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-04-30 date: 2024-04-24 date: 2024-04-25 name: University of Louisville class: OTHER briefSummary: This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. conditions: Myocardial Injury studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 700 type: ESTIMATED name: CCTA scan measure: MACE measure: Cardiovascular (CV) mortality measure: Nonfatal MI, stroke measure: Hospitalization for unstable angina measure: Hospitalization for heart failure measure: Unplanned revascularization measure: All-cause mortality measure: In-hospital and 90-day costs measure: Patient quality of life at 90 days measure: Diagnostic certainty scores measure: Individual components of the primary endpoint sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases city: Louisville state: Kentucky zip: 40202 country: United States name: Dinesh Kalra, MD role: CONTACT phone: 502-588-7010 email: [email protected] name: Rongras Damrongwatanasuk, MD role: CONTACT phone: 502-588-7010 email: [email protected] lat: 38.25424 lon: -85.75941 hasResults: False |
<|newrecord|> nctId: NCT06382389 id: DR220204 id: 2023-504691-18-00 type: CTIS briefTitle: Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial- acronym: PROTO-EHPAD overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-08 date: 2026-08 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Tours class: OTHER briefSummary: Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects. |
Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes. |
The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure. conditions: Depression conditions: Neurocognitive Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel assignement primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: EMONO name: Medical air measure: Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline). measure: CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8 measure: CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8 measure: The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8 measure: Collection of adverse events at all study visits sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382376 id: 2024-60 briefTitle: The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2024-03-01 date: 2024-04-24 date: 2024-04-26 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries. |
The key question(s) it aims to answer are: |
\[Is intrathecal morphine more effective in postoperative analgesia?\] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use. conditions: Gynecological Cancer Surgery conditions: Regional Anesthesia Morbidity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 71 type: ACTUAL name: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group measure: postoperative numerical rating scale measure: postoperative opioid use sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Başakşehir Çam and Sakura City Hospital city: Istanbul state: Basaksehir country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06382363 id: UW21-363 briefTitle: Improving T2DM Detection Using Spot cHbA1c Test - a Cluster RCT acronym: DM-REACH overallStatus: RECRUITING date: 2022-06-11 date: 2024-09-30 date: 2024-09-30 date: 2024-04-24 date: 2024-04-24 name: The University of Hong Kong class: OTHER name: Hospital Authority, Hong Kong name: Food and Health Bureau, Hong Kong briefSummary: Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients. |
Design: Pragmatic cluster randomized controlled trial. |
Setting: 8 public primary care clinics in Hong Kong. |
Participants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months. |
Intervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive. |
Main outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups. |
Secondary outcomes include number-needed-to-screen to detect one more T2DM case. |
Data analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated. |
Expected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population. conditions: Diabetes Mellitus conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 776 type: ESTIMATED name: POC-cHbA1c testing measure: Proportional difference in detection of T2DM measure: Uptake rate measure: Proportion of high-risk HbA1c concentration measure: Difference in uptake rate of OGTT measure: Number-needed-to-screen to detect one more T2DM case measure: Proportion of patients who refuse to join the study sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aberdeen Jockey Club General Out-Patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Kwun Tong Community Health Centre status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Lek Yuen General Out-Patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Li Po Chun General Out-Patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Ma On Shan Family Medicine Centre status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Sai Ying Pun Jockey Club General Out-patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Tseung Kwan O (Po Ning Road) General Out-patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Yau Ma Tei Jockey Club Specialist Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False |
