Datasets:

hackint0sh
/

md_dataset

Dataset card Data Studio Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## Stop Smoking in Spine Surgery - NCT ID: NCT06361459 - Study ID: NL83858.058.12 - Status: RECRUITING - Start Date: 2023-07-06 - Completion Date: 2026-12-31 - Lead Sponsor: Leiden University Medical Center ### Study Description Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome. ### Conditions - Smoking Cessation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stop smoking ### Outcomes Primary Outcomes - ODI or NDI Secondary Outcomes - VAS leg or arm pain - HADS - EuroQol - perceived recovery - radiological evaluation for fusion ### Location - Facility: Leiden University Medical Centre, Leiden, Zuid Holland, 2300RC, Netherlands @@
## Zonisamide Versus Propranolol in Migraine - NCT ID: NCT06361446 - Study ID: 023098816 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2025-04-20 - Lead Sponsor: Kafrelsheikh University ### Study Description Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency ### Conditions - Migraine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Zonisamide 50 MG - Propranolol ### Outcomes Primary Outcomes - The change in migraine days per 28 days Secondary Outcomes - The total number of migraine days after three months of treatment - The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. - HIT-6 score absolute change in each group after three months of treatment - The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. ### Location - Facility: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, N/A, 33511, Egypt @@
## Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage - NCT ID: NCT06361433 - Study ID: R5-11 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-02 - Lead Sponsor: Hokkaido University Hospital ### Study Description The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are:* The safety of the product* The efficacy of the product ### Conditions - Intracerebral Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HUFF-01 ### Outcomes Primary Outcomes - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Secondary Outcomes - Change in mRS examination - Change in NIHSS examination - Change in FIM examination - Change in Fugl-Myer examination - Change in Barthal index examination - Change in FDG-PET examination - Change in IMZ-SPECT examination ### Location - Facility: Hokkaido University Hospital, Sapporo, Hokkaido, 0608638, Japan @@
## Driving Pressure-guided Lung Protective Ventilation - NCT ID: NCT06361420 - Study ID: 2023YF051-01 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2025-03-31 - Lead Sponsor: Yong Lin, PhD ### Study Description The study, named as "The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an open-label, randomized control clinical trial", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery. ### Conditions - Hypoxemia - Ventilator Lung ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Driving pressure-guided positive end expiratory pressure - Optimal oxygenation-guided positive end expiratory pressure - Ventilation strategy - Management of hypoxemia ### Outcomes Primary Outcomes - The incidence of postoperative hypoxemia Secondary Outcomes - The trend of perioperative oxygenation function - Postoperative pulmonary complications except hypoxemia - Early/late death - Vasoactive-inotropic score at the end of surgery - Postoperative adverse cardiovascular events - Length of stay in intensive care unit - Ventilation assistance time - Postoperative extrapulmonary complications ### Location - Facility: Fujian medical university union hospital, Fuzhou, Fujian, 350001, China @@
## Sensory and Cognitive Predictions, and Their Disruptions in Schizophrenia - NCT ID: NCT06361407 - Study ID: 2023-A02464-41 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-02-28 - Lead Sponsor: Centre Psychothérapique de Nancy ### Study Description Disturbances in the sense of self and time could play an important role in the development of psychotic symptoms. Previous work has shown that patients have difficulty preparing to process information on the scale of a second, but are abnormally disturbed by slightly asynchronous information on the millisecond scale. In both cases, the anomalies could explain the patients' unusual experience of time. The hypothesis in neurotypical patients is that small delays or asynchronies asynchronies are treated as irrelevant information and ignored and ignored, whereas in patients suffering from schizophrenia they would disrupt the flow of time. This hypothesis is tested with a new visual illusion. ### Conditions - Schizophrenia - Sensory Processing Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Illusion task ### Outcomes Primary Outcomes - Effect of a millisecond-level trajectory perturbation Secondary Outcomes - Baseline rate of illusion - Effect of a rebound (top-down, conscious influence) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students - NCT ID: NCT06361394 - Study ID: CORPFIN0021 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-08-31 - Lead Sponsor: Chang Gung University of Science and Technology ### Study Description The aims of this study are to develop a mindfulness-based course for nursing students. As well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students. ### Conditions - Students ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mindfulness course ### Outcomes Primary Outcomes - perceived stress at baseline - perceived stress at T0 - perceived stress at T1 - perceived stress at T2 - anxiety disorder at baseline - anxiety disorder at T0 - anxiety disorder at T1 - anxiety disorder at T2 - mindful attention awareness at baseline - mindful attention awareness at T0 - mindful attention awareness at T1 - mindful attention awareness at T2 - empathy at baseline - empathy at at T0 - empathy at at T1 - empathy at at T2 - practicum stress at T1 - practicum stress at T2 - Nursing Competence at T1 - Nursing Competence at T2 Secondary Outcomes ### Location - Facility: Ya-Chu Hsiao, Taoyuan City, N/A = Not Applicable, 333 03, Taiwan @@
## The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects - NCT ID: NCT06361381 - Study ID: 24-01-281 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: University of Hartford ### Study Description Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects.The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) - Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) - Transcutaneous Electrical Nerve Stimulation ### Outcomes Primary Outcomes - Pressure Pain Threshold Secondary Outcomes - Heat Pain Threshold - Heart rate - Oxygen saturation - Blood pressure ### Location - Facility: University of Hartford, West Hartford, Connecticut, 06117, United States @@
## Efficacy Assessment of Probiotics in Improving Sleep Indices - NCT ID: NCT06361368 - Study ID: NYCU112174AF - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: National Yang Ming University ### Study Description To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions. ### Conditions - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PS150 - Placebo ### Outcomes Primary Outcomes - Polysomnography (PSG) Secondary Outcomes - Pittsburgh Sleep Quality Index (PSQI) - Insomnia Severity Index (ISI) - Beck Depression Inventory-Second Edition (BDI-II) - Beck Anxiety Inventory (BAI) - VAS-Sleep - Epworth Sleepiness Scale (ESS) - Standford Sleepiness Scale (SSS) - Visual Analogue Scale for gastrointestinal symptoms (VAS-GI) - Saliva Melatonin - Saliva Cortisol - Saliva IL-6 - Saliva Total Antioxidant Capacity (TAC) - Saliva Serotonin - Saliva GABA - Saliva Orexin - Urine 6-sulfatoxymelatonin - Urine Norepinephrine - Actigraphy - Sleep Diary ### Location - Facility: Institute of Brain Science National Yang Ming Chiao Tung University, Taipei, N/A, 112304, Taiwan @@
## Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers - NCT ID: NCT06361355 - Study ID: CMAB807-I-002 - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2024-06 - Lead Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd ### Study Description This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Post-change CMAB807 - Prolia ### Outcomes Primary Outcomes - Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time - Maximum Concentration of Denosumab Secondary Outcomes - Time to Maximum Concentration of Denosumab - Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3000 Hours - Half-time - Clearance Rate - Apparent Volume - Serum type 1 C-telopeptide (CTX1) - anti-drug antibodies(ADA) - Neutralization antibodies(Nab) ### Location - Facility: The Second Hospital of Anhui Medical University, Hefei, Anhui, N/A, China @@
## Smartphones Aggravating Anxiety Symptoms - NCT ID: NCT06361342 - Study ID: 23-003633 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-08 - Completion Date: 2025-03 - Lead Sponsor: Mayo Clinic ### Study Description The goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives. ### Conditions - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - General decrease in smartphone use - Avoiding Social Media Apps ### Outcomes Primary Outcomes - Change in anxiety Secondary Outcomes - Change in depression ### Location - Facility: Mayo Clinic Minnesota, Rochester, Minnesota, 55905, United States @@
## Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL - NCT ID: NCT06361329 - Study ID: 20240030C - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-03-31 - Lead Sponsor: First Affiliated Hospital of Zhejiang University ### Study Description ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients. ### Conditions - ETP-ALL ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Homoharringtonine - venetoclax - Cytarabine - G-CSF - Vindesine - Daunorubicin - cyclophosphamide - Dexamethasone - L-ASP ### Outcomes Primary Outcomes - 1-year EFS Secondary Outcomes - CR/CRi - OS - MRD - Safety of induction therapy ### Location - Facility: The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China @@
## Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer - NCT ID: NCT06361316 - Study ID: CSPC-DEY-PC-JS01 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2028-07-31 - Lead Sponsor: Kuirong Jiang ### Study Description The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer. ### Conditions - Pancreatic Cancer - Adjuvant Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Irinotecan liposome injection ### Outcomes Primary Outcomes - Disease Free Survival, DFS Secondary Outcomes - Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE - Overall Survival, OS - Quality of life, QOL - The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy - he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance ### Location - Facility: FirstNanjingMU, Nanjing, Jiangsu, 025, China @@
