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The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will:
* measure the amount of BAY3630942 radiation found in different organs over time.
* measure the amount of BAY3630942 radiation absorbed by different organs.
* use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment.
Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions.
The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day.
Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes:
* a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.
* up to 5 visits during the imaging intervention period. During this period, participants:
* will receive the study interventions and have blood tests on the first visit,
* will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit.
* may have blood tests on the last visit.
* a follow-up visit to check their health after 30 days of receiving the study interventions.
During the study, the doctors and their study team will:
* check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)
* track and study BAY3630942 using PET/CT imaging tests
As the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required. conditions: Hepatocellular Carcinoma (HCC) studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 17 type: ESTIMATED name: BAY3630942 name: BAY3547922 measure: Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans measure: Zirconium-89 absorbed doses (mGy/MBq) in normal organs measure: Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated measure: Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922 measure: Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood) measure: AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood) measure: Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time) measure: AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HonorHealth city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: University of Southern California Keck School of Medicine city: Los Angeles state: California zip: 90089 country: United States lat: 34.05223 lon: -118.24368 facility: Biogenix Molecular, LLC city: Miami state: Florida zip: 33165 country: United States lat: 25.77427 lon: -80.19366 hasResults: False
<|newrecord|> nctId: NCT06344988 id: 2023/41-10 briefTitle: Physical and Functional Effects of Online Exercise Program on Musicians Playing Stringed Instruments overallStatus: RECRUITING date: 2024-01-22 date: 2024-06 date: 2025-01 date: 2024-04-03 date: 2024-04-03 name: Bandırma Onyedi Eylül University class: OTHER briefSummary: Musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. Different interventions such as strength training, endurance training and yoga have been used in the management of these problems. The first specific exercise program for professional orchestra musicians was developed by Chan et al. However, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as DVDs, USBs, and educational exercise videos may have a potential role.
On the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. Based on the literature, in our study, the exercise program developed by Chan et al., will be done online via "Google Meet" and symptoms can be evaluated with objective evaluation methods. Unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. In addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated. conditions: Musculoskeletal Diseases or Conditions conditions: Musculoskeletal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: The exercise program name: Online education presentation name: Smart band measure: Musculoskeletal problems measure: Muscle oxygenation measure: Pressure pain threshold measure: Reaction time measure: Grip strength measure: Upper extremity function measure: Physical activity level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Regional State Symphony Orchestra status: RECRUITING city: Bursa zip: 16000 country: Turkey name: Umut Çanakçı, Musician role: CONTACT phone: +90 (224) 225 59 70 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 facility: Bursa Uludağ University Faculty of Education Fine Arts Education Department, Department of Music Education status: RECRUITING city: Bursa zip: 16285 country: Turkey name: Gülnihal Gül, Assoc. Prof. role: CONTACT phone: +90 (224) 294 09 42 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 facility: Bursa Uludağ University State Conservatory status: RECRUITING city: Bursa zip: 16285 country: Turkey name: Görkem Çalgan, Prof. Dr. role: CONTACT phone: +90 (224) 294 27 00 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 facility: Ege University State Conservatory of Turkish Music status: RECRUITING city: İzmir zip: 35100 country: Turkey name: Nurdan Gürtunca, Assoc. Prof. role: CONTACT phone: +90 (232) 311 29 44 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06344975 id: Starna Therapeutics briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults acronym: STR-V003 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Starna