<|newrecord|> nctId: NCT06382350 id: KHL-002-2024 briefTitle: Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems acronym: SAFEDRIVE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2026-05 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Motol class: OTHER briefSummary: The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy conditions: Type 1 Diabetes Mellitus conditions: Type 1 Diabetes Mellitus With Hypoglycemia conditions: Drive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: MiniMed 780 G measure: The frequency of hypoglycemia (<3.9 mmol/l) during the driving periods measure: Period of time spent in a range between 3.9 and 4.5 mmol/l (a risky period) during driving. measure: Specific CGM analysis in relation to recorded the daily activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382337 id: A03010240S briefTitle: Immediate Dental Implants in The Upper Anterior Region overallStatus: NOT_YET_RECRUITING date: 2024-04-21 date: 2025-03 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: Mansoura University class: OTHER briefSummary: The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically. conditions: Teeth Loss conditions: Alveolar Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 16 type: ESTIMATED name: Group A : ice cream cone technique name: Group B : the vestibular socket therapy measure: Bone changes measure: soft tissue changes sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Dentistry Mansoura University city: Mansoura zip: 7650001 country: Egypt role: CONTACT phone: 050 2248512 email: [email protected] name: Mohamed Fa Shoeib, demonstrator role: PRINCIPAL_INVESTIGATOR lat: 31.03637 lon: 31.38069 hasResults: False |
<|newrecord|> nctId: NCT06382324 id: 202301280B0 briefTitle: The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction overallStatus: RECRUITING date: 2024-04 date: 2025-06 date: 2025-12 date: 2024-04-24 date: 2024-04-24 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports. |
Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep. |
Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction. conditions: Anterior Cruciate Ligament (Acl) Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention method: |
* Mindfulness napping group: listening to a record of mindfulness meditation practice for 40 minutes. |
* Control group: listening to light music for 40 minutes. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor of polysomnography did not know the data belongs which group whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: mindfulness practice of body scan name: listening to light music measure: Electroencephalogram (EEG) measure: Electrooculography (EOG) measure: Electromyography (EMG) measure: ECG (Electrocardiography) measure: Nasal/Oral airflow measure: Thermistor measure: Chest and abdominal belt measure: Oximetry measure: Snoring measure: Karolinska Sleepiness Scale (KSS) measure: Five Facet Mindfulness Questionnaire (FFMQ) measure: State-Trait Anxiety Inventory (STAIS) measure: Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGungMH status: RECRUITING city: Keelung zip: 204004 country: Taiwan name: Jian-Hong Chen role: CONTACT phone: 096-130-7506 email: [email protected] name: Chang Gung Memorial Hospital role: PRINCIPAL_INVESTIGATOR lat: 25.12825 lon: 121.7419 hasResults: False |
<|newrecord|> nctId: NCT06382311 id: 221824 briefTitle: A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults overallStatus: RECRUITING date: 2024-04-18 date: 2024-08-21 date: 2025-05-21 date: 2024-04-24 date: 2024-04-24 name: GlaxoSmithKline class: INDUSTRY briefSummary: The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age. conditions: Influenza, Human studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Data will be collected in an observer-blind manner in Phase 1 and Phase 2. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1080 type: ESTIMATED name: Flu Pandemic mRNA_Dose level 1 name: Flu Pandemic mRNA_Dose level 2 name: Flu Pandemic mRNA_ Dose level 3. name: Flu Pandemic mRNA_ Dose level 4 name: Flu Pandemic mRNA_Dose level 5 name: Flu Pandemic mRNA_Dose level 6 name: Flu Pandemic mRNA_Dose level 7 name: Placebo measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A] measure: Phase 1: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 measure: Phase 1: Percentage of participants with increased in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29 measure: Phase 1: Percentage of participants with increased in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 measure: Phase 1: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29 measure: Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited administration site events [Phase 2 Part B] measure: Percentage of participants with solicited systemic events [Phase 2 Part B] measure: Percentage of participants with unsolicited AEs [Phase 2 Part B] measure: Percentage of participants with MAAEs [Phase 2 Part B] measure: Percentage of participants with SAEs [Phase 2 Part B] measure: Percentage of participants with AESIs [Phase 2 Part