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<|newrecord|> nctId: NCT06277960 id: CNS2301 briefTitle: Septal Ablation for Obstructive HCM overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-06-30 date: 2024-11-30 date: 2024-02-26 date: 2024-02-26 name: SuZhou Sinus Medical Technologies Co.,Ltd class: INDUSTRY briefSummary: Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited. |
Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches. |
The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy. conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: percutaneous intramyocardial septal radiofrequency ablation system measure: 30-day major adverse clinical events (MACE) measure: Technical success rate measure: Short Form 36 (SF-36) health survey questionnaire measure: Improvement of left ventricular outflow tract gradient (LVOTG) measure: Improvement of NYHA functional classification measure: 6-min walk distance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China name: Yaxun Sun, MD role: CONTACT phone: +86 15057173170 email: sunyaxun@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06277947 id: SYSKY-2024-096-01 briefTitle: Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward acronym: GARD-HIPEC overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2025-05 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER name: Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University briefSummary: Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24 hours. primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC) measure: The incidence of adverse events of grade 3-5 measure: Time to progress (TTP) measure: The Time to the First Subsequent Therapy，TTFST measure: Quality of life, QLQ-C30 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06277934 id: RGT001-075-203 briefTitle: A Study of RGT001-075 in Adult Patients With Obesity overallStatus: RECRUITING date: 2024-03-08 date: 2024-06 date: 2024-07 date: 2024-02-26 date: 2024-04-04 name: Regor Pharmaceuticals Inc. class: INDUSTRY briefSummary: This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: RGT001-075 name: Placebo measure: Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings measure: Percent change in body weight measure: Change in body weight in kilogram measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction measure: Change in Body mass index (BMI) in kg/m^2 measure: Change in waist circumference in centimetre measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research status: RECRUITING city: Los Angeles state: California zip: 90057 country: United States name: David Guzman, MD role: CONTACT lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research status: RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States name: Robert Buynak, MD role: CONTACT lat: 41.47309 lon: -87.06114 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 facility: Velocity Clinical Research status: RECRUITING city: Vestal state: New York zip: 13850 country: United States name: Eric Lorraine, MD role: CONTACT lat: 42.08507 lon: -76.05381 facility: Velocity Clinical Research status: RECRUITING city: Durham state: North Carolina zip: 27701 country: United States name: William Cromwell, MD role: CONTACT lat: 35.99403 lon: -78.89862 facility: Velocity Clinical Research status: RECRUITING city: Cleveland state: Ohio zip: 44122 country: United States name: Margaret Rhee, MD role: CONTACT lat: 41.4995 lon: -81.69541 facility: Velocity Clinical Research status: RECRUITING city: Medford state: Oregon zip: 97504 country: United States name: Sarah Smiley, MD role: CONTACT lat: 42.32652 lon: -122.87559 facility: Velocity Clinical Research status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: David Fried, MD role: CONTACT lat: 41.66038 lon: -71.45589 facility: Velocity Clinical Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender, MD role: CONTACT lat: 32.78306 lon: -96.80667 facility: Velocity Clinical Research status: RECRUITING city: West Jordan state: Utah zip: 84088 country: United States name: Barbara Rizzardi, MD role: CONTACT lat: 40.60967 lon: -111.9391 hasResults: False |
<|newrecord|> nctId: NCT06277921 id: 110-2 briefTitle: Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery acronym: ESOSTAT overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-09-18 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: P. Herzen Moscow Oncology Research Institute class: OTHER_GOV name: National Medical Research Radiological Centre of the Ministry of Health of Russia briefSummary: Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure. |
However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation. conditions: Esophageal Cancer conditions: Oesophageal Cancer conditions: Siewert Type I Adenocarcinoma of Esophagogastric Junction conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Elective Surgery for gastric cancer measure: the type of complications and the incidence of it sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.S. Loginov Moscow Clinical Scientific Center city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: P.Herzen Moscow Oncological Research Institute city: Moscow country: Russian Federation name: Andrey Ryabov role: CONTACT name: Nuriddin Abdulkhakimov role: CONTACT lat: 55.75222 lon: 37.61556 facility: Petrovsky National Research Centre of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Vishnevsky National Medical Research Center of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Oncological Dispensary city: Nizhny Novgorod country: Russian Federation lat: 56.32867 lon: 44.00205 facility: A.Tsyb Medical Radiological Research Centre city: Obninsk country: Russian Federation lat: 55.09681 lon: 36.61006 facility: National Medical Research Centre for Oncology city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Petrov National Medical Research Center of Oncology city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False |
