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Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE. conditions: Hepatic Encephalopathy conditions: Covert Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Number of Beans Clamping in 1 minute measure: Participants' feedback on CBT1 test sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Changzheng hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06367114 id: ssCART-19-II-1 briefTitle: Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2025-12 date: 2024-04-16 date: 2024-04-19 name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd class: INDUSTRY name: The First Affiliated Hospital of Soochow University name: Peking University People's Hospital briefSummary: This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. conditions: Relapsed or Refractory Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ssCART-19 name: Fludarabine name: Cyclophosphamide measure: Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL). measure: Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia. measure: Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion. measure: Duration of response (DOR) measure: Recurrence free survival (RFS) measure: Event Free Survival (EFS) measure: Overall survival (OS) measure: Incidence of adverse events following ssCART-19 infusion measure: Pharmacodynamic of ssCART-19 cells measure: Pharmacodynamic of ssCART-19 cells measure: Pharmacodynamic of ssCART-19 cells measure: Anti-drug antibody sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd. city: Shanghai state: Shanghai zip: 201210 country: China lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of Soochow University city: Suzhou country: China name: Depei Wu, Dr. role: CONTACT lat: 31.30408 lon: 120.59538 hasResults: False |
<|newrecord|> nctId: NCT06367101 id: 202002525B0 briefTitle: AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease overallStatus: RECRUITING date: 2022-01-18 date: 2025-05-31 date: 2025-07-31 date: 2024-04-16 date: 2024-04-16 name: Chang Gung University class: OTHER briefSummary: A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinson's disease (PD) patients through a novel approach involving heart rate variability (HRV) feedback and Augmented Reality (AR) training. The project is based on the premise that improving HRV, which reflects the adaptability of the autonomic nervous system, can enhance both motor functions like gait and non-motor symptoms. conditions: Parkinson Disease(PD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: AR training with gait and HRV feedback measure: Walking Speed measure: Step Length measure: Step Time measure: Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR) measure: Time-Domain Index of HRV：pNN50 measure: Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD) measure: Frequency-Domain Index of HRV: Low Frequency (LF) measure: Frequency-Domain Index of HRV: High Frequency (HF) measure: Frequency-Domain Index of HRV: Ratio of LF to HF Power measure: Total Time to Complete the Time Up and Go test (TUG test) measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence measure: Total UPDRS-III Score measure: Total NFOG-Q Score measure: Overall PDQ-39 Score measure: Total HADS Score measure: Overall PSQI Score measure: Non-linear Index of HRV: SD1 measure: Non-linear Index of HRV: SD2 measure: Non-linear Index of HRV: Ratio of SD1-to-SD2 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False |
<|newrecord|> nctId: NCT06367088 id: Sophia briefTitle: Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-16 date: 2024-04-16 name: Wuhan Union Hospital, China class: OTHER briefSummary: The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients. conditions: Triple-negative Breast Cancer conditions: Cadonilimab studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Cadonilimab measure: Objective Response Rate measure: AE measure: Progression-free survival measure: Overall survival measure: Disease control rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Jie Xiong role: CONTACT phone: +8615927611872 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06367075 id: AK104-sarcoma-202401 briefTitle: A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-31 date: 2029-03-31 date: 2024-04-16 date: 2024-04-16 name: Wuhan Union Hospital, China class: OTHER name: Sun Yat-sen University name: Xiangya Hospital of Central South University name: Yunnan Cancer Hospital name: The Affiliated Hospital Of Guizhou Medical University name: First Affiliated Hospital of Guangxi Medical University briefSummary: This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin. conditions: Advanced Soft-tissue Sarcoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cadonilimab (AK104) with adriamycin primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Cadonilimab name: Adriamycin measure: objective response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Adverse event (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367062 id: SH9H-2023-T296 briefTitle: General Anesthesia/Surgical Exposure on White Matter Development in Children overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development. conditions: Neurodevelopmental Delay studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 210 type: ESTIMATED name: MRI measure: MRI-based assessment of brain development sex: ALL minimumAge: 12 Years maximumAge: 15 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06367049 id: 2023-FXY-230-NPC briefTitle: Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma overallStatus: COMPLETED date: 2023-06-01 date: 2023-09-30 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-sen University class: OTHER name: Guangdong Women and Children Hospital name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University briefSummary: Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer. |
DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening. |
There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma. |
Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer. conditions: Nasopharyngeal Carcinoma conditions: Early Diagnosis of Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 470 type: ACTUAL name: Methylation-specific PCR measure: Sensitivity measure: Specificity sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06367036 id: 2021-52 briefTitle: Effect of Hypericum Perforatum Oil on Ecchymosis and Pain overallStatus: COMPLETED date: 2022-01-02 date: 2022-12-29 date: 2023-06-15 date: 2024-04-16 date: 2024-04-16 name: Uskudar University class: OTHER briefSummary: Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test. conditions: Pain conditions: Ecchymosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Two researchers do not know which site was injected. whoMasked: INVESTIGATOR count: 160 type: ACTUAL name: Topical hypericum perforatum oil intervention measure: Pain point measure: Ecchymosis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hatice Demirdağ city: Üsküdar state: İstanbul zip: 34672 country: Turkey lat: 41.02252 lon: 29.02369 hasResults: False |
