Split (1)

train · 22k rows

Record stringlengths 1 197k
<\|newrecord\|> nctId: NCT06301581 id: ABIntl-23-42 briefTitle: Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant overallStatus: RECRUITING date: 2024-01-22 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: Advanced Bionics AG class: INDUSTRY briefSummary: This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices. conditions: Cochlear Hearing Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: Freiburger monosyllabic word recognition score in quiet in the implanted ear sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Medizinische Hochschule Hannover status: RECRUITING city: Hannover zip: D-30625 country: Germany name: Andreas Büchner role: CONTACT name: Andreas Büchner role: PRINCIPAL_INVESTIGATOR lat: 52.37052 lon: 9.73322 hasResults: False
<\|newrecord\|> nctId: NCT06301568 id: ABIntl-23-12 briefTitle: Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation overallStatus: RECRUITING date: 2024-01-22 date: 2024-04 date: 2024-05 date: 2024-03-08 date: 2024-03-08 name: Advanced Bionics AG class: INDUSTRY briefSummary: This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks. conditions: Cochlear Hearing Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Freiburger monosyllabic word recognition score in quiet measure: HSM sentence score or OlSa recognition score in quiet sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Medizinische Hochschule Hannover status: RECRUITING city: Hannover zip: D-30625 country: Germany name: Andreas Büchner role: CONTACT lat: 52.37052 lon: 9.73322 hasResults: False
<\|newrecord\|> nctId: NCT06301555 id: db2023 briefTitle: Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms overallStatus: COMPLETED date: 2023-11-01 date: 2024-01-01 date: 2024-02-01 date: 2024-03-08 date: 2024-03-08 name: Adai Technology (Beijing) Co., Ltd. class: OTHER briefSummary: Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 223 type: ACTUAL name: Reinforcement learning algorithm powered cognitive and behavioral intervention name: cognitive and behavioral intervention measure: PHQ9 Response measure: GAD7 Response sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: the First Hospital of China Medical University city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 hasResults: False
<\|newrecord\|> nctId: NCT06301542 id: 2020P003474 briefTitle: Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation overallStatus: RECRUITING date: 2024-02-07 date: 2024-05-01 date: 2024-05-01 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER name: Boston University briefSummary: The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home. conditions: Post-stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Functional electrical stimulation measure: Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients measure: Accurate motion assistance while using the functional electrical stimulation in the laboratory. measure: Accurate motion assistance while using the functional electrical stimulation in the home. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: David M Levine, MD MPH MA role: CONTACT phone: 617-732-7063 email: dmlevine@partners.org name: David M Levine, MD MPH MA role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06301529 id: ALRx008 briefTitle: The Efficacy and Tolerability of Canagliflozin in Healthy Individual overallStatus: ENROLLING_BY_INVITATION date: 2024-02-12 date: 2024-04-29 date: 2024-04-29 date: 2024-03-08 date: 2024-03-08 name: AgelessRx class: INDUSTRY briefSummary: The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.
The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol. conditions: Healthy Aging studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Invokana Pill measure: Change in blood glucose values after taking Canagliflozin measure: Number of participants with treatment-related side effects through collected survey responses sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AgelessRx city: Ann Arbor state: Michigan zip: 48104 country: United States lat: 42.27756 lon: -83.74088 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-24 uploadDate: 2024-02-21T09:47 filename: Prot_SAP_ICF_000.pdf size: 1174837 hasResults: False
<\|newrecord\|> nctId: NCT06301516 id: HM20027823 id: R41MH133540 type: NIH link: https://reporter.nih.gov/quickSearch/R41MH133540 briefTitle: Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD overallStatus: RECRUITING date: 2024-02-16 date: 2024-12 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: Virginia Commonwealth University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD. conditions: Conduct Disorder conditions: Conduct Disorders in Children conditions: Conduct Disorders in Adolescence conditions: Callous-Unemotional Traits studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial of psychological intervention. Once all assessments are completed, the treatment group allocation will be disclosed to the administrating researcher, youth, and caregiver. This blinded approach to block randomization prevents any bias from occurring during the assessment phase by the researcher. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Virtual Reality name: Comparative Control measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Nicholas Johnson role: CONTACT phone: 804-828-6386 email: Nicholas.Thomson@VCUHealth.org lat: 37.55376 lon: -77.46026 hasResults: False
<\|newrecord\|> nctId: NCT06301503 id: 0103/UN14.2.2.VII.14/LT/2024 briefTitle: Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB) overallStatus: RECRUITING date: 2024-03-08 date: 2024-04-20 date: 2024-04-25 date: 2024-03-08 date: 2024-04-11 name: Udayana University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia.
The main questions it aims to answer are:
* Will there be a significant difference in QoR-40 scores between both groups?
* Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours?
* Will the combined LPB-SNB significantly increases postoperative duration of analgesia?
Participants will:
* Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants.
* Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire.
Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries. conditions: Lower Extremity Surgery studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One hundred participants are to be randomly assigned by a computer-generated random number table into two parallel groups and 1:1 allocation to either receive a combination of LPB-SNB or no block at all. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Numbers were prepared in sealed envelopes prepared by a third party not involved in the study to ensure allocation concealment, and handed over to the anesthetist performing the block before surgery. Participants would be blinded to the group allocation. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: USG Guided Combined LPB-SNB with Isobaric Bupivacaine name: Control measure: Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire measure: Postoperative Intravenous Opioid Consumption measure: Postoperative Analgesia Duration sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. Dr. I.G.N.G. Ngoerah General Hospital status: RECRUITING city: Denpasar state: Bali zip: 80114 country: Indonesia name: Tjokorda GA Senapathi, Professor role: CONTACT phone: +6281337711220 email: tjoksenapathi@unud.ac.id name: Tjokorda GA Senapathi, Professor role: SUB_INVESTIGATOR name: Pontisomaya Parami, Consultant role: SUB_INVESTIGATOR name: Made Wiryana, Professor role: SUB_INVESTIGATOR name: I Made G Widnyana, Doctorate role: SUB_INVESTIGATOR name: I Putu P Suarjaya, Doctorate role: SUB_INVESTIGATOR name: I Gusti NM Aribawa, Doctorate role: SUB_INVESTIGATOR name: Ida Bagus KJ Sutawan, Consultant role: SUB_INVESTIGATOR name: Georgina M Tiberias, MD role: SUB_INVESTIGATOR lat: -8.65 lon: 115.21667 hasResults: False
<\|newrecord\|> nctId: NCT06301490 id: Taif university briefTitle: The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome overallStatus: COMPLETED date: 2024-01-11 date: 2024-02-15 date: 2024-03-02 date: 2024-03-08 date: 2024-04-24 name: Taif University class: OTHER briefSummary: BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.
OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.
METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale. conditions: Subacromial Impingement Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ACTUAL name: Myofascial Release measure: pain intensity measure: disability measure: rang of motion measure: psychological distress, and health-related quality of life (HRQoL) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Taif University city: Taif state: Makkah zip: 11099 country: Saudi Arabia lat: 21.27028 lon: 40.41583 hasResults: False
<\|newrecord\|> nctId: NCT06301477 id: 23/109X briefTitle: PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial acronym: PROMOTE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-03-01 date: 2027-03-01 date: 2024-03-08 date: 2024-03-12 name: Children's Hospital of Eastern Ontario class: OTHER briefSummary: To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes. conditions: Inflammatory Bowel Diseases conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A single-center, randomized, placebo-controlled, double-blinded, pilot trial primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Resistant Starch name: Placebo measure: Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis measure: Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis measure: Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis measure: Change in intensification as measured by anti-TNFa dose escalation measure: Change in intensification as measured by anti-TNFa interval shortening measure: Change in disease activity measure: Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples measure: Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples measure: Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire measure: Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire measure: Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: Children's Hospital of Eastern Ontario city: Ottawa state: Ontario zip: K1H 8L1 country: Canada name: David Mack, MD, FRCPC role: CONTACT phone: (613)737-7600 phoneExt: 2516 email: dmack@cheo.on.ca name: Ruth Singleton, RN, CCRP role: CONTACT phone: (613)737-7600 phoneExt: 4123 email: rsingleton@cheo.on.ca name: David Mack, MD, FRCPC role: PRINCIPAL_INVESTIGATOR name: Alain Stintzi, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 hasResults: False
<\|newrecord\|> nctId: NCT06301464 id: B-2003-603-103 briefTitle: Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2003-03-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Seoul National University Bundang Hospital class: OTHER briefSummary: The aim of this study to validate the role of pepsinogens in gastric cancer screening. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 24000 type: ESTIMATED measure: The level of serum pepsinogens sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital city: Seongnam-si state: Gyeonggi-do zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 hasResults: False
<\|newrecord\|> nctId: NCT06301451 id: XD2021-1 briefTitle: Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia overallStatus: RECRUITING date: 2022-04-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-08 date: 2024-03-08 name: Sun Jia class: OTHER briefSummary: In the past 30 years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia patients has increased significantly. Hyperlipidemia is a disease caused by abnormal blood lipid levels, also known as abnormal lipid metabolism. Common clinical indicators include total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL) and high-density lipoprotein ( HDL).The number of patients with abnormal blood lipid levels in China accounts for as high as 40% of the total. It is estimated that between 2010 and 2030,cardiovascular disease events will increase by 9.2 million, which seriously endangers human health and becomes a high risk factor for various cardiovascular diseases, such as atherosclerosis. One of the pathological foundations of atherosclerosis is that abnormal lipid levels in the body cause a large amount of lipid to be deposited in the arterial endothelial matrix, which is phagocytosed by smooth muscle and macrophages to form foam cells.
Hydrogen, the lightest and smallest molecular gas in the atmosphere, is considered a novel antioxidant that reduces oxidative stress. Accumulating evidence from various biomedical fields in clinical studies and experimental models of many diseases suggests that hydrogen inhalation or drinking hydrogen-containing solutions can be used as a therapeutic strategy. Due to the special physical properties of hydrogen gas that is easy to diffuse, hydrogen molecules can penetrate cell membranes to reach organelles and cell nuclei. Hydrogen's moderate reducing properties make it effective in reducing cytotoxicity, protecting nuclear DNA and mitochondria, and reducing the risk of lifestyle-related diseases and cancer.
In addition, hydrogen intake can reduce oxidative stress, improve cellular function, and reduce chronic inflammation, which are associated with the pathology and etiology of hyperlipidemia and other related diseases. Molecular hydrogen can regulate important metabolic functions such as signal transduction, protein phosphorylation, miRNA expression, and autophagy. Studies have shown that intake of hydrogen water in APOE knockout mice can reduce serum total cholesterol and low-density lipoprotein levels and prevent the progression of atherosclerosis. A study by Song et al. in 2013 included 20 subjects who drank 0.9 to 1 L of hydrogen-rich water per day for 10 weeks, and the subjects' LDL-C levels decreased significantly before and after treatment. Another study showed that subjects with underlying lipid metabolism abnormalities were treated with high-concentration hydrogen water (5.5mmol/d) for up to 24 weeks, and serum total cholesterol and low-density lipoprotein levels were significantly reduced. Protein function and redox status (eg, increased serum superoxide dismutase and decreased malondialdehyde) were improved, markers of inflammation (eg, serum tumor necrosis factor-alpha) decreased and fasting blood glucose decreased. At present, the research on the treatment of hyperlipidemia with hydrogen water is very limited. The portable hydrogen water hydrogen machine used in this study has passed the registration test of the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. In order to evaluate the use of the portable hydrogen water hydrogen machine for hyperlipidemia The efficacy and safety of adjuvant therapy in patients, this clinical trial is specially carried out. conditions: Hyperlipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is estimated that 180 subjects will be enrolled and randomly divided into the experimental group and the control group according to 2:1. During the observation period, the experimental group drink the hydrogen water prepared by the experimental equipment on the basis of the general dietary guidance, while the control group adopted the general dietary guidance. Every subject's diet and lifestyle remains largely unchanged during the treatment period. primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine measure: Percent change from baseline in LDL-C at 3 months of intervention. measure: Absolute change from baseline in LDL-C at 3 months of intervention. measure: Percent change from baseline in LDL-C at 1 month of intervention. measure: Absolute change from baseline in LDL-C at 1 month of intervention. measure: Percent change from baseline in LDL-C at 6 months of intervention. measure: Absolute change from baseline in LDL-C at 6 months of intervention. measure: Percent change from baseline in triglycerides at 1 month of intervention. measure: Absolute change from baseline in triglycerides at 1 month of intervention. measure: Percent change from