## The Happiest Baby, Inc. SNOO Postmarket Surveillance Study - NCT ID: NCT06361303 - Study ID: PS230001 - Status: RECRUITING - Start Date: 2023-11-29 - Completion Date: 2025-09 - Lead Sponsor: Happiest Baby, Inc. ### Study Description This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID). This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet. ### Conditions - Infant Death - Serious Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SNOO Bassinet ### Outcomes Primary Outcomes - Serious Injury - Infant death Secondary Outcomes - Infant age during SNOO use - Degree of SNOO use - Weaning rationale ### Location - Facility: Happiest Baby, Inc., Los Angeles, California, 90064, United States @@
## Diaphyseal Reconstruction of Malignant Tumors in Children - NCT ID: NCT06361290 - Study ID: APHP231703 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Primary malignant bone tumors represent 5% of malignant tumors in children, 90% of which are osteosarcomas or Ewing sarcomas.The objective of oncological resection is local control of the disease. Excision of the entire tumor should make it possible to maintain good function of the limb, minimizing morbidity, and promoting acceptance by the patient.Biological reconstructions offer the best long-term functional results. Several possibilities are then available: the Induced Membrane technique, the Vascularized Fibula and Vascularized Fibula associated with an Allograft.Until today, no reconstruction technique in children has proven its superiority over another and no decision-making algorithm for therapeutic care has been determined based on the importance of the bone resection and the affected segment in diaphyseal tumor reconstruction surgery of the lower limb.The aim of the present research is to compare the three techniques concerning the consolidation aspect, the reoperation rates, the rates of bone complications, septic, and the functional results by the study of the medical files of approximately 90 patients operated between 1986 and 2017. ### Conditions - Childhood Malignant Tumors of Lower Limbs ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection from hospital medical records ### Outcomes Primary Outcomes - Duration of bone consolidation period Secondary Outcomes - Rate of surgical re-intervention - Short- and long-term complication rates - Long-term functional results - Relationship between radiotherapy and biological reconstruction result ### Location - Facility: Hôpital Armand-Trousseau, Paris, N/A, 75012, France @@
## To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers - NCT ID: NCT06361277 - Study ID: JW22104 - Status: COMPLETED - Start Date: 2023-11-03 - Completion Date: 2023-11-27 - Lead Sponsor: JW Pharmaceutical ### Study Description The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Reference Drug or Test Drug ### Outcomes Primary Outcomes - AUCt - Cmax Secondary Outcomes ### Location - Facility: Clinical Trial Center, Jeonbuk National University Hospital, Jeonju, N/A, N/A, Korea, Republic of @@
## Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide - NCT ID: NCT06361264 - Study ID: Karanahan - Status: RECRUITING - Start Date: 2018-11-01 - Completion Date: 2025-12-01 - Lead Sponsor: KARANAHAN ### Study Description The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days. ### Conditions - Stage IV Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Karanahan ### Outcomes Primary Outcomes - The size of tumor foci Secondary Outcomes - The quality of life score - The immunomodulatory effect ### Location - Facility: Karanahan Llc, Novosibirsk, Novosibirsk Region, 630090, Russian Federation @@
## Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face - NCT ID: NCT06361251 - Study ID: CS5_10 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Cryonove Pharma ### Study Description The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:* the tolerance of 2 prototypes of cyto-selective cryotherapy treatments* the performance of 2 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits.Researchers will compare the tolerance and performance of the 3 prototypes. ### Conditions - Lentigo - Solar Lentigo - Post Inflammatory Hyperpigmentation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CRYONOVE (EC14_4osc) - CRYONOVE (EC05osc) ### Outcomes Primary Outcomes - Tolerance Secondary Outcomes - Performance (Acquisitions C-cube) ### Location - Facility: SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University, Pretoria, N/A, N/A, South Africa @@
## Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery - NCT ID: NCT06361238 - Study ID: 2023-LCYJ-PY-21 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-03-31 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. ### Conditions - Delirium, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Liraglutide injection - Placebo injection ### Outcomes Primary Outcomes - The incidence of delirium Secondary Outcomes - The severity of delirium - Cognitive function - Anxiety - Depression - Duration of ICU stay - Mechanical ventilation time - Duration of hospital stay - In-hospital mortality - Incidence of adverse events - Rate of major cardiovascular adverse events - Serum levels of NSE - Serum levels of CRP - Serum levels of IL-1α - Serum levels of TNF-α - Serum levels of C3 - Serum levels of LDH - Serum levels of CK - Serum levels of CK-MB - Serum levels of AST - Serum levels of cTNT - Serum levels of BNP - Serum levels of C1q - Serum levels of IL-1β - Serum levels of IL-6 - Serum levels of S100β - Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd) - Left Ventricular End-Diastolic Dimension (LVDd) - Left Ventricular End-Systolic Diameter (LVDs) - Left Atrial Diameter (LAD) - Ejection Fraction (EF) - Fractional Shortening (FS) - Early Diastolic Velocity/Atrial Diastolic Velocity (E/A) - Interventricular Septum Thickness in Diastolic (IVSTd) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Routine Use of RUSH Protocol in the Intensive Care Unit - NCT ID: NCT06361225 - Study ID: 0075-24-MMC - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-08-01 - Lead Sponsor: Meir Medical Center ### Study Description The RUSH protocol has been used for several years for the rapid evaluation of a patient admitted to the emergency room with shock. Traditionally, its use was especially common in trauma victims, but later its use was extended to patients admitted to the emergency room with shock from any reason. The protocol includes rapid assessment with the guideness of ultrasound of heart contraction, assessment for pleural effusions, assessment of intra-abdominal blood (FAST), diagnosis of venous thrombosis (DVT), and rulling out hydronephrosis. It can also add a pupil size assessment and an evaluation of the gallbladder and bile ducts, as well as the size of the bladder. In intensive care, we use this protocol (or part of it) for the evaluation of a patient who is deteriorating in the ICU for an unknown reason . In some patients we use this protocol as a routine part of the physical examination as part of the daily patient evaluation.We would like to investigate whether the routine use of the RUSH protocol as part of the daily patient evaluation in the general intensive care unit will lead to any change in the patient's management. ### Conditions - RUSH Protocol ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - evaluation with RUSH protocol ### Outcomes Primary Outcomes - Change of patient medical therapy - Performing unplanned laboratory tests - Performing unplanned image tests - Performing unplanned invasive procedure Secondary Outcomes ### Location - Facility: Meir Medical Center, Kfar Saba, N/A, N/A, Israel @@
## Ethoximod Pharmacokinetics In Healthy Subjects - NCT ID: NCT06361212 - Study ID: BJXH-2022-002 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2024-01-12 - Lead Sponsor: Longevity Inc. ### Study Description The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects. The main questions it arms to answer are:1. to evaluate the safety and tolerance of Ethoximod in healthy subjects after single or repeated doses.2. to assess the pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects after single or repeated doses.3. to evaluate of the effect of food on the pharmacokinetics of Ethoximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples. ### Conditions - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ethoximod ### Outcomes Primary Outcomes - Peak plasma concentration (Cmax) - Time to peak plasma concentration (Tmax) - The lowest plasma concentration (Cmin) - Half-life (t1/2) - Number of adverse events and number of participants with adverse events Secondary Outcomes - Lymphocyte count - Percentage of CD3+CD4+ and CD3+CD8+ T cells ### Location - Facility: The first hospital of Jilin University, Changchun, Jilin, N/A, China @@
## Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis - NCT ID: NCT06361199 - Study ID: BJXH-2021-001 - Status: COMPLETED - Start Date: 2021-12-16 - Completion Date: 2023-10-08 - Lead Sponsor: Longevity Inc. ### Study Description The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are:1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis.Participants will receive test tablets or placebo at the indicated date and collect blood samples. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Proximod - Placebo ### Outcomes Primary Outcomes - Peak plasma concentration (Cmax) - Time to peak plasma concentration (Tmax) - The lowest plasma concentration (Cmin) - Half-life (t1/2) - Area under the plasma concentration versus time curve (AUC) - Number of adverse events and number of participants with adverse events Secondary Outcomes - Lymphocyte count - Percentage of CD3+CD4+ and CD3+CD8+T cells - ACR20 score in Patients With Rheumatoid Arthritis - Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis ### Location - Facility: The first hospital of Jilin University, Changchun, Jilin, N/A, China @@
## Proximod Pharmacokinetics In Healthy Subjects - NCT ID: NCT06361186 - Study ID: BJXH-2017-001 - Status: COMPLETED - Start Date: 2017-09-14 - Completion Date: 2021-06-22 - Lead Sponsor: Longevity Inc. ### Study Description The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:1. to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.2. to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.3. to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Proximod - Placebo ### Outcomes Primary Outcomes - Peak plasma concentration (Cmax) - Time to peak plasma concentration (Tmax) - The lowest plasma concentration (Cmin) - Half-life (t1/2) - Number of adverse events and number of participants with adverse events Secondary Outcomes - Lymphocyte count - Percentage of CD3+CD4+ and CD3+CD8+ T cells ### Location - Facility: The first hospital of Jilin University, Changchun, Jilin, N/A, China @@
## Spanish BMT4me Usability & Acceptability - NCT ID: NCT06361173 - Study ID: STUDY00004127 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-05-01 - Lead Sponsor: Nationwide Children's Hospital ### Study Description The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site. ### Conditions - Bone Marrow Transplant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - BMT4me ### Outcomes Primary Outcomes - Assess app usability using the System Usability Scale (SUS) Secondary Outcomes ### Location - Facility: Columbia University Irving Medical Center, New York, New York, 10027, United States @@
## Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation - NCT ID: NCT06361160 - Study ID: D23-P037 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Centre Hospitalier St Anne ### Study Description Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the "continuous theta burst" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system.The research project comprises two phases:-Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions.Phase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866). ### Conditions - Treatment Resistant Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Active Transcranial Magnetic Stimulation (TMS) - Sham Transcranial Magnetic Stimulation (TMS) ### Outcomes Primary Outcomes - Duration of auditory-verbal hallucinations Secondary Outcomes - Clinical scales scores - Measure of the duration and/or intensity of HAV (in seconds) during active phasic stimulation sessions compared to sham sessions (phase 1) among TMS responders and non-responders in phase 2 - Intensity of auditory-verbal hallucinations ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Psychoeducation of Adult Siblings of ASD People (Autism Spectrum Disorder). - NCT ID: NCT06361147 - Study ID: 3764/2-10-2019 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-10 - Lead Sponsor: Hellenic Mediterranean University ### Study Description The aim of this study is to apply a psychoeducational program in adult siblings of people with ASD as a means to provide knowledge related to the disorder and improving their quality of life.The psycho-educational program will be implemented in adult siblings of people with ASD and its effectiveness will be assessed.Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified. ### Conditions - Autism Spectrum Disorder - Sibling Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cygnet program for ASD ### Outcomes Primary Outcomes - Psychoeducation effectiveness on siblings of ASD - Psychoeducation effectiveness on the knowledge of ASD - Psychoeducation effectiveness on siblings relationship - Psychoeducation effectiveness on resilience of siblings of ASD - Psychoeducation effectiveness on the well-being of siblings of ASD Secondary Outcomes ### Location - Facility: Hellenic Mediterranean University, Heraklion, Crete, 82102, Greece @@