Therapeutics class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: STR-V003/Placebo measure: Immediate unsolicited AEs for 30 minutes post-vaccination measure: Solicited injection site (local) and systemic reactions for 7 days postvaccination. measure: Unsolicited AEs for 28 days postvaccination measure: Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344962 id: QYFYKYLL930611921 briefTitle: Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection overallStatus: RECRUITING date: 2023-02-28 date: 2024-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem. conditions: Suture, Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Absorbable Suture name: Non-absorbable Suture measure: Incidence rate of anastomotic complications measure: Time of bronchial anastomosis measure: Number of stitches measure: 5-year survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Affiliated Hospital of Qingdao University status: RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Zhe Wu, PhD role: CONTACT phone: +86 17863934867 email: [email protected] lat: 36.06488 lon: 120.38042 hasResults: False
<|newrecord|> nctId: NCT06344949 id: B2024-074 briefTitle: Ciprofol Versus Propofol for Tracheal Intubation in ICU overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-12-31 date: 2024-04-03 date: 2024-04-03 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients. conditions: Emergency Tracheal Intubation in Critically Ill Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Ciprofol name: Propofol measure: cardiovascular collapse within 30minutes from the start of the intubation procedure measure: Success rate of sedation measure: Successful intubation on the first attempt measure: Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes) measure: The incidence of cardiac arrest within 30 minutes after tracheal intubation measure: The incidence of bradycardia within 30 minutes after tracheal intubation measure: The incidence of hypoxemia within 30 minutes after tracheal intubation measure: new requirement or increase of vasopressors measure: new requirement or increase of antiarrhythmic drugs sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344936 id: HRS-1780-103 briefTitle: Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-03 date: 2024-04-03 name: Shandong Suncadia Medicine Co., Ltd. class: INDUSTRY briefSummary: The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects conditions: Chronic Kidney Disease(CKD) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules measure: Assess the Cmax of HRS-1780 in plasma. measure: Assess the Tmax of HRS-1780 in plasma. measure: Assess the t1/2 of HRS-1780 in plasma. measure: Assess the AUC0-t of HRS-1780 in plasma. measure: Assess the AUC0-inf of HRS-1780 in plasma. measure: Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing Hospital city: Beijing state: Beijing zip: 100730 country: China name: Xin Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06344923 id: KYLL briefTitle: Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-09-01 date: 2024-04-03 date: 2024-04-03 name: Qilu Hospital of Shandong University class: OTHER briefSummary: In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated. conditions: Ileostomy - Stoma conditions: Rectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing name: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing measure: postoperative complications related to ileostomy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344910 id: 20230416-C1_v2 briefTitle: PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC acronym: PROMPT-HF-AUMC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: AstraZeneca name: Yale University briefSummary: This is a prospective cohort study, where we aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies measure: Use of guideline-directed medical therapy (GDMT) measure: All-cause mortality measure: Hospitalisation for Heart Failure measure: other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) measure: renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344897 id: mac1 briefTitle: The Effect of Kinesio Taping in Pediatric Surgery overallStatus: COMPLETED date: 2024-02-25 date: 2024-03-21 date: 2024-04-01 date: 2024-04-03 date: 2024-04-03 name: KTO Karatay University class: OTHER name: Nigde Omer Halisdemir University name: University of Health Sciences Konya Health Application and Research Center briefSummary: This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery. conditions: Appendicitis conditions: Surgery conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The effect of kinesio taping on pain in children aged 6-12 years who had open appendicitis surgery. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The research is in a parallel group, single-blind randomized controlled experimental design.
Simple randomization will be applied to children who have had open appendicitis surgery and meet the inclusion criteria, without any stratification in the study.