baseline in triglycerides at 3 months of intervention. measure: Absolute change from baseline in triglycerides at 3 months of intervention. measure: Percent change from baseline in triglycerides at 6 months of intervention. measure: Absolute change from baseline in triglycerides at 6 months of intervention. measure: Percent change from baseline in total cholesterol at 1 month of intervention. measure: Absolute change from baseline in total cholesterol at 1 month of intervention. measure: Percent change from baseline in total cholesterol at 3 months of intervention. measure: Absolute change from baseline in total cholesterol at 3 months of intervention. measure: Percent change from baseline in total cholesterol at 6 months of intervention. measure: Absolute change from baseline in total cholesterol at 6 months of intervention. measure: Percent change from baseline in HDL cholesterol at 1 month of intervention. measure: Absolute change from baseline in HDL cholesterol at 1 month of intervention. measure: Percent change from baseline in HDL cholesterol at 3 months of intervention. measure: Absolute change from baseline in HDL cholesterol at 3 months of intervention. measure: Percent change from baseline in HDL cholesterol at 6 months of intervention. measure: Absolute change from baseline in HDL cholesterol at 6 months of intervention. measure: Percent change from baseline in non-HDL cholesterol at 1 month of intervention. measure: Absolute change from baseline in non-HDL cholesterol at 1 month of intervention. measure: Percent change from baseline in non-HDL cholesterol at 3 months of intervention. measure: Absolute change from baseline in non-HDL cholesterol at 3 months of intervention. measure: Percent change from baseline in non-HDL cholesterol at 6 months of intervention. measure: Absolute change from baseline in non-HDL cholesterol at 6 months of intervention. measure: Percent change from baseline in small and dense LDL at 1 month of intervention. measure: Absolute change from baseline in small and dense LDL at 1 month of intervention. measure: Percent change from baseline in small and dense LDL at 3 months of intervention. measure: Absolute change from baseline in small and dense LDL at 3 months of intervention. measure: Percent change from baseline in small and dense LDL at 6 months of intervention. measure: Absolute change from baseline in small and dense LDL at 6 months of intervention. measure: Percent change from baseline in apolipoprotein B at 1 month of intervention. measure: Absolute change from baseline in apolipoprotein B at 1 month of intervention. measure: Percent change from baseline in apolipoprotein B at 3 months of intervention. measure: Absolute change from baseline in apolipoprotein B at 3 months of intervention. measure: Percent change from baseline in apolipoprotein B at 6 months of intervention. measure: Absolute change from baseline in apolipoprotein B at 6 months of intervention. measure: Percent change from baseline in TNF-alpha at 1 month of intervention. measure: Absolute change from baseline in TNF-alpha at 1 month of intervention. measure: Percent change from baseline in TNF-alpha at 3 months of intervention. measure: Absolute change from baseline in TNF-alpha at 3 months of intervention. measure: Percent change from baseline in TNF-alpha at 6 months of intervention. measure: Absolute change from baseline in TNF-alpha at 6 months of intervention. measure: Adverse Event (AE) Frequency measure: Severe Adverse Event (SAE) Frequency measure: Device deficiency rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Sun Jia role: CONTACT phone: 13751822925 lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06301438 id: LY2024-022-A briefTitle: Dalpiciclib in HR+/HER2- ABC overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-12 date: 2028-12 date: 2024-03-08 date: 2024-04-16 name: RenJi Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer. conditions: Advanced Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 103 type: ESTIMATED name: dalpiciclib measure: Progression-Free Survival measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University city: Shanghai zip: 200127 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06301425 id: TROPHY-AML01 briefTitle: MRD Response-adapted Allo-HSCT for Adverse-risk AML overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-03-08 date: 2024-03-08 name: Peking University People's Hospital class: OTHER name: Ruijin Hospital name: Wuhan TongJi Hospital name: Anhui Provincial Hospital briefSummary: This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 178 type: ESTIMATED name: Intervention group name: Control group measure: Event-free survival (EFS) measure: Relapse measure: Leukemia-free survival (LFS) measure: Non-relapse mortality (NRM) measure: Overall survival (OS) measure: Acute graft-versus-host disease (aGvHD) measure: Chronic graft-versus-host disease (cGvHD) sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301412 id: COTTIS-2_Version4.0-13Nov23 briefTitle: Combination of Hypothermia and Thrombectomy in Acute Stroke acronym: COTTIS-2 overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2026-03-18 date: 2026-06-18 date: 2024-03-08 date: 2024-03-08 name: University of Freiburg class: OTHER name: European Union name: E+E CRO consulting, Vienna, Austria name: Center for Medical data science, University of Vienna, Austria briefSummary: The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.
The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed.
Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications. conditions: Ischemic Stroke conditions: Large Vessel Occlusion conditions: Endovascular Treatment studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: hypothermia measure: functional outcome measure: infarction volume measure: increase in infarction measure: recanalization result measure: neurological improvement measure: outcome at discharge measure: shift in functional outcome measure: very good clinical outcome measure: mortality measure: Length of ventilation measure: Length of stay measure: body temperature measure: time to groin puncture measure: time to recanalization measure: Occurrence of intracerebral haemorrhage (ICH) measure: Complications associated with hypothermia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301399 id: Rituximab01 briefTitle: Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy measure: ORR measure: PFS measure: OS measure: DoR measure: DCR sex: ALL minimumAge: 17 Years maximumAge: 79 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute & Hospital city: Tianjin state: Tianjin zip: 300060 country: China lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06301386 id: EVOLUTION briefTitle: Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-05-01 date: 2026-12-01 date: 2024-03-08 date: 2024-03-08 name: Fudan University class: OTHER name: Anyang Tumor Hospital briefSummary: The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Everolimus name: PD-1 measure: objective response rate (ORR) measure: progression-free survival (PFS） measure: overall survival (OS) measure: disease control rate (DCRs) measure: advert events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anyang Tumor Hospital city: Anyang state: Henan country: China name: Yanjun Wang, PhD role: CONTACT phone: +8613837266702 email: m13837266702@163.com lat: 36.096 lon: 114.38278 facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai country: China name: Dawei Li, PhD role: CONTACT phone: +8613774201693 email: li_dawei@fudan.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06301373 id: SYSKY-2023-1185-02 briefTitle: Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2030-04-01 date: 2030-04-01 date: 2024-03-08 date: 2024-03-08 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy.