<|newrecord|> nctId: NCT06367023 id: 32-2024 briefTitle: Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth in the Deaddiction Center of Biratnagar overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2025-03-30 date: 2024-04-16 date: 2024-04-16 name: Manipur International University class: OTHER name: Brahmakumaris briefSummary: Drug addiction is a public health problem, mainly youths are involved in the addiction and the major reason were due to peer pressure. Spiritual meditation is thought to foster a deeper sense of meaning, which creates new sources of positive reinforcement, increasing motivation for alternative behavior patterns, such as entering treatment or maintaining abstinence. Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed. The major variables will be Anxiety and depression score, Happiness index, Quality of life, Rate of Relapse, Age, Gender, Occupation, Education, Income, Family Size, Family Income, Family support, Social status- High/Middle/Low, History of drug use self, Types of drugs, Duration of usage: Reason of drug use, how they have started, Amount of drugs, Frequency of use, Family history of drug use, Money spent on drugs per month. A modified validated Questionnaire will be used. CRCT will be done by CONSORT Guidelines. A total of 160 samples will be taken, (40 from each center, two were given Meditation intervention and 80 were given standard treatment as a control group) and 16 qualitative interviews will be taken (4 from each center). The intervention will be given for 3 months, for 6 days one hour per day Rajyoga meditation basic course will be provided, followed by a 1-hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group, and in the control group standard treatment will be given. Follow-up will be done after 1 month of discharge from the rehabilitation centers. Ethical clearance will be taken from the Ethical Review Board (ERB) of the Nepal Health Research Council (NHRC). This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention. conditions: Prevalence conditions: Depression conditions: Happiness conditions: Quality of Life conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ESTIMATED name: Rajyoga Meditation Practice measure: Anxiety score measure: Depression score measure: quality of life score measure: Rate of Relapse sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Rehabilitation center city: Biratnagar state: Koshi zip: 56613 country: Nepal name: Rajiv Ranjan Karn, MPH role: CONTACT phone: +9779842068053 email: [email protected] name: Ajaya Bhattarai, PhD role: CONTACT phone: +9779842077434 email: [email protected] lat: 26.45505 lon: 87.27007 hasResults: False |
<|newrecord|> nctId: NCT06367010 id: MR-36-24-010942 briefTitle: Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients overallStatus: COMPLETED date: 2019-01-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-16 date: 2024-04-16 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy. conditions: Thyroid Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8 type: ACTUAL name: Iodine-125 brachytherapy combine with Anlotinib measure: The CT images were used to measure the change in the maximum diameter of the lesion in millimeters. measure: Serological assessment measure: Use the Numerical Rating Scale (NRS) to record patients' pain scores. measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangxi Cancer Hospital city: Nanchang state: Jiangxi zip: 330029 country: China lat: 28.68396 lon: 115.85306 hasResults: False |
<|newrecord|> nctId: NCT06366997 id: CQGOG0207 briefTitle: Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test overallStatus: COMPLETED date: 2019-10-09 date: 2023-04-18 date: 2023-05-05 date: 2024-04-16 date: 2024-04-16 name: Chongqing University Cancer Hospital class: OTHER name: Zhejiang Cancer Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: The First Affiliated Hospital of Zhengzhou University name: 3D Medicines Corporation briefSummary: The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study. conditions: Epithelial Ovarian Cancer conditions: Adnexal Mass studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1352 type: ACTUAL measure: the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: No.181, Hanyulu Road, Shapingba District city: Chongqing state: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 hasResults: False |
<|newrecord|> nctId: NCT06366984 id: Adeel4 briefTitle: Outcome of Plastibell Circumcision Versus Open Method Circumcision overallStatus: COMPLETED date: 2022-01-11 date: 2022-07-11 date: 2022-08-11 date: 2024-04-16 date: 2024-04-16 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital. |
Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition). conditions: Bleeding conditions: Site Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controll trial primaryPurpose: OTHER masking: SINGLE maskingDescription: outcome assessor is unaware of group allocated whoMasked: OUTCOMES_ASSESSOR count: 174 type: ACTUAL name: plastibell name: open method measure: infection sex: MALE minimumAge: 1 Day maximumAge: 12 Months stdAges: CHILD facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06366971 id: auhucgun01 briefTitle: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction overallStatus: COMPLETED date: 2023-12-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-16 date: 2024-04-16 name: Biruni University class: OTHER briefSummary: The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD. conditions: Sacroiliac Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: The Patient Education name: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training measure: The Level of Low Back Pain measure: Mobility measure: Flexibility measure: Lumbar Range of Motion measure: Posture measure: Trunk Muscle Endurance sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Atlas University city: Istanbul state: Kagıthane zip: 34408 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06366958 id: Dorsal wrist ganglion briefTitle: Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-02-02 date: 2025-04-02 date: 2024-04-16 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion conditions: Hand Ganglion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: excision of dorsal wrist ganglion measure: comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion measure: compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion sex: ALL minimumAge: 10 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366945 id: SYSKY-2024-157-02 briefTitle: Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-12-30 date: 2029-05-30 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis conditions: Head and Neck Squamous Cell Carcinoma conditions: Head and Neck Cancer conditions: HNSCC conditions: Head Cancer Neck studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Carboplatin name: Tislelizumab name: Polymeric Micellar Paclitaxel name: Surgical Resection of Primary +/- Neck Dissection name: Post-operative radiation therapy measure: Major pathological response (MPR) rate of metastatic lymph nodes measure: Major pathological response (MPR) rate of primary tumor measure: Event-free survival (EFS) measure: Overall survival（OS） measure: Incidence of treatment-related adverse events measure: EORTC QLQ-C30 measure: pathological downstaging rate measure: Distant metastasis-free survival(DMFS) rate measure: logical regional-free survival(LRFS) rate measure: Correlation between ctDNA dynamic detection and 1-year and 2-year EFS and OS rate after Neoadjuvant immunochemotherapy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366932 id: DermAtOmics-II briefTitle: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models overallStatus: RECRUITING date: 2023-09-25 date: 2025-09 date: 2025-09 date: 2024-04-16 date: 2024-04-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment. primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Second-line systemic treatment name: Folllow-up of second-line systemic treatment already started measure: Percentage of patients with primary non-response to second-line treatment. measure: Percentage of patients achieving EASI-75 measure: Time to treatment failure after week 16 measure: Mean percentage of change in Eczema Area and Severity Index (EASI) score measure: Percentage of change in SCORAD (SCORing Atopic Dermatitis) measure: Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis) measure: Change of IGA (Investigator Global Assessment) measure: Time to IGA score of 0/1 (Investigator Global Assessment) measure: Change of BSA (Body surface area) measure: Change in NRS measure: Change in RECAP measure: Percentage of patients having a variation of 4 points in their improvement in DLQI measure: Change in POEM (Patient-Oriented Eczema Measure) measure: Rate of adverse events associated to second-line systemic treatment measure: Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain name: Irene García, MD role: CONTACT phone: +34-912071466 email: [email protected] lat: 40.4165 lon: -3.70256 hasResults: False |
<|newrecord|> nctId: NCT06366919 id: DPT/Batch-Fall19/559 briefTitle: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-05-15 date: 2024-06-15 date: 2024-04-16 date: 2024-04-16 name: Superior University class: OTHER briefSummary: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: Alexander Technique (AT) name: Feldenkrais Technique (FT) measure: Northwick Park Neck Pain Questionnaire measure: REEDCO Posture Assessment and Sleep Quality Scale sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06366906 id: SYSKY-2023-426-01 briefTitle: 10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma overallStatus: COMPLETED date: 2023-05-10 date: 2024-02-10 date: 2024-02-10 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions. |
Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features. |
Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis. conditions: HNSCC conditions: AI conditions: Radiomic conditions: MRI studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 319 type: ACTUAL name: The Resnet50 deep learning (DL) model measure: AUC(the area under the curve) values of the model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen memorial hospital city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 facility: Sun yat-sun memorial hospital city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06366893 id: PR(AG)297/2019 briefTitle: Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-04 date: 2025-03-04 date: 2024-04-16 date: 2024-04-19 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency. |
The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency. |
The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona. conditions: Infant, Premature, Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: DHA/AA emulsion supplement for preterm infant measure: Percentage comparison of erythrocyte membrane levels of DHA and AA measure: Tolerance of DHA emulsion administration measure: Compare the presence of pathologies in preterm infants between the supplemented group and the control group sex: ALL maximumAge: 7 Days stdAges: CHILD facility: Hospital Materno Infantil Vall d'Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Félix Castillo Salinas, Dr. role: CONTACT phone: +34 934893899 email: [email protected] name: Félix Castillo Salinas, Dr. role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False |
<|newrecord|> nctId: NCT06366880 id: 2022.HPS.DI.434 briefTitle: Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn overallStatus: RECRUITING date: 2024-03-11 date: 2024-12-15 date: 2025-12-15 date: 2024-04-16 date: 2024-04-16 name: Hospital Pediátrico de Sinaloa class: OTHER_GOV briefSummary: Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants. |
The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice. |
The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants. conditions: Cholestasis in Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Parenteral nutrition cycling measure: Incidence of cholestasis on Day 28 of admission. measure: are total plasma bilirrubine profiles measure: the incidence of hypoglycaemia sex: ALL minimumAge: 1 Hour maximumAge: 28 Days stdAges: CHILD facility: Hospital Pediatrico de Sinaloa status: RECRUITING city: Culiacán state: Sinaloa zip: 80200 country: Mexico name: Ana Karen Camargo Angulo, Dr. role: CONTACT phone: 6681890586 phoneExt: +52 email: [email protected] lat: 24.79032 lon: -107.38782 hasResults: False |
<|newrecord|> nctId: NCT06366867 id: Pro00097579 briefTitle: An Open Platform of Serious Games for Cognitive Intervention overallStatus: RECRUITING date: 2022-08-03 date: 2025-08-01 date: 2025-12-01 date: 2024-04-16 date: 2024-04-16 name: University of Alberta class: OTHER name: Alberta Health services name: CapitalCare briefSummary: Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings. |
VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training. |
Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes. |
The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning. conditions: Mild Cognitive Impairment conditions: Dementia conditions: Alzheimer Disease conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities. primaryPurpose: DEVICE_FEASIBILITY masking: DOUBLE maskingDescription: Random allocation, 1:1 ratio by a computer-based randomizer whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: VibrantMinds measure: Cognition - Global measure: Depression measure: Agitation measure: Occupational Performance measure: Engagement measure: Affect sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: CapitalCare Group Inc Facilities status: RECRUITING city: Edmonton zip: T5J 3M9 country: Canada name: Adriana Rios Rincon, PhD, R.OT role: CONTACT phone: 7804921728 email: [email protected] lat: 53.55014 lon: -113.46871 hasResults: False |