## Efficacy of Supporting SAFE Early Intervention - NCT ID: NCT06361134 - Study ID: 14574941-302,08,01- - Status: COMPLETED - Start Date: 2021-01-15 - Completion Date: 2022-11-15 - Lead Sponsor: Gazi University ### Study Description Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention. ### Conditions - Infant Development - Physiotherapy - Early Intervention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SAFE Early İntervention - NDT based therapy ### Outcomes Primary Outcomes - Test of Infant Motor Profile Secondary Outcomes - Bayley Scales of Infant and Toddler Development, Third Edition, - Infant/Toddler Sensory Profile 2 - Infant/Toddler HOME Inventory ### Location - Facility: Erzurum Technical University, Erzurum, N/A, N/A, Turkey @@
## Mid-point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block in Posterolateral Thoracotomy - NCT ID: NCT06361121 - Study ID: D361 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03 - Lead Sponsor: Fayoum University Hospital ### Study Description The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL)Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks.In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries.In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions. ### Conditions - Bronchiectasis - Lung Neoplasm - Emphysematous Bleb of Lung ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mid-point transverse process to pleura (MTP) block - Thoracic Paravertebral Block ### Outcomes Primary Outcomes - The total postoperative fentanyl consumption Secondary Outcomes - Demographic data - visual analogue scale score both during rest and with cough - intra operative fentanyl consumption - Duration of surgery - Blood pressure - Heart rate - Oxygen saturation - complications related to the block - complications related to IV opioids - Hospital length of stay in days - Participant satisfaction ### Location - Facility: Fayoum University Hospital, Fayoum, N/A, 63514, Egypt @@
## Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain - NCT ID: NCT06361108 - Study ID: YJ001-103 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-03-20 - Lead Sponsor: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. ### Study Description This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11. ### Conditions - Diabetic Peripheral Neuropathic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - YJ001 for Spray Use - Placebo of YJ001 for Spray Use ### Outcomes Primary Outcomes - Safety Assessments - AEs - Safety Assessments -Number of Participants With Abnormal Laboratory Values - Safety Assessments - Skin Reaction Secondary Outcomes - Pharmacokinetics-AUC - Pharmacokinetics- Cmax - Pharmacokinetics - tmax - Pharmacokinetics - tlag - Pharmacokinetics - t1/2 - Pharmacokinetics - CLr/f,ss - Efficacy evaluation indicator - Efficacy evaluation indicators - ADSIS - Efficacy evaluation indicators - SF-MPQ - Efficacy evaluation indicators - VPT ### Location - Facility: Clinical Trials of Texas,LLC, Fredericksburg, Texas, 78229, United States @@
## Confirmatory Efficacy Trial of Attention Bias Modification for Depression - NCT ID: NCT06361095 - Study ID: R01GABM - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-03-01 - Lead Sponsor: University of Texas at Austin ### Study Description The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:* Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM* Aim 1: establish that gamified ABM is at least as effective as traditional ABM.* Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.* Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-upParticipants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional Attention Bias Modification - Gamified Attention Bias Modification - Sham Attention Bias Modification ### Outcomes Primary Outcomes - QIDS (Quick Inventory of Depression Symptoms) SR-16 Secondary Outcomes - Sheehan Disability Scale (SDS) - Snaith-Hamilton Pleasure Scale (SHAPS) - Hamilton Depression Rating Scale (HAM-D) - Generalized Anxiety Disorder (GAD-7) - Perseverative Thinking Questionnaire (PTQ) ### Location - Facility: Institute for Mental Health Research, Austin, Texas, 78705, United States @@
## Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases - NCT ID: NCT06361082 - Study ID: CORPG5N0061 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description This study explores ultrasonic scattering imaging technology in patients undergoing anterior cruciate ligament (ACL) reconstruction and those with shoulder musculoskeletal disorders. Ultrasonography, widely utilized for diagnosing musculoskeletal conditions, faces limitations due to factors like operator experience and equipment settings, often lacking in quantifiable disease metrics. Nakagami imaging, employing the backscattering statistical distribution model, offers a quantitative assessment method that minimizes subjective interpretation by extracting tissue properties through the interaction between ultrasound and tissue microstructure. The Nakagami model effectively describes tissue scattering statistics, enabling the identification and classification of tissue features based on specific scattering conditions.ACL reconstruction is commonly performed, with postoperative complications including joint stiffness and muscle strength decline, associated with changes in muscle quality and volume. Similarly, soft tissue injuries around the shoulder and ankle are prevalent in sports medicine, with ultrasound used to assess the severity of injuries to soft tissues such as the rotator cuff tendons/muscles and surrounding ligaments of the shoulder, as well as the medial and lateral ligament complexes of the ankle. Preliminary findings suggest that Nakagami imaging can differentiate layers within normal tendons, proposing its potential for visualizing and quantifying soft tissue lesions post-ultrasound, aiming for standardized diagnostic criteria.The results of this project could significantly improve the diagnostic efficacy of musculoskeletal ultrasound, facilitating earlier treatment and reducing the socio-economic impacts. Academically, it positions the investigating team as pioneers in the application of ultrasound inverse scattering imaging technology. ### Conditions - ACL Injury - ACL Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - ACL reconstruction ### Outcomes Primary Outcomes - MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles - Ultrasound Nakagami back scattering analysis- Nakagami index Secondary Outcomes - Physical examination of limbs- Angles of Range of Motion of knee - MRI of affected limb- Quality of knee structures documented with descriptions for MR signals - Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings - Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles - Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reducing Anxiety in Children Undergoing Day Surgery - NCT ID: NCT06361069 - Study ID: aslıakdeniz - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2024-01-01 - Lead Sponsor: Bilecik Seyh Edebali Universitesi ### Study Description Aim: This study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data. ### Conditions - Anxiety - Child, Only - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - distraction cards, kaleidoscope and finger puppet ### Outcomes Primary Outcomes - Anxiety Secondary Outcomes ### Location - Facility: Bilecik Şeyh Edebali University, Bilecik, N/A, N/A, Turkey @@
## Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials - NCT ID: NCT06361056 - Study ID: LCCC2140 - Status: RECRUITING - Start Date: 2022-05-02 - Completion Date: 2026-01 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Survey - mHealth app ### Outcomes Primary Outcomes - Feasibility of Mobile Health Application (mHealth app)- subjects - Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff Secondary Outcomes - Overall satisfaction ### Location - Facility: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27514, United States @@
## Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC) - NCT ID: NCT06361043 - Study ID: 2023-01833 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-02-28 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description Despite multimodal therapy, patients with esophageal cancer have poor prognosis with 5-year overall survival around 25%. Considering tumor-related death as main reason for high mortality rate in those patients, treatment-related cardio-pulmonary toxicities could also play a role in this regard. Online adaptive radiotherapy offers the possibility for daily re-planning and therefore helps radiation oncologists to better spare the organs at risk and reduce radiation-induced toxicity. Tha aim of ARTEC is to assess the pulmonary toxicity in patients with esophageal cancer treated with online adaptive radiotherapy. ### Conditions - Esophageal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of patients with pulmonary toxicity Secondary Outcomes - Number of patients with pathological complete response - Dosimetrical analysis between scheduled and adaptive plans ### Location - Facility: Inselspital, University of Berne, Deparftment of Radio-Oncology, Berne, N/A, 3010, Switzerland @@
## Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer - NCT ID: NCT06361030 - Study ID: HMPL-012-C2-PC01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer ### Conditions - Pancreatic Cancer - Pancreatic Cancer Non-resectable - Pancreatic Ductal Adenocarcinoma, PDAC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - surufatinib combined with gemcitabine plus nab-paclitaxel ### Outcomes Primary Outcomes - Surgical conversion rate Secondary Outcomes - Objective Response Rate (ORR) - Disease control rate (DCR) - R0 surgical conversion rate - progression free survival(PFS) - Overall Survival (OS) - Adverse Event ### Location - Facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China @@
