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<\|newrecord\|> nctId: NCT06302296 id: Hama University/ briefTitle: Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement overallStatus: RECRUITING date: 2024-04-20 date: 2024-05-15 date: 2025-07-15 date: 2024-03-08 date: 2024-03-08 name: Hama University class: OTHER briefSummary: One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize. conditions: Tooth Mobility conditions: Injectable Platelet-rich Fibrin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 14 type: ESTIMATED name: injectable form of PRF name: Placebo injection measure: Leveling and alignment maxillary incisors sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Fadi Jnaid status: RECRUITING city: Hama country: Syrian Arab Republic name: Fadi Jnaid, Associate Professor role: CONTACT email: Drfadijnaid@gmail.com name: PhD role: CONTACT phone: 0988499015 lat: 35.13179 lon: 36.75783 hasResults: False
<\|newrecord\|> nctId: NCT06302283 id: 114/23-EP briefTitle: Collateral Effects of Pandemics - Care for Informal Caregivers acronym: COLLPAN-3A overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: University of Bonn class: OTHER name: Wuerzburg University Hospital name: Johannes Gutenberg University Mainz name: Universitätsklinikum Hamburg-Eppendorf briefSummary: The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics. conditions: Bereavement studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Survey measure: Bereavement burden measure: Anxiety measure: Depression measure: Caregiving burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn city: Bonn zip: 53127 country: Germany lat: 50.73438 lon: 7.09549 hasResults: False
<\|newrecord\|> nctId: NCT06302270 id: K2024-0507 briefTitle: CFTR Modulators in Pregnancy and Postpartum overallStatus: RECRUITING date: 2024-03-15 date: 2034-01-31 date: 2039-01-31 date: 2024-03-08 date: 2024-03-08 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED measure: Health effects in the newborn infant sex: ALL maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Stockholm CF center status: RECRUITING city: Stockholm country: Sweden name: Terezia Pinzikova, MD, PhD role: CONTACT phone: +46 8 123 80000 email: jenny.svedenkrans@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06302257 id: 0532-23-HMO briefTitle: Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine in Labor Epidural Analgesia. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-08 date: 2024-03-12 name: Hadassah Medical Organization class: OTHER briefSummary: Abstract: Background: The current "gold standard" epidural analgesia involves some undesirable side effects such as motor and sympathetic blockade. Here, the investigators suggest a new approach for inducing prolonged differential pain blockade during labor by selectively targeting local anesthetic chloroprocaine to the pain-related peripheral (nociceptive) fibers. The investigators approach involves nociceptor-selective anesthesia by selective targeting of ionized local anesthetics into nociceptive fibers via activation of nociceptor-specific TRPV1 channels. The authors demonstrated that activation of these channels by specific TRPV1-agonists (capsaicin or the local anesthetic lidocaine), allows entry of a polarized, membrane-impermeable lidocaine derivative (QX-314) specifically into nociceptive neurons, inhibiting their activity and pain blockade, without causing other neural effects. Capsaicin and QX-314 are not suitable for clinical use, as capsaicin causes severe injection pain and QX-314 is neurotoxic. Here, the investigators use lidocaine as the TRPV1 agonist, and use the high pKa chloroprocaine as the ionized local anesthetic instead of the toxic QX-314. Both drugs are in routine clinical use, but have not been described in co-administration before. The investigators preclinical results show that co-administration of chloroprocaine with TRPV1 agonists, leads to prolonged nociceptor-specific analgesia. KKK Hypothesis: The investigators hypothesize that co-administration of epidural lidocaine (to activate TRPV1 channels) and chloroprocaine (as a polarized local anesthetic which can gain preferential access to nociceptors via opened TRPV1 pores) will elicit selective nociceptive-anesthesia. Methodology: This study assess epidural local analgesia in nulliparous labor. There are 2 stages: Stage 1: Prior to direct comparison of lidocaine (Group L), chloroprocaine (Group C), and a lidocaine-chloroprocaine combination (Group L-C), the investigators first determine equipotential doses of epidural chloroprocaine and lidocaine using double-blinded up-down sequential analysis using the well-established minimum local anesthetic concentration (MLAC or ED50) design. ED50 is estimated using Dixon-Massey analysis and Wilcoxon and Litchfield probit regression. Stage 2: The main phase of the study involves a randomized double-blinded comparison between Groups L, C and L-C where all drug concentrations are based on the ED50/MLAC from the Stage 1. The primary endpoint is a composite measure of selective nociceptive analgesia (VAS pain score / modified Bromage motor score). Secondary outcomes are: 1. pain (VAS 0-100), 2. modified Bromage motor score, 3. thermal imaging of feet and hands, 4. sensory assessment to cold sensation using ice, 5. anesthesia requirement from the PCEA pump, 6. maternal blood pressure. 7. ambulation, and pushing ability in labor. Primary endpoint is assessed using repeated measures ANOVA (first 30-min) and mixed models ANOVA until first analgesic request. Implications: Positive findings will be the first evidence in humans of nociceptor-specific local anesthesia; will provide a more effective neuraxial analgesia protocol for labor, and will lead to future studies of systemic nociceptor-specific local anesthesia. conditions: Labor Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Chlorprocaine name: Lidocaine name: Lidocaine-chlorprocaine combination measure: VAS pain score / modified Bromage motor block score measure: Segmental sympathectomy measure: Sensory assessment to cold sensation measure: Anesthesia requirement. measure: Pushing ability in labor. measure: Maternal Blood pressure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Hadassah Hebrew University Medical Center, POB 12000 city: Jerusalem zip: 91120 country: Israel lat: 31.76904 lon: 35.21633 hasResults: False
<\|newrecord\|> nctId: NCT06302244 id: R-21075263 briefTitle: Multimodal Neuromonitoring in Acute Brain Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2017-03-27 date: 2023-06-01 date: 2024-11-01 date: 2024-03-08 date: 2024-03-12 name: Rigshospitalet, Denmark class: OTHER briefSummary: Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.
The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.