In order to determine which group the 68 children who meet the sample selection criteria in the study group will be included in, numbers from 1 to 68 will be randomly distributed to 2 groups through a computer program (https://www.randomizer.org/) without number repetition. 34 patients will be assigned to the experimental group and 34 patients to the control group. Since the person who will actively apply the taping in the study is the researcher, only the children will be blinded, therefore a single blind design will be applied. whoMasked: PARTICIPANT count: 68 type: ACTUAL name: Kinesio taping measure: Kinesio tape applying affects pain in children aged 6-12 years who have appendicitis surgery. measure: Kinesio tape applying affects fear in children aged 6-12 years who have appendicitis surgery. measure: Kinesio taping affects gas output time in children aged 6-12 years who have appendicitis surgery sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: University of Health Sciences Konya Health Application and Research Center city: Konya state: Karatay zip: 42020 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<|newrecord|> nctId: NCT06344884 id: 23-2619 briefTitle: Early Patient Removal of Urinary Catheters After Urogynecologic Surgery acronym: CARES2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-04-03 date: 2024-04-03 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4. conditions: Urinary Retention Postoperative conditions: Postoperative Urinary Tract Infection conditions: Catheter Site Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 128 type: ESTIMATED name: Early catheter removal measure: Number of patients with ongoing urinary retention (noninferiority) measure: Number of patient contacts for voiding dysfunction by Type measure: Total patient contacts for voiding dysfunction Combined measure: Number of patients treated for postoperative UTI. measure: Number of patients with ongoing urinary retention measure: Patient Satisfaction Survey Score-Pain measure: Patient Satisfaction Survey Score-Ease of Use measure: Patient Satisfaction Survey Score-Satisfaction measure: Patient Satisfaction Survey Score-Likelihood to Use Again sex: FEMALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Health Rex city: Raleigh state: North Carolina zip: 27607 country: United States name: Lauren Tholemeier, MD role: CONTACT phone: 984-974-0496 email: [email protected] lat: 35.7721 lon: -78.63861 hasResults: False
<|newrecord|> nctId: NCT06344871 id: 002 briefTitle: Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF overallStatus: RECRUITING date: 2024-03-13 date: 2024-11-30 date: 2024-11-30 date: 2024-04-03 date: 2024-04-05 name: Positrigo AG class: INDUSTRY name: University of Zurich name: University of Leipzig briefSummary: The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.
The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype. conditions: Brain Diseases studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: NeuroLF name: Conventional PET scan measure: PET Image of the Brain measure: Ease of Placement (Usability) measure: Usage of accessories for patient placement (Usability) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Leipzig status: RECRUITING city: Leipzig country: Germany name: Henryk Barthel, Prof.Dr. role: CONTACT phone: +49 341 97 18082 email: [email protected] name: Henryk Barthel, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 51.33962 lon: 12.37129 facility: University Hospital Zurich status: NOT_YET_RECRUITING city: Zürich country: Switzerland name: Martin Hüllner, Prof. Dr. role: CONTACT phone: +41 44 255 25 80 email: [email protected] name: Martin Hüllner, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
<|newrecord|> nctId: NCT06344858 id: 124/2021 briefTitle: Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI acronym: Keta-ANI overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-08-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: Pontificia Universidad Catolica de Chile class: OTHER briefSummary: Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose. conditions: Analgesia conditions: Ketamine conditions: Pharmacokinetic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Ketamine measure: To measure ANI values after ketamine bolus dose administration. measure: To determine the time maximum predicted concentrations in each patient measure: To determine the time to maximum effect of a bolus dose of ketamine measure: To predict ketamine plasma concentrations values after ketamine bolus measure: To calculate the difference between the time of maximum ANI effect measure: Patient weight sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pontificia Universidad Catolica de Chile city: Santiago state: Metropolitana zip: 450881 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False
<|newrecord|> nctId: NCT06344845 id: PUMCH-NM-PBB3 briefTitle: Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases overallStatus: RECRUITING date: 2022-11-01 date: 2024-11 date: 2025-11 date: 2024-04-03 date: 2024-04-03 name: Peking Union Medical College Hospital class: OTHER briefSummary: In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through \[18F\]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of \[11C\]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications. conditions: Neurodegenerative Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 80 type: ESTIMATED name: 18F-PBB3 PET/CT scan measure: Diagnostic Performance measure: Clinical Stage sex: ALL minimumAge: 49 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Chenhao Jia, M.D. role: CONTACT phone: 18548703382 email: [email protected] name: Ruixue Cui, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06344832 id: K5098 briefTitle: SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-03-01 date: 2030-03-01 date: 2024-04-03 date: 2024-04-03 name: Peking Union Medical College Hospital class: OTHER briefSummary: The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated. conditions: Gastro-entero-pancreatic Neuroendocrine Tumor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: lymph node metastasis status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344819 id: 24-062 briefTitle: An Acupuncture Study for People At High Risk for Sepsis overallStatus: RECRUITING date: 2024-03-20 date: 2028-03-20 date: 2028-03-20 date: 2024-04-03 date: 2024-04-03 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 78 type: ESTIMATED name: Acupuncture name: Sham Acupuncture measure: Number of participants recruited compared to the number of participants who complete study treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Gary Deng, MD, PhD role: CONTACT phone: 646-608-8556 lat: 40.71427 lon: -74.00597 hasResults: False
<|newrecord|> nctId: NCT06344806 id: oyunlastirmabeslenme briefTitle: The Effect of Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women acronym: gamification overallStatus: COMPLETED date: 2023-02-01 date: 2023-03-30 date: 2023-05-30 date: 2024-04-03 date: 2024-04-03 name: Lokman Hekim Üniversitesi class: OTHER_GOV briefSummary: Objective: This study was conducted to determine the effect of breastfeeding education given through gamification on breastfeeding self-efficacy and infant feeding attitudes of pregnant women.