## The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy - NCT ID: NCT06361017 - Study ID: QNPY2022007 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes. ### Conditions - Acute Ischemic Stroke - Endovascular Thrombectomy - Dynamic Cerebral Autoregulation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - endovascular thrombectomy ### Outcomes Primary Outcomes - The occurrence of hemorrhage transformation - Patients without hemorrhage transformation - The occurrence of unfavorable outcome - The occurrence of favorable outcome Secondary Outcomes - The occurrence of long-term unfavorable outcome - The occurrence of long-term favorable outcome ### Location - Facility: Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University, Beijing, Beijing, 100053, China @@
## Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome - NCT ID: NCT06361004 - Study ID: DBS for TR-TS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2029-12-31 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) in patients with Treatment-refractory Tourette's syndrome (TR-TS) implantation targeting the Antero-medial globus pallidus interna (GPi), Antero-medial globus pallidus interna (amGPi), Postero-ventrolateral GPi (pvGPi), Centromedian nucleus, substantia periventricularis and nucleus ventro-oralis internus (Cm-Spv-Voi), Centre median nucleus and nucleus ventro-oralis (Cm-Voi), or Nucleus Accumbens/ Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets. ### Conditions - Tourette's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Deep Brain Stimulation (DBS) ### Outcomes Primary Outcomes - Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 6 months Secondary Outcomes - YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12. - YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12. - YGTSS: remission, and response rate - Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12. - Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score. - Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months. - Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12. - Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S) - Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. - EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L. - Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. - Safety as indicated by the number of Adverse Events: Week 2, Month 3, Month 6, and Month 12. - Change from baseline in the Verbal Fluency Test (COWAT) - Change from baseline in the Trailmaking Test A&B - Change in Rey-Osterrieth Complex Figure Test ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, N/A, 100053, China @@
## DBS for Treatment-resistant Obsessive-compulsive Disorder - NCT ID: NCT06360991 - Study ID: DBS for TR-OCD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2029-12-31 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation targeting the anteromedial region of subthalamic nucleus (amSTN), or nucleus accumbens (NAc), or bed nucleus of the stria terminalis (BNST), or ventral capsule/ventral striatum (VC/VS), or the ventral anterior limb of the internal capsule (vALIC) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD). ### Conditions - Obsessive-Compulsive Disorder (OCD) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Deep brain stimulation (DBS) ### Outcomes Primary Outcomes - Yale-Brown Obsessive Compulsive Scale (Y-BOCS): the change from baseline to 1 year in the Y-BOCS total score. Secondary Outcomes - Yale-Brown Obsessive Compulsive Scale (Y-BOCS): remission, response, and partial response rate - Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in the HAMA total score. - Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year. - Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 1, Month 3, Month 6, and Month 1. - Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in Clinical Global Impression-Severity (CGI-S) - Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. - EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12 in EQ-5D-5L. - Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. - Safety as indicated by the number of Adverse Events Week 2, Month 1, Month 3, Month 6, and Month 12. ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, N/A, 100053, China @@
## Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer - NCT ID: NCT06360978 - Study ID: docetaxel as a radiosenstizer - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-06 - Lead Sponsor: Assiut University ### Study Description Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries.Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%.Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group.The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC. ### Conditions - Head and Neck Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Docetaxel ### Outcomes Primary Outcomes - progression free survival Secondary Outcomes - incidence of treatment adverse events - Overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain - NCT ID: NCT06360965 - Study ID: Shoufa2024-3-7045 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine ### Study Description Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. This study compares the effectiveness of warm meridians and relieve pain plaster in relieving the sequelae of pelvic inflammatory disease and chronic pelvic pain symptoms, and evaluates the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals. ### Conditions - Pelvic Inflammatory Disease - Chronic Pelvic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Improved warm meridians and relieve pain plaster - Traditional warm meridians and relieve pain plaster - Placebo plaster ### Outcomes Primary Outcomes - Main symptoms (lower abdominal pain) improvement level (visual analogue scale) Secondary Outcomes - TCM syndrome score scale - Local physical sign rating scale - Pelvic masses and fluid accumulation - EuroQol Five Dimensions Questionnaire - Recurrence of abdominal pain during 1-month menstrual cycle was followed up. ### Location - Facility: Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, N/A, N/A, China @@
## A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC - NCT ID: NCT06360952 - Study ID: T23-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-07-30 - Lead Sponsor: Tasso Inc. ### Study Description This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.This investigation will include a minimum of 40 sample sets from unique patients. ### Conditions - Leukopenia - Leukocytosis - Neutropenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tasso+ CBC ### Outcomes Primary Outcomes - Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count Secondary Outcomes - Agreement between capillary and venous blood in the measurement of secondary biomarkers ### Location - Facility: Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States @@
## Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease - NCT ID: NCT06360939 - Study ID: ETH02659 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-04-15 - Lead Sponsor: Western Sydney Local Health District ### Study Description The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:* What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months* What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care). ### Conditions - Ventricular Tachycardia - Cardiomyopathies - Arrhythmias, Cardiac - Ventricular Arrythmia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SBRT - CA ### Outcomes Primary Outcomes - VT burden Secondary Outcomes - Recurrent sustained VT - VT storm - Absolute VT burden - Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) - ICD shocks - Hospitalization - All cause mortality - Cardiovascular Mortality - Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation - Ventricular function - Quality of Life as per Short Form - 36 (SF-36) Score - Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score - Number of AADs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improvement Image Quality for SuperSonic® MACH Ultrasound System - NCT ID: NCT06360926 - Study ID: 2024-A00526-41 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: SuperSonic Imagine ### Study Description The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe). ### Conditions - Diagnosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - SuperSonic® Ultrasound System ### Outcomes Primary Outcomes - Qualitative assessment of image quality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Blood Spot and Urine Metabolomic Screening Applied to Rare Diseases - NCT ID: NCT06360913 - Study ID: 2023/09AOU/346 - Status: RECRUITING - Start Date: 2024-01-03 - Completion Date: 2028-01 - Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Study Description The primary goal of this study is to establish a biobank of dried blood spots and urines from a large control cohort and collect several cohorts as large as possible of patients affected or suspected of being affected by rare diseases (mainly hereditary metabolic diseases) or by autism spectrum disorders.A metabolomic database using a high-resolution mass spectrometer (i.e. the "Device") will be generated and specific biomarkers for the diseases will be confirmed or uncovered. The ultimate goal is to facilitate and improve the diagnosis and screening of the patients affected by these disorders, but also to improve the knowledge about the biochemical mechanisms involved over the course of the selected pathologies.High-resolution mass spectrometry allows the measurement of thousands of metabolites in a single analysis. The current biochemical tests used for the diagnosis of hereditary metabolic diseases are only using a combination of maximum a few dozens of biomarkers in one analysis.Objectives Unravel new biomarkers for diagnosis (+/- explore the altered pathways...) Uncover and/or validate newborn screening biomarkers through retrospective analysis of preserved newborn DBS from confirmed patients (useful for first or second tier biochemical NBS testing!) Validation of LC-MS qTOF for metabolomics screening as first line diagnostic test (thousands of metabolites) using diagnostic algorithms (modified z-scores) \& continuous optimization by adding new cases and new controls in the database Generation of a biobank of urines and DBS from rare diseases (IEMs) \& from a large reference population useful for other research applications ### Conditions - Inborn Errors of Metabolism - Rare Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - High resolution mass spectrometry ### Outcomes Primary Outcomes - Uncover new biomarkers in dried blood spots and urines samples able to improve the diagnosis of rare diseases Secondary Outcomes ### Location - Facility: Hôpital Universitaire des enfants Reine Fabiola (HUDERF-ULB), Brussels, N/A, B-1020, Belgium @@
## Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia - NCT ID: NCT06360900 - Study ID: 2024P000849 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-03 - Lead Sponsor: Spaulding Rehabilitation Hospital ### Study Description The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements. ### Conditions - Functional Dyspepsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - taVNS - CBT - Education Control - Sham taVNS ### Outcomes Primary Outcomes - Nepean Dyspepsia Index (NDI) - Visceral Sensitivity Index (VSI) Secondary Outcomes - Gastric peristaltic velocity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Management of Proximal Humerus Fractures in Adults: a Clinical Trial - NCT ID: NCT06360887 - Study ID: DRKS00030614 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-01-31 - Lead Sponsor: Regional Hospital of Bolzano ### Study Description Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment. ### Conditions - Shoulder Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Conservative - ORIF - CRPP ### Outcomes Primary Outcomes - Oxford Shoulder Score Secondary Outcomes - The visual analogue scale - Rate of complications ### Location - Facility: Academic Hospital of Bolzano (SABES-ASDAA), Bolzano, Alto Adige, 39100, Italy @@