B] measure: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B] measure: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B] measure: Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B] measure: Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A] measure: Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A] measure: GMT of Anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B] measure: Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B] sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Anniston state: Alabama zip: 36207 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Almena L Free role: PRINCIPAL_INVESTIGATOR lat: 33.65983 lon: -85.83163 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72204 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Derek Lewis role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Fort Collins state: Colorado zip: 80525 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Michael Thakor role: PRINCIPAL_INVESTIGATOR lat: 40.58526 lon: -105.08442 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Fort Myers state: Florida zip: 33912 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Pedro P Ylisastigui role: PRINCIPAL_INVESTIGATOR lat: 26.62168 lon: -81.84059 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: West Palm Beach state: Florida zip: 33409 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Mira Baron role: PRINCIPAL_INVESTIGATOR lat: 26.71534 lon: -80.05337 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Chamblee state: Georgia zip: 30341 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Adebowale Akintayo role: PRINCIPAL_INVESTIGATOR lat: 33.89205 lon: -84.29881 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: El Dorado state: Kansas zip: 67042 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Michael Rausch role: PRINCIPAL_INVESTIGATOR lat: 37.81724 lon: -96.86225 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Lenexa state: Kansas zip: 66219 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Carlos A Fierro role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Mark S Adams role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64114 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Martha Sue Fanning role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68144 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Tamara Doehner role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Raj Singh role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Rochester state: New York zip: 14609 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Matthew G Davis role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Alexander Vance Murray role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Robert Dean Rosen role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Edmond state: Oklahoma zip: 73013 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Kyle Rickner role: PRINCIPAL_INVESTIGATOR lat: 35.65283 lon: -97.4781 facility: GSK Investigational Site status: RECRUITING city: Yukon state: Oklahoma zip: 73099 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Robert J. Lockwood role: PRINCIPAL_INVESTIGATOR lat: 35.50672 lon: -97.76254 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19111 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Max Mercado role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site status: RECRUITING city: Austin state: Texas zip: 78705 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Laurence Chu role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Norfolk state: Virginia zip: 23502 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Mary Bailey role: PRINCIPAL_INVESTIGATOR lat: 36.84681 lon: -76.28522 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98015 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Ashley Fuller role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06382298 id: PROJECT00009332 briefTitle: Cottonseed Oil Versus Matched PUFA Effects overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-12 date: 2028-05 date: 2024-04-24 date: 2024-04-26 name: University of Georgia class: OTHER name: United States Department of Agriculture (USDA) briefSummary: Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk. |
The specific aims are: |
* Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. |
* Examine the impact of CSO on other markers of chronic disease risk. |
Participants will be asked to: |
* Consume provided meal replacement shakes daily for 28-days. |
* Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials, |
* Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. |
Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets. conditions: Dyslipidemia conditions: Overweight and Obesity conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three groups of 28-day parallel feeding trials with two groups receiving 20% of energy needs from CSO, or matched PUFA diet, and one group serving as control receiving 20% of energy needs as a mixture of oils that match the fatty acid profile of the average American intake. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants are blinded to oil intervention group. Investigator blinded to participant's oil intervention group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: COTTONSEED OIL name: MATCHED PUFA DIET name: CONTROL measure: Change in fasting serum lipoprotein and cholesterol concentrations measure: Change in fasting serum lipoprotein particle numbers measure: Change in fasting and postprandial plasma triglyceride concentrations measure: Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations measure: Change in fasting and postprandial plasma glucose concentrations measure: Change in fasting and postprandial plasma insulin concentrations measure: Change in fasting and postprandial plasma appetite control hormones concentrations measure: Change in fasting and postprandial subjective feelings related to appetite measure: Change in fasting and postprandial plasma Malondialdehyde (MDA) measure: Change in fasting and postprandial plasma total antioxidant capacity measure: Change in fasting inflammatory cytokine concentrations measure: Change in fasting plasma markers of coagulation potential measure: Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins measure: Change in fasting insulin resistance metrics measure: Desaturation index measure: Change in fasting serum hepatic enzymes measure: Change in fasting serum hepatic proteins measure: Change in fasting serum bilirubin measure: Change in additional fasting plasma inflammatory cytokine concentrations measure: Change in additional fasting plasma markers of coagulation potential measure: Change in acute dietary intake measure: Change in blood pressure measure: Change in body weight measure: Change in body composition measure: Change in diet composition measure: Change in fasting tocopherol concentrations measure: Change in anthropometric circumferences measure: Change in resting metabolic rate measure: Change in Perceived Stress measure: Change in anxiety measure: Change in self reported physical activity levels measure: Change in Body Mass Index (BMI) sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Georgia city: Athens state: Georgia zip: 30602 country: United States lat: 33.96095 lon: -83.37794 hasResults: False |
<|newrecord|> nctId: NCT06382285 id: 0206-22-ASF briefTitle: The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2025-10-30 date: 2026-01-31 date: 2024-04-24 date: 2024-04-24 name: Assaf-Harofeh Medical Center class: OTHER_GOV briefSummary: The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery conditions: Knee Replacement Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Continues peripheral block measure: Pain level measure: Analgesic use measure: Physiotherapy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382272 id: IRB23-2027 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-24 date: 2024-04-24 name: [Redacted] hasResults: False |
<|newrecord|> nctId: NCT06382259 id: H24-Acute-Movement-Breaks briefTitle: The Acute Effect of Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2025-07-15 date: 2025-07-15 date: 2024-04-24 date: 2024-04-24 name: University of British Columbia class: OTHER name: McMaster University briefSummary: To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Movement breaks measure: Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring measure: Time in range determined using continuous glucose monitoring measure: Time above range determined using continuous glucose monitoring measure: Time below range determined using continuous glucose monitoring measure: Glycemic variability determined using continuous glucose monitoring measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382246 id: H24-Acute-ExSnacks briefTitle: The Acute Effect of "Exercise Snacks" on Glycemic Responses in Individuals With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2025-07-15 date: 2025-07-15 date: 2024-04-24 date: 2024-04-24 name: University of British Columbia class: OTHER name: McMaster University briefSummary: To conduct a randomized crossover trial to determine the acute impact of exercise snacks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized controlled crossover design primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Exercise snacks measure: Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring measure: Time in range determined using continuous glucose monitoring measure: Time above range determined using continuous glucose monitoring measure: Time below range determined using continuous glucose monitoring measure: Glycemic variability determined using continuous glucose monitoring measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382233 id: PRO-FUTURE project briefTitle: The PRO-FUTURE Project acronym: PRO-FUTURE overallStatus: RECRUITING date: 2024-01-30 date: 2026-01-30 date: 2028-01-30 date: 2024-04-24 date: 2024-04-24 name: University of Campania "Luigi Vanvitelli" class: OTHER name: University of Milan name: A.O.R.N. Santobono-Pausilipon name: University of Modena and Reggio Emilia name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico briefSummary: The goal of this observational study is to learn about specific biomarkers of unilateral ureteropelvic junction obstruction (UPJO) in children undergoing surgical intervention for unilateral UPJO compared with controls. The main question it aims to answer are: |