Method: This study is a randomized controlled pretest-posttest parallel group experimental study, and 28 women included in the experimental group and 28 women in the control group. In the study, "Sociodemographic Information Form", "Breastfeeding Self-Efficacy Scale Short Form-Antenatal Form (BSES-SF), ", "Infant Nutrition Attitude Scale (IOWA)" Form was used. The data analyzed in SPSS program.
Breastfeeding education content integrated into the game program designed with the gamification technique. A training program was applied to the women in the experimental group in the last trimester. Women in the control group received the standard breastfeeding training in the hospital. Measurement tools was applied to all participants before and after the training.
Conclusion and Suggestions: In this planned study, it was aimed to teach women about breastfeeding in a digital environment in a fun way. In this study, it is found that breastfeeding education given through gamification have a positive effect on breastfeeding self-efficacy and infant feeding attitudes of pregnant women. conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Gamified Breastfeeding Education measure: breastfeeding self-efficacy measure: infant feeding attitudes sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Lokman Hekim University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06344793 id: YOUNGBC-30 briefTitle: Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer overallStatus: RECRUITING date: 2023-05-20 date: 2024-10-01 date: 2024-11-01 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: PFS measure: OS sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344780 id: YOUNGBC-28 briefTitle: Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer overallStatus: RECRUITING date: 2023-05-20 date: 2024-10-01 date: 2024-11-01 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED measure: PFS measure: OS sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344767 id: YOUNGBC-27 briefTitle: Positive ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-negative Primary Tumor overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-05-05 date: 2024-05-05 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT). conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 19 type: ACTUAL measure: Progression free survival (PFS) measure: Adverse events sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China,Shanghai city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344754 id: gamifiedfamilyplanning briefTitle: Gamification in Family Planning Education: Impact on University Students overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-02-15 date: 2024-04-15 date: 2024-04-03 date: 2024-04-03 name: Lokman Hekim Üniversitesi class: OTHER_GOV briefSummary: More than 3 billion of the worlds population are young people under the age of 25. According to WHO data, one million girls under the age of 15 give birth each year, mostly in low- and middle-income countries, and 3 million adolescent girls between the ages of 15 and 19 are exposed to unsafe abortions. Failure to meet the family planning needs of young people in a timely, adequate and appropriate manner can have significant public health impacts. According to World Health Statistics, the global birth rate for girls between 15 and 19 years of age is 49 out of 1000, and early pregnancy and childbirth can lead to serious health and social problems. In addition, this age group does not have sufficient information about pregnancy and its complications, and their access to and utilization of health services is low. Inadequacies in the education of adolescents on sexual issues and sociocultural differences further increase the sexual and reproductive health risks of young people in the university period. Information and services that will enable individuals to understand their sexuality and help them protect themselves from sexual risks should be provided specifically for that age. Therefore, it is important for young people to know family planning methods. In this study, it was aimed to examine the effect of family planning education to be given with gamification method, which is different from the classical method in the literature, on the knowledge and attitudes of university students. conditions: Gamification conditions: Reproductive Health conditions: Family Planning conditions: Students studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pre-test and post-test interventional study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: the person doing the statistical analysis will be blinded count: 40 type: ESTIMATED name: Gamified education measure: Knowledge and attitude towards