<|newrecord|> nctId: NCT06277908 id: 110-1 briefTitle: Postoperative Morbidity and Mortality After Gastric Cancer Surgery acronym: GASTROSTAT overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-09-18 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: P. Herzen Moscow Oncology Research Institute class: OTHER_GOV name: National Medical Research Radiological Centre of the Ministry of Health of Russia briefSummary: Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation. conditions: Gastric Cancer conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction conditions: Stomach Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 700 type: ESTIMATED name: Elective Surgery for gastric cancer measure: the type of complications and the incidence of it sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.S. Loginov Moscow Clinical Scientific Center city: Moscow country: Russian Federation name: Roman Izrailov role: CONTACT name: Nikolay Semenov role: CONTACT lat: 55.75222 lon: 37.61556 facility: A.Tsyb Medical Radiological Research Centre city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: P.Herzen Moscow Oncological Research Institute city: Moscow country: Russian Federation name: Andrey Ryabov role: CONTACT name: Nuriddin Abdulkhakimov role: CONTACT lat: 55.75222 lon: 37.61556 facility: Petrovsky National Research Centre of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Vishnevsky National Medical Research Center of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Oncological Dispensary city: Nizhny Novgorod country: Russian Federation lat: 56.32867 lon: 44.00205 facility: National Medical Research Centre for Oncology city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Petrov National Medical Research Center of Oncology city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False |
<|newrecord|> nctId: NCT06277895 id: KYLL-202401-047 briefTitle: VOCs in Patients With Acute Cardiogenic Chest Pain overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain |
1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought. |
2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure. conditions: Acute Coronary Syndrome conditions: Acute Aortic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1400 type: ESTIMATED name: VOCs measure: Baseline VOCs (aldehydes) levels in healthy population measure: MACE in patients with cardiogenic chest pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: yuan bian role: CONTACT phone: 18560084775 email: 15165110975@163.com lat: 36.66833 lon: 116.99722 hasResults: False |
<|newrecord|> nctId: NCT06277882 id: Si 067/2024 briefTitle: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-01 date: 2025-05-31 date: 2024-02-26 date: 2024-03-19 name: Mahidol University class: OTHER briefSummary: The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications. |
However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population |
HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population. |
The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis. |
The main questions it aims to answer are: |
* Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis. |
* Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis. conditions: Cirrhosis conditions: Hep A conditions: Vaccination studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: HAVRIX measure: Post-vaccination serological response rate measure: Post-vaccination serological response measure: Post-vaccination serological response measure: Anti-hepatitis A Virus (HAV) antibody at month 1 measure: Anti-hepatitis A Virus (HAV) antibody at month 7 measure: Anti-hepatitis A Virus (HAV) antibody at 1 year sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Siriraj Hospital status: RECRUITING city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand name: Watcharasak Chotiyaputta, Asso Prof role: CONTACT phone: 6624197281 email: watcharasak.cho@mahidol.ac.th lat: 13.76266 lon: 100.47798 hasResults: False |
<|newrecord|> nctId: NCT06277869 id: PR-22146 briefTitle: Effectiveness Trial of Thermal Jacket overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-22 date: 2024-12-31 date: 2024-02-26 date: 2024-03-07 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh name: Directorate General of Health Services (DGHS), Bangladesh name: Poeticgem International Ltd briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. |
Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation. |
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings. |
Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh. |
Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh. conditions: Preterm Neonate conditions: Low Birthweight Neonate studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Stepped wedge cluster randomised trial primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Thermal Jacket name: Kangaroo Mother Care measure: Body temperature of preterm or low birthweight neonates maintain the euthermic range. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lakshmipur District Hospital status: RECRUITING city: Lakshmipur state: Chattogram zip: 3700 country: Bangladesh name: Ahmed Kabir, MBBS role: CONTACT phone: 01842587456 email: laxmipur@hospital.dghs.gov.bd lat: 22.9443 lon: 90.83005 facility: Kushtia 250 Bedded General Hospital status: RECRUITING city: Kushtia state: Khulna zip: 7000 country: Bangladesh name: Md. Rafiqul Islam, MBBS role: CONTACT phone: 01829699289 email: kushtia@hospi.dghs.gov.bd lat: 23.9028 lon: 89.11943 facility: Jamalpur 250 Beded General Hospital status: NOT_YET_RECRUITING city: Jamalpur state: Mymensingh zip: 2000 country: Bangladesh name: Muhammad Mahfuzur Rahman, MBBS role: CONTACT phone: 01716267689 email: jamalpur@hospital.dghs.gov.bd lat: 24.91965 lon: 89.94812 hasResults: False |
<|newrecord|> nctId: NCT06277856 id: Aysun Eksioglu id: Ayse Akyar type: OTHER domain: Ege University briefTitle: Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience overallStatus: RECRUITING date: 2023-09-15 date: 2024-06-15 date: 2024-09-15 date: 2024-02-26 date: 2024-02-26 name: Ege University class: OTHER briefSummary: The World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed. |
Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding. conditions: Mothers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: In order to eliminate selection bias in the study, "block randomisation" method, one of the fixed probability randomisation methods, will be used and women who meet the inclusion criteria will be distributed to the intervention and control groups. whoMasked: INVESTIGATOR count: 128 type: ESTIMATED name: Peer interaction/control measure: breastfeeding self-efficacy measure: exclusive breastfeeding rate sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Ege University status: RECRUITING city: Izmir zip: 35100 country: Turkey name: Ayşe Akyar, Midwife role: CONTACT phone: +905538507280 email: akyarayse_02@hotmail.com; lat: 38.41273 lon: 27.13838 hasResults: False |
<|newrecord|> nctId: NCT06277843 id: PR-21131 briefTitle: Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates. overallStatus: COMPLETED date: 2022-06-13 date: 2022-09-01 date: 2022-09-30 date: 2024-02-26 date: 2024-02-26 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh name: Directorate General of Health Services (DGHS), Bangladesh name: Poeticgem International Ltd name: University of Dhaka briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. |
Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation. |
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates. |
Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours. conditions: Preterm conditions: Low Birthweight conditions: Hypothermia Neonatal studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm non-randomized trial primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: Thermal Jacket measure: Body temperature of preterm or low birthweight neonates and duration of time in euthermic range. sex: ALL minimumAge: 0 Hours maximumAge: 72 Hours stdAges: CHILD facility: Bangabandhu Sheikh Mujib Medical University (BSMMU) city: Dhaka zip: 1000 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False |
<|newrecord|> nctId: NCT06277830 id: 2023P002788 briefTitle: Physical Activity Monitoring in Myasthenia Gravis overallStatus: RECRUITING date: 2024-02-14 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-04 name: Massachusetts General Hospital class: OTHER name: BioSensics briefSummary: The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG). |
The main question\[s\] it aims to answer are: |
* To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales. |
* To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures. |
Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic. conditions: Myasthenia Gravis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: Wearable sensor measure: Primary outcome measure: Exploratory outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Carina Stafstrom, BS role: CONTACT email: cstafstrom@mgh.harvard.edu role: CONTACT phone: 617-726-5175 lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06277817 id: 2021/1916 briefTitle: The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics overallStatus: COMPLETED date: 2021-05-19 date: 2021-06-25 date: 2022-10-24 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER briefSummary: Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support. conditions: Patient Involvement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 78 type: ACTUAL name: expiratory rib cage compression name: percussion vibration measure: The effect of percussion vibration on the amount of secretion measure: Effect of expiratory rib cage compression on the amount of secretion measure: Effect of percussion vibration on blood gas parameters measure: Effect of expiratory rib cage compression on blood gas parameters measure: Perküsyon vibrasyonun yaşam bulgularına etkisi measure: Effect of expiratory rib cage compression on vital signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunceli State Hospital city: Tunceli zip: 62000 country: Turkey lat: 39.09921 lon: 39.54351 hasResults: False |