The individual studies are detailed below: conditions: Acute Brain Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL measure: Correlation between systemic glucose and microdialysis glucose measure: Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg). measure: Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure. measure: The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening measure: The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome measure: Length of hospital stay measure: Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg). measure: Functional outcome at six months measure: Mortality at six months measure: Length of stay in the ICU sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06302231 id: 16690919.5.0000.5347 briefTitle: Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.
Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.
The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity. conditions: Time Restricted Eating conditions: Obesity conditions: Intermittent Fasting conditions: Overweight and Obesity conditions: Time Restricted Feeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Dietary and Exercise Approaches name: Dietary and Exercise Approaches name: Dietary Approach measure: Insulin sensitivity (indices) measure: Insulin resistance (indices) measure: Fasting insulin levels (µIU/mL) measure: Fasting glucose levels (mg/dL) measure: Glucose tolerance measure: Fasting lipid profile levels measure: β cell function (indices) measure: Fat Mass (kg) measure: Fat Percentage (%) measure: Fat Free Mass (kg) measure: Body Weight (kg) measure: Body Weight (kg) measure: Bone Mineral Content (kg) measure: Body Mass Index (kg/m^2) measure: Fasting ketones (β-hydroxybutyrate) levels (mmol/L) measure: Resting metabolic rate (Kcal/day) measure: Substrate Oxidation (respiratory exchange ratio) measure: Absolute Peak oxygen consumption measure: Relative Peak oxygen consumption measure: Fasting Leptin Levels measure: Fasting Adiponectin Levels measure: Inflammatory Markers Levels measure: LDL-cholesterol levels measure: Non-HDL-cholesterol levels sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302218 id: 5/2024 briefTitle: ESPB vs iPACK+ACB in Total Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-10-30 date: 2024-03-08 date: 2024-03-08 name: Poznan University of Medical Sciences class: OTHER briefSummary: Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty conditions: Knee Arthritis conditions: Knee Arthropathy conditions: Knee Osteoarthritis conditions: Knee Pain Chronic conditions: Knee Disease conditions: Knee Rheumatism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ropivacaine 0.2% Injectable Solution name: Ropivacaine 0.2% Injectable Solution name: control group measure: Opioid consumption measure: Time to first rescue opiate analgesia measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Numerical Rating Scale [range 0:10] measure: Neutrophil-to-lymphocyte ratio measure: Neutrophil-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Platelet-to-lymphocyte ratio measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5] sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Poznan University of Medical Sciences city: Poznan state: Poznań zip: 61-701 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False
<\|newrecord\|> nctId: NCT06302205 id: S66232 briefTitle: A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity acronym: PHOENIX-L overallStatus: RECRUITING date: 2023-03-01 date: 2026-01 date: 2026-12 date: 2024-03-08 date: 2024-04-01 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: KU Leuven briefSummary: Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator.
At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.
To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase. conditions: Liver Transplantation conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two interventional groups and one control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The nature of the intervention does not allow blinding of study participants. However, outcome assessors and data investigators will be blinded to the participants' group allocation. whoMasked: OUTCOMES_ASSESSOR count: 147 type: ESTIMATED name: Physical activity name: Sham intervention measure: Cardiorespiratory fitness measure: Functional exercise capacitiy measure: Hand grip strength measure: Knee-extensor strength measure: Endothelial function measure: Arterial stiffness measure: Graft function measure: Occurence of adverse events measure: Motor fitness measure: Blood pressure measure: Blood profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Hanne Van Criekinge role: CONTACT phone: +3216343162 email: hanne.vancriekinge@kuleuven.be name: Diethard Monbaliu, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
<\|newrecord\|> nctId: NCT06302192 id: 4302 briefTitle: Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study) acronym: RED-AKI overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-31 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Policlinico Hospital class: OTHER briefSummary: This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:
* PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
* SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation conditions: Acute Kidney Injury conditions: ARDS, Human studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 164 type: ESTIMATED name: ARDS+AKI measure: cumulative incidence measure: AKI14 measure: AKIstage measure: cross talk lung-kidney measure: CRRT measure: incidence of failed exam measure: CKD progression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302179 id: 140-14/24 briefTitle: Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery overallStatus: COMPLETED date: 2015-01 date: 2017-12 date: 2023-05 date: 2024-03-08 date: 2024-03-08 name: Pirogov Russian National Research Medical University class: OTHER briefSummary: Aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. There were 137 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2016 to December 2017. Compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism. conditions: Colorectal Cancer conditions: Venous Thromboembolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 137 type: ACTUAL measure: Venous Thromboembolism sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pirogov Russian National Research Medical University city: Moscow zip: 117997 country: Russian Federation lat: 55.75222 lon: 37.61556 hasResults: False
<\|newrecord\|> nctId: NCT06302166 id: HafsaJaved briefTitle: Effects of HICT and Intermittent Fasting on PCOS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-01 date: 2024-07-01 date: 2024-03-08 date: 2024-03-08 name: Riphah International University class: OTHER briefSummary: The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.
Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns. conditions: Polycystic Ovary Syndrome conditions: PCO studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: High Intensity Circuit training (HICT) name: Intermittent Fasting (IF) name: Combination of HICT and IF measure: PCOS Morphology measure: Anthropometrics measure: Clinical Hyperandrogenism measure: Body Image concerns sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: AlMuratza Hospital city: Rawalpindi state: Punjab zip: 44000 country: Pakistan name: Sarah Ehsan, PP-DPT role: CONTACT phone: 03217770829 email: sarah.ehsaan@riphah.edu.pk name: Hafsa Javed, DPT role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False
<\|newrecord\|> nctId: NCT06302153 id: amnashahid briefTitle: Progressive Loading Exercises and Conditioning Exercises on Calf Strain acronym: runners overallStatus: COMPLETED date: 2023-06-01 date: 2024-02-10 date: 2024-02-10 date: 2024-03-08 date: 2024-03-08 name: Riphah International University class: OTHER briefSummary: Calf pain is a common complaint among runners of all ages but is most frequent in masters athletes. The most common calf injury is a tear of the medial gastrocnemius muscle (Tennis Leg) but other structures including the lateral gastrocnemius, plantaris and soleus also may be the cause of muscular pain.There are multiple techniques for the management that involves loading the strained calf musculature through rest, taping techniques, and appropriate soft tissue massage techniques, modalities such as dry needling or western acupuncture can be popular amongst runners and may also be useful. Progressive loading is a principle of resistance training exercise program design that typically relies on increasing load to increase neuromuscular demand to facilitate further adaptations whereas Athletic performance is based on a number of skills that can be developed through a sports conditioning program. This particular program focuses on improving both muscular strength and power using a technique called post-activation potentiation (PAP), also commonly referred to as complex training. conditions: Range of Motion, Pain, Sports Injuries, Stretching, Triceps Surae studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Progressive Loading Exercises measure: pain , range of motion, functions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jawad club, Alfatah sports complex city: Faisalābad state: Punjab zip: 38000 country: Pakistan lat: 31.41554 lon: 73.08969 facility: Riphah International University, Raiwind Campus city: Faisalābad state: Punjab zip: 5400 country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False
<\|newrecord\|> nctId: NCT06302140 id: VT3996-102 briefTitle: A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers overallStatus: RECRUITING date: 2024-02-28 date: 2025-02 date: 2025-10 date: 2024-03-08 date: 2024-03-29 name: Viracta Therapeutics, Inc. class: INDUSTRY briefSummary: This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers. conditions: Advanced Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This clinical trial is divided into 3 parts (Part A, Part B, and Part C).