family planning sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lokman Hekim University city: Ankara zip: 06300 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06344741 id: sdilek6 briefTitle: Consequences of Admission to the Delivery Room in the Early and Late Phases overallStatus: RECRUITING date: 2023-11-13 date: 2024-04-30 date: 2024-05-31 date: 2024-04-03 date: 2024-04-03 name: Kocaeli University class: OTHER briefSummary: This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G\*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses. conditions: Fear of Childbirth conditions: Neonatal conditions: Pain conditions: Maternal Distress (During Labor) conditions: Satisfaction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Accepted in latent phase name: Accepted in active phase measure: Neonatal pain and stress measure: Birth satisfaction measure: Maternal Anxiety measure: Fear of Birth sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Sena Dilek Aksoy, Ph.D. role: CONTACT phone: +902623034739 email: [email protected] name: Cemile Gokce role: SUB_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False
<|newrecord|> nctId: NCT06344728 id: INS1007-110 briefTitle: A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants acronym: INS1007 overallStatus: RECRUITING date: 2024-04-30 date: 2024-05-21 date: 2024-05-21 date: 2024-04-03 date: 2024-04-09 name: Insmed Incorporated class: INDUSTRY briefSummary: The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Brensocatib Oral Solution name: Brensocatib Oral Tablet measure: Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma measure: Number of Participants who Experienced at Least one Adverse Event (AE) measure: Concentration of Brensocatib in Plasma sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USA001 status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 hasResults: False
<|newrecord|> nctId: NCT06344715 id: SL-T10-001_P1 briefTitle: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. overallStatus: RECRUITING date: 2022-10-17 date: 2024-10-31 date: 2024-10-31 date: 2024-04-03 date: 2024-04-03 name: SL VAXiGEN class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC). conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC) studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 78 type: ESTIMATED name: SL-T10 name: GX-I7 name: Pembrolizumab measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 measure: PSA response rate measure: PSA progression free survival measure: Radiographic progression free survival measure: Change of induced T-cell responses for SL-T10 vaccine sex: MALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06344702 id: 2024PHB065-001 briefTitle: The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-05-01 date: 2024-04-03 date: 2024-04-23 name: Peking University People's Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about the impact of CPAP on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. The main questions aim to answer are:
\[question 1\]Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS; \[question 2\]Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.
The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care. conditions: Maternal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: CPAP measure: Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women. sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06344689 id: SH9H-2023-T477 briefTitle: Surgical Correction of Cicatricial Ectropion overallStatus: COMPLETED date: 2023-12-12 date: 2024-02-28 date: 2024-03-27 date: 2024-04-03 date: 2024-04-03 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.
Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery. conditions: Patients With Cicatricial Ectropion conditions: Over 18-year-old conditions: With Complete Clinical Record studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 26 type: ACTUAL name: Surgical treatment measure: Ectropion Grading Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ninth people's hospital city: Shanghai zip: 200011 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344676 id: FSIE2024Robot id: 6773 type: OTHER domain: CERec UAB briefTitle: Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes acronym: WITHPEPPER overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-30 date: 2024-09-30 date: 2024-04-03 date: 2024-04-03 name: Sara Domenech class: OTHER briefSummary: The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:
* Can social robots reduce unwanted loneliness?
* Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.
To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.
The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.