<|newrecord|> nctId: NCT06277804 id: LTC004-102 briefTitle: A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-07-01 date: 2027-07-01 date: 2024-02-26 date: 2024-02-26 name: Letolab class: INDUSTRY briefSummary: This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors. conditions: Adult Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: LTC004 in Combination With Cyclophosphamide and Fludarabine measure: Safety, tolerability and antitumor efficacy of Combination. measure: PK Characteristics and immunogenicity of Combination sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06277791 id: HStomatologyWuhan1 briefTitle: The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma overallStatus: RECRUITING date: 2023-08-19 date: 2024-07-31 date: 2025-07-31 date: 2024-02-26 date: 2024-02-26 name: Hospital of Stomatology, Wuhan University class: OTHER briefSummary: The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are: |
• \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.\]. conditions: Clinical IVb Stage Oral Squamous Cell Carcinomas Patients studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Adebrelimab measure: Effective mitigation rate（EMR） measure: DFS measure: R0 resection rate measure: ORR measure: mOS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Stomatology Wuhan University status: RECRUITING city: Hubei state: Wuhan zip: 430079 country: China name: JJia Associate Professor role: CONTACT phone: +8613277924848 email: junjia@whu.edu.cn name: zili Yu role: PRINCIPAL_INVESTIGATOR hasResults: False |
<|newrecord|> nctId: NCT06277778 id: HSEARS20211117003-03 briefTitle: Effect of Combined Music and Taekwondo Training for Children With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-02-26 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Taekwondo training with music therapy name: Taekwondo training alone measure: Engagement in the Training Sessions measure: Gross Motor Skills measure: Physical Activity Level measure: Enjoyment State measure: Rate of Perceived Exertion measure: Taekwondo skills performance measure: Conners' Continuous Performance Test II measure: Comprehensive Trail-Making Test (CTMT) measure: Social Responsiveness Scale, second edition (SRS-2) measure: Childhood Autism Spectrum Test measure: Strength and Difficulties Questionnaires (SDQ) measure: Clinical Global Improvement (CGI) score sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06277765 id: CM310-101212 briefTitle: Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2025-05-30 date: 2024-02-26 date: 2024-02-26 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: CM310 name: placebo measure: Proportion of subjects achieving EASI-75 at week 18 sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Peking University People's hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06277752 id: CIBI128A101 briefTitle: A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor) overallStatus: COMPLETED date: 2024-03-05 date: 2024-03-16 date: 2024-03-16 date: 2024-02-26 date: 2024-03-22 name: Innovent Biologics (Suzhou) Co. Ltd. class: INDUSTRY briefSummary: A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects. conditions: Gout Arthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: dose-5 group name: dose-1 group name: dose-2 group name: dose-4 group name: dose-3 group measure: PK parameter: Cmax measure: PK parameter: AUC measure: PK parameter: Tmax measure: PK parameter: T1/2 measure: Safety parameter: AE measure: PD parameter: serum UA (uric acid） measure: Tolerability parameter: SAE sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Affiliated city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False |
<|newrecord|> nctId: NCT06277739 id: 20220117020315695 briefTitle: Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-01 date: 2026-09-01 date: 2026-09-01 date: 2024-02-26 date: 2024-02-28 name: Zhou Xingchen class: OTHER briefSummary: The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH. conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Spinal Manipulative Therapy name: Sham Laser Treatment measure: visual analogue scale (VAS) measure: Japanese Orthopaedic Association Scores (JOA) measure: Amplitude of Low-Frequency Fluctuation (ALFF) measure: Regional Homogeneity (ReHo) measure: Functional Connectivity (FC) measure: Magnetic Resonance Spectrum （MRS） sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University city: Hangzhou state: Zhejiang zip: 310053 country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06277726 id: IU-SBE-CGI-01 briefTitle: The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application. overallStatus: RECRUITING date: 2023-07-01 date: 2024-04 date: 2024-04 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The purpose of this study is to determine the effect of emotional freedom technique and music, which are effective in relieving pain and anxiety, on the pain and anxiety that occur during intrauterine device application. conditions: Intrauterine Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled study with pre-test post-test group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In order to ensure randomization and prevent contamination between groups, data will be collected in a sequence such that emotional freedom technique is collected one week, music is collected one week, and control group data is collected one week. It will be decided by drawing lots which group's data will be collected first. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 168 type: ESTIMATED name: Emotional freedom technique group name: Music group name: Control group measure: Visual Analog Scale (VAS) measure: State Anxiety Inventory sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Şırnak State Hospital status: RECRUITING city: Şırnak zip: 73000 country: Turkey name: Ceylan GÜZEL İNAL, Lecturer role: CONTACT phone: +095432588644 email: cylngzl@hotmail.com lat: 37.51393 lon: 42.45432 hasResults: False |