## A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults - NCT ID: NCT06360874 - Study ID: ND003-I-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-02 - Lead Sponsor: Shenzhen NewDEL Biotech, Co., Ltd ### Study Description The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ND-003 40mg - ND-003 placebo 40mg - ND-003 80mg - ND-003 placebo 80mg - ND-003 160mg - ND-003 placebo 160mg - ND-003 240mg - ND-003 placebo 240mg - ND-003 300mg - ND-003 placebo 300mg - MAD_ND003_Dose 1 - MAD_placebo_Dose 1 - MAD_ND003_Dose 2 - MAD_placebo_Dose 2 - MAD_ND003_Dose 3 - MAD_ placebo_Dose 3 - Food effect_Cohort 1 - Food effect_Cohort 2 ### Outcomes Primary Outcomes - Adverse Events (AE) Secondary Outcomes - maximum concentration (Cmax) - Time to maximum concentration (Tmax) - Elimination Half-life (t1/2) - Clearance (CLz/F) - AUC from time 0 to last time of quantifiable concentration (AUC0-t) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis - NCT ID: NCT06360861 - Study ID: 1400-1-233-51589 - Status: COMPLETED - Start Date: 2019-07-23 - Completion Date: 2024-03-06 - Lead Sponsor: Tehran University of Medical Sciences ### Study Description To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers. ### Conditions - Multiple Sclerosis - Secondary-Progressive Multiple Sclerosis - Mesenchymal Stem Cells ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Allogenic placenta derived mesenchymal stem cells ### Outcomes Primary Outcomes - Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]. Secondary Outcomes - Number of participants with a change in disability as measured by Expanded Disability Status Scale . - Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test . - Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery. - Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging . - Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging . - Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test . - Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition . - Proportion of patients with change in CD20 / CD19 B cells surface markers - Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines. - Proportion of patients with change in T2 lesion volume on brain MRI. - Proportion of patients with change in brain volume on MRI. - Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised . - Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test . - Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests. - Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test . - Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised . - Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale . - Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test. - Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test. ### Location - Facility: Tehran University of Medical Sciences,Tehran, Iran, Tehran, N/A, N/A, Iran, Islamic Republic of @@
## Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases) - NCT ID: NCT06360848 - Study ID: IRB00001192 - Status: COMPLETED - Start Date: 2005-01-01 - Completion Date: 2021-01-01 - Lead Sponsor: Ibn Jazzar Hospital ### Study Description Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used. ### Conditions - Humerus Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - surgery ### Outcomes Primary Outcomes - Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) - Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) - Time to consolidation depending on the type of pseudarthrosis (in months) - Average Constant score postoperatively according to the means of restraint Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases) - NCT ID: NCT06360835 - Study ID: IRB00001193 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2021-12-02 - Lead Sponsor: Ibn Jazzar Hospital ### Study Description Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications. ### Conditions - Proximal Femur Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - total hip arthroplasty ### Outcomes Primary Outcomes - Surgical Approach - Preparation of the Patient - Anesthesia - Type of Surgical Revision - Types of Prosthesis Secondary Outcomes - Age Distribution - Distribution by Sex - Distribution According to Affected Side - Distribution According to Circumstances of Trauma ### Location - Facility: IBN jazzar hospital, Kairouan, N/A, 3190, Tunisia @@
## Increasing Equity in Lung Cancer Screening - NCT ID: NCT06360822 - Study ID: 19317 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2027-02-01 - Lead Sponsor: Indiana University ### Study Description The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - ED-LCS ### Outcomes Primary Outcomes - Rate of patients receive Lung Cancer Screening Secondary Outcomes - Patients ratings of intervention ### Location - Facility: Eskenazi Health, Indianapolis, Indiana, 46202, United States @@
## Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC) - NCT ID: NCT06360809 - Study ID: 2024 PARINEFC 00001 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-06 - Lead Sponsor: Institut Nacional d'Educacio Fisica de Catalunya ### Study Description To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology.This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected.The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prehabilitation exercise program ### Outcomes Primary Outcomes - Quality of life score - Cancer quality of life score - Cancer-related fatigue - Body composition - Bone density - Cardiorespiratory fitness - Maximum isometric manual grip strength - Upper body maximum strength - Lower body maximum strength - Shoulder range of motion - Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor - Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor - Oxygen saturation (StO2) in the microenvironment of the tumor - Blood flow (BF) in the microenvironment of the tumor Secondary Outcomes - Height - Body mass - Body mass index - Wait circumference - Anthropometric measurements - Bioimpedance measurements - Maximal heart rate ### Location - Facility: Hospital Clínic, Barcelona, N/A, 08036, Spain @@
## Study of Pharmacokinetics and Metabolism on [(14)C]ADC189 - NCT ID: NCT06360796 - Study ID: 2023-ADC189-I-010 - Status: RECRUITING - Start Date: 2023-11-24 - Completion Date: 2024-07-30 - Lead Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd ### Study Description This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants. ### Conditions - Pharmacokinetics - Metabolism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - [(14)C]ADC189 ### Outcomes Primary Outcomes - The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites - The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites - The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi) - The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi) Secondary Outcomes ### Location - Facility: The First Affilicated Hospital of Bengbu Medical University, Bengbu, Anhui, 233004, China @@
## COVID-19 Quick Start - Test and Treat in Africa - NCT ID: NCT06360783 - Study ID: Pro00111388 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-01 - Completion Date: 2024-06 - Lead Sponsor: Duke University ### Study Description Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T\&T) demonstration programs ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Stakeholder Perspectives Secondary Outcomes ### Location - Facility: Duke Global Health Institute, Durham, North Carolina, 27705, United States @@
## Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia - NCT ID: NCT06360770 - Study ID: NIRSCovidSBCelje - Status: COMPLETED - Start Date: 2021-12-01 - Completion Date: 2023-04-30 - Lead Sponsor: General and Teaching Hospital Celje ### Study Description Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested. ### Conditions - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - sepsis development Secondary Outcomes - mortality ### Location - Facility: SB Celje, Celje, N/A, 3000, Slovenia @@
## Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19) - NCT ID: NCT06360757 - Study ID: DHF-21-2141-1 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2024-09-01 - Lead Sponsor: QIAGEN Gaithersburg, Inc ### Study Description A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems. ### Conditions - SARS-CoV-2 Acute Respiratory Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NeuMoDx SARS-CoV-2 Assay ### Outcomes Primary Outcomes - Sensitivity as compared to the comparator method Secondary Outcomes - Specificity ### Location - Facility: QIAGEN Gaithersburg, Inc, Manchester, N/A, M130BH, United Kingdom @@
## A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines. - NCT ID: NCT06360744 - Study ID: ENFORCE PLUS - Status: COMPLETED - Start Date: 2021-07-05 - Completion Date: 2023-12-31 - Lead Sponsor: Jens D Lundgren, MD ### Study Description A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent). ### Conditions - SARS CoV 2 Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Johnson & Johnson ### Outcomes Primary Outcomes - Assessment of the J& J vaccine Secondary Outcomes ### Location - Facility: Aarhus Universitetshospital, Skejby, Aarhus, Aarhus N, 8200, Denmark @@
## The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus - NCT ID: NCT06360731 - Study ID: 1018 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-05-31 - Lead Sponsor: Ege University ### Study Description The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.There will be a parallel-group randomized controlled trial study and consists of two groups.Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application. ### Conditions - Tinnitus, Subjective ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 4-7-8 breathing exercise technique and informative session on tinnitus - Informative session on tinnitus ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) - Visual Analog Scale (VAS) - Tinnitus Handicap Inventory (THI) - Tinnitus Handicap Inventory (THI) - Insomnia severity index (ISI) - Insomnia severity index (ISI) - Perceived stress scale -10 (PSS-10) - Perceived stress scale -10 (PSS-10) - Trait Anxiety Scale (TAS) - Trait Anxiety Scale (TAS) Secondary Outcomes ### Location - Facility: Gokce Saygi Uysal, Ankara, N/A, N/A, Turkey @@
## Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress. - NCT ID: NCT06360718 - Study ID: CHLA-23-00170 - Status: RECRUITING - Start Date: 2024-02-03 - Completion Date: 2025-05-15 - Lead Sponsor: Children's Hospital Los Angeles ### Study Description The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress.The main questions it aims to answer are:* What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up?* Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding?Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling).Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone. ### Conditions - Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - "Who is Luke Eemia?" Storybook ### Outcomes Primary Outcomes - Parental Stress, prior to and following child life intervention Secondary Outcomes - Parent perception of the child's stress - Parent's Comfort Explaining Aspects of Leukemia Diagnosis - Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline). - Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline). ### Location - Facility: Children's Hospital Los Angeles, Los Angeles, California, 90027, United States @@