The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention. conditions: Elderly People conditions: Nursing Home Residents conditions: Loneliness conditions: Quality of Life conditions: Wellbeing conditions: Social Interaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 162 type: ESTIMATED name: Cognitive name: Mobility name: Social name: Relational name: Usual Care measure: Loneliness measure: Well-being measure: Quality of life, irrespective of the disease measure: Satisfaction with life measure: Depressive symptoms measure: Social Support measure: Communication sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344663 id: KSIU-SBF-ES-02 briefTitle: Motivational Interviewing Inadequate Milk and Cortisol overallStatus: RECRUITING date: 2024-03-25 date: 2024-03-25 date: 2024-12-25 date: 2024-04-03 date: 2024-04-03 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level. conditions: Motivation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: motivational interview measure: Insufficient Milk Perception Scale (ANN) measure: Breastfeeding Motivation Scale (EMS) measure: Visual Analog Scale (VAS) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Eda Sever status: RECRUITING city: Kahramanmaraş state: Onikişubat zip: 46370 country: Turkey name: eda sever role: CONTACT phone: +90 531 232 10 96 email: [email protected] lat: 37.5847 lon: 36.92641 hasResults: False
<|newrecord|> nctId: NCT06344650 id: RF-2021-12373584 briefTitle: Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study overallStatus: RECRUITING date: 2023-09-28 date: 2024-07 date: 2024-07 date: 2024-04-03 date: 2024-04-03 name: IRCCS San Raffaele class: OTHER name: Fondazione Policlinico Universitario Campus Bio-Medico name: Istituto Auxologico Italiano briefSummary: Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients conditions: Acromegaly conditions: Bone Fracture studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Blood sample measure: Identify the rate of morphometric vertebral fractures in acromegalic patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Giustina status: RECRUITING city: Milan zip: 20132 country: Italy name: Gabriela Felipe role: CONTACT phone: 0226435062 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06344637 id: 2566/081 I briefTitle: Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-14 date: 2024-05-30 date: 2024-07-30 date: 2024-04-03 date: 2024-04-03 name: UdonThani Hospital class: OTHER_GOV briefSummary: This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration conditions: Pain, Procedural conditions: Lidocaine conditions: Obstetric Surgical Procedures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 216 type: ACTUAL name: 10 % lidocaine spray without adrenaline name: Placebo measure: pain score during manual vauum aspiration measure: pain score after manual vauum aspiration sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: UdonThani Hospital city: Udon Thani state: UdonThani zip: 41000 country: Thailand lat: 17.41567 lon: 102.78589 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-30 uploadDate: 2024-03-20T05:36 filename: Prot_SAP_000.pdf size: 178265 hasResults: False
<|newrecord|> nctId: NCT06344624 id: Mersin_U briefTitle: The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-06-02 date: 2025-02-01 date: 2024-04-03 date: 2024-04-03 name: Mersin University class: OTHER briefSummary: The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled trial with a pretest-posttest design primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, the sampled students will be split into two groups: the CBT group and the laughter group. Six will be the block size. Excel will be used to create blocks (allocation concealment) and random numbers will be generated by an assistant researcher who does not attend therapy sessions. The purpose of the program is to support mental health and evaluate its effectiveness; students will not be informed about which group they are in (participant blinding).
Research data will be coded as A and B and entered into the computer database by someone other than the researchers conducting the therapy sessions, and statistical analysis will be performed using this coding (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: CBT group name: Laughter group measure: The change in mental symptoms will be assessed using the Brief Symptom Inventory. measure: Psychological resilience will be assessed using the Psychological Resilience Scale. measure: Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Turkey, Mersin University city: Mersin zip: 33180 country: Turkey name: EMİNE ÖNCÜ, Assoc.Prof. role: CONTACT email: [email protected] name: Zeliha Yaman, Doctorate role: SUB_INVESTIGATOR name: Filiz Değirmenci, Doctorate role: SUB_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False
<|newrecord|> nctId: NCT06344611 id: ILBS-DCLD-01 briefTitle: Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria overallStatus: NOT_YET_RECRUITING date: 2024-04-07 date: 2026-03-31 date: 2026-03-31 date: 2024-04-03 date: 2024-04-03 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis. conditions: Decompensated Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Other measure: To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria measure: To evaluate the predictive factors of recompensation in pediatric DCLD subjects measure: To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis. measure: To assess incidence of re-decompensation in patients with recompensation. sex: ALL minimumAge: 3 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institute of Liver and Biliary Sciences city: New Delhi state: Delhi zip: 110070 country: India name: Dr Anmol Anmol, MD role: CONTACT phone: 01146300000 email: [email protected] lat: 28.63576 lon: 77.22445 hasResults: False