<|newrecord|> nctId: NCT06277713 id: CME2023/069 briefTitle: Preventing Exercise Resistance With Sedentary Interruptions acronym: PERSI overallStatus: RECRUITING date: 2024-02-19 date: 2024-10-30 date: 2025-07-01 date: 2024-02-26 date: 2024-03-04 name: Hasselt University class: OTHER briefSummary: The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease. |
The main question this study aims to answer is if the lipid-lowering effects of an exercise bout can be more pronounced by implementing alternations between a seated and a standing working position throughout the day. |
Participants will be asked to: |
* Complete three intervention periods for a duration of 2 days at their workplace, |
* Attend a supervised training session (60min) at the research facility at the end of each intervention period, |
* Attend three assessment days at the research facility where postprandial metabolism will be evaluated after a standardised meal test. conditions: Sedentary Behavior conditions: Lipid Metabolism Disorder conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will follow three regimes of 2 days each including a sedentary control, a sedentary with exercise and a standing breaks with exercise regimen. The sequence of the regimens will be randomised. Each regimen will be followed by a minimum wash-out period of 7 days during which subjects will continue their normal lifestyle. |
We will use a balanced design with 6 randomisation blocks (ABC, ACB, BAC,BCA, CAB, CBA). The randomisation will be computer-generated and allocation will be determined by a member of the research team drawing a sealed, non-translucent envelop with herein written the scheme. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessor will be blinded to the allocation of participants as samples will be code labeled. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Standing interruptions name: Exercise bout name: Sedentary measure: Total and incremental area under the curve of postprandial response in lipid metabolism measure: Total and incremental area under the curve of glucose and insulin postprandial responses measure: Resting metabolic rate sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hasselt University status: RECRUITING city: Diepenbeek state: Limburg zip: 3590 country: Belgium name: Bert Op 't Eijnde, Prof. dr. role: CONTACT phone: +3211292121 email: bert.opteijnde@uhasselt.be name: Jen Vanherle, Drs. role: CONTACT email: jen.vanherle@uhasselt.be name: Bert Op 't Eijnde, Prof. dr. role: PRINCIPAL_INVESTIGATOR name: Jen Vanherle, Drs. role: SUB_INVESTIGATOR lat: 50.90769 lon: 5.41875 hasResults: False |
<|newrecord|> nctId: NCT06277700 id: CMT001 briefTitle: Effects Of Dynamic Stabilizatıon Exercises And HVLA Manipulatıon in Low Back Paın acronym: DNSHVLA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-06-01 date: 2024-02-26 date: 2024-02-26 name: SEFA HAKTAN HATIK class: OTHER briefSummary: Our aim is to contribute to the literature by comparatively examining the effects of DNS exercises and chiropractic HVLA manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain. conditions: Low Back Pain conditions: Neuromuscular Subluxation of Joint studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 60 people will participate in the study and the participants will be divided into four groups. The groups will be formed as chiropractic manipulation (CM) group (n=15), dynamic neuromuscular stabilization (DNS) group (n=15), CM + DNS group (n=15) and control group (CG) (n=15). Chiropractic manipulation will be performed once in the side-lying position. An individualized exercise program will be applied to the DNS group under the supervision of a physiotherapist. Kruskal Wallis test for comparisons of quantitative variables between 4 independent groups; Mann Whitney U test with Bonferonni correction will be used in double subgroup comparisons of significant variables. Friedman test was used for comparisons of quantitative variables in 3 dependent groups. Wilcoxon test with Bonferonni correction will be used for two-way subgroup comparisons for significant variables. In all statistical analyzes in the study, results with a p value below 0.05 will be considered statistically significant. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chiropractic Manipulation (HVLA - high velocity low amplitude) name: Dynamic Neuromuscular Stabilization measure: Visual Analog Scale measure: Physical Adequacy Level measure: Disability Level measure: Dynamic Stabilization and Adaptibility measure: Posture sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Sefa Haktan Haktik city: Sinop country: Turkey lat: 42.02683 lon: 35.16253 hasResults: False |
<|newrecord|> nctId: NCT06277687 id: SYSKY-2024-023-02 briefTitle: Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning overallStatus: RECRUITING date: 2024-02-15 date: 2025-01-01 date: 2026-01-01 date: 2024-02-26 date: 2024-03-19 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. The tissue defects in this area not only seriously affect the physiological function, but also lead to facial deformity and aesthetic damage, affecting the quality of life of patients. The anterolateral thigh flap has become one of the main methods for defect repair due to its large tissue volume and high survival rate, and one of the key steps to ensure a high survival rate is the location of the perforator. How to find the perforator more accurately by improving the detection scheme or locating the perforator according to the anatomical structure, and guide the preparation and cutting of the flap, is the main direction of current research. This study intends to conduct a exploratory study on perforator localization of flap , and explore its effectiveness and accuracy through sensitivity and specificity. |