<|newrecord|> nctId: NCT06366854 id: IRAS: 332418 briefTitle: UK ANDROMEDA-Shock-2 RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2028-04-30 date: 2024-04-16 date: 2024-04-16 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: Pontificia Universidad Catolica de Chile name: University of Rotterdam, The Netherlands briefSummary: The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care. conditions: Septic Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Personalised fluid and haemodynamic resuscitation measure: hospital mortality measure: organ support measure: length of stay measure: mortality measure: vital organ support measure: length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366841 id: 6439 briefTitle: Stigma and Psychological profilE in REctal-anal caNcer pAtients acronym: SERENA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2026-04-30 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time. conditions: Rectal Cancer conditions: Anal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 148 type: ESTIMATED name: Psychological tests administration measure: Evaluation of rectal and anal cancer stigma measure: Evaluation of psychological characteristics in rectal and anal cancer measure: Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version measure: Toronto Alexithymia Scale measure: EORTC QLQ - CR29 and EORTC QLQ-ANL27 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06366828 id: 11446 briefTitle: Prediction Models for Complications After CRT in Esophageal Cancer acronym: MODELS overallStatus: RECRUITING date: 2023-02-01 date: 2025-06 date: 2030-06 date: 2024-04-16 date: 2024-04-16 name: University Medical Center Groningen class: OTHER name: Dutch Cancer Society name: Comprehensive Cancer Centre The Netherlands name: Dutch Institute for Clinical Auditing (DICA) name: ZorgTTP briefSummary: The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer conditions: The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: retrospective measure: Multivariable NTCP models will be developed for the prediction of the following measure: Cardiac events grade II or higher (CTCAE v 5.0), including: measure: Mortality measure: Complication Sum Score, that will be determined in Delphi consensus measure: Patient-rated dysphagia measure: Patient-rated nausea measure: Patient-rated fatigue / daily functioning measure: Hospitalization after esophagectomy (days) measure: Intensive care unit stay after esophagectomy (days) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud UMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525GA country: Netherlands name: H. Rutten, MD role: CONTACT lat: 51.8425 lon: 5.85278 facility: Maastro clinic status: RECRUITING city: Maastricht state: Limburg zip: 6229ET country: Netherlands name: M. Berbee, MD, PHD role: CONTACT lat: 50.84833 lon: 5.68889 facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: P. van Rossum, MD, PHD role: CONTACT name: H.W.M. van Laarhoven, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015GE country: Netherlands name: J. Nuyttens, MD, PHD role: CONTACT name: B. Wijnhoven, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: Holland PTC status: NOT_YET_RECRUITING city: Delft country: Netherlands name: Yvonne Klaver, MD, PHD role: CONTACT lat: 52.00667 lon: 4.35556 facility: UMCG status: RECRUITING city: Groningen zip: 9715GZ country: Netherlands name: Christina Muijs, MD, PHD role: CONTACT phone: 0503616161 email: [email protected] name: C. T. Muijs, MD, PHD role: PRINCIPAL_INVESTIGATOR name: J. A. Langendijk, Prof., MD, PHD role: SUB_INVESTIGATOR name: B. van Etten, MD, PHD role: SUB_INVESTIGATOR name: J. J. de Haan, MD, PHD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Zuyderland hospital status: RECRUITING city: Heerlen country: Netherlands name: Meindert Sosef, MD role: CONTACT lat: 50.88365 lon: 5.98154 facility: UMCU status: RECRUITING city: Utrecht zip: 3584CX country: Netherlands name: G Meijer, PHD role: CONTACT lat: 52.09083 lon: 5.12222 hasResults: False |
<|newrecord|> nctId: NCT06366815 id: 4619 briefTitle: phenotypeS in Non Ambulant Duchenne Muscular Dystrophy acronym: GUP21003 overallStatus: RECRUITING date: 2022-08-30 date: 2024-09-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function conditions: Duchenne Muscular Dystrophy conditions: Natural History conditions: Motor Function; Retardation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Different Phenotypes of non ambulant patients with Duchenne Muscular Dystrophy measure: motor function measure: respiratory function measure: cardiac function measure: identify patterns of severity and of progression related to differnt genotypes sex: MALE minimumAge: 8 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: IRCCS catholic univeristy status: RECRUITING city: Roma country: Italy name: Marika Pane, prof role: CONTACT phone: 0038063015 phoneExt: 6742 email: [email protected] name: Daniela Leone role: CONTACT phone: 00390630158821 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06366802 id: Prognosis model-MM09 briefTitle: Cohort Construction and Prognostic Model Construction for Multiple Myeloma overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-03 date: 2027-05-02 date: 2027-05-02 date: 2024-04-16 date: 2024-04-16 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Overall survival measure: Progression free survival(PFS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China lat: 31.30408 lon: 120.59538 hasResults: False |
<|newrecord|> nctId: NCT06366789 id: ZE46-0134-0002 id: CT-2024-CTN-00161-1 type: OTHER domain: Therapeutic Goods Administration briefTitle: Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2027-12 date: 2024-04-16 date: 2024-04-16 name: Eilean Therapeutics class: INDUSTRY briefSummary: This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 mutated Relapsed or Refractory Acute Myeloid Leukemia conditions: AML With Gene Mutations studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: dose escalation and dose optimization study primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: ZE46-0134 measure: The incidence of DLTs measure: Incidence of AE/SAE measure: Incidence of clinically significant abnormal laboratory results measure: Incidence of abnormal clinically significant ECG results measure: Number of patients with AEs of Grade ≥ 3 measure: Number of treatment-related deaths measure: Plasma Cmax measure: Plasma Css measure: Plasma Cmin measure: Plasma AUC measure: Number of patients attaining any type of Complete Remission (CR, CRh, CRi) by Cycle 6 measure: Number of patients attaining CR by Cycle 6 measure: Number of patients attaining response (CR, CRh, CRi, MLFS) by Cycle 6 measure: Proportion of patients who became FLT3 ITD and TKD undetectable measure: Number of patients with Genomic or proteomic abnormalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Linear Clinical Research Ltd city: Perth state: Nedlands, WA zip: 6009 country: Australia name: Carolyn Grove, Prof role: CONTACT lat: -31.95224 lon: 115.8614 hasResults: False |