* Are Urinary single-cell and extracellular vesicles (EVs) screening useful to stage the intrarenal injury and repair processes in UPJO babies? |
* Do babies with unilateral UPJO have a whole blood gene expression profiling (WBGEP) allowing an accurate unilateral UPJO diagnosis? conditions: Ureteropelvic Junction Obstruction conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 85 type: ESTIMATED name: Identification of Diagnostic Biomarkers measure: Urine Biomarkers measure: Blood Biomarkers sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Univeristà degli Studi della Campania Luigi Vanvitelli status: RECRUITING city: Naples state: Campania zip: 80138 country: Italy name: Pierluigi Marzuillo role: CONTACT name: Pierluigi Marzuillo role: PRINCIPAL_INVESTIGATOR name: Paolo Montaldo role: PRINCIPAL_INVESTIGATOR name: Carmine Noviello role: PRINCIPAL_INVESTIGATOR name: Alfonso Papparella role: SUB_INVESTIGATOR name: Stefano Guarino role: SUB_INVESTIGATOR name: Anna Di Sessa role: SUB_INVESTIGATOR name: Grazia Cirillo role: SUB_INVESTIGATOR name: Giusy Capasso role: SUB_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Department of Clinical Sciences and Community Health, University of Milano status: ACTIVE_NOT_RECRUITING city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Giovanni Montini role: CONTACT name: Giovanni Montini role: PRINCIPAL_INVESTIGATOR name: Alfredo Berrettini role: PRINCIPAL_INVESTIGATOR name: Michele Gnech role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia status: RECRUITING city: Modena country: Italy name: Giovanni Grandi role: CONTACT name: Giovanni Grandi role: PRINCIPAL_INVESTIGATOR name: Stefano Puliatti role: SUB_INVESTIGATOR lat: 44.64783 lon: 10.92539 facility: AORN Santobono-Pausilipon status: RECRUITING city: Naples country: Italy name: Giovanni Di Iorio role: CONTACT name: Giovanni Di Iorio role: PRINCIPAL_INVESTIGATOR name: Agnese Roberti role: SUB_INVESTIGATOR lat: 40.85216 lon: 14.26811 hasResults: False |
<|newrecord|> nctId: NCT06382220 id: R550 briefTitle: Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics overallStatus: RECRUITING date: 2024-04-23 date: 2024-07-25 date: 2024-08-15 date: 2024-04-24 date: 2024-04-25 name: Fayoum University Hospital class: OTHER briefSummary: Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications . |
Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade. |
Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration, |
The aim of this study |
To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people. conditions: Recruitment studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bupivacain measure: The rate of occurrence of hypotension sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fayoum University hospital status: RECRUITING city: Fayoum state: Faiyum Governorate zip: 63514 country: Egypt name: Mohamed A Hamed, MD role: CONTACT phone: 01118560065 phoneExt: 02 email: [email protected] name: Mahdy A Abdelhady, MD role: CONTACT phone: 0120363256 phoneExt: 02 email: [email protected] lat: 29.30995 lon: 30.8418 hasResults: False |
<|newrecord|> nctId: NCT06382207 id: HM20029298 briefTitle: Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: Virginia Commonwealth University class: OTHER name: Eko Devices, Inc. briefSummary: When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. conditions: Tachyarrhythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This proof-of-concept study will enroll infants, defined as individuals \<1 year of age. It will assess the feasibility and effectiveness of a physician and parent/caregiver in using the Eko DUO and CORE 500 to capture ECGs in patients \<10 kg in a clinic and home setting. primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Eko Duo electronic stethoscope name: CORE 500 electronic stethoscope measure: Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500 measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500 measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500 measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only sex: ALL maximumAge: 1 Year stdAges: CHILD facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States lat: 37.55376 lon: -77.46026 hasResults: False |
<|newrecord|> nctId: NCT06382194 id: STUDY00014522 id: 1R21AG076362-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AG076362-01 briefTitle: Decision Making Tool for Firearm Storage overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Washington class: OTHER name: National Institute on Aging (NIA) briefSummary: This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage. conditions: Dementia, Mild conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 66 type: ESTIMATED name: Decision aid measure: Firearm storage (adapted from the National Firearm Survey) measure: Low-Literacy Decisional Conflict Scale measure: Knowledge Questionnaire measure: Feasibility of intervention delivery measure: Acceptability of Intervention Measure sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98104 country: United States name: Rachel Ross, MPH role: CONTACT phone: 509-596-1438 email: [email protected] name: Elizabeth A Phelan, MD role: PRINCIPAL_INVESTIGATOR name: Laura