In this study, a total of 24 patients with maxillofacial defects caused by tumors, trauma and other reasons requiring anterolateral femoral flap repair were included, and the perforator branch of femoral anterolateral flap was positioned preoperatively by Virtual augmented reality combined with perforator positioning device and color Doppler ultrasound. After the anterolateral thigh flap was prepared, the incision was closed in the donor area of the leg, and the flap was transplanted free to the maxillofacial defect area for repair. The sensitivity, specificity, positive predictive value, negative predictive value, distance difference and odds ratio of the two methods were calculated respectively, and the differences of each evaluation index between the two groups were compared, mainly to evaluate the sensitivity and specificity between the two groups. conditions: Blood Vessel Perforation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: After performing CTA examination, input the CTA data into Cinematic Anatomy reconstruction software to analyze blood vessels, muscles and other tissues are reconstructed in three dimensions. Before the operation, the Finder is used to restore the position of the thigh during CTA examination. The Hololens is used to match the reconstructed three-dimensional image with the Finder and the thigh. Before the operation, the pedicles of the descending branches of the lateral arteries and the perforating vessels are marked on the skin of the thigh to achieve the positioning and marking of the perforating branches. primaryPurpose: DIAGNOSTIC masking: NONE count: 24 type: ESTIMATED name: Virtual Augmented Reality Combined With Finder measure: Sensitivity measure: Specificity measure: positive predictive value measure: negative predictive value measure: Youden Index sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University status: RECRUITING city: Guanzhou state: Guangdong zip: 510000 country: China name: Song Fan, Doctor degree role: CONTACT phone: 020-81332477 email: fansong2@mail.sysu.edu.cn name: Song Fan, Doctor degree role: PRINCIPAL_INVESTIGATOR hasResults: False |
<|newrecord|> nctId: NCT06277674 id: ZF2023-252 briefTitle: Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI overallStatus: RECRUITING date: 2023-11-02 date: 2024-12 date: 2025-06 date: 2024-02-26 date: 2024-03-08 name: Guangzhou University of Traditional Chinese Medicine class: OTHER name: Akeso Pharmaceuticals, Inc. briefSummary: This study was designed to evaluate the efficacy and safety of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) in combination with pemetrexed and anlotinib for treatment of elderly patients with T790M-negative advanced non-squamous non-small cell lung cancer following resistance to EGFR-TKI. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Cadonilimab plus Pemetrexed and Anlotinib measure: ORR(Objective response rate) measure: Progression-free survival (PFS) measure: (Disease control rate assessed by investigators) DCR (CR+PR+SD) measure: Overall survival (OS) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Guangdong Provincial Hospital of Traditional Chinese Medicine status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Haibo Zhang, Prof role: CONTACT phone: 86-020-81887233 phoneExt: 34830 email: haibozh@gzucm.edu.cn lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06277661 id: 2023H0305 briefTitle: The Mom and Infant Outcomes (MOMI) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-30 date: 2028-05-30 date: 2024-02-26 date: 2024-04-09 name: Ohio State University class: OTHER briefSummary: The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites. conditions: Postpartum Depression conditions: Postpartum Anxiety conditions: Cardiometabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 384 type: ESTIMATED name: MOMI PODS name: Enhanced Usual Care (EUC) measure: Change in Life's Essential 8 (LE8) Composite Score measure: Change in Life's Essential 8 (LE8) Composite Score measure: Change in Life's Essential 8 (LE8) Composite Score measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States name: Shannon L. Gillespie, PhD, RN role: CONTACT phone: 614-292-4589 email: gillespie.175@osu.edu name: Sandra Solove, MA role: CONTACT phone: 6142478366 email: solove.3@osu.edu lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06277648 id: 18-2021 briefTitle: the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients overallStatus: RECRUITING date: 2022-01-01 date: 2024-04-01 date: 2024-04-15 date: 2024-02-26 date: 2024-02-28 name: Haseki Training and Research Hospital class: OTHER briefSummary: This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures. |