<|newrecord|> nctId: NCT06366776 id: 23-278 briefTitle: Emulated Study of Vitamin D Correction vs Non-Correction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-12 date: 2024-04-16 date: 2024-04-16 name: The Cooper Health System class: OTHER name: Won Sook Chung Foundation briefSummary: * This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database. |
* The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels. conditions: Vitamin D Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 9000 type: ESTIMATED measure: Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A. measure: Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A. measure: Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B). measure: Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366763 id: ChengduUTCMvs5 briefTitle: Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation overallStatus: RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-16 date: 2024-04-16 name: Chengdu University of Traditional Chinese Medicine class: OTHER briefSummary: Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. conditions: Vascular Diseases, Peripheral conditions: Venous Insufficiency of Leg conditions: Varicose Veins of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Among the 210 patients included in the study (82 males, 128 females; average age of 59 years), 7 patients were lost to follow-up, and the remaining patients completed the treatment and follow-up.To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Questionnaires measure: Pain after radiofrequency ablation measure: Bleeding after radiofrequency ablation measure: Tension blisters after radiofrequency ablation measure: The rate of occlusion of treated vein post-procedure measure: Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14) measure: Clinical Change using Venous Clinical Severity Score (VCSS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of Chengdu University of Traditional Chinese Medicine status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Chunshui He, Doctor role: CONTACT phone: 86-18981885601 email: [email protected] name: Qiqi Wangqiqi, Master role: CONTACT phone: 86-15184495605 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06366750 id: CDX0159-10 id: 2023-510279-80-00 type: OTHER domain: EU CT briefTitle: A Study of Barzolvolimab in Patients With Prurigo Nodularis overallStatus: RECRUITING date: 2024-04 date: 2026-01 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Celldex Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis. conditions: Prurigo Nodularis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: barzolvolimab name: Matching Placebo measure: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24). measure: Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24. measure: Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24. measure: Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24. measure: Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24. measure: Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24. measure: Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24. measure: Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24. measure: Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24. measure: Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. measure: Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. measure: Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24. measure: Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24. measure: Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24. measure: Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24. measure: Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24. measure: Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD. measure: Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24. measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Revival Research Institute, LLC status: RECRUITING city: Troy state: Michigan zip: 48084 country: United States name: Sikar Grewal role: CONTACT email: [email protected] lat: 42.60559 lon: -83.14993 facility: Center for Clinical Studies status: RECRUITING city: Webster state: Texas zip: 77598 country: United States name: Perla Rivas role: CONTACT email: [email protected] lat: 29.53773 lon: -95.11826 hasResults: False |
<|newrecord|> nctId: NCT06366737 id: CEBD-CU-2024-03-02 briefTitle: En-mass Retraction by Lingual Retractor Versus Clear Aligner Appliances overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Cairo University class: OTHER briefSummary: en-mass retraction by lingual retractor versus clear alighner therapy conditions: Maxillary Prognathism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Lingual Retractor Appliance name: clear aligner measure: patient satisfaction ( time , cost , quality) measure: inclination of upper anterior teeth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry city: Cairo country: Egypt name: zainab abdulrhman role: CONTACT phone: 00201092445775 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06366724 id: 2024P000087 briefTitle: LIFT: Life Improvement Trial acronym: LIFT overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Brigham and Women's Hospital class: OTHER name: Open Medicine Foundation briefSummary: The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance. |
This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily. |
The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial. |
The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete. |
The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition. conditions: ME/CFS studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Randomized factorial group double-blinded placebo-controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The Mass General Brigham Investigational Drug Services (IDS) will be responsible for randomizing the four arms. The rest of the study staff and collaborators will be blinded as well as the participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Pyridostigmine name: Low-Dose Naltrexone name: Placebo measure: Functional Capacity measure: Physiologic Response - Oxygen Uptake Efficiency Slope (OUES) measure: Physiologic Response - Oxygen Utilization (VO2) measure: Physiologic Response - Heart Rate Recovery (HRR) measure: Post-Exertional Malaise measure: PROMIS-29-Pain measure: Daily Activity measure: Heart Rate Variability measure: Blood Oxygen measure: Resting Heart Rate measure: DANA Brain Vital-Simple Reaction Time (SRT) measure: DANA Brain Vital-Procedural Reaction Time (PRT) measure: DANA Brain Vital-Memory Search (MS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06366711 id: 23/BW/MAT/NO/754 briefTitle: Remote Telemedicine Fetal Monitoring Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Birmingham Women's NHS Foundation Trust class: OTHER_GOV name: GE Healthcare name: Nestmedic S.A. briefSummary: During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited. |
Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received. |
Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research. conditions: Pregnancy, High Risk conditions: Telemonitoring conditions: Telemedicine conditions: Ultrasound conditions: Cardiotocography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: 15 participants split in to three arms. The sample size has been determined as a pragmatic sample taking into consideration the needs of the feasibility study to meet the stated objectives as well as being achievable within the time and cost constraints of the study. 15 participants will ensure a thorough assessment of the stated objectives. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 15 type: ESTIMATED name: Pregnabit Pro device and PregnaOne platform name: Pulsenmore device measure: The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring. measure: The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring. measure: The number of participants completing the full schedule of home maternal-fetal monitoring episodes. measure: To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home? measure: The number of women approached who agreed to participate within the study. measure: What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring. measure: What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring. measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring. measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring. measure: The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06366698 id: 23-55 briefTitle: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia acronym: IDA overallStatus: RECRUITING date: 2023-11-21 date: 2025-12-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Arrowhead Regional Medical Center class: OTHER briefSummary: This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded. conditions: Iron Deficiency Anemia of Pregnancy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia. primaryPurpose: TREATMENT masking: NONE count: 900 type: ESTIMATED name: Venofer 200 MG Per 10 ML Injection name: Ferrous sulfate measure: Hemoglobin difference measure: Ferritin difference measure: Delivery Hemoglobin measure: Rates of blood transfusion measure: Symptoms measure: Preterm delivery measure: Depression measure: Birthweight sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arrowhead Regional Medical Center status: RECRUITING city: Colton state: California zip: 92324 country: United States name: Guillermo Valenzuela, MD role: CONTACT phone: 909-580-4145 email: [email protected] name: Tina M Bui, DO role: PRINCIPAL_INVESTIGATOR name: Kristina Roloff, DO role: SUB_INVESTIGATOR name: Guillermo Valenzuela, MD role: SUB_INVESTIGATOR name: Lily Zhu, DO role: SUB_INVESTIGATOR name: Phoebe Jen, DO role: SUB_INVESTIGATOR name: Mary Tsaturian, MD role: SUB_INVESTIGATOR lat: 34.0739 lon: -117.31365 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-21 uploadDate: 2024-04-10T14:44 filename: ICF_000.pdf size: 165063 hasResults: False |
<|newrecord|> nctId: NCT06366685 id: YJS20230170 briefTitle: Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy acronym: Recovery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2025-02-01 date: 2024-04-16 date: 2024-04-16 name: Mengmeng Yuan class: OTHER name: Anhui Medical University briefSummary: Esophageal cancer imposes a significant burden in China, accounting for over 60% of the global disease burden. While surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. Although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist. |
This project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. Taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. Initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (CSCA_EC) and objective (6MWT) measurement indicators, named "Recovery For EC." Subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. The final clinical trial version of the Recovery For EC program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management. conditions: Esophageal Cancer conditions: Exercise Training conditions: Psychotherapy conditions: Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Exercise and Psychological Intervention measure: the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC) measure: 6-Minute Walk Test measure: Hospital Anxiety and Depression Scale (HADS) measure: Postoperative Complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Medical University city: Hefei state: Anhui zip: 234000 country: China name: Mengmeng Yuan, Graduate role: CONTACT phone: 18205575607 email: [email protected] name: Shaoxue Li, Graduate role: CONTACT phone: 18712335223 email: [email protected] name: Shuwen Li, Professor role: PRINCIPAL_INVESTIGATOR lat: 31.86389 lon: 117.28083 hasResults: False |
<|newrecord|> nctId: NCT06366672 id: 202312043 briefTitle: Evaluating the Human Immune Response to the JYNNEOS Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Washington University School of Medicine class: OTHER briefSummary: This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow. conditions: Vaccinia conditions: Virus Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will be vaccinated with MVA-BN according to the FDA-approved labeling and immune responses in the blood, lung mucosa, skin, and bone marrow will be monitored prior to and following vaccination using phlebotomy, research bronchoscopy, skin punch biopsy, and bone marrow aspiration procedures. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection name: Phlebotomy name: Research bronchoscopy name: Skin punch biopsy name: Bone marrow aspiration measure: Change in magnitude of the MVA-BN antigen-specific T cell response in the blood measure: Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma measure: Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways measure: Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid measure: Evaluate the magnitude and surface phenotype of T cells in the blood, airspace, and skin over time measure: Evaluate the magnitude and surface phenotype of B cells in the blood and bone marrow over time. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Washington University in Saint Louis School of Medicine Emergency Care and Research Core city: Saint Louis state: Missouri zip: 63110 country: United States name: Jamie Mills role: CONTACT phone: 314-305-1054 email: [email protected] lat: 38.62727 lon: -90.19789 hasResults: False |