Patients may begin their study participation in Part A or Part B. Part B (for patients who participate in Part A) and Part C (for patients who participate in Part A and/or Part B) are optional for patients who meet certain conditions for crossover.
In Part A, patients will be given a single dose of radiolabeled nanatinostat by mouth on Day 1. Patients may stay in the hospital up to 8 days.
In Part B, patients will receive both nanatinostat in a salt form and a non-salt form, coadministered with valganciclovir in different order across 2 treatment days. Patients will be randomly assigned to either receive the salt or the non-salt form of nanatinostat first. Patients may stay in the hospital up to 4 days.
Part C will allow patients to continue receiving nanatinostat treatment as long as they are deriving clinical benefit. This part will not require a hospital stay. primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: [14C]-Nanatinostat name: Nanatinostat (free base) tablets in combination with Valganciclovir name: Nanatinostat mesylate tablets in combination with Valganciclovir name: Single-agent Nanatinostat (free base) tablets measure: The amount of radioactivity in excreta [Part A] measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B] measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B] measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B] measure: Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B] measure: Incidence of adverse events and serious adverse events [Part C] measure: Incidence of adverse events and serious adverse events [Parts A and B] measure: Incidence of clinically significant changes in selected safety assessments [Parts A and B] measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A] measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A] measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A] measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A] measure: Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A] measure: Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A] measure: Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A] measure: The ratio of total radioactivity in blood relative to plasma [Part A] measure: [14C]-metabolic profile and identification of metabolites in plasma [Part A] measure: Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A] measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B] measure: Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B] measure: Objective Response Rate (ORR) [Part C] measure: Time to Response (TTR) [Part C] measure: Duration of Response (DOR) [Part C] measure: Disease Control Rate (DCR) [Part C] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Madrid - CIOCC - Hospital Universitario HM Sanchinarro status: RECRUITING city: Madrid zip: 28050 country: Spain role: CONTACT email: ClinicalTrials@Viracta.com lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06302127 id: CCHDS briefTitle: County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial acronym: RISIMA overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-05-20 date: 2024-03-08 date: 2024-03-08 name: Peking University class: OTHER briefSummary: The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management. conditions: Hypertension conditions: Diabetes Mellitus Type 2 conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The follow-up data collection, data entry, and data quality checks will be conducted by researchers unaware of the group assignments. The analysis of results will also be performed by statisticians unaware of the allocation. whoMasked: OUTCOMES_ASSESSOR count: 2560 type: ESTIMATED name: Team-based care name: Risk-stratified care pathway name: Strengthened health education name: Financial incentives for integration of care name: Supporting health information system measure: CVD 10-year risk measure: CVD incidence rate measure: systolic blood pressure measure: total cholesterol sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302114 id: Tubitak briefTitle: Upper Extremity Asymmetries in Overhead Athletes overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-27 date: 2024-03-30 date: 2024-03-08 date: 2024-03-26 name: Pamukkale University class: OTHER name: Tübitak briefSummary: Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance. conditions: Extremity Asymmetries conditions: Injury;Sports conditions: Performance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 58 type: ESTIMATED name: Assessment of overhead athletes measure: Medicine ball forward throw measure: Y balanced test measure: Range of motion of internal and external rotation measure: Strength of Internal and External Rotator Muscles sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University status: RECRUITING city: Pamukkale state: Denizli zip: 20000 country: Turkey name: Fatma Ünver role: CONTACT email: funver@pau.edu.tr name: Erhan Kızmaz role: CONTACT phone: +905418966676 email: erhankizmaz@hotmail.com lat: 37.91644 lon: 29.11729 hasResults: False
<\|newrecord\|> nctId: NCT06302101 id: Exercise in older adults briefTitle: Telerehabilitation Exercise in Older Adults overallStatus: RECRUITING date: 2024-02-21 date: 2024-04-18 date: 2024-04-30 date: 2024-03-08 date: 2024-03-08 name: Pamukkale University class: OTHER briefSummary: The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.