Prater, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06382181 id: 2023- ENFPOD-2621979 id: Silvia Corchón Arreche type: OTHER domain: University of Valencia id: Omar Cauli type: OTHER domain: University of Valencia briefTitle: A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness overallStatus: COMPLETED date: 2023-04-01 date: 2023-07-01 date: 2023-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Valencia class: OTHER briefSummary: The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise). conditions: Loneliness conditions: Mental Health Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were assigned to three groups in parallel for the duration of the study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ACTUAL name: Music therapy for community-dwelling individuals with unwanted loneliness name: Health education for community-dwelling individuals with unwanted loneliness name: Physical exercise for community-dwelling individuals with unwanted loneliness measure: Score on the Jong Gierveld Loneliness Scale measure: Score on Goldberg Anxiety and Depression Scale sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: Vanessa Ibáñez del Valle city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False |
<|newrecord|> nctId: NCT06382168 id: D19-11186 briefTitle: Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-03-31 date: 2025-06-30 date: 2024-04-24 date: 2024-04-24 name: Delta-Fly Pharma, Inc. class: INDUSTRY briefSummary: This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants. conditions: Leukemia, Myeloid, Acute studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: DFP-10917 name: Venetoclax measure: Number of patients with dose-limiting toxicities assessed by CTCAE v5.0. measure: Number of patients with treatment-related adverse events assessed by CTCAE v5.0. measure: Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period). measure: The proportion of patients who achieve complete remission. measure: The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery. measure: The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state. measure: Overall survival. measure: Progression-free survival. measure: Maximum concentration of DFP-10917. measure: Area under the curve of DFP-10917. measure: Volume of distribution of DFP-10917. measure: Clearance of DFP-10917. measure: Time to maximum concentration of venetoclax. measure: Maximum concentration of venetoclax. measure: Elimination half-life of venetoclax. measure: Area under the curve of venetoclax. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCI Chao Family Comprehensive Cancer Center city: Orange state: California zip: 92868 country: United States name: Kiran Naqvi role: PRINCIPAL_INVESTIGATOR lat: 33.78779 lon: -117.85311 facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Timothy Pardee role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: Simmons Cancer Center: UT Southwestern city: Dallas state: Texas zip: 75235 country: United States lat: 32.78306 lon: -96.80667 facility: University of Vermont Cancer Center city: Burlington state: Vermont zip: 05401 country: United States name: Diego Adrianzen Herrer role: PRINCIPAL_INVESTIGATOR lat: 44.47588 lon: -73.21207 facility: University of Virginia Cancer Center city: Charlottesville state: Virginia zip: 22911 country: United States name: Michael Keng role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 hasResults: False |
<|newrecord|> nctId: NCT06382155 id: 111-210 briefTitle: A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-06 date: 2036-12 date: 2024-04-24 date: 2024-04-24 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH), in children with idiopathic short stature (ISS). conditions: Idiopathic Short Stature studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Vosoritide Injection name: Human Growth Hormone name: Placebo measure: Change from baseline in Annualized Growth Velocity (AGV) measure: Change from baseline in height measure: Change from baseline in height Z-score measure: Incidence of treatment-emergent adverse events measure: Change from baseline in AGV Z-score (average stature reference) measure: Change from baseline in height measure: Change from baseline in height Z score measure: Change from baseline at prespecified timepoints in urine cyclic guanine monophosphate (cGMP) measure: Change from baseline at pre-specified timepoints in serum collagen X marker (CXM) measure: Change from baseline in bone age minus chronological age at pre-specified timepoints measure: Change from baseline in total body (less head) bone mineral density (BMD) Z-score measure: Change from baseline in lumbar spine BMD Z-score measure: Change from baseline in total body (less head) bone mineral content (BMC) measure: Change from baseline in lumbar spine BMC measure: Maximum concentration (Cmax) of vosoritide in plasma measure: Area under the plasma vosoritide concentration time-curve from time 0 to infinity (AUC0-∞) measure: Area under the plasma vosoritide concentration time-curve from time 0 to the last measurable concentration (AUC0-t) measure: Elimination half-life of vosoritide (t½) measure: Apparent clearance of vosoritide measure: Apparent volume of distribution of vosoritide based upon the terminal phase (Vz/F) measure: Time vosoritide is present at maximum concentration (Tmax) sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06382142 id: BL-B01D1-307 briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-24 date: 2024-04-24 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure. conditions: Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 436 type: ESTIMATED name: BL-B01D1 name: Eribulin name: Vinorelbine name: Gemcitabine name: Capecitabine measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai country: China name: Jiong Wu role: CONTACT name: Jiong Wu role: PRINCIPAL_INVESTIGATOR name: Jian Zhang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06382129 id: BL-B01D1-302 briefTitle: A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-24 date: 2024-04-24 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 558 type: ESTIMATED name: BL-B01D1 name: Docetaxel measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences city: Beijing state: Beijing country: China name: Jie Wang role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06382116 id: BL-B01D1-301 briefTitle: A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-24 date: 2024-04-24 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: BL-B01D1 name: Pemetrexed+Cisplatin or Carboplatin measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong country: China name: Li Zhang role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06382103 id: B2024-108R briefTitle: Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-05-20 date: 2026-05-20 date: 2024-04-24 date: 2024-04-24 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: ctDNA monitoring name: Plasma proteomic analysis measure: Correlation between ctDNA level and recurrence-free survival (RFS) measure: Correlation between specific plasma protein expression level and recurrence-free survival (RFS) measure: Correlation between tumor mutation numbers and recurrence-free survival (RFS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06382090 id: PamukkaleU-SBE-BB-01 briefTitle: Premenstrual Syndrome and Laughter Yoga overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-05-24 date: 2025-05-24 date: 2024-04-24 date: 2024-04-24 name: Pamukkale University class: OTHER briefSummary: In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined. conditions: Premenstrual Syndrome conditions: Laughter studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups: comparative experiment and control primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ESTIMATED name: Laughter yoga measure: Premenstrual Symptom Scale sex: FEMALE minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06382077 id: CPSP5502 briefTitle: Chronic Post Surgical Pain-Cardiac acronym: CPSP-Cardiac overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-04-25 date: 2025-10-25 date: 2024-04-24 date: 2024-04-24 name: Ondokuz Mayıs University class: OTHER briefSummary: The CPSP-Cardiac is a large, multi-center, observational study with the aim to investigate the incidence of chronic pain in the 3rd month postoperatively in cardiac surgery and its affecting factors. conditions: Chronic Post-surgical Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1176 type: ESTIMATED measure: The incidence of chronic postsurgical pain measure: Postoperative opioid consumption in the first 24 hours measure: Postoperative pain scores measure: The incidences of postoperative nausea and vomiting measure: The number of patients with side effects and complications measure: Time to extubation measure: Length of stay in the intensive care unit measure: Length of stay in the hospital measure: Chronic pain status at 3 and 6 months measure: Psychological assessment measure: Quality of life assessment measure: Postoperative complications at 3 and 6 months sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University city: Samsun state: Atakum zip: 55139 country: Turkey lat: 41.27976 lon: 36.3361 facility: Istanbul University city: Istanbul country: Turkey name: Zerrin Sungur role: CONTACT lat: 41.01384 lon: 28.94966 facility: Marmara University city: Istanbul country: Turkey name: Alper Kararmaz role: CONTACT lat: 41.01384 lon: 28.94966 facility: Burhan Dost city: Samsun zip: 55270 country: Turkey name: BURHAN DOST role: CONTACT phone: 05327042493 email: [email protected] lat: 41.27976 lon: 36.3361 hasResults: False |
<|newrecord|> nctId: NCT06382064 id: 2024H0089 briefTitle: Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-16 date: 2024-09 date: 2025-05 date: 2024-04-24 date: 2024-04-24 name: Ohio State University class: OTHER briefSummary: This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks. primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Biweekly replacement contact lenses name: One week replacement contact lenses measure: Subjective assessment of lens wear experience sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University College of Optometry city: Columbus state: Ohio zip: 43210 country: United States lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06382051 id: CAIN457ACA06 briefTitle: Modifying PEST for Psoriatic Arthritis Screening acronym: ScreenX overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2025-04-30 date: 2025-04-30 date: 2024-04-24 date: 2024-04-24 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada. |
Patients will be enrolled in the study for up to 66 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status. conditions: Plaque Psoriasis conditions: Psoriatic Arthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 502 type: ESTIMATED name: PEST Screening group measure: Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs measure: Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist measure: Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist measure: Proportion of patients with a false positive score between each group measure: Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests measure: Patient acceptability/user experience of the PEST+2 questionnaire measure: Administration of dermatologist quantitative surveys measure: Qualitative interview with selected dermatologists measure: Intervention Appropriateness Measure (IAM) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382038 id: HZKY-PJ-2024-19 briefTitle: Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism acronym: SmaPE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-31 date: 2026-10-31 date: 2024-04-24 date: 2024-04-24 name: Navy General Hospital, Beijing class: OTHER briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention. |
The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE. conditions: Venous Thromboembolism conditions: Pulmonary Thromboembolisms conditions: Clinical Decision Support Systems conditions: Digital Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 3078 type: ESTIMATED name: mobile venous thromboembolism application (mVTEA) measure: VTE-related composite event measure: Patient satisfaction with anticoagulant treatment measure: Generic quality of life measure: Recurrent VTE measure: Chronic thromboembolic pulmonary hypertension (CTEPH) measure: Major bleeding measure: VTE-related hospitalization measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100048 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06382025 id: Alkinstorybook briefTitle: Preoperative Information With Storybook for Pediatric Anesthesia overallStatus: COMPLETED date: 2018-03-09 date: 2020-02-20 date: 2020-05-29 date: 2024-04-24 date: 2024-04-24 name: Trakya University class: OTHER briefSummary: Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period. conditions: Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 168 type: ACTUAL name: showing cartoons -storybook name: showing cartoons - standard measure: preoperative anxiety scale measure: State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents measure: Children's Hospital of Eastern Ontario Pain (CHEOP) Scale measure: Pediatric Anesthesia Emergence Delirium (PAED) scale sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Trakya University city: Edirne state: Edi̇rne zip: 22030 country: Turkey lat: 41.67719 lon: 26.55597 hasResults: False |
<|newrecord|> nctId: NCT06382012 id: 2024-15703 briefTitle: Antiemetic Fosaprepitant To Remedy Nausea and Vomiting acronym: AFTR NV RCT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-26 name: Montefiore Medical Center class: OTHER briefSummary: The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration. conditions: Nausea and Vomiting conditions: Nausea conditions: Vomiting studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Fosaprepitant 150 mg name: Ondansetron 4 mg measure: Sustained Relief from NV measure: Severity of Nausea measure: Need for rescue antiemetic medication measure: Medication Preference measure: Functional disability measure: Vomiting measure: Hospitalization measure: Fluid Treatment measure: Mean Fluid Volume measure: Length of Stay measure: QTc Interval (QT interval corrected for heart rate) measure: Revisit Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center (Montefiore and Weiler EDs) city: Bronx state: New York zip: 10467 country: United States name: Mustfa K Manzur, MD role: CONTACT phone: 718-920-6626 email: [email protected] lat: 40.84985 lon: -73.86641 hasResults: False |
<|newrecord|> nctId: NCT06381999 id: M602011083 briefTitle: Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool acronym: I-REFER overallStatus: COMPLETED date: 2023-10-27 date: 2024-02-26 date: 2024-02-26 date: 2024-04-24 date: 2024-04-24 name: Merz Therapeutics GmbH class: INDUSTRY briefSummary: The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool. conditions: Post-stroke Spasticity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 73 type: ACTUAL measure: Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral measure: Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gailtal-Klinik city: Hermagor zip: 9620 country: Austria lat: 46.62722 lon: 13.36722 hasResults: False |
<|newrecord|> nctId: NCT06381986 id: SHJ002-SJP2 briefTitle: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-02 date: 2024-04-24 date: 2024-04-24 name: Sunhawk Vision Biotech, Inc. class: INDUSTRY briefSummary: The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.