<|newrecord|> nctId: NCT06344598 id: 0123РК00314 id: AP19680262 type: OTHER domain: Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan briefTitle: Identification and Assessment of Risk Factors for the Development of Osteoporosis in Adults and Children Living in the Abay Region of the Republic of Kazakhstan Using the Method of Dual-energy X-ray Absorptiometry and Clinical and Epidemiological Research overallStatus: RECRUITING date: 2023-09-01 date: 2025-11-15 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Semey State Medical University class: OTHER name: Ministry of Science and Higher Education of the Republic of Kazakhstan briefSummary: A survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. Diagnosis of osteoporosis by dual-energy X-ray absorptiometry. Conducting a correlation analysis of the relationship of the data obtained. conditions: Improving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of Kazakhstan studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: Risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults measure: to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination measure: to assess the state of BMD in adults using X-ray absorptiometry (DXA) measure: To carry out a correlation analysis of the relationship between the obtained data in adults of the Abay region of of the Republic of Kazakhstan sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semey Medical University status: RECRUITING city: Semey zip: 071400 country: Kazakhstan name: Madina MD Madiyeva, PhD role: CONTACT phone: +77085244745 email: [email protected] name: Gulzhan MD Bersimbekova role: CONTACT phone: +77023728412 email: [email protected] lat: 50.42675 lon: 80.26669 hasResults: False
<|newrecord|> nctId: NCT06344585 id: DROPOUT briefTitle: Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years acronym: dropout overallStatus: COMPLETED date: 2012-01-01 date: 2021-12-31 date: 2023-07-31 date: 2024-04-03 date: 2024-04-24 name: Istituto Clinico Humanitas class: OTHER briefSummary: Conducted at a single-center, this prospective-retrospective study focused on all couples who initiated their journey at the Fertility Center of Humanitas Research Hospital, Rozzano (Milan), Italy.
The prospective study focused on the couples whose first consultation occurred in 2021. A tailored questionnaire was administered via telephone by staff members to gather insights into the personal reasons for treatment discontinuation among non-returning patients.
Conversely, the retrospective study included all infertile couples initiating treatment between January 2012 and December 2021 at the Fertility Center. Data encompassing personal history and demographic details were extracted from the internal database of Humanitas Fertility Center to assess the factors involved in a treatment discontinuation. conditions: Infertility studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 24773 type: ACTUAL name: Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation measure: Dropout rate measure: Reasons for dropout collected by a phone call questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 46 Years stdAges: ADULT facility: Istituto Clinico Humanitas city: Rozzano state: Milano zip: 20089 country: Italy lat: 45.38193 lon: 9.1559 hasResults: False
<|newrecord|> nctId: NCT06344572 id: SAT001-KP-002 briefTitle: Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia overallStatus: RECRUITING date: 2023-09-27 date: 2025-08-31 date: 2025-09-30 date: 2024-04-03 date: 2024-04-16 name: S-Alpha Therapeutics, Inc. class: INDUSTRY briefSummary: The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients. conditions: Myopia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: SAT-001 name: Single vision spectacles measure: Change in Cycloplegic Spherical Equivalent Refractive Error measure: Change in Cycloplegic Spherical Equivalent Refractive Error measure: Change in Axial Length measure: Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia) measure: Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia) sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Gachon University Gil Hospital status: RECRUITING city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 hasResults: False
<|newrecord|> nctId: NCT06344559 id: 2023001006 briefTitle: Brain Criticality, Oculomotor Control, and Cognitive Effort overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-06-01 date: 2024-04-03 date: 2024-04-03 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will involve three sessions of within-subject, crossover, double-blind transcranial magnetic stimulation with either 1) active intermittent theta burst stimulation, 2) active continuous theta burst stimulation or 3) sham intermittent or continuous theta burst stimulation. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Participants numbers will be assigned three blinded codes which are linked with either sham, active continuous, or active intermittent theta burst stimulation in the stimulator protocol. The investigator will enter the code to initiate the corresponding stimulator protocol, but will not know which protocol is active.