Older adults will be divided into two groups (intervention group n=16; control group n=16) . conditions: Pain conditions: Elderly conditions: Balance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: chair-based exercises name: cognitive exercises measure: Berg Balance Scale measure: Timed Up and Go Test During Dual Tasking measure: Geriatric Pain Measure measure: Older people's quality of life-brief (OPQOL-brief) measure: Hodkinson Mental Test measure: Dominant Side One Leg Stand Test measure: Timed Up and Go Test measure: chair sit and stand test measure: Geriatric Depression Scale measure: Successful Aging Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Elif Gur Kabul status: RECRUITING city: Usak state: Center zip: 64200 country: Turkey name: Elif Gur Kabul role: CONTACT lat: 38.67351 lon: 29.4058 hasResults: False
<\|newrecord\|> nctId: NCT06302088 id: STUDY00026205 briefTitle: The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals acronym: SAINTS overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2027-10 date: 2027-12 date: 2024-03-08 date: 2024-03-22 name: Oregon Health and Science University class: OTHER briefSummary: The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act). conditions: Accidental Falls conditions: Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All participating clinics will take part in baseline surveys of unit staff (n=240-360) and safety stakeholders will be identified. Following surveys, hospitals will be randomized to the control arm (n=3) or the intervention arm (n=3). Both groups will engage in key informant interviews on safety culture (n=30-60). Control group hospitals will continue standard operating procedures. Intervention group hospitals will engage in social network analysis of surveys, have peer leaders identified, and engage in safety leadership training and quality improvement cycles. All hospitals regardless of arm will take part in 6-and-12-month surveys and 24-month interviews. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 240 type: ESTIMATED name: SAINTS program measure: Safety participation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302075 id: UKA-L2086 briefTitle: Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol acronym: UKA-L2086 overallStatus: RECRUITING date: 2021-11-16 date: 2024-12-31 date: 2025-12-01 date: 2024-03-08 date: 2024-03-12 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B). conditions: Gonarthrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: One Day Rehabilitation name: Fast Rehabilitation measure: Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Clinico San Siro status: RECRUITING city: Milan state: Italia country: Italy name: Elena Cittera role: CONTACT phone: 0283502224 email: direzionescientifica.iog@grupposandonato.it name: Andrea Parente, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06302062 id: FIT003-001 briefTitle: Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors acronym: TAL-T overallStatus: RECRUITING date: 2023-06-06 date: 2025-12-30 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: Guangzhou FineImmune Biotechnology Co., LTD. class: INDUSTRY briefSummary: A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.
To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others. conditions: Advanced Solid Tumor conditions: Tumor Associated Lymph Node T Cell conditions: Immunotherapy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Tumor Associated Lymph node T cell name: cyclophosphamide name: IL-2 name: Serplulimab Injection measure: DLT measure: MDT measure: Number of participants with treatment-related adverse events as assessed by CTCAE V4.03 measure: ORR measure: PFS measure: life quality score sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Gaungdong zip: 510700 country: China name: Xuzhi Pan role: CONTACT phone: 86-020-87343135 email: panxzh@sysucc.org.cn name: Xiaoshi Zhang, professor role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06302049 id: 12345 briefTitle: Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-03-08 date: 2024-03-08 name: Sadat City University class: OTHER briefSummary: The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters. conditions: Fatty Liver Disease conditions: Steatohepatitis, Nonalcoholic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 46 type: ESTIMATED name: Esomeprazole name: Placebo measure: Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) measure: Liver function improvement measure: Reduction of oxidative stress sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302036 id: 7777777 briefTitle: Emotional Freedom Techniques (EFT) on Stress, Anxiety and Depression in University Students Experiencing Earthquakes overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-04-05 date: 2024-04-28 date: 2024-03-08 date: 2024-03-08 name: Emine Yıldırım class: OTHER briefSummary: After two earthquakes in Kahramanmaraş Pazarcık in our country, the continuation of long-term aftershocks caused repetition of psychological problems and difficulties in recovery. Social and spiritual support plays a key role in the post-traumatic recovery period. It is necessary to use psychological support methods that can be applied in a short time and whose effect can be observed in a short time in the spiritual healing and healing of traumas. The emotional freedom technique (EFT) is One of the short-term psychotherapeutic techniques and ıt can also be applied online. EFT, which can be easily applied by individuals or professionals after receiving the necessary training; Cognitive therapy, acceptance and commitment therapy combine elements of acupuncture point stimulation, relying on manual stimulation of acupuncture points rather than using acupuncture needles. When we look at the literature, many scientific studies have been found in which the effectiveness of EFT on anxiety, stress and depression has been evaluated, but there has been no randomized controlled study evaluating the effectiveness of EFT online on individuals who have experienced earthquakes. With this project, it is aimed to determine the effect of online Emotional Freedom Techniques (EFT) on stress, anxiety and depression in university students who experienced earthquakes.
This study, which will be carried out as a randomized controlled experimental study, will be carried out between 16.12.2023 and 20.12.2023 by online with university students who score 17 or higher on the Beck Depression Scale. Total of 60 students with depressive symptoms will be recruited to the intervention and control groups, EFT sessions will be applied to the intervention group, and the control group will only be followed. At the beginning of the application, pre-tests (Information Form, Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Inventory) and at the end of the last session, post-tests will be applied for both groups.
With this study, a randomized controlled study will be brought to the literature on the effectiveness of a therapeutic method such as EFT, which is a method that can be used after an earthquake, which is easy to apply, has no cost, and can be accessed online in hard-to-reach areas. Our project will both contribute to the literature and provide short and long-term benefits in practice, in terms of raising awareness of students about important mental problems such as anxiety and depression, which are likely to be experienced after the earthquake, and enabling them to continue their education in a healthy way. It is aimed to present the work planned within the project as a paper in at least one national / international congress. It is aimed to publish in journals within the scope of SCI, SCI-Expanded related to the research area. The results and outputs of the research will be shared in various media (Kırklareli University and Osmaniye Korkut Ata University website and social media accounts).
By determining the stress, anxiety and depression status of university students who have experienced an earthquake, it will be possible to reduce their stress, anxiety and depression with EFT application. The fact that the application used is a short-term, effective and easy psychotherapy method will prevent the disruption of the normal education processes of the students. It will make an economic contribution by reducing the need for psychological drugs that may be needed to reduce the effects of the earthquake. conditions: Emotional Problem conditions: University Students Who Experienced an Earthquake studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: EFT will be applied and surveys will be administered to the intervention group. No application will be made to the control group and surveys will be asked. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: EFT measure: depression measure: stress, anxiety sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302023 id: HE661462 briefTitle: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-08 date: 2024-03-08 name: Khon Kaen University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor
The main questions it aims to answer are:
* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?
* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups
* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day
* Group 2 (control) Participant will not need to take a DHA conditions: Pregnant Women Diagnosed With Threatened Preterm Labor studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Docosahexaenoic acid (DHA) 1000 mg measure: Number of Participants with preterm birth measure: Rate of low birth weight neonate measure: Rate of Neonatal Intensive care unit admission sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06302010 id: KafkasU3636 briefTitle: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-08 date: 2024-03-08 name: Hümeyra TÜLEK DENİZ class: OTHER briefSummary: This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST. conditions: Anxiety conditions: Fetal Conditions conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Stress Ball Intervention measure: Anxiety measure: Fetal well-being measure: Fetal well-being measure: Fetal well-being measure: Fetal well-being measure: Fetal well-being sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301997 id: IRCT20210218050404N5 id: IR.FUMS.REC.1400.125 type: OTHER domain: Fasaums briefTitle: A Herbal Compound for Psoriasis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2024-03-30 date: 2024-12-30 date: 2024-03-08 date: 2024-03-08 name: Fasa University of Medical Sciences class: OTHER name: Zarrin Avaye Kowsar Salamat (ZAX company) briefSummary: The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:
• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.
Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks. conditions: Psoriasis conditions: Inflammation conditions: Skin Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ACTUAL name: ZAX.1400.P03 name: Placebo measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 measure: Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Fasa university of medical sciences city: Fasa state: Fars zip: 7461686688 country: Iran, Islamic Republic of lat: 28.9383 lon: 53.6482 hasResults: False
<\|newrecord\|> nctId: NCT06301984 id: ANDROMEDA_01_2023_V1 briefTitle: Safety and Efficacy Evaluation of Insight GS Growing System overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-06 date: 2027-08 date: 2024-03-08 date: 2024-03-08 name: EVEREST PESQUISA E DESENVOLVIMENTO LTDA class: OTHER briefSummary: Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.
The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).
Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.
Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events. conditions: Early Onset Scoliosis (EOS) studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Insight GS measure: Cobb Angle measure: Adverse event measure: Trunk height measure: Pain measure: Satisfaction sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD facility: Hospital Ortopédico AACD city: São Paulo state: SP zip: 04027-000 country: Brazil name: Mariana F Goncalves role: CONTACT email: mfgoncalves@aacd.org.br name: Alexandre F Cristante role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False
<\|newrecord\|> nctId: NCT06301971 id: CVL-231-HV-1011 briefTitle: A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants overallStatus: RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-08 date: 2024-03-08 name: Cerevel Therapeutics, LLC class: INDUSTRY briefSummary: The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of \[14C\]-emraclidine in healthy adult male participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Emraclidine measure: Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine measure: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine measure: Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine measure: Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity measure: Amount Excreted in Urine (Aeu) of Total Radioactivity measure: Cumulative Aeu of Total Radioactivity measure: Percentage Excreted in Urine (feu) of Total Radioactivity measure: Cumulative feu of Total Radioactivity measure: Amount Excreted in Feces (Aef) of Total Radioactivity measure: Cumulative Aef of Total Radioactivity measure: Percentage Excreted in Feces (fef) of Total Radioactivity measure: Cumulative fef of Total Radioactivity measure: Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined measure: Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined measure: Metabolite Profile of Emraclidine in Plasma, Urine and Feces measure: Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values measure: Number of Participants with Clinically Significant Changes in Vital Signs measure: Number of Participants with Clinically Significant Changes in Laboratory Assessments measure: Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Austin, Texas status: RECRUITING city: Austin state: Texas zip: 78744 country: United States lat: 30.26715 lon: -97.74306 hasResults: False
<\|newrecord\|> nctId: NCT06301958 id: 202102567A3 briefTitle: Dextrose Prolotherapy on Articular Cartilage overallStatus: RECRUITING date: 2023-01-21 date: 2024-08-31 date: 2024-08-31 date: 2024-03-08 date: 2024-03-08 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.
We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions. conditions: Arthritis Knee studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Dextrose prolotherapy measure: Visual Analogue Scale (VAS) measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) measure: Interleukin 6 (IL-6) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memorial Hospital, Chiayi status: RECRUITING city: Chiayi City state: 嘉義市 zip: 600 country: Taiwan name: HUNG-CHIH HSU, PhD role: CONTACT phone: +886-3-3621000 phoneExt: 2601 email: dr.tonyhsu@gmail.com lat: 23.47917 lon: 120.44889 hasResults: False
<\|newrecord\|> nctId: NCT06301945 id: Maastro Clinic id: 72725524 type: OTHER_GRANT domain: Hanarth Fonds briefTitle: Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors acronym: INTHYM overallStatus: RECRUITING date: 2023-08-01 date: 2027-08-01 date: 2027-08-01 date: 2024-03-08 date: 2024-03-27 name: Erasmus Medical Center class: OTHER name: Maastro Clinic, The Netherlands name: Hospices Civils de Lyon briefSummary: Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.
In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.
The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.
In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.
The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy. conditions: Thymic Epithelial Tumor conditions: Thymic Carcinoma conditions: Thymoma conditions: Thymoma and Thymic Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1020 type: ESTIMATED name: Artificial Intelligence Diagnostics name: Recurrence Prediction Tool measure: WP1 - Databases/Data Pre-processing measure: WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction measure: WP3: Clinical Evaluation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC status: RECRUITING city: Rotterdam state: South Holland zip: 3015 GD country: Netherlands name: Anna Salut Esteve Domínguez role: CONTACT email: a.estevedominguez@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06301932 id: ANE-2562-06771 briefTitle: The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy overallStatus: COMPLETED date: 2006-01-01 date: 2018-12-31 date: 2023-12-31 date: 2024-03-08 date: 2024-03-12 name: Chiang Mai University class: OTHER briefSummary: This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.
The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA? conditions: Epidural Analgesia conditions: Patient Controlled Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 654 type: ACTUAL name: Open liver resection measure: Post-operative opioid consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301919 id: IRBN042024/CHUSTE briefTitle: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-08 date: 2024-03-12 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.
Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.