This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48.
This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Methotrexate Combined With Tofacitinib name: Methotrexate measure: The proportion of subjects who achieved ACR20 measure: Changes in disease activity scores (DAS28-CRP) relative to baseline measure: Changes in disease activity scores (DAS28-ESR) relative to baseline measure: Changes in disease activity scores (SDAI) relative to baseline measure: Changes in disease activity scores (CDAI) relative to baseline measure: Proportion of subjects with low disease activity and remission (SDAI standard) at weeks 4, 8, 12, 24, 36, and 48 after treatment measure: The proportion of subjects who met ACR50 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment measure: The proportion of subjects who met ACR70 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment measure: Changes in the Disability Index (HAQ-DI) of the Health Assessment Questionnaire relative to baseline measure: Changes in EQ-5D-5L relative to baseline measure: The proportion of subjects with joint destruction progression at 48 weeks after treatment measure: The proportion of adverse events (AE) in subjects at 4, 8, 12, 24, 36, and 48 weeks after treatment measure: The proportion of severe adverse events (SAE) in subjects at 4, 8, 12, 24, 36, and 48 weeks after treatment measure: Changes in serum MMP-3 levels relative to baseline sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301360 id: KOSMOS2 2023-04956-01 briefTitle: Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support overallStatus: RECRUITING date: 2023-12-01 date: 2025-06-01 date: 2025-12-31 date: 2024-03-08 date: 2024-03-12 name: Daniel Maroti class: OTHER name: Wayne State University briefSummary: Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.
Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).
The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.
The research question for this specific study is:
Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD? conditions: Functional Somatic Disorder conditions: Somatic Symptom Disorder conditions: Functional Somatic Syndromes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT with two treatment arms primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Internet based Emotional Awareness and Expression Therapy (I-EAET) measure: Patient Health Questionnaire -15 (PHQ-15) measure: Numeric Rating Scales according to EURONET-SOMA measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Post traumatic stress disorder checklist-5 (PCL-5) measure: Difficulties in Emotion Regulation Scale-16 (DERS-16) measure: Sheehan Disability Scale (SDS) measure: The revised illness perception questionnaire (IPQ-R) measure: Mediational measure: DERS-16 measure: Mediational measure: PHQ-15 measure: Mediational measure: PHQ-4 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stockholm University status: RECRUITING city: Stockholm zip: 10691 country: Sweden name: Daniel Maroti, Med Dr role: CONTACT phone: +46738028474 email: daniel.maroti@su.se lat: 59.33258 lon: 18.0649 facility: Stockholm University status: RECRUITING city: Stockholm zip: 11419 country: Sweden name: Daniel Maroti role: CONTACT phone: 0738028474 email: daniel.maroti@su.se lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06301347 id: LTP+P briefTitle: Learning Through Play Plus for Psychosis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-30 date: 2025-12-30 date: 2024-03-08 date: 2024-03-08 name: Pakistan Institute of Living and Learning class: OTHER briefSummary: Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia. conditions: Psychosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Learning through Play Plus measure: Recruitment Rate measure: Attrition Rate measure: Intervention attendance log measure: Positive and Negative Syndrome Scale measure: Psychotic Rating Scale measure: Parenting Stress Index measure: Maternal Attachment Inventory measure: Knowledge attitude and practices of Child Development measure: Calgary Depression Scale measure: Social and Occupational Functioning Scale measure: Euro-Qol 5 Dimensions measure: Client Service Receipt Inventory measure: Ages and Stages Questionnaire measure: Manchester Assessment of Caregiver-Infant Interaction measure: Bayley Scale of infant development measure: Child Height measure: Child Weight measure: Child head circumference sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301334 id: Soh-Med-24-01-11MS briefTitle: Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-08 date: 2024-03-08 name: Sohag University class: OTHER briefSummary: A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications
Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy conditions: Pain Mangement of Thoracotomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Bupivacaine 0.25% Injectable Solution measure: study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy. measure: The secondary outcome is the total postoperative morphine consumption, time of first analgesic, sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301321 id: 461_2566 briefTitle: The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients acronym: BCR-ABL1 overallStatus: RECRUITING date: 2024-03-20 date: 2024-03-30 date: 2024-07-30 date: 2024-03-08 date: 2024-03-08 name: Siriraj Hospital class: OTHER briefSummary: Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves. conditions: Chronic Myelogenous Leukemia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: Sensitivity measure: Specificity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Siriraj hospital status: RECRUITING city: Bangkok zip: 10700 country: Thailand name: weerapat Owattanapanich, MD role: CONTACT phone: 0891081963 email: weerapato36733@gmail.com name: Wananchi Saisaard, MT role: CONTACT phone: 0817141717 email: wern.si12@gmail.com name: weerapat Owattanapanich, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06301308 id: 2022021 briefTitle: A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial overallStatus: WITHDRAWN date: 2023-10-01 date: 2024-02-29 date: 2024-02-29 date: 2024-03-08 date: 2024-04-24 name: Second Xiangya Hospital of Central South University class: OTHER briefSummary: The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 0 type: ACTUAL name: Intraurethral lidocaine gel alone name: Intraurethral lidocaine gel + lidocaine 2% injection name: intraurethral lidocaine gel + liquid paraffinl measure: Access the pain score using the Visual Analogue Scale (VAS) measure: Postoperative complications sex: MALE maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: The second xiangya hospital city: Changsha state: Hunan zip: 410000 country: China lat: 28.19874 lon: 112.97087 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-01 uploadDate: 2024-03-03T08:40 filename: Prot_SAP_ICF_000.pdf size: 387410 hasResults: False
<\|newrecord\|> nctId: NCT06301295 id: 2402-017-136 briefTitle: Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients Suspicious of Early-stage Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-08 date: 2024-03-08 name: Pusan National University Hospital class: OTHER briefSummary: This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Ultarthin bronchoscopy with intratumoral washing measure: Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid measure: Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue measure: Turn-around time measure: Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301282 id: 2021-02341 briefTitle: Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease acronym: Transition overallStatus: RECRUITING date: 2023-03-03 date: 2025-12 date: 2025-12 date: 2024-03-08 date: 2024-03-08 name: University Hospital, Geneva class: OTHER briefSummary: Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.