## StrataMGT for the Treatment of Vulvar Lichen Sclerosus - NCT ID: NCT06360705 - Study ID: CVVD003 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Center for Vulvovaginal Disorders ### Study Description This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus. ### Conditions - Vulvar Lichen Sclerosus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - StrataMGT ### Outcomes Primary Outcomes - Histopathologic Inflammation Secondary Outcomes ### Location - Facility: Centers for Vulvovaginal Disorders, New York, New York, 10036, United States @@
## Impact of Nipple Micropigmentation in Mastectomized Women - NCT ID: NCT06360692 - Study ID: Marta Lluesma Vidal Carden - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: Cardenal Herrera University ### Study Description This will be a multicenter prospective descriptive case series study following a cohort.The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women. ### Conditions - Body Image - Female Sexual Function - Self Esteem - Intimacy With Your Partner ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Body imagen Secondary Outcomes - Self-esteem - Sexual Function - Intimacy with the partner ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients. - NCT ID: NCT06360679 - Study ID: CIP000004 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2025-06-01 - Lead Sponsor: BariaTek Medical ### Study Description Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endoscopic gastric restriction and biliodigestive diversion ### Outcomes Primary Outcomes - Safety of the BariTon™ - Safety of the BariTon™ Secondary Outcomes - Safety of the BariTon™ - Safety of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ ### Location - Facility: BMI Clinic Double Bay, Sydney, New South Wales, 2028, Australia @@
## Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia - NCT ID: NCT06360666 - Study ID: Neurax1 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-10-01 - Completion Date: 2024-12-31 - Lead Sponsor: Asst Melegnano e Martesana ### Study Description The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is:Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery ### Conditions - Mortality - Surgical Complication - Neurological Complication - Respiratory Complication - Cardiovascular Complication - Nephrotoxicity - Metabolic Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality - Morbidity Secondary Outcomes - Surgical revisions - organ dysfunctions ### Location - Facility: ASST Melegnano e Martesana - Ospedale Vizzolo Predabissi, Vizzolo Predabissi, Milan, 20070, Italy @@
## a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer - NCT ID: NCT06360653 - Study ID: 76CIVICO2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: ARNAS Civico Di Cristina Benfratelli Hospital ### Study Description The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer ### Conditions - Endometrial Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Stereotactic Post-operative Radiotherapy for Endometrial Cancer ### Outcomes Primary Outcomes - Acute G3 or higher Gastrointestinal and Genitourinary Toxicity Secondary Outcomes - Late Gastrointestinal and Genitourinary Toxicity - Distant Progression Free Survival - Local Control - Overall Survival - Overall Quality of Life ### Location - Facility: ARNAS Civico Hospital, Palermo, PA, 90100, Italy @@
## A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults - NCT ID: NCT06360640 - Study ID: APC148-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-03 - Lead Sponsor: AdjuTec Pharma AS ### Study Description The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - APC148 and Placebo ### Outcomes Primary Outcomes - Incidence and intensity of adverse events (AEs) - Incidence and intensity of serious adverse events (SAEs) - Incidence and intensity of infusion-related AEs - Time course of local tolerability reactions - Changes from baseline in blood pressure - Changes from baseline in respiratory rate - Changes from baseline in body temperature - Changes from baseline in heart rate - Changes from baseline in PQ/PR interval - Changes from baseline in QRS interval - Changes from baseline in QT interval - Changes from baseline in QTcF interval - Changes from baseline in Clinical Laboratory Profile - Changes from baseline in physical examination Secondary Outcomes - APC148 plasma concentrations - APC148 urine concentrations - Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24 - PK parameter in plasma - AUC0-inf - PK parameter in plasma - AUC0-last - PK parameter in plasma - Cmax - PK parameter in plasma - Tmax - PK parameter in plasma - T1/2 - PK parameter in plasma - Clearance (CL) - PK parameter in plasma - Vz - PK parameter in plasma - Vss determination of plasma concentrations will be collected. - PK parameters in urine - A(e) - PK parameters in urine - fe - PK parameter in urine - renal clearance (CLr) ### Location - Facility: Clinical Trial Consultants AB, Uppsala, N/A, N/A, Sweden @@
## Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT - NCT ID: NCT06360627 - Study ID: 2022_D0008 - Status: RECRUITING - Start Date: 2023-02-20 - Completion Date: 2027-12-01 - Lead Sponsor: University of Zurich ### Study Description Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT ### Conditions - Radiation Exposure - Lung Embolism - Lung Cancer - Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Computed Tomography ### Outcomes Primary Outcomes - Dose Reduction by new scanner - stable Image Quality in reduced dose scans Secondary Outcomes ### Location - Facility: University Hospital Zurich - Diagnostic Radiology, Zurich, N/A, 8091, Switzerland @@
## The Effect of Hand Massage Applied to Palliative Care Oncology Patients - NCT ID: NCT06360614 - Study ID: 2024s01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: murat koç ### Study Description World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. ### Conditions - Hand Massage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Hand massage application - routine monitoring and nursing care ### Outcomes Primary Outcomes - İndividual Information Form - Patient Follow-up Form - General Comfort Scale - Pittsburgh Sleep Quality Index - Smart Bracelet Secondary Outcomes ### Location - Facility: Sultanbeyli State Hospital, Istanbul, N/A, 34000, Turkey @@
## Intravenous Labetalol Versus Hydralazine in Preeclampsia - NCT ID: NCT06360601 - Study ID: 36264PR589/3/24 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09 - Lead Sponsor: Tanta University ### Study Description We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome ### Conditions - Preeclampsia Severe ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Labetalol Injection - HydrALAZINE Injection ### Outcomes Primary Outcomes - Cerebral blood flow Secondary Outcomes ### Location - Facility: Faculty of Medicine, Tanta, N/A, 3511, Egypt @@
## Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) - NCT ID: NCT06360588 - Study ID: NCI-2024-01141 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-06-19 - Completion Date: 2024-11-15 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description The phase II MATCH treatment trial tests how well copanlisib works to treat patients with cancer with PTEN loss. Copanlisib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. ### Conditions - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Copanlisib - Radiologic Examination ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall survival (OS) - 6-month progression-free survival (PFS) rate - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) - NCT ID: NCT06360575 - Study ID: NCI-2024-01127 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2016-05-30 - Completion Date: 2024-11-15 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial tests how well crizotinib works to treat patients with cancers with MET exon 14 deletion genetic changes. Crizotinib is in a group of medications called tyrosine kinase inhibitors. It works by blocking enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Crizotinib - Radiologic Examination ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall survival (OS) - 6-month progression-free survival (PFS) rate - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Reconnecting to Ourselves and Others in Virtual Meetings (ROOM) - NCT ID: NCT06360562 - Study ID: 2020P002418 - Status: RECRUITING - Start Date: 2020-09-15 - Completion Date: 2025-04-25 - Lead Sponsor: Massachusetts General Hospital ### Study Description This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality. ### Conditions - Mood Disorders - Anxiety Disorders - Psychotic Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Resilience Training ### Outcomes Primary Outcomes - Discomfort with Others - Intervention Feasibility and Acceptability - Penn Emotion Recognition Test - Stop Distance Paradigm Secondary Outcomes - Beck Depression Inventory - Spielberger State-Trait Anxiety Inventory - Prodromal Questionnaire- Brief - Connor-Davidson Resilience Scale ### Location - Facility: Massachusetts General Hospital, Charlestown, Massachusetts, 02129, United States @@
## Effect of Percutaneous Acupoint Electrical Stimulation on Delirium - NCT ID: NCT06360549 - Study ID: TJ-IRB202403019 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: Qin Zhang ### Study Description This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium. ### Conditions - Delirium, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Electrical Acupoint Stimulation ### Outcomes Primary Outcomes - Delirium (using the Delirium Rating Scale, DRS) Secondary Outcomes - Mini-Mental State Examination (MMSE) ### Location - Facility: Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, 510000, China @@
## Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women - NCT ID: NCT06360536 - Study ID: IRB-300012634 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-06-30 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program. ### Conditions - Overweight or Obesity - Prediabetes or Diabetes - Prehypertension (Elevated Blood Pressure) or Hypertension - Resistance Training ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Resistance Training ### Outcomes Primary Outcomes - Feasibility of recruitment - Feasibility of retention - Intervention adherence Secondary Outcomes - Change in resistance training behaviors - Change in blood pressure - Change in HbA1C - Change in body composition - Change in handgrip strength - Change in the number of chair stands ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence - NCT ID: NCT06360523 - Study ID: CRE-2024.141 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-20 - Lead Sponsor: Chinese University of Hong Kong ### Study Description It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI modal ### Outcomes Primary Outcomes - Prostate Cancer detection rate of ISUP grade group ≥2 Secondary Outcomes - Diagnosis of any grade of prostate cancer ### Location - Facility: Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome - NCT ID: NCT06360510 - Study ID: 44 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-05-05 - Completion Date: 2024-05-05 - Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital ### Study Description The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS). ### Conditions - Carpal Tunnel Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - %5 dextrose injection - betamethasone injection ### Outcomes Primary Outcomes - vas Secondary Outcomes - boston carpal tunnel syndrome questionnaire - median nerve cross sectional area - tinnel test positivity - phalen test positivity - duruöz hand index - global evaluation of treatment outcomes ### Location - Facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, Ankara, N/A, N/A, Turkey @@
## The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress - NCT ID: NCT06360497 - Study ID: 202206090070 - Status: COMPLETED - Start Date: 2022-06-03 - Completion Date: 2022-10-09 - Lead Sponsor: Beijing Normal University ### Study Description The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory. ### Conditions - MM Group - LKCM Group - Waitlist Group ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - mindfulness meditation intervention and loving-kindness and compassion meditation intervention ### Outcomes Primary Outcomes - The Depression Anxiety Stress Scale - The Philadelphia Mindfulness Scale - The Sensitivity to Punishment and Sensitivity to Reward Questionnaire Secondary Outcomes - The Emotional Word Lists ### Location - Facility: Xianglong Zeng, Beijing, Beijing, 100875, China @@
## Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus - NCT ID: NCT06360484 - Study ID: PrevelanceHDVSudan - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2022-09-10 - Lead Sponsor: National Center for Gastroentestinal and Liver Disease ### Study Description Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG ### Conditions - Hepatitis B - Hepatitis D - Viral Hepatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - investigations for Hepatitis D virus ### Outcomes Primary Outcomes - the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. Secondary Outcomes ### Location - Facility: National Center for Gastrointestinal and Liver Diseases, Khartoum, N/A, 15004, Sudan @@
## Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer - NCT ID: NCT06360471 - Study ID: FS-FMC - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2032-10-01 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.Statistical analysis of the data will be performed. ### Conditions - Fertility Issues - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - fertility preservation ### Outcomes Primary Outcomes - 5-year cumulative live birth rate Secondary Outcomes - Ovarian function(AMH levels) - Ovarian function(AFC counts) - Newborn malformation rate - Tumor recurrence rate - Tumor survival rate ### Location - Facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 210000, China @@
## Methylprednisolone Adjunctive to Endovascular Treatment for Stroke - NCT ID: NCT06360458 - Study ID: MRCTA,ECFAH of FMU[2024]368 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-03-01 - Lead Sponsor: Wan-Jin Chen ### Study Description The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Methylprednisolone ### Outcomes Primary Outcomes - Mortality at 90 days Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects - NCT ID: NCT06360445 - Study ID: HD1912BE202201 - Status: COMPLETED - Start Date: 2022-05-26 - Completion Date: 2022-08-21 - Lead Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. ### Study Description This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Olaparib Tablet test formulation 100mg - Olaparib Tablet reference formulation 100mg - Olaparib Tablet test formulation 150mg - Olaparib Tablet reference formulation 150mg ### Outcomes Primary Outcomes - Cmax Description: Maximum observed plasma concentration - AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time - AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration Secondary Outcomes - Time of maximum observed plasma concentration (Tmax) - Terminal elimination half-life (T1/2) - Apparent total body clearance (Cl/F) - Apparent volume of distribution (V/F) - Number of participants with Adverse Events ### Location - Facility: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China @@
## Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity - NCT ID: NCT06360432 - Study ID: HSEARS20240214001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-04-30 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:* their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,* nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0. ### Conditions - Sarcopenic Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary modification program - Exercise training - The EatWellLog App ### Outcomes Primary Outcomes - Changes of muscle strength - Changes of muscle mass - Changes of body mass index - Changes of waist circumference - Changes of fat mass - The Short Physical Performance Battery (SPPB) scale Secondary Outcomes - Mini Nutritional Assessment (MNA) Short-form - Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale - Dietary Quality Index-International (DQI-I) - EuroQoL 5D (EQ-5D) - Diet Adherence - Exercise Adherence ### Location - Facility: The Hong Kong Polytechnic University, Hong Kong, N/A, N/A, Hong Kong @@
## Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol - NCT ID: NCT06360419 - Study ID: SOL-MDD-301 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-12 - Lead Sponsor: Axsome Therapeutics, Inc. ### Study Description PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Solriamfetol 300 mg - Placebo ### Outcomes Primary Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS) - Incidence of treatment-emergent adverse events Secondary Outcomes ### Location - Facility: Clinical Research Site, Encino, California, 91316, United States @@
## Real-World Treatment Study of Koselugo (Selumetinib) - NCT ID: NCT06360406 - Study ID: D1346R00009 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2031-09-30 - Lead Sponsor: AstraZeneca ### Study Description As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.This study will provide information on the Korean patient population that is treated with the study drug. ### Conditions - Neurofibromatosis 1 - Neurofibroma, Plexiform ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Adverse events (AEs) rate - Physeal dysplasia occurance rate Secondary Outcomes - Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics - NCT ID: NCT06360393 - Study ID: 17384 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: University Medical Center Groningen ### Study Description Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to:1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores.3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Smart spacer ### Outcomes Primary Outcomes - Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12) - Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse Secondary Outcomes - Assessing the association of smart spacer assessed adherence with annual exacerbation rate - Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA) - Assess the association of smart spacer assessed adherence with oral corticosteroids use - Assess the association of smart spacer assessed adherence with FeNO results - Assess the association of smart spacer assessed adherence with blood eosinophils - Assess the association of smart spacer assessed adherence with asthma control (ACQ-6) - Assess the association of smart spacer assessed adherence with spirometry results ### Location - Facility: Medisch Centrum Leeuwarden, Leeuwarden, Friesland, 8934AD, Netherlands @@
## Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System - NCT ID: NCT06360380 - Study ID: AQP-CLP-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-03 - Completion Date: 2024-12-29 - Lead Sponsor: AquaPass Medical Ltd. ### Study Description The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.Patients will wear a lightweight suit that helps remove excess fluids through their sweat.We want to see if AquaPass can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.Participants will select if to be treated at their home or in the outpatient clinic. ### Conditions - Chronic Heart Failure - CKD Stage 3 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - AquaPass System ### Outcomes Primary Outcomes - AquaPass Performance Evaluation Secondary Outcomes - AquaPass Safety Evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii - NCT ID: NCT06360367 - Study ID: 2023-00060 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2024-10-22 - Lead Sponsor: University of Hawaii ### Study Description The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY. ### Conditions - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HI-FLY Curriculum - HI-FLY Curriculum + PortionSize Ed app ### Outcomes Primary Outcomes - Feasibility- Study enrollment - Acceptability- User Satisfaction Survey (USS) scores and qualitative responses - Acceptability- Computer System Usability Questionnaire (CSUQ) scores - Acceptability- PortionSize Ed app usage data - Acceptability- Reason for study drop out - Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score - Efficacy- Change in HEI-2020 component scores - Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey - Feasibility- Study Attrition Secondary Outcomes - Change in body weight ### Location - Facility: University of Hawaii at Manoa, Honolulu, Hawaii, 96822, United States @@
## A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion - NCT ID: NCT06360354 - Study ID: 20230223 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-06-29 - Lead Sponsor: Amgen ### Study Description The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers. ### Conditions - Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AMG 193 - Gemcitabine - Nab-paclitaxel - Cisplatin - Pembrolizumab - Modified FOLFIRINOX ### Outcomes Primary Outcomes - Number of Participants Experiencing Dose Limiting Toxicities (DLT) - Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) - Number of Participants Experiencing Serious Adverse Events (SAE) Secondary Outcomes - Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) - Disease Control (DC) per RECIST v1.1 - Duration of Response (DOR) per RECIST v1.1 - Time to Response (TTR) per RECIST v1.1 - Overall Survival (OS) per RECIST v1.1 - Progression-free Survival (PFS) per RECIST v1.1 - Maximum Plasma Concentration (Cmax) of AMG193 - Time to Maximum Plasma Concentration (tmax) of AMG193 - Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 ### Location - Facility: City of Hope National Medical Center, Duarte, California, 91010, United States @@
## Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes - NCT ID: NCT06360341 - Study ID: 202301946 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-01-01 - Lead Sponsor: University of Florida ### Study Description The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes. ### Conditions - Low Back Pain, Mechanical - Acute Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Emergency Department Digital Pain Self-Management Intervention (EDPSI) - Routine Discharge Care ### Outcomes Primary Outcomes - Improving Self-Management Health Outcomes Secondary Outcomes ### Location - Facility: UF Health Shand's Adult Emergency Department, Gainesville, Florida, 32608, United States @@
## Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial) - NCT ID: NCT06360328 - Study ID: 033-2024 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-08-01 - Lead Sponsor: University Hospital Heidelberg ### Study Description Securing the airway through endotracheal intubation (ETI) is a fundamental skill for anaesthetists. It is used during surgery, in the intensive care unit, during periprocedural anaesthesia and in emergency medicine. The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management. increasing technological developments in recent years (e.g. video laryngoscopy \[VL\]) aim to reduce the complication rate in the area of airway management. however, there are currently a large number of VLs available, which differ massively in their application. Therefore, it is essential to systematically collect data and develop structured training in airway management, taking into account current technological developments.While endotracheal intubation is traditionally performed with a direct laryngoscope, indirect video laryngoscopy, with chip-based camera technology at its tip, has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment. Doctors in advanced training are trained with a focus on direct laryngoscopy; the use of and training in indirect video laryngoscopy does not follow any standards; in addition, the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology, although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt, the so-called "first-pass success".The main aim of this clinical prospective, randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy (VL) on the other, with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success. ### Conditions - Intubation Complication - Intubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - video laryngoscopy ### Outcomes Primary Outcomes - Rate of Successful tracheal intubation on the first attempt (First-Pass-Success). Secondary Outcomes - Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma. - Specify the number of attempts made during laryngoscopy. - Compare the level of training with intubation success. - Mention any failures or transitions to other rescue techniques. - Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position. - When using VL, record the occurrence of fogging. - Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view) - assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view) ### Location - Facility: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,, Heidelberg, Baden-Wuerttemberg, 69120, Germany @@
## Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician - NCT ID: NCT06360315 - Study ID: 202201265 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-02 - Completion Date: 2024-06 - Lead Sponsor: University Hospital, Montpellier ### Study Description Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure. ### Conditions - Chronic Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Incentive letter for pneumococcal vaccination to the patient and to the GP ### Outcomes Primary Outcomes - 1-year Pneumococcus vaccination rate Secondary Outcomes - 1-year all-cause hospital admission rate - 1-year specific hospital admission rate - 1-year all-cause mortality rate ### Location - Facility: Montpellier University Hospital, Montpellier, N/A, 34090, France @@
## Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients - NCT ID: NCT06360302 - Study ID: RECHMPL22_0505 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: University Hospital, Montpellier ### Study Description This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.The hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects.In this way, the metabolomics approach during exercise would provide a biological and functional "signature" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation.Participants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities.Researchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects:* V'O2-adjusted lactate at rest and during exercise* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids ### Conditions - Metabolic Syndrome - Dialysis; Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Exercise test - Blood sample - Impedancemetry ### Outcomes Primary Outcomes - Compare V'O2-adjusted plasma lactate profile at rest and during exercise (metabolic stress test), between chronic renal failure patients, patients with metabolic syndrome and healthy subjects. Secondary Outcomes - Compare between the 3 groups their metabolic profile (Krebs cycle cofactors/substrates) adjusted to V'O2 at rest and during exercise. - Compare between the 3 groups their metabolic profile (ß-oxidation cofactors/substrates) adjusted to V'O2 at rest and during exercise. - Compare between the 3 groups their metabolic profile (amino acids) adjusted to V'O2 at rest and during exercise. - Compare between the 3 groups their metabolic profile (acyl-carnitine profiles) adjusted to V'O2 at rest and during exercise. - Anthropometry Comparison between the 3 groups ### Location - Facility: AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie, Montpellier, N/A, 34295, France @@
## Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy - NCT ID: NCT06360289 - Study ID: ALN-TTR-NT-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Alnylam Pharmaceuticals ### Study Description This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy. ### Conditions - Hereditary Amyloidosis, Transthyretin-Related - Asymptomatic Carrier State ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Standard of Care ### Outcomes Primary Outcomes - NfL Levels in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline - Change in NfL Levels Over Time in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy Secondary Outcomes - Correlation Between the NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline - Correlation Between the Change in NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy - Comparison of the Measured NfL Levels to the Normal Levels Expected to be Seen in the General Population by Using the Existing Reference Ranges and Databases - Time to Onset of Active Disease in Asymptomatic Carriers of TTR Variants - Disease Progression in Symptomatic hATTR Amyloidosis Patients with Polyneuropathy ### Location - Facility: Centre Hospitalier Universitaire (CHU) Le Kremlin-Bicêtre Assistance Publique-Hôpitaux de Paris (APHP), Paris, Île-de-France, 94270, France @@
## Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy - NCT ID: NCT06360276 - Study ID: 14012021 - Status: COMPLETED - Start Date: 2022-03-14 - Completion Date: 2022-08-12 - Lead Sponsor: Alexandria University ### Study Description This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.Hypotheses for research:1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping. ### Conditions - Fatigue - Coping Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Seated Exercises - Psychoeducational Rehabilitation - Routine Care ### Outcomes Primary Outcomes - Piper Fatigue Scale - Mini-Mental Adjustment to Cancer Scale Secondary Outcomes ### Location - Facility: Faculty of Nursing, Alexandria, N/A, 56321, Egypt @@
## OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT - NCT ID: NCT06360263 - Study ID: #1-6/2023 - Status: RECRUITING - Start Date: 2023-07-11 - Completion Date: 2024-08 - Lead Sponsor: Esraa Salem Kamal ### Study Description Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement. ### Conditions - Bone Loss, Alveolar ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Densah bur in combination with activated plasma albumin gel ### Outcomes Primary Outcomes - Postoperative pain - Implant stability - Vertical bone height gain - Bone density around implant Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Alexandria University, Alexandria, N/A, N/A, Egypt @@
## Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation - NCT ID: NCT06360250 - Study ID: B2001-F20220601 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-10-30 - Lead Sponsor: Changchun BCHT Biotechnology Co. ### Study Description To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation ### Conditions - Clostridium Tetanus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation - Tetanus human immunoglobulin (HTIG) - Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo - Adsorbed tetanus vaccine (TT) ### Outcomes Primary Outcomes - Safety evaluation index Secondary Outcomes - PK evaluation index - PK evaluation index - PK evaluation index - PK evaluation index - PK evaluation index - PK evaluation index - PD evaluation index - PD evaluation index - PD evaluation index - Immunogenicity evaluation index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) - NCT ID: NCT06360237 - Study ID: ISIS 678354 - Status: AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: Ionis Pharmaceuticals, Inc. ### Study Description The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS). ### Conditions - Familial Chylomicronemia Syndrome ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Olezarsen ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Collect Flow and Ultrasound Images of Coronary Bypass Grafts - NCT ID: NCT06360224 - Study ID: CASES - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2029-05-15 - Lead Sponsor: Medistim ASA ### Study Description This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG). ### Conditions - Cardiac Bypass Surgery (CABG) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes ### Outcomes Primary Outcomes - Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants - NCT ID: NCT06360211 - Study ID: 22251 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2024-06-11 - Lead Sponsor: Bayer ### Study Description Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:* Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of midazolam in participants' bloodThe study will have 3 treatment periods:Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.Participants will visit the study clinic:* More than/at least once, within 2 to 28 days before the treatment starts* Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment* Once, within 7 to 10 days after they finish treatment for a health checkupDuring the study, the doctors and their study team will:* do physical examinations* collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are havingAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. ### Conditions - Advanced Non-small Cell Lung Cancer - EGFR Mutation - HER2 Mutation - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - BAY2927088 - Midazolam ### Outcomes Primary Outcomes - Cmax of midazolam when given with and without BAY2927088 - AUC of midazolam when given with and without BAY2927088 Secondary Outcomes - Number of participants with TEAEs - Severity of TEAEs ### Location - Facility: PAREXEL International, Baltimore, Baltimore, Maryland, 21225, United States @@
## The Relationship Between Posture, Sense of Position, Musculoskeletal Discomfort and Anxiety - NCT ID: NCT06360198 - Study ID: 2022-874/08 - Status: COMPLETED - Start Date: 2022-06-30 - Completion Date: 2022-12-30 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description It is known that posture is affected by various factors such as somatosensation, visual perception and cognition. In addition, it is also thought to affect conditions such as stress and anxiety through receptors. The aim of this study was to investigate the relationship between postural changes such as thoracic kyphosis, musculoskeletal problems, trunk position sense and anxiety in young individuals who were asymptomatic in terms of musculoskeletal problems. ### Conditions - Kyphosis Postural Thoracic - Proprioception - Musculoskeletal System - Anxiety ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Throcic Kyphosis Secondary Outcomes - Trunk Position Sense - Musculoskeletal Discomfort - Anxiety ### Location - Facility: Ankara Yıldırım Beyazıt University, Ankara, N/A, N/A, Turkey @@
## Retrospective Study of Patients With Acute Presentation for Asthma to an Emergency Department in UK (RAPAE) - NCT ID: NCT06360185 - Study ID: Asthma V2 October 2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust ### Study Description Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records. ### Conditions - Asthma Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in body weight - Change in body height Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial - NCT ID: NCT06360172 - Study ID: 3-2024 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-06-15 - Lead Sponsor: Alexandria University ### Study Description Motivational interviewing, or MI, is a collaborative, person-centered counseling technique to uncover and enhance a person\'s motivation for behavior change . MI was first created for the treatment of substance dependence, but it has since been successfully implemented in several fields, including healthcare and education (. Given the vital role that nursing students play in the healthcare system, Saudi Arabia, like many other nations, has realized how important it is to improve the motivation and well-being of its nursing students ### Conditions - Nursing Students ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Motivational Interviewing ### Outcomes Primary Outcomes - Kernis-Goldman Authenticity Inventory - The Life Orientation Test-Revised form for Adolescents - Academic Motivation Scale Secondary Outcomes ### Location - Facility: Faculty of Nursing, Alexandria university, Alexandria, N/A, N/A, Egypt @@

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.