The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively. conditions: Collum Femoris Fracture conditions: Pericapsular Nerve Group Block conditions: Suprainguinal Fascia Iliaca Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a double-blind, prospective, randomized, controlled study primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The orthopaedic surgeon responsible for the study was blinded to the study groups. This surgeon was the sole evaluator of postoperative pain scores and total analgesia consumption. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: PENG block name: SIFIB measure: pain scores measure: rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital status: RECRUITING city: Istanbul state: Sultangazi country: Turkey name: Berna Caliskan role: CONTACT email: caliskan.b@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06277635 id: TAPAC001 briefTitle: Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases overallStatus: RECRUITING date: 2024-02-01 date: 2025-04 date: 2025-04 date: 2024-02-26 date: 2024-02-26 name: Phramongkutklao College of Medicine and Hospital class: OTHER briefSummary: To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis conditions: Rheumatoid Arthritis conditions: Psoriatic Arthritis conditions: Psoriasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 72 type: ESTIMATED name: Silymarin name: Placebo measure: AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L) measure: AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN measure: AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L) measure: AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice measure: Discontinuation rate of methotrexate measure: Adverse events measure: Change of DAS-28 ESR or CRP Score measure: Change of BASDAI Score measure: Change of ASDAS ESR or CRP Score measure: Change of BSA for psoriasis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine status: RECRUITING city: Bangkok, Thailand, 10400 state: Bangkok zip: 10400 country: Thailand name: Rattapol Pakchotanon, M.D. role: CONTACT phone: 66+23547980 email: rattapolpmk@gmail.com name: Rattapol Pakchotanon, M.D. role: SUB_INVESTIGATOR name: Supasa Niyompanichakarn, M.D. role: SUB_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False |
<|newrecord|> nctId: NCT06277622 id: PekingUTH ZFCY PFUN briefTitle: A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture overallStatus: RECRUITING date: 2024-01-01 date: 2025-09-30 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: Peking University Third Hospital class: OTHER name: Beijing Yanqing Hospital briefSummary: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture. conditions: Femoral Intertrochanteric Fractures studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up.The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: PFUN name: PFNA measure: Internal fixation failure rate measure: Number of Participants with Bone nonunion measure: Harris hip score measure: operation time measure: The times of intraoperative fluoroscopy measure: Number of Participants with Postoperative adverse events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yuan Cao, MD role: CONTACT phone: +86-01082266699 email: cy6415@126.com name: Fang Zhou, MD role: CONTACT phone: +86010-82267010 email: zhouf@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06277609 id: 20508A briefTitle: A Trial Investigating Lu AF28996 in Healthy Adult Participants overallStatus: RECRUITING date: 2024-02-27 date: 2024-05-18 date: 2024-05-18 date: 2024-02-26 date: 2024-03-07 name: H. Lundbeck A/S class: INDUSTRY briefSummary: The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Lu AF28996 name: Acetylsalicylic Acid name: Mefenamic Acid name: Amoxicillin/clavulanic acid measure: Maximum Observed Concentration (Cmax) of Lu AF28996 measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996 measure: Nominal Time Corresponding to the Occurrence of Cmax sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Covance Dallas CRU status: RECRUITING city: Dallas state: Texas zip: 75247 country: United States lat: 32.78306 lon: -96.80667 hasResults: False |
<|newrecord|> nctId: NCT06277596 id: ETK00-2023-0101 briefTitle: The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia overallStatus: RECRUITING date: 2024-04-10 date: 2024-07-30 date: 2024-08-30 date: 2024-02-26 date: 2024-04-16 name: Eastern Mediterranean University class: OTHER briefSummary: The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Exercise measure: Visual Analog Scale ( VAS ) measure: Sociodemographic information (age) measure: Sociodemographic information (height) measure: Sociodemographic information (weight) measure: Trunk Muscle Endurance (McGill Endurance Test and Plank Test) measure: Chair Sit to stand test measure: 6 minute walk test measure: Fatigue Severity Scale measure: Pittsburgh Sleep Quality Index measure: Revised Fibromyalgia Impact Questionnaire measure: Fear-Avoidance Beliefs Questionnaire measure: Pain Self-Efficacy Questionnaire measure: Body Awareness Questionnaire measure: Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ) measure: Short form-36 (SF-36) measure: Treatment Satisfaction Evaluation sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Eastern Mediterranean University status: RECRUITING city: Famagusta zip: 99628 country: Cyprus name: Sevim Oksüz, Asst.Prof.Dr role: CONTACT phone: 5488351465 phoneExt: +90 email: sevim.oksuz@emu.edu.tr lat: 35.12054 lon: 33.93894 hasResults: False |