<|newrecord|> nctId: NCT06366659 id: M2024049 briefTitle: Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-08-20 date: 2025-08-20 date: 2024-04-16 date: 2024-04-16 name: Peking University class: OTHER name: Peking University Third Hospital briefSummary: This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP. conditions: Intrahepatic Cholestasis of Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED measure: Progesterone metabolites (levels in plasma) measure: Itch intensity measure: Total bile acids (levels in plasma) sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100000 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: [email protected] name: Yulong Li role: PRINCIPAL_INVESTIGATOR name: Yuan Wei role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sichuan University West China Second University Hospital city: Chengdu state: Sichuan zip: 610001 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: [email protected] name: Yaoyao Zhang role: PRINCIPAL_INVESTIGATOR name: Xue Xiao role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06366646 id: 035901 briefTitle: Competency-based Intervention for Head Nurses overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-16 date: 2024-04-16 name: Matrouh University class: OTHER briefSummary: Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness. conditions: Intervention conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention. whoMasked: PARTICIPANT count: 90 type: ACTUAL name: Competency-based intervention measure: Questionnaire to measure head nurses' knowledge of leadership competency measure: Questionnaire to measure head nurses' ability to use leadership competency measure: Questionnaire to measure leadership effectiveness sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Mersa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False |
<|newrecord|> nctId: NCT06366633 id: 2024P000713 id: 1K23AT012364-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23AT012364-01 briefTitle: Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-01-31 date: 2025-03-31 date: 2024-04-16 date: 2024-04-22 name: Jafar Bakhshaie class: OTHER name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use. |
Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT. |
Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations. conditions: Orthopedic Disorder conditions: Nontraumatic Injury conditions: Substance Use conditions: Upper Extremity Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Web-TIRELESS measure: Credibility and Expectancy Questionnaire (CEQ) measure: Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery measure: The percent of patients that agree to participate to assess feasibility of recruitment measure: Rate at which program was accepted, measured by attendance to assess acceptability of treatment measure: Adherence to homework measure: Rate of participant's completion of self-report measures to assess feasibility of assessments measure: Adverse Events measure: Graded Chronic Pain Scale (GCPS) measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0 measure: PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0 measure: Pain Catastrophizing Scale (PCS) measure: Pain Anxiety Symptoms Scale - Short Form (PASS-20) measure: Pain Vigilance and Awareness Questionnaire (PVAQ) measure: Brief Experiential Avoidance Questionnaire (BEAQ) measure: Current Opioid Misuse Measure (COMM) measure: The Timeline Follow Back (TLFB) measure: Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02129 country: United States name: Jafar Bakhshaie, MD, PhD role: CONTACT phone: 617-643-7641 email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06366620 id: STUDY00003416 briefTitle: Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports overallStatus: RECRUITING date: 2024-04-10 date: 2024-06-19 date: 2024-06-19 date: 2024-04-16 date: 2024-04-16 name: Seattle Children's Hospital class: OTHER briefSummary: Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports. conditions: Child Disruptive Behavior Disorders conditions: Parent Child Relationship conditions: Parent Management Training conditions: Peer Support conditions: Child Behavior Problems conditions: Challenging Behavior conditions: Positive Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: FAST-B PEERS name: FAST-B (First Approach Skills Training - Behavior) measure: Acceptability of FAST-B PEERS measure: Acceptability of FAST-B measure: FAST-B PEERS support calls attended measure: Weekly Assessment of Child Behavior - P measure: Coping with Child Negative Emotions Scale measure: Strengths and Difficulties Questionnaire sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seattle Children's status: RECRUITING city: Seattle state: Washington zip: 98115 country: United States name: Doug Mason role: CONTACT phone: 206-987-7000 email: [email protected] name: Alissa D Hemke, MD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06366607 id: 0306066 briefTitle: Managing High-alert Medication Administration and Errors overallStatus: COMPLETED date: 2023-03-01 date: 2023-05-31 date: 2023-05-31 date: 2024-04-16 date: 2024-04-16 name: Matrouh University class: OTHER briefSummary: High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. conditions: Knowledge conditions: Practice Nurse's Scope conditions: Competence conditions: Nurse's Role conditions: Error Disclosure studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 300 type: ACTUAL name: high-alert medication administration measure: Questionnaire to measure nurses' knowledge about high-alert medication administration measure: Questionnaire to measure medication safety climate measure: Questionnaire to measure nurses' competency measure: observational check list to measure nurses' practice during administration of high-alert medications measure: Questionnaire to measure errors associated with administering high-alert medications sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Mersa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False |
<|newrecord|> nctId: NCT06366594 id: 0305897 briefTitle: First-line Nurse Manager Authentic Leadership Training Program overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-16 date: 2024-04-16 name: Matrouh University class: OTHER briefSummary: Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes. conditions: Intervention studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A quasi-experimental research design primaryPurpose: OTHER masking: SINGLE maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention. whoMasked: PARTICIPANT count: 37 type: ACTUAL name: Authentic leadership training program measure: Questionnaire to measure first-line nurse managers' knowledge about authentic leadership measure: questionnaire to measure authentic leadership behavior among first-line nurse managers measure: Questionnaire to measure nursing care self-efficacy measure: Questionnaire to measure nurses' trust in their workplace sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Mersa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False |