The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.
For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.
This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states measure: Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge measure: Correlation of electroencephalographic resting-state oscillatory activity with motor scores during the levodopa challenge sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital, Geneva status: RECRUITING city: Geneva zip: 1204 country: Switzerland name: Vanessa Fleury, MD role: CONTACT phone: +41223728337 email: Vanessa.FleuryNissen@hcuge.ch lat: 46.20222 lon: 6.14569 hasResults: False
<\|newrecord\|> nctId: NCT06301269 id: 202312124RINA briefTitle: A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia overallStatus: RECRUITING date: 2024-03-10 date: 2024-05-30 date: 2024-07-30 date: 2024-03-08 date: 2024-03-08 name: National Taiwan University Hospital class: OTHER briefSummary: The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.
The main questions it aims to answer are:
1. What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?
2. Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?
3. What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?
Participants will fill out the questionnaire to complete the study. conditions: Dementia studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 160 type: ESTIMATED measure: Self-Compassion Scale measure: PHQ-9 Scale measure: Quality-of-Life Scale sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: wen lin YE role: CONTACT phone: +886-2312-3456 email: vovo951357@ntuh.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06301256 id: I8F-NS-I002 briefTitle: Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-03-11 date: 2025-03-11 date: 2024-03-08 date: 2024-03-08 name: Florida Academic Centers Research and Education, LLC class: INDUSTRY briefSummary: The purpose of this study is to determine the clinical efficacy and safety of tirzepatide in subjects with moderate to severe hidradenitis suppurativa. The study will be conducted over 24 weeks on active therapy followed by a eight-week observational follow-up visit. The total length of the study will be 32 weeks . conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TIRZEPATIDE measure: Hidradenitis Suppurativa Clinical Response (HiSCR) 50% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301243 id: FY24-62 briefTitle: Molecular Signature of Inactivity Induced Exercise Responsiveness overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Concordia University Wisconsin class: OTHER briefSummary: Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases. conditions: Metabolic Diseases conditions: Aerobic Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Inactivity measure: Circulating lipid and carbohydrate metabolism measure: Basal and post-exercise gene expression with inactivity sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kevin J Gries status: RECRUITING city: Mequon state: Wisconsin zip: 53092 country: United States name: Kevin J Gries, PhD role: CONTACT phone: 262-243-4293 email: kevin.gries@cuw.edu lat: 43.21573 lon: -88.02962 hasResults: False
<\|newrecord\|> nctId: NCT06301230 id: PLET-2022 briefTitle: Home- vs. Hospital-based Surgical Training overallStatus: COMPLETED date: 2020-09-01 date: 2021-12-31 date: 2021-12-31 date: 2024-03-08 date: 2024-03-08 name: Clarunis - Universitäres Bauchzentrum Basel class: OTHER name: University of Basel briefSummary: The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data. conditions: Surgical Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 24 type: ACTUAL name: Portable Laparoscopic Trainer (PLET) measure: Exercise time measure: Assessment rating measure: Qualitative feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clarunis Universitäres Bauchzentrum Basel city: Basel zip: 4002 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False
<\|newrecord\|> nctId: NCT06301217 id: NO: PT. BU. EC. 7 briefTitle: Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-17 date: 2024-03-10 date: 2024-03-20 date: 2024-03-08 date: 2024-03-08 name: Delta University for Science and Technology class: OTHER briefSummary: Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue. conditions: Neck Pain conditions: Electromyohgraph studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: There is no intervention measure: Neck disability measure: Curvature angle of the cervical spine measure: root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Delta university for science and technology city: Gamasa state: Dakahleya zip: 7731168 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
<\|newrecord\|> nctId: NCT06301204 id: 21.06.2022-E.67046 briefTitle: Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients overallStatus: COMPLETED date: 2022-03-01 date: 2023-11-01 date: 2023-11-01 date: 2024-03-08 date: 2024-03-08 name: Bezmialem Vakif University class: OTHER briefSummary: The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data. conditions: Tranexamic Acid conditions: Orthognathic Surgery conditions: Edema conditions: Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Tranexamic acid injection name: Saline measure: intraoperative bleeding during the surgery (ml) measure: postoperative edema calculation for the first 1-3 and 7 day (cm) measure: intraoperative surgical site evaluation (Fromme Scale) measure: Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakıf Universty city: Istanbul state: Fatih zip: 34093 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06301191 id: 133/21-02-2022 briefTitle: The Effect of Semaglutide on Cardiovascular Markers and Liver Function overallStatus: RECRUITING date: 2022-03-01 date: 2023-03-01 date: 2024-05-01 date: 2024-03-08 date: 2024-03-08 name: Attikon Hospital class: OTHER briefSummary: Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study.
25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors.
At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function. conditions: Diabetes Type 2 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Semaglutide, 1.0 mg/mL name: Dipeptidyl Peptidase 4 inhibitor measure: Comparison of arterial stiffness markers difference among treatment groups measure: Comparison of endothelial glycocalyx thickness difference among treatment groups measure: Comparison of liver stiffness difference among treatment groups sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Attikon University General Hospital status: RECRUITING city: Athens zip: 12462 country: Greece name: Vaia Lambadiari, Professor role: CONTACT phone: 2105831148 email: vlambad@otenet.gr lat: 37.97945 lon: 23.71622 hasResults: False
<\|newrecord\|> nctId: NCT06301178 id: 12548 briefTitle: Effect of Vitamin D Injection on Hypertrophic Scars and Keloids overallStatus: RECRUITING date: 2024-02-27 date: 2025-02-20 date: 2026-02-20 date: 2024-03-08 date: 2024-03-21 name: Mostafa Bahaa class: OTHER briefSummary: Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.