<|newrecord|> nctId: NCT06277583 id: NUS-IRB-2023-191 briefTitle: Urban Care Farming on Living Well and Productive Engagement of Older Adults overallStatus: RECRUITING date: 2023-11-28 date: 2024-12-31 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: National University of Singapore class: OTHER name: National Medical Research Council (NMRC), Singapore briefSummary: The goal of the randomized controlled trials is to learn about the effects of urban farming interventions on older adults' physical, mental, and social well-being of older adults aged 50 and above. The main questions the study aims to answer are Q1. Would participants who have undergone the urban care farming intervention have lower stress levels compared to those who did not undergo the intervention? Q2. Would the quality of life and biopsychosocial factors of older adults who participate in the urban farming interventions be better before the intervention and compared to those who did not participate? Q3. Would running intervention programs as such demonstrate cost-effectiveness? Participants will be enrolled in 24 weekly lessons providing hands-on urban farming techniques, including physical activity, planting, and social interactions. Researchers will compare older participants with similar demographic profile to determine if the biological, psychological, and social factors are better for the intervention group. conditions: Stress, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Waitlist controlled trials: Participants from both the intervention and waitlist control groups will undergo the intervention 6 months apart. primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Urban care farming measure: WHO Quality of Life Scale (WHOQOL-BREF) measure: Immuno-biomarkers: IL-1RA, IL-6, IL-8 (CXCL8), IL-10, IL-13, IL-17A (CTLA-8), MIP-3 beta (CCL19), SDF-1 alpha, MMP-3, MMP-9, MCP-1 (CCL2), and TNF alpha measure: Brief sense of community scale (BSCS) measure: Fried phenotype of frailty measure: Lubben social network scale (LSNS-6) measure: Functional near-infrared spectroscopy measure: EQ5D measure: Geriatric anxiety scale (GAS-10) measure: MOCA measure: Brief resilience scale measure: De jong Gierveld loneliness scale measure: Fitbit measure: Body weight and height measure: Fasting plasma glucose, HbA1c measure: Serum Creatinine measure: Attitude towards eating healthy food measure: Waist and hip circumference measure: Blood pressure measure: Lipid panel measure: Eating fruits and vegetables behavior sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NUS status: RECRUITING city: Singapore zip: 117549 country: Singapore name: Ezra Chiam role: CONTACT phone: +6566016036 email: ezra.chiam@nus.edu.sg name: Cynthia Chen, PhD role: PRINCIPAL_INVESTIGATOR name: Choon Nam Ong, MD, PhD role: SUB_INVESTIGATOR name: Schwarz Herbert, PhD role: SUB_INVESTIGATOR name: Mary Chong, PhD role: SUB_INVESTIGATOR name: Roger Ho, PhD role: SUB_INVESTIGATOR name: Leng Leng Theng, PhD role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 facility: Jurong Lake Garden status: RECRUITING city: Singapore zip: 618661 country: Singapore name: Joan Hung role: CONTACT email: Joan_HUNG@nparks.gov.sg lat: 1.28967 lon: 103.85007 hasResults: False |
<|newrecord|> nctId: NCT06277570 id: 2023-487 briefTitle: Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis. overallStatus: RECRUITING date: 2023-10-31 date: 2025-03-31 date: 2025-06-30 date: 2024-02-26 date: 2024-02-26 name: Gulhane School of Medicine class: OTHER briefSummary: The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample of the study will consist of participants who applied to Etlik City Physical Therapy and Rehabilitation Hospital, were diagnosed with knee osteoarthritis by the physician, and will receive routine treatment in the electrotherapy unit. Patients will be randomly assigned to groups. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: conventional physiotherapy name: NMES name: Superimposed NMES measure: Muscle strength measure: Joint position sense measure: Muscle structure and knee joint cartilage thickness measure: Joint range of motion measure: Short Form-36 measure: Western Ontario and McMaster Universities Osteoarthritis Index Scale measure: Visual Analog Scale (VAS) measure: Balance assessment measure: Functional capacity sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physiotherapy and Rehabilitation, University of Health Sciences status: RECRUITING city: Ankara state: Etlik zip: 06018 country: Turkey name: Oğuzhan METE role: CONTACT email: oguzhan.mete@sbu.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06277557 id: HSEARS20211229002 briefTitle: Evaluation of the Effects of Virtual Reality Learning Environment on Nursing Student Non-technical Skills Development overallStatus: COMPLETED date: 2022-01-10 date: 2023-08-31 date: 2023-08-31 date: 2024-02-26 date: 2024-02-26 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The goal of this waitlist control study is to evaluate the benefits of virtual reality teaching pedagogy to developing non-technical skills in nursing students. |
The main question\[s\] it aims to answer are: |
1. What is the relationship between VR training programs and students' situation awareness skills development? |
2. What is the relationship between VR training programs and students' communication skills development? |
3. What is the relationship between VR training programs and students' satisfaction/self-confidence in learning? |
4. What is the relationship between the sense of presence and satisfaction/ self-confidence in learning? |
5. How does the student's learning experience after VR training programs? |
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