<|newrecord|> nctId: NCT06366581 id: HD20240307 briefTitle: Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology overallStatus: COMPLETED date: 2023-03-01 date: 2023-09-01 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: Fudan University class: OTHER briefSummary: This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix. conditions: Incisional Hernia conditions: Extracellular Matrix Alteration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 36 type: ACTUAL name: Transcriptomic analysis measure: the gene expression list sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hua Dong Hospital Affiliated to Fu Dan University city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06366568 id: CRO-2022-10-PG-MER-MW-JG briefTitle: Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-06 date: 2024-03-06 date: 2024-04-16 date: 2024-04-16 name: Colgate Palmolive class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial. conditions: Plaque, Dental studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 86 type: ACTUAL name: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product name: fluoride toothpaste containing 1450 ppm of MFP in a PCC base measure: Turesky Modification of the Quigley & Hein Plaque Index measure: questionnaire sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras city: Dresden zip: 01307 country: Germany lat: 51.05089 lon: 13.73832 hasResults: False |
<|newrecord|> nctId: NCT06366555 id: 24-02-0268 briefTitle: The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-22 date: 2024-06-22 date: 2024-04-16 date: 2024-04-26 name: Indonesia University class: OTHER briefSummary: Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition . |
That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training conditions: Muscle Soreness conditions: Stiffness of Elbow, Not Elsewhere Classified studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This research design used a randomized controlled single-blind crossover trial method (Crossover Single Blinded Randomized Control Trial). Reasons for choosing to use the Crossover method because apart from being able to implement it, it can also provide far more output results with a smaller number of subjects. |
The research subjects will then receive two treatments spaced 1 week apart which is called a wash out period to eliminate the carry-over effect of the treatment given. Research subjects will undergo randomization . Subjects in group A will undergo manual twisting acupuncture followed by sham manual acupuncture. The subject in group B will receive a sham acupuncture manual followed by a round of manual acupuncture twirling primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Participant will be randomized using a computerized table and the Outcome Assessor dont know which Subjects receive the manual acupuncture twirling or sham manual acupuncture on each period whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Manual Acupuncture Twirling, name: Manual Acupuncture Sham measure: Visual Analog Scale measure: Pain Pressure Threshold measure: Range of Motion sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower city: Jakarta state: DKI Jakarta zip: 10430 country: Indonesia name: IMERI, Research Center role: CONTACT phone: 29189160 lat: -6.21462 lon: 106.84513 hasResults: False |
<|newrecord|> nctId: NCT06366542 id: 2/2024 briefTitle: Virtual Reality in People With Persistent Postural-Perceptual Dizziness: RCT overallStatus: COMPLETED date: 2022-05-01 date: 2023-12-31 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: University of Jordan class: OTHER briefSummary: This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD). The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation. The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks. The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life. conditions: Vestibular Dizziness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: Vestibular rehabilitation therapy name: Virtual reality exercises name: Optokinetic Stimulation exercises measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) measure: Dizziness Handicap Inventory (DHI) measure: Dizziness Handicap Inventory (DHI) measure: Falls Efficacy Scale International (FES-I) measure: Falls Efficacy Scale International (FES-I) measure: Dynamic Gait Index (DGI) measure: Dynamic Gait Index (DGI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Hospital Anxiety and Depression Scale (HADS) measure: Hospital Anxiety and Depression Scale (HADS) measure: Medical Outcomes Study Short Form 12 (SF-12) measure: Medical Outcomes Study Short Form 12 (SF-12) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Medical Services city: Amman country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False |
<|newrecord|> nctId: NCT06366529 id: TJ-IRB202308123 briefTitle: Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction overallStatus: RECRUITING date: 2023-09-01 date: 2030-09 date: 2030-09 date: 2024-04-16 date: 2024-04-17 name: Zhen Li class: OTHER briefSummary: Currently, renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis, but it is invasive and carries the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias. The lack of reliable, comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs. Therefore, the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved. |
With the continuous development and update of technology, imaging provides a new way to non-invasively evaluate renal fibrosis. Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis, magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes. Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status, physical properties, and molecular properties of the kidney. |
In recent years, in the context of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis. It can extract and learn features in images with high throughput, make greater use of information in medical images that cannot be recognized by the human eye, and achieve disease diagnosis, prognosis assessment, and efficacy prediction by building models. However, most of the current research is in the preliminary stage, and there are still few studies on the assessment of renal insufficiency and renal fibrosis. I believe that with the continuous improvement of algorithms and the optimization of models, the progress of radiomics and machine learning will be great. To a certain extent, it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis. conditions: Renal Insufficiency, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: ESKD sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital, NO.1095 jiefang avenue status: RECRUITING city: Wuhan state: Hubei zip: 430074 country: China name: Zhen Li, Doctor role: CONTACT email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False |
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