Half of participants will be assigned a sham code corresponding to sham continuous theta burst stimulation and half will be assigned a sham code corresponding to sham intermittent theta burst stimulation. So, for any given session, either continuous or intermittent theta burst stimulation will be used, but it will be unclear whether the stimulation is active or sham. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: transcranial magnetic stimulation measure: Critical dynamics - immediate effects of cTBS versus sham stimulation measure: Functional E/I balance - immediate effects of cTBS versus sham stimulation measure: Avalanche branching ratio - immediate effects of cTBS versus sham stimulation measure: Critical dynamics - immediate effects of iTBS versus sham stimulation measure: Functional E/I balance - immediate effects of iTBS versus sham stimulation measure: Avalanche branching ratio - immediate effects of iTBS versus sham stimulation measure: Memory-guided saccade accuracy - effects of cTBS versus sham stimulation measure: Memory-guided saccade accuracy - effects of iTBS versus sham stimulation measure: Anti-saccade accuracy - effects of cTBS versus sham stimulation measure: Anti-saccade accuracy - effects of iTBS versus sham stimulation measure: Subjective effort discounting - cTBS versus sham stimulation measure: Subjective effort discounting - iTBS versus sham stimulation measure: Subjective effort rating - cTBS versus sham stimulation measure: Subjective effort rating - iTBS versus sham stimulation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-17 uploadDate: 2024-03-27T17:23 filename: Prot_000.pdf size: 1099938 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-30 uploadDate: 2024-03-27T17:01 filename: ICF_001.pdf size: 711815 hasResults: False
<|newrecord|> nctId: NCT06344546 id: K 2023-10247 briefTitle: Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-04-03 date: 2024-04-03 name: Karolinska University Hospital class: OTHER briefSummary: The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS. conditions: Critical Illness conditions: Refeeding Syndrome conditions: Hypophosphatemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Metabolomics measure: Metabolomics measure: Metabolomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Královské Vinohrady city: Prague country: Czechia lat: 50.08804 lon: 14.42076 facility: University Hospital Policlinico of Foggia city: Foggia country: Italy lat: 41.45845 lon: 15.55188 facility: Karolinska University Hospital city: Huddinge state: Stockholm zip: 14186 country: Sweden name: Martin Sundström Rehal, MD PhD role: CONTACT phone: +46-8-12381507 email: [email protected] name: Olav Rooyackers, PhD role: CONTACT email: [email protected] lat: 59.23705 lon: 17.98192 facility: Karolinska Universitetssjukhuset Solna city: Stockholm country: Sweden name: Jonas Blixt, MD PhD role: CONTACT email: [email protected] lat: 59.33258 lon: 18.0649 facility: Södersjukhuset city: Stockholm country: Sweden name: Rebecka Rubenson Wahlin, MD PhD role: CONTACT email: [email protected] lat: 59.33258 lon: 18.0649 hasResults: False
<|newrecord|> nctId: NCT06344533 id: JMKX003142iv-101 briefTitle: Study of JMKX003142 Injection in Chinese Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-01-31 date: 2025-05-30 date: 2024-04-03 date: 2024-04-03 name: Jemincare class: INDUSTRY name: Zhejiang Hangyu Pharmaceutical Co., Ltd briefSummary: To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects conditions: Healthy Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: JMKX003142 Injection name: Placebo measure: Number of the Adverse Events that are related to the single dose treatment measure: Number of the Adverse Events that are related to the multiple dose treatment sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China name: Haiyan Li role: CONTACT name: Haiyan Li, MD role: PRINCIPAL_INVESTIGATOR name: Dongyang Liu, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06344520 id: IsiU briefTitle: Pectoralis Minor Shorthening and Swimming Performance overallStatus: COMPLETED date: 2022-12-29 date: 2023-08-30 date: 2023-10-30 date: 2024-04-03 date: 2024-04-03 name: Istinye University class: OTHER briefSummary: Swimming is one of the sports branches that includes many factors such as aerobic and anaerobic endurance, strength, flexibility, speed, quickness, rhythm, coordination as well as sportive performance and technical skills.