The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting. conditions: Haemostasis Embolisation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Clinical data name: Imaging data name: Biological data measure: Evaluation of technical success measure: Assessment of clinical success measure: Assessment of clinical success measure: Assessment of clinical success measure: Assessment of clinical success measure: Assessment of clinical success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Saint-Etienne status: RECRUITING city: Saint-Priest-en-Jarez zip: 42270 country: France name: Rémi Grange, MD role: CONTACT phone: (0)477828963 phoneExt: +33 email: remi.grange@chu-st-etienne.fr name: Sylvain Grange, MD role: SUB_INVESTIGATOR name: Rémi Grange, MD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 hasResults: False
<\|newrecord\|> nctId: NCT06301906 id: 202301060A3 briefTitle: Red Yeast Rice for Primary Prevention of Hypercholesterolemia overallStatus: RECRUITING date: 2024-02-26 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota. conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: LipoCol Forte Capsule 600mg bid measure: Low Density Lipoprotein-Cholesterol (LDL-C) measure: 10-Year ASCVD Risk sex: MALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: Taoyuan branch of Chang Gung Memorial Hospital status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Yueh Hsiang Huang, PhD role: CONTACT phone: 886-975360240 email: igighuang@gmail.com lat: 24.95233 lon: 121.20193 hasResults: False
<\|newrecord\|> nctId: NCT06301893 id: US-3_Uganda (IRB#2013-4576) briefTitle: Uganda Sickle Surveillance Study (US-3) overallStatus: RECRUITING date: 2013-09-07 date: 2030-12-31 date: 2032-12-31 date: 2024-03-08 date: 2024-03-12 name: Children's Hospital Medical Center, Cincinnati class: OTHER name: Makerere University name: Ministry of Health, Uganda name: Mulago Hospital, Uganda briefSummary: It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda. conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000000 type: ESTIMATED measure: Incidence of HbSS and HbA measure: Incidence of HbSS and HbA sex: ALL maximumAge: 12 Months stdAges: CHILD facility: Makerere University status: RECRUITING city: Kampala country: Uganda name: Grace Ndeezi, MBChB, MMed, PhD role: CONTACT lat: 0.31628 lon: 32.58219 facility: Minister of Health status: RECRUITING city: Kampala country: Uganda name: Jane R. Aceng, MD role: CONTACT lat: 0.31628 lon: 32.58219 facility: National Coordinator EID Program status: RECRUITING city: Kampala country: Uganda name: Charles Kiyaga, MBLSM role: CONTACT name: Charles Kiyaga, PhD role: SUB_INVESTIGATOR lat: 0.31628 lon: 32.58219 facility: Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital status: RECRUITING city: Kampala country: Uganda name: Deogratias Manube, MBChB, MMed role: CONTACT lat: 0.31628 lon: 32.58219 hasResults: False
<\|newrecord\|> nctId: NCT06301880 id: 3200 briefTitle: Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-31 date: 2023-01-31 date: 2024-03-08 date: 2024-03-08 name: Damascus University class: OTHER briefSummary: Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2). conditions: Internal Mammary Artery Syndrome conditions: Vasodilation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All surgical procedures and measurements were carried out by a single surgeon (MBI) who was blinded to the topical agent which was applied. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: The topical application of a vasodilator on the LIMA graft measure: LIMA free flow sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus University Cardiac Surgery Hospital city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False
<\|newrecord\|> nctId: NCT06301867 id: Pro00113877 briefTitle: Preventing Failed Extubations acronym: PreFIX overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-08-31 date: 2024-03-08 date: 2024-03-21 name: Duke University class: OTHER briefSummary: More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure. conditions: Mechanical Ventilation Complication conditions: Weaning Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Plateau Pressure measure: Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility measure: Percentage of patients who were reintubated prior to hospital discharge sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University Medical Center status: RECRUITING city: Durham state: North Carolina zip: 27710 country: United States name: Elias H Pratt, MD role: CONTACT email: elias.pratt@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06301854 id: TPN171H-E302 briefTitle: Long-term Safety of TPN171H Tablet in Erectile Dysfunction. overallStatus: RECRUITING date: 2024-04-12 date: 2025-04-30 date: 2025-04-30 date: 2024-03-08 date: 2024-04-26 name: Vigonvita Life Sciences class: INDUSTRY briefSummary: This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: TPN171H measure: Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation. measure: Change From Baseline in the International Index of Erectile Function - Erectile Function. measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses. measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication. measure: Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. measure: Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month. measure: Change From Baseline in the International Index of Erectile Function - Erectile Function. measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responses. measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication. measure: Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. measure: Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month . sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Anhui Medical University status: RECRUITING city: Hefei state: Anhui zip: 230000 country: China name: Xiansheng Zhang role: CONTACT lat: 31.86389 lon: 117.28083 facility: Peking University First Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100032 country: China name: Hui Jiang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Kai Hong role: CONTACT lat: 39.9075 lon: 116.39723 facility: Guangzhou First People's Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Junhong Deng role: CONTACT lat: 23.11667 lon: 113.25 facility: The Fifth Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510700 country: China name: Xianhan Jiang role: CONTACT lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Geng An role: CONTACT lat: 23.11667 lon: 113.25 facility: Shantou Central Hospital