The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes conditions: Dermatologic Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Cholecalciferol measure: Clinical scoring by Vancouver Scale Score sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: faculty of medicine-Fayoum university status: RECRUITING city: Fayoum zip: 63519 country: Egypt name: Marwa Kamal, PhD role: CONTACT phone: 01021365897 email: mka05@fayou.edu.eg lat: 29.30995 lon: 30.8418 hasResults: False
<\|newrecord\|> nctId: NCT06301165 id: 2023-FXY-129 briefTitle: TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-19 date: 2024-12-31 date: 2028-12-31 date: 2024-03-08 date: 2024-04-09 name: Sun Yat-sen University class: OTHER briefSummary: The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: TPC induction chemotherapy name: GP induction chemotherapy measure: Progression-free survival measure: Overall survival measure: Distant progression measure: Locoregional progression measure: Short-term response rate measure: Incidence of acute and late toxicity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Hai-Qiang Mai role: CONTACT phone: 860-020-8734 phoneExt: 86-20-8734-364 email: maihq@sysucc.org.cn name: Hai-Qiang Mai, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Affiliated cancer hospital and institute of guangzhou medical university status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Weijun Zhang role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Shoumin Bai role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangzhou Medical University status: NOT_YET_RECRUITING city: Guangzhou state: Please Select zip: 510060 country: China name: Jiancong Sun role: CONTACT lat: 23.11667 lon: 113.25 facility: Dongguan people's hospital status: NOT_YET_RECRUITING city: Dongguan country: China name: Zhigang Liu role: CONTACT lat: 23.01797 lon: 113.74866 facility: Foshan First People's Hospital status: NOT_YET_RECRUITING city: Foshan country: China name: Ning Zhang role: CONTACT lat: 23.02677 lon: 113.13148 facility: Peking university shenzhen hospital status: NOT_YET_RECRUITING city: Shenzhen country: China name: Yajie Liu, MD role: CONTACT lat: 22.54554 lon: 114.0683 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: NOT_YET_RECRUITING city: Wuhan country: China name: Kunyu Yang role: CONTACT lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06301152 id: E2-22-1905 briefTitle: Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy overallStatus: COMPLETED date: 2022-09-01 date: 2022-10-01 date: 2023-05-30 date: 2024-03-08 date: 2024-03-08 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).
Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment. conditions: Lateral Epicondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two different treatment modalities were applied in two groups primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: high intensive laser name: extracorporeal shock wave therapy measure: Visual analog scale measure: Quick Disability Arm, Shoulder and Hand questionary, measure: hand grip strength measure: musculoskeletal ultrasonography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emine Esra Bilir city: Ankara state: Çankaya zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06301139 id: P17-004 briefTitle: Goat Milk Infant Formula Comfort Study overallStatus: COMPLETED date: 2019-05-01 date: 2021-04-01 date: 2024-02-01 date: 2024-03-08 date: 2024-03-08 name: Ausnutria Hyproca B.V. class: INDUSTRY name: HM hospitales briefSummary: In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops. conditions: Gastrointestinal Diseases conditions: Cow's Milk Intolerance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled pilot study primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: Goat milk-based infant formula name: Cow's milk-based infant formula with probiotic drops measure: Cow's Milk-related Symptoms measure: Cow's Milk-related Symptoms measure: Parental stress measure: Parental quality of life measure: Weight measure: Length measure: Weight-for-age measure: Length-for-age measure: Weight-for-length sex: ALL minimumAge: 6 Weeks maximumAge: 3 Months stdAges: CHILD facility: HM hospitales city: Madrid zip: 28015 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06301126 id: P.T.REC/012/004985 briefTitle: Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries overallStatus: RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2025-03-01 date: 2024-03-08 date: 2024-03-12 name: Cairo University class: OTHER briefSummary: After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain. conditions: Abdomen Hernia conditions: Respiratory Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Virtual reality name: conventional physical therapy exercise program measure: Forced vital capacity (FVC) measure: Forced expiratory volume in 1 second (FEV1) measure: Peak expiratory flow (PEF) measure: Respiratory muscle strength measure: diaphragmatic mobility measure: Functional capacity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Giza zip: 12111 country: Egypt name: Nesma M Allam, PhD role: CONTACT phone: +201281968332 email: dr.nesma2011@yahoo.com lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06301113 id: IRB#: 01202023_torabiDH_CBDloz briefTitle: This Research Study Examines the Effects of Cannabidiol-infused Candy on Reducing the Bacteria Causing Tooth Decay, When Comparing it to a Sugar Free Candy on Adults. overallStatus: COMPLETED date: 2023-01-27 date: 2023-02-11 date: 2023-02-11 date: 2024-03-08 date: 2024-03-08 name: West Coast University class: OTHER briefSummary: The goal of this clinical trial is to compare the effect of CBD candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults The main question is to see whether CBD have any effect on reducing the number of Streptococcus mutans, in the oral cavity the main bacteria causing tooth decay.
Participants will be randomly placed in a group, and assigned to take either CBD-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days.
A sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth. conditions: Tooth Decay studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 30 Participants were randomly assigned to groups A (experimental group)and B (Control group). primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ACTUAL name: CBD infused candy name: Sugar free Candy measure: To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Coast University city: Anaheim state: California zip: 92802 country: United States lat: 33.83529 lon: -117.9145 hasResults: False
<\|newrecord\|> nctId: NCT06301100 id: E20230371 briefTitle: Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT overallStatus: RECRUITING date: 2023-04-28 date: 2024-04-28 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT. conditions: Image Quality and Contouring Accuracy of the Tumor in Radiotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Dual energy CT after routine simulation measure: DICE value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huan-Hu-Xi status: RECRUITING city: Tianjin state: Tianjin zip: 300381 country: China name: Zhiyong Yuan, Doctor role: CONTACT phone: +86 186 2222 1199 email: zyuan@tmu.edu.cn lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06301087 id: WP-2024-01 briefTitle: Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App overallStatus: COMPLETED date: 2022-05-01 date: 2024-02-08 date: 2024-02-08 date: 2024-03-08 date: 2024-03-15 name: Weprom class: OTHER name: Kelindi briefSummary: The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :
* the median age of possible neurodevelopmental disorders notification of infants
* the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data conditions: Development, Child conditions: Postnatal Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 55618 type: ACTUAL name: Web Application measure: Time to neurodevelopment desorder diagnostic measure: User's satisfaction measure: Relevance of the neurodevelopmental desorder notification measure: Rate of mothers'postnal depression measure: Time of mothers'postnatal depression sex: ALL maximumAge: 10 Years stdAges: CHILD facility: ILC city: Le Mans country: France lat: 48.0 lon: 0.2 hasResults: False
<\|newrecord\|> nctId: NCT06301074 id: HS-10509-101 briefTitle: The Phase I Study of HS-10509 in Chinese Adult Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-10 date: 2024-03-08 date: 2024-03-08 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia.
Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For each cohort, participants will be assigned to receive HS-10509 or placebo in parallel primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: HS-10509 name: Placebo measure: Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. measure: Changes from baseline in lab tests measure: Changes from baseline in vital signs measure: Change from baseline in body weight measure: Change from baseline in Electrocardiogram (ECG) measure: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS) measure: Change from baseline in Barnes Akathisia Rating Scale (BARS) measure: Change from baseline in Simpson-Angus Scale (SAS) measure: Cmax measure: Tmax measure: AUC0-t measure: AUC0-∞ measure: λz measure: t½ measure: CL/F measure: Vd/F measure: MRT measure: Css, max measure: Css, min measure: Css, av measure: Tss, max measure: AUCss measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China name: Xiaojiao Li, Dr. role: CONTACT phone: +86 13514314089 email: Xingxingsuo123456@126.com lat: 43.88 lon: 125.32278 hasResults: False
<\|newrecord\|> nctId: NCT06301061 id: PB001 briefTitle: Focal Microvibration and Chronic Lumbosacral Radicular Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2026-04-01 date: 2024-03-08 date: 2024-03-08 name: Federico II University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question\[s\] it aims to answer are:
* Can focal microvibration improve pain in this patient population?
* Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.
Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy. conditions: Pain, Chronic conditions: Lumbosacral Radiculopathy conditions: Radicular; Neuropathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: Equistasi® name: Sham name: Gabapentin; Pregabalin; Duloxetine; Amitriptyline measure: Pain intensity measure: Pain interference in daily life measure: Disability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06301048 id: BFHHZS20230203 briefTitle: Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma overallStatus: COMPLETED date: 2023-11-07 date: 2023-12-07 date: 2023-12-07 date: 2024-03-08 date: 2024-03-08 name: Beijing Friendship Hospital class: OTHER briefSummary: This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates. conditions: Duodenal Adenoma conditions: Complication of Treatment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 79 type: ACTUAL name: Stent Placement in Pancreatic and Bile Ducts measure: Rate of complications measure: Rate of complete resection measure: Rate of recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06301035 id: 2024-01-012 briefTitle: Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-10-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Samsung Medical Center class: OTHER name: Fisher and Paykel Healthcare briefSummary: Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.
Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.
Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.
Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure. conditions: Acute Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Asymmetric High flow nasal cannula name: Standard(symmetric) High flow nasal cannula measure: Respiratory Rate Oxygenation (ROX) Index measure: The Lowest value of SpO2 within 24 hours after extubation measure: PaO2/FiO2 measure: SpO2/FiO2 measure: changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT) measure: Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index) measure: Respiratory rate measure: work of breath (Modified Borg Scale, MBS) measure: systolic blood pressure measure: mean arterial pressure measure: heart rate measure: Rate of reintubation within 7 days measure: Length of ICU stay measure: Length of hospital stay measure: ICU Mortality measure: Hospital Mortality measure: 28 Day Mortality measure: 90 Day Mortality sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center city: Seoul country: Korea, Republic of name: Hye Rim Chung role: CONTACT phone: +82-2-3410-6399 email: hyerim37.jeong@samsung.com lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06301022 id: WXZ-Finerenone briefTitle: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus overallStatus: RECRUITING date: 2022-12-15 date: 2024-10-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: First Affiliated Hospital of Harbin Medical University class: OTHER briefSummary: Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.
Methods:
Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED measure: 24 hours urinary total protein measure: estimate Gromerular filtration rate measure: serum potassium sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Aaffiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: XINGZHI WANG, PHD.,MD role: CONTACT phone: +8613904506176 email: WANG.XINGZHI@HRBMU.EDU.CN lat: 45.75 lon: 126.65 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-15 uploadDate: 2024-02-26T03:42 filename: Prot_SAP_000.pdf size: 207441 hasResults: False
<\|newrecord\|> nctId: NCT06301009 id: AI-CAC-PVS briefTitle: The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray acronym: AI-CAC-PVS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2025-10-01 date: 2024-03-08 date: 2024-03-08 name: Azienda Ospedaliera Città della Salute e della Scienza di Torino class: OTHER name: Compagnia di San Paolo briefSummary: The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing. conditions: Cardiovascular Diseases conditions: Atherosclerosis conditions: Coronary Artery Calcification studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 500 type: ESTIMATED name: AI-CAC score measure: Diagnostic accuracy of the AI-CAC score to identify the presence of subclinical atherosclerosis on chest x-ray measure: Percentage of individuals with a therapeutic management change by the attending physician based on the CAC score, with concordant AI-CAC. measure: Comparison of ASCVD events occurring in patients without (AI-CAC=0) vs. with subclinical atherosclerosis (AI-CAC >0) based on the AI-CAC score, as assessed by Kaplan Meier estimates of ASCVD events occurring until study completion. sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300996 id: STUDY23110042 briefTitle: Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2029-05 date: 2024-03-08 date: 2024-04-03 name: Marco Capogrosso class: OTHER name: Roche-Genentech briefSummary: Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted. conditions: Spinal Muscular Atrophy conditions: Spinal Muscular Atrophy Type 3 conditions: Spinal Muscular Atrophy Type II conditions: Spinal Muscular Atrophy 4 conditions: SMA studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-arm, open-label study performed to quantify variables that are predictive of the efficacy of spinal cord stimulation to improve motor control. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads) measure: Muscle Weakness Torque measure: Number and Severity of Adverse Events measure: Muscle Weakness Muscle Activation measure: Motor Function ROM measure: Motor Function RULM measure: Motor Function Fatigue measure: Discomfort/Pain measure: Sensorimotor Network Structure Density measure: Impression measure: Sensorimotor Network Structure Integrity measure: Sensorimotor Network Function measure: Cortico-spinal Tract Integrity measure: Spinal Circuit Excitability measure: Motoneuron Firing Rates measure: Motor Firing Number sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sydney Bader, MS role: CONTACT email: syb17@pitt.edu name: Cierra Clark, MS role: CONTACT email: cic27@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06300983 id: PR(AG)398/2022 briefTitle: Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being acronym: HRQoL overallStatus: COMPLETED date: 2022-09-15 date: 2022-10-31 date: 2022-10-31 date: 2024-03-08 date: 2024-03-08 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.
Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups. conditions: Quality of Life conditions: Myositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 34 type: ACTUAL name: Psychoeducative name: Placebo measure: Health related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona city: Barcelona zip: 08035 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06300970 id: 0900f3eb81e634a9 briefTitle: Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia overallStatus: COMPLETED date: 2022-08-09 date: 2023-08-16 date: 2023-08-16 date: 2024-03-08 date: 2024-03-08 name: Centers for Disease Control and Prevention class: FED name: Ministry of Health, Liberia briefSummary: To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia. conditions: Plasmodium Falciparum conditions: Malaria conditions: Uncomplicated Malaria studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 352 type: ACTUAL name: Amodiaquine-artesunate (ASAQ) name: Artemether+Lumefantrine (AL) measure: Number of Participants with Early Treatment Failure (ETF) measure: Number of Participants with Late Treatment Failure (LTF) measure: Number of Participants with Adequate Clinical and Parasitological Response (APCR) measure: Number of Patients with Adverse Events measure: Number of samples with confirmed Histidine-rich protein 2/3 (HRP2/3) gene deletions measure: Number of samples with molecular markers of anti-malarial resistance sex: ALL minimumAge: 6 Months maximumAge: 59 Months stdAges: CHILD facility: Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County city: Sinje state: Grand Cape Mount County country: Liberia facility: Saclepea-Mahn Comprehensive Health Center Saclepea-Mahn District, Nimba County city: Saclepea state: Nimba County country: Liberia lat: 6.9625 lon: -8.84056 hasResults: False
<\|newrecord\|> nctId: NCT06300957 id: IRB00023124 id: CE003310 type: OTHER_GRANT domain: CDC id: OMB NO: 0920-1301 type: OTHER domain: OMB briefTitle: Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children overallStatus: RECRUITING date: 2023-10-24 date: 2026-05-31 date: 2026-10-31 date: 2024-03-08 date: 2024-03-08 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: Barry University name: University of Massachusetts, Lowell briefSummary: This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential. conditions: Program Evaluation conditions: Child Sexual Abuse conditions: Perpetration of Child Sexual Abuse conditions: Prevention Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In Phase one investigators will recruit 10 participants to test out the study protocols. All 10 participants will go through the same study procedures.
In Phase two, investigators will recruit 300 participants to take part in the RCT, 200 in the HW group and 100 in the WL group. After consenting to participate and completing the first online survey, participants will be randomized to either an intervention condition (N =200) or wait-list control condition (N =100) using a 2:1 allocation. The intervention group will gain access to Help Wanted for 1 month after which the participants will complete a post-intervention survey and then a three-month follow up survey. Participants in the control group will receive alternative resources for one month, then complete a one-month post-waitlist survey before being granted access to Help Wanted for a one-month period. The control group participants will then complete a one-month post-intervention survey and three-month follow-up survey. primaryPurpose: PREVENTION masking: NONE count: 310 type: ESTIMATED name: Help Wanted Prevention Intervention name: Waitlist Control measure: Sexual Behavior Involving Minors Scale (SBIMS). measure: Sexual Child Molestation Risk Assessment (SChiMRA) score measure: Depression, Anxiety and Stress Scale-21 (DASS-21) measure: Suicidal Ideation Attributes Scale (SIDAS) measure: General Self-Efficacy Scale - Short Form (GSE-6). measure: Revised University of California, Los Angeles (UCLA) Loneliness Scale measure: Self-Efficacy Scale Related to Minors (SESM) measure: Hypersexual Behavior Inventory-19 score measure: Sexual Attraction to Children measure: Cognitions of internet sexual offending score measure: Cognitions that condone and support sexual offending against children scale - short form measure: Emotional Congruence with Children score measure: Brief Aggression Questionnaire score measure: Short Self-Regulation Questionnaire score measure: Alcohol Use Disorders Identification Test (AUDIT) score measure: Recent Alcohol & Cannabis Use score measure: Demographic characteristics as assessed by survey developed by study team measure: Number of Sexual Health Services Used measure: Sexual Offence Self-Report Risk Scale (SOSRS): measure: Minor Attraction Outness Scale measure: Revised Adverse Childhood Experiences Scale measure: Balanced Inventory of Desirable Responding - Impression Management Subscale (BIDR-Version 6-Form 40 - IMS). measure: Impact of Research Participation as assessed by survey sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Bloomberg School of Public Health status: RECRUITING city: Baltimore state: Maryland zip: 21231 country: United States name: Elizabeth J Letourneau, PhD role: CONTACT phone: 843-343-6865 email: elizabethletourneau@jhu.edu name: Amanda E Ruzicka, MA role: CONTACT phone: 7172699886 email: aruzicka@jhu.edu lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06300944 id: Ran Gao-2023-12 briefTitle: The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery overallStatus: RECRUITING date: 2023-12-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-08 date: 2024-03-08 name: General Hospital of Ningxia Medical University class: OTHER briefSummary: The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: saline name: Esketamine measure: Moderate to severe pain measure: Incidence of adverse reactions including nausea, vomiting and dizziness measure: Sleep quality measure: Remifentanil dosage measure: Additional post-operative analgesics measure: Postoperative exhaust time of patients sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital of Ningxia Medical University status: RECRUITING city: Yinchuan state: Ningxia country: China name: Ma Hanxiang role: CONTACT phone: 86-13519591508 email: mahanxiang@hotmail.com lat: 38.46806 lon: 106.27306 hasResults: False
<\|newrecord\|> nctId: NCT06300931 id: KAPSDFE0948 briefTitle: KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-08 date: 2024-03-08 name: Cairo University class: OTHER briefSummary: This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention. conditions: SDF studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: OTHER count: 449 type: ESTIMATED name: educational lecture measure: Assessment of knowledge levels and attitude regarding SDF use before educational intervention measure: Assessment of knowledge levels and attitude regarding SDF use after educational intervention Correlation between demographic data and use of SDF. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

Subsets and Splits

No community queries yet

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