status: RECRUITING city: Shantou state: Guangdong country: China name: hong huang role: CONTACT lat: 23.36814 lon: 116.71479 facility: The Second Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Shantou state: Guangdong country: China name: Junhong Zheng role: CONTACT lat: 23.36814 lon: 116.71479 facility: Shenzhen Songgang People's Hospital status: RECRUITING city: Shenzhen state: Guangdong zip: 518105 country: China name: Qin Xiang role: CONTACT lat: 22.54554 lon: 114.0683 facility: The 2nd Affiliated Hospital of Guilin Medical University status: RECRUITING city: Guilin state: Guangxi country: China name: Li Gao role: CONTACT lat: 25.28194 lon: 110.28639 facility: The Affiliated Hospital of Guizhou Medical University status: RECRUITING city: Guiyang state: Guizhou country: China name: Qiang Wang role: CONTACT lat: 26.58333 lon: 106.71667 facility: Qingyuan People's Hospital status: RECRUITING city: Qingyuan state: G country: China name: Jianwen Zeng role: CONTACT lat: 23.7 lon: 113.03333 facility: The Second Hospital of Hebei Medical Uniyersity status: RECRUITING city: Shijiazhuang state: Hebei country: China name: Yaxuan Wang role: CONTACT lat: 38.04139 lon: 114.47861 facility: Xingtai People's Hospital status: RECRUITING city: Xingtai state: Hebei country: China name: Junli Wei role: CONTACT lat: 37.06306 lon: 114.49417 facility: Henan Provincial People's Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450100 country: China name: Xiangsheng Zhang role: CONTACT lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital of Henan University status: RECRUITING city: Zhengzhou state: Henan country: China name: Guoliang Xu role: CONTACT lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Wuhan status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430014 country: China name: Yonglian Guo role: CONTACT lat: 30.58333 lon: 114.26667 facility: Wuhan Union Hospital status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Zhaohui Zhu role: CONTACT lat: 30.58333 lon: 114.26667 facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine status: RECRUITING city: Changsha state: Hunan country: China name: Yifeng Yuan role: CONTACT lat: 28.19874 lon: 112.97087 facility: Loudi Central Hospital status: RECRUITING city: Loudi state: Hunan country: China name: Liang Peng role: CONTACT lat: 27.73444 lon: 111.99444 facility: Yueyang People's Hospital status: RECRUITING city: Yueyang state: Hunan country: China name: Zeping Li role: CONTACT lat: 29.37455 lon: 113.09481 facility: Second Affiliated Hospital of Suzhou University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Boxin Xue role: CONTACT lat: 31.30408 lon: 120.59538 facility: Nanchang reproductive hospital status: RECRUITING city: Nanchang state: Jiangxi zip: 330001 country: China name: Wenliang Yao role: CONTACT lat: 28.68396 lon: 115.85306 facility: Yichang Central People's Hospital (Xiling Campus) status: RECRUITING city: Yichang state: Jiangxi country: China name: Junfeng Yu role: CONTACT lat: 30.71444 lon: 111.28472 facility: The First Hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130021 country: China name: Fubiao Li role: CONTACT lat: 43.88 lon: 125.32278 facility: The Second Hospital of Dalian Medical University status: NOT_YET_RECRUITING city: Dalian state: Liaoning zip: 116011 country: China name: Tao Jiang role: CONTACT lat: 38.91222 lon: 121.60222 facility: Chifeng Municipal Hospital status: RECRUITING city: Chifeng state: Neimenggu country: China name: Xin Chen role: CONTACT lat: 42.26833 lon: 118.96361 facility: The Affiliated Hospital of Qinghai University status: RECRUITING city: Xining state: Qinghai country: China name: Guoliang Chen role: CONTACT lat: 36.62554 lon: 101.75739 facility: Xianyang Central Hospital status: RECRUITING city: Xianyang state: Shanxi country: China name: Nan Li role: CONTACT lat: 34.33778 lon: 108.70261 facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine status: RECRUITING city: Xian state: Shanxi country: China name: Wei Zheng role: CONTACT lat: 34.25833 lon: 108.92861 facility: Nuclear Industry 416 Hospital status: RECRUITING city: Chengdu state: Sichuang country: China name: Jichun Shao role: CONTACT lat: 30.66667 lon: 104.06667 facility: The Affiliated Hospital of Chengdu University status: RECRUITING city: Chengdu state: Sichuang country: China name: Jin Yang role: CONTACT lat: 30.66667 lon: 104.06667 facility: Suining Central Hospital status: RECRUITING city: Suining state: Sichuang country: China name: Yougang Feng role: CONTACT lat: 30.50802 lon: 105.57332 facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine status: RECRUITING city: Urumqi state: Xinjiang country: China name: Feng Wang role: CONTACT lat: 43.80096 lon: 87.60046 hasResults: False
<\|newrecord\|> nctId: NCT06301841 id: 2023-A00903-42 briefTitle: An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care acronym: BPCTréa2 overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-04-15 date: 2026-07-15 date: 2024-03-08 date: 2024-03-08 name: University Hospital, Caen class: OTHER briefSummary: Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia. conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: experimental measure: Duration of antibiotic therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Intensive Care Unit, CHU Caen city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False
<\|newrecord\|> nctId: NCT06301828 id: KY202401 briefTitle: Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors overallStatus: RECRUITING date: 2024-02-21 date: 2025-06-21 date: 2026-02-21 date: 2024-03-08 date: 2024-03-08 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment. conditions: Gastrointestinal Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Gastrointestinal neoplasms primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Envafolimab Injection name: Endostar measure: DCR measure: ORR measure: PFS measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: wei x wei, M.D. role: CONTACT phone: 52271000 phoneExt: 025 lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06301815 id: Shaw_Stroke_REC24/YH/0010_2024 briefTitle: Feasibility of Measuring Vertical Perception in Acute Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: University of Winchester class: OTHER name: Hampshire Hospitals NHS Foundation Trust name: University Hospitals Dorset NHS Foundation Trust briefSummary: The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is:
• To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss.
Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments.
If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Scale for Contraversive Pushing name: Catherine Bergego Scale name: Bucket Test measure: Bucket Test to measure subjective visual vertical (SVV). measure: Catherine Bergego Scale to measure neglect. measure: Scale for Contraversive Pushing to measure lateropulsion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Hampshire County Hospital city: Winchester zip: SO22 5DG country: United Kingdom name: Amelia Shaw, MSc role: CONTACT phone: 01962 824940 email: amelia.shaw@hhft.nhs.uk lat: 51.06513 lon: -1.3187 hasResults: False
<\|newrecord\|> nctId: NCT06301802 id: myelomeningocele management briefTitle: Outcomes of Proactive Management of Children With Myelomeningocele overallStatus: RECRUITING date: 2024-03-04 date: 2026-03-10 date: 2026-03-15 date: 2024-03-08 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence. conditions: Urologic Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: CIC name: Anticholinergic measure: upper tract affection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut university hospital status: RECRUITING city: Assiut zip: 11571 country: Egypt name: Islam Mahmoud, DR role: CONTACT phone: 00201090088672 email: doctorislam672@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06301789 id: Quadratus lumborum block briefTitle: Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-03 date: 2024-03-08 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries. conditions: QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Effect of adding Mg sulphate as an adjuvant to bupivacaine for postoperative analgesia in cases of lower abdominal cancer surgeries primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ESTIMATED name: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries measure: Postoperative analgesia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301776 id: Bridge-2023-02-0A briefTitle: A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge overallStatus: RECRUITING date: 2023-12-05 date: 2025-12-31 date: 2026-06-30 date: 2024-03-08 date: 2024-03-08 name: The Fourth Affiliated Hospital of China Medical University class: OTHER briefSummary: To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy. conditions: Brain Disease conditions: Vertebral Artery Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 560 type: ESTIMATED name: Ticagrelor measure: Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months. measure: Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months. measure: Incidence of target vessel-related stroke and neurological death at 1month measure: Incidence of stroke and neurological death at 12 month. measure: Incidence of all-cause mortality at 12 month. measure: Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up). sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Fourth Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning zip: 110032 country: China name: Lianbo Gao role: CONTACT email: gaolbdoc@163.com lat: 41.79222 lon: 123.43278 hasResults: False
<\|newrecord\|> nctId: NCT06301763 id: nosencekCancer-old briefTitle: Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-25 date: 2022-12-31 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: Intermittent Oral-esophageal Tube Feeding name: nasogastric tube feeding measure: Hemoglobin Level measure: Serum albumin Level measure: Total serum protein Level measure: Serum prealbumin Level measure: Body Mass Index Level measure: Depression measure: Swallowing-Quality of Life questionnaire measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ubonratchathani Hospital city: Ubon Ratchathani country: Thailand lat: 15.23844 lon: 104.84866 hasResults: False
<\|newrecord\|> nctId: NCT06301750 id: Tube-Alzheimer briefTitle: Oral Enteral Nutrition Feeding in Alzheimer's Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Conventional Care name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric tube measure: Level of Hemoglobin measure: Level of Serum albumin measure: Level of Total serum protein measure: Level of Serum prealbumin measure: Body Mass Index measure: Pulmonary Infections measure: Mini Nutritional Assessment sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301737 id: SGB-YanD briefTitle: Lidocaine Injection: A Nove Block Therapy for Stroke-related Dysphagia overallStatus: COMPLETED date: 2022-06-21 date: 2023-05-02 date: 2023-05-17 date: 2024-03-08 date: 2024-03-25 name: Muhammad class: OTHER briefSummary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 65 type: ACTUAL name: Comprehensive rehabilitation name: Injection name: Lidocaine Hydrochloride measure: Video fluoroscopic swallowing study measure: Rosenbek penetration-aspiration scale measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhen No.1 Hos. city: Taiwan country: China lat: 32.32812 lon: 118.76384 hasResults: False
<\|newrecord\|> nctId: NCT06301724 id: SGB-PKS briefTitle: Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.
Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease 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: ESTIMATED name: Injection name: Lidocaine hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301711 id: SGB-CVSD briefTitle: Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Mini-Mental State Examination measure: Swallowing duration measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301698 id: SGB-BP briefTitle: The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function. conditions: Bulbar Palsy 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: ESTIMATED name: Comprehensive rehabilitation name: Injection name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Murray secretion severity scale measure: Yale pharyngeal residue severity rating scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301685 id: SGB-AST briefTitle: Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:
Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated. conditions: Autistic Disorder 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: ESTIMATED name: Routine therapy name: Injection name: Lidocaine Hydrochloride measure: Childhood Autism Rating Scale measure: Children's Communication Checklist measure: Social Interaction Assessment Scale measure: Children's Depression Inventory measure: Childhood Anxiety Sensitivity Index sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06301672 id: NecknoseCancer-Xin briefTitle: Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Nasogastric Tube Feeding name: Intermittent Oral-esophageal Tube Feeding name: comprehensive rehabilitation therapy measure: concentration of Hemoglobin measure: concentration of Serum albumin measure: concentration of Serum prealbumin measure: Body Mass Index measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Feeding amount sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301659 id: Jingxiang-Jiu briefTitle: Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke overallStatus: COMPLETED date: 2022-08-01 date: 2023-07-12 date: 2023-08-31 date: 2024-03-08 date: 2024-03-08 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. On day 1 and day 30, patients' Upper Limb function were compared. conditions: Hemiparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 116 type: ACTUAL name: routine rehabilitation therapy name: Modified mirror therapy measure: Fugl-Meyer Assessment-Upper Extremity measure: coordinated contraction rate-Surface electromyography measure: Visual Analog Scale measure: Anxiety measure: Depression sex: ALL minimumAge: 35 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital city: Yangon country: Myanmar lat: 16.80528 lon: 96.15611 hasResults: False
<\|newrecord\|> nctId: NCT06301646 id: IOE-psy briefTitle: Oral Enteral Nutrition Tube Feeding on Stroke Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-08 name: Ahmadu Bello University Teaching Hospital class: OTHER briefSummary: The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom. conditions: Cerebrovascular Accident studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Social Functioning Scale measure: Social Support Questionnaire measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301633 id: IOE-STROKE briefTitle: Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia overallStatus: COMPLETED date: 2022-01-31 date: 2023-12-10 date: 2023-12-30 date: 2024-03-08 date: 2024-04-11 name: Muhammad class: OTHER briefSummary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 126 type: ACTUAL name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Penetration-Aspiration Scale measure: Body weight measure: total protein measure: albumin measure: Yale pharyngeal residue severity rating scale measure: Patient health questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The 1st afi. Hos. city: Zhenzhou country: China lat: 32.28034 lon: 119.16999 hasResults: False
<\|newrecord\|> nctId: NCT06301620 id: GUANJIEQIANG briefTitle: Intra-articular Injection: A Innovational Approach for Joint Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction
The main question it aims to answer is:
• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction conditions: Temporomandibular Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Routine rehabilitation treatment name: Intra-articular Injection measure: Friction Index measure: The Visual Analog Scale measure: The maximum mouth opening limit measure: Mann Assessment of Swallowing Ability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301607 id: Feedingamount briefTitle: The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube name: comprehensive rehabilitation therapy measure: Feeding Amount measure: total protein level measure: hemoglobin level measure: albumin level measure: prealbumin level measure: Body weight measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301594 id: Dys-prevent briefTitle: Impact of Neck and Facial Exercises on Swallowing Function in Elderly Individuals overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-03-08 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Systematic simple swallowing training measure: Swallowing-Related Quality of Life Questionnaire measure: Eating Assessment Tool-10 measure: Time consumed in eating measure: Standardized Swallowing Assessment measure: